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Effect of probiotics or prebiotics on thyroid function: A meta-analysis of eight randomized controlled trials

by Qinxi Shu, Chao Kang, Jiaxin Li, Zhenzhu Hou, Minfen Xiong, Xingang Wang, Hongyan Peng

Background

Microbiome-directed therapies are increasingly utilized to optimize thyroid function in both healthy individuals and those with thyroid disorders. However, recent doubts have been raised regarding the efficacy of probiotics, prebiotics, and synbiotics in improving thyroid function. This systematic review aimed to investigate the potential relationship between probiotics/prebiotics and thyroid function by analyzing the impact on thyroid hormone levels.

Methods

We conducted a comprehensive systematic review and meta-analysis of randomized controlled trials that investigated the effects of probiotics, prebiotics, and synbiotics on free triiodothyronine (fT3), free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroid stimulating hormone receptor antibody (TRAb) levels. We searched for articles from PubMed, Scopus, Web of Science, and Embase up until April 1st, 2023, without any language restriction. Quantitative data analysis was performed using a random-effects model, with standardized mean difference (SMD) and 95% confidence interval as summary statistics. The methods and results were reported according to the PRISMA2020 statement.

Results

A total of eight articles were included in this review. The meta-analysis showed no significant alterations in TSH (SMD: -0.01, 95% CI: −0.21, 0.20, P = 0.93; I2: 0.00%), fT4 (SMD: 0.04, 95% CI: −0.29, 0.21, P = 0.73; I2: 0.00%) or fT3 (SMD: 0.45, 95% CI: −0.14, 1.03, P = 0.43; I2: 78.00%), while a significant reduction in TRAb levels was observed (SMD: -0.85, 95% CI: -1.54, -0.15, P = 0.02; I2: 18.00%) following probiotics/prebiotics supplementation. No indication of publication bias was found.

Conclusions

Probiotics/prebiotics supplementation does not influence thyroid hormone levels, but may modestly reduce TRAb levels in patients with Graves’ disease.

Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPDEXCEPT): protocol for a multicentre superiority randomised controlled trial

Por: You · J. · Zhang · J. · Cai · H. · Wang · X. · Wang · H. · Li · Y. · Yu · C. · Wang · L. · Zhou · X. · Peng · B. · Cai · Y.
Introduction

Postoperative pancreatic fistula (POPF) remains one of the most severe complications of laparoscopic pancreaticoduodenectomy (LPD). Theoretically, transecting the pancreatic neck more distally has both advantages (more blood supply, and more central pancreatic duct) and disadvantages (maybe smaller the pancreatic duct) in preventing POPF. This theoretical contradiction pushed us to organise this trial to explore the impact of the level of pancreatic transection in clinical practice. We conduct this randomised trial with the hypothesis that extended pancreatic neck transection has superiority to conventional pancreatic neck transection.

Methods and analysis

The LPDEXCEPT (Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy) trial is a multicentre, randomised-controlled, open-label, superiority trial in 4 centres whose annual surgical volume for LPD is more than 25 cases with pancreatic surgeons who had completed their learning curve. A total of 154 patients who meet the inclusive and exclusive criteria are randomly allocated to the extended pancreatic neck transection group or conventional pancreatic neck transection group in a 1:1 ratio. The stratified randomised block design will be applied, with stratified factors are surgical centre and the diameter of the main pancreatic duct measured by preoperative CT scan (preMPD). The primary outcome is the incidence of the clinically relevant pancreatic fistula.

Ethics and dissemination

Ethics Committee on Biomedical Research of West China Hospital of Sichuan University has approved this trial in March 2023 (approval no. 2023-167). Results of this trial will be published in peer-reviewed journals and conference proceedings.

Trial registration number

NCT05808894.

PIK3CA regulates development of diabetes retinopathy through the PI3K/Akt/mTOR pathway

by Ruijuan Guan, Zefeng Kang, Ling Li, Xin Yan, Tianpeng Gao

Objective

To explore their association with the development of diabetes retinopathy (DR), single nucleotide polymorphism (SNP) mutations were screened out by high-throughput sequencing and validated in patients diagnosed with DR. To understand the role of PIK3CA in the pathogenesis of DR and explore the relationship between PIK3CA,phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR),and DR, the effect of PIK3CA.rs17849079 mutation was investigated in a DR cell model.

Methods

Twelve patients diagnosed with DR at the Qinghai Provincial People’s Hospital from September 2020 to June 2021 were randomly selected as the case group, while 12 healthy subjects of similar age and gender who underwent physical examination in Qinghai Provincial People’s Hospital physical examination center during the same period were randomly selected as the control group. Blood samples (2 mL) were collected from both groups using EDTA anticoagulant blood collection vessels and frozen at −20°C for future analysis. SNP mutations were detected by high-throughput sequencing, and the shortlisted candidates were subjected by Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses. The detected SNP candidates were verified by expanding the sample size (first validation: 56 patients in the case group and 58 controls; second validation: 157 patients in the case group and 96 controls). A lentivirus vector carrying mutated or wild-type PIK3CA.rs17849079 was constructed. ARPE-19 cells were cultured in a medium supplemented with 10% fetal bovine serum (FBS) to establish a DR cell model. PIRES2-PIK3CA-MT and PIRES2-PIK3CA-WT vectors were transfected into DR model cells, which were categorized into control, mannitol, model, empty vector, PIK3CA wild-type, and PIK3CA mutant-type groups. Cell activity was detected by the cell counting kit (CCK)-8 assay, and cellular apoptosis was evaluated by flow cytometry. Glucose concentration and levels of cytokines tumor necrosis factor (TNF)-α and interleukin (IL)-1β were detected using enzyme-linked immunosorbent assay kits. The expression of PIK3CA, AKT1, mTOR, and VEGF genes was detected by real-time quantitative polymerase chain reaction (RT-qPCR), while the expression of PI3K, p-PI3K, AKT1, p-AKT1, mTOR, p-mTOR, and VEGF proteins was detected by western blotting.

Results

The mutated SNPs were mainly enriched in the PI3K/AKT pathway, calcium ion pathway, and glutamatergic synaptic and cholinergic synaptic signaling pathways. Seven SNPs, including PRKCE.rs1533476, DNAH11.rs10485983, ERAP1.rs149481, KLHL1.rs1318761, APOBEC3C.rs1969643, FYN.rs11963612, and KCTD1.rs7240205, were not related to the development of DR. PIK3CA.rs17849079 was prone to C/T mutation. The risk of DR increased with the presence of the C allele and decreased in the presence of the T allele. High glucose induced the expression of PIK3CA and VEGF mRNAs as well as the expression of PI3K, p-PI3K, p-AKT1, p-mTOR, and VEGF proteins in ARPE-19 cells, which led to secretion of inflammatory factors TNF-αand IL-1, cell apoptosis, and inhibition of cell proliferation. The PIK3CA.rs17849079 C allele accelerated the progression of DR. These biological effects were inhibited when the C allele of PIK3CA.rs17849079 was mutated to T allele.

Conclusion

The mutated SNP sites in patients with DR were mainly enriched in PI3K/AKT, calcium ion, and glutamatergic synaptic and cholinergic synaptic signaling pathways. The rs17849079 allele of PIK3CA is prone to C/T mutation where the C allele increases the risk of DR. High glucose activates the expression of PIK3CA and promotes the phosphorylation of PI3K, which leads to the phosphorylation of AKT and mTOR. These effects consequently increase VEGF expression and accelerate the development of DR. The C to T allele mutation in PIK3CA.rs17849079 can play a protective role and reduce the risk of DR.

Clinical efficacy of blood derivatives on wound healing: A systematic review and network meta‐analysis

Abstract

This study aims to evaluate the clinical effects of different blood derivatives on wound healing using network meta-analysis. PubMed, Embase, OVID, Web of Science, SCOPUS and Cochrane Central were searched to obtain studies about blood derivatives on wound healing until October 2023. R 4.2.0 and Stata 15.0 softwares were used for data analysis. Forty-four studies comprising 5164 patients were included. The results of network meta-analysis showed that the healing area from high to low was GF + ORCCB, ORCCB, GF, PRF, Unnas paste dressing, APG, PRP injection, PRP, PRP + thrombin gel, PPP, HPL, CT. The healing time from low to high was PRP + thrombin gel, GF, PRP, PC + K, PC, APG, PRF, CT, Silver sulfadiazine ointment. The number of patients cured from high to low was APG, PRP injection, PRP, Aurix, PRF, Leucopatch, HPL, Antimicrobial Ointment Dressing, CT, 60 μg/cm2 repifermin, 120 μg/cm2 repifermin, AFG, PPP. The order of analgesic effect from high to low was AFG, Aminogam gel, PRF, PRP, Oxidised oil, APG, GF, CT. The order of the number of wound infection cases from low to high is APG, 20 μg/cm2 repifermin, 60 μg/cm2 repifermin, PRP, LeucoPatch, CT, PPP, Antiseptic ointment dressing. Healing area: GF + ORCCB had the best effect; Healing time: PRP + thrombin gel took the shortest time. The number of cured patients and the reduction of wound infection: APG has the best effect. Analgesic effect: AFG has the best effect. More studies with large sample sizes are needed to confirm the above findings.

Impact of perioperative enhanced recovery after surgery on wound infection in patients undergoing orthopaedic surgery: A meta‐analysis

Abstract

The aim of this study was to evaluate the effects of perioperative application of enhanced recovery after surgery (ERAS) concepts on wound infections and post-operative complications in patients receiving orthopaedic surgery, to provide a theoretical basis for post-operative care. Randomised controlled trials (RCTs) on the application of ERAS to patients receiving orthopaedic surgery, published up to October 2023, were identified in PubMed, Web of Science, Cochrane Library, Embase, Wanfang, China Biomedical Literature Database and China National Knowledge Infrastructure databases. Literature was screened and evaluated by two reviewers based on the inclusion and exclusion criteria, and data were extracted from the final included articles. Data were analysed using RevMan 5.4 software. A total of 20 RCTs were included in the analysis, which included 1875 patients undergoing orthopaedic surgery, of whom 938 and 937 were in the ERAS and control groups, respectively. The analysis revealed that in patients undergoing orthopaedic surgery, implementation of ERAS in the perioperative period was associated with a significantly reduced the rate of wound infections (1.6% vs. 6.19%, risk ratio [RR]: 0.30, 95% confidence interval [CI]: 0.18–0.50, p < 0.001) and complication (5.12% vs. 21.88%, RR: 0.23, 95% CI: 0.17–0.32, p < 0.001) and can effectively shorten the hospital length of stay (standardised mean difference [SMD]: −2.50 days, 95% CI: −3.17 to −1.83 days, p < 0.001) compared with that of conventional care. The available evidence suggests that the implementation of ERAS in the perioperative period of patients undergoing orthopaedic surgery could effectively reduce the rate of wound infections and complications, shorten the hospital length of stay and promote the early recovery of patients.

The impact of ulinastatin on wound infection and healing in patients with burn wounds: A meta‐analysis

Abstract

Burn injuries result in localised tissue damage and precipitate systemic responses; routine clinical treatments, which typically include metabolic nutritional support and anti-infection therapies, do not yield optimal outcomes. Therefore, we aimed to systematically evaluate the effects of ulinastatin on wound infection and healing in patients with burns to provide reliable evidence-based recommendations for burn treatment. An electronic search of the Web of Science, PubMed, Cochrane Library, Embase, Wanfang, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure databases, supplemented by manual searches, was conducted from database inception to October 2023 to collect randomised controlled trials (RCTs) assessing the efficacy of ulinastatin for the treatment of burns. Two researchers screened all retrieved articles according to the inclusion and exclusion criteria; the included studies were evaluated for quality, and the relevant data were extracted. Stata 17.0 software was employed for data analysis. Overall, 8 RCTs with 803 patients were included, with 404 and 399 in the ulinastatin and conventional treatment groups, respectively. The analysis revealed that wound infections (odds ratio [OR] = 0.08, 95% CI: 0.02–0.35, p = 0.001) and complications (OR = 0.21, 95% CI: 0.10–0.42, p < 0.001) were significantly lower, and wound healing time (standardised mean differences [SMD] = −1.31, 95% CI: −2.05 to −0.57, p = 0.001) was significantly shorter, in the ulinastatin groups than in the control group. This meta-analysis revealed that ulinastatin can effectively reduce the incidence of wound infections and complications and significantly shorten the duration of wound healing in patients with burns, thereby promoting early recovery in these patients.

Evaluating a technologically enhanced rehabilitation programme for wound healing in patients with coronary heart disease

Abstract

Wound healing symptoms in patients with coronary heart disease (CHD) are frequently problematic, potentially resulting in complications. In order to tackle this concern, a state-of-the-art rehabilitation programme was created, which incorporated telehealth, virtual reality and robotics in an effort to optimize wound healing in patients with coronary heart disease. The purpose of this research was to assess the efficacy of a rehabilitation programme that utilized cutting-edge technology in enhancing the outcomes of wound recovery for individuals diagnosed with (CHD). Data from 120 CHD patients who participated in this longitudinal randomized controlled trial of a specialized rehabilitation programme intended to promote wound repair were utilized in a cross-sectional analysis. Anthropometric measurements, sociodemographical factors, exercise capacity and the progression of wound recovery were gathered as data. The research participants were primarily comprised of older males from various socioeconomic backgrounds. Age, gender, BMI, socio-educational orientation, physical activity, identified regulation and identified regulation were all significant determinants of wound healing. The significance of customized strategies in cardiac rehabilitation programmes that aim to achieve favourable wound healing outcomes is underscored by these results. In conclusion, this study emphasized the importance of incorporating unique patient attributes when designing technologically advanced rehabilitation protocols aimed at facilitating wound recovery in patients with coronary heart disease. Personalized interventions that consider these variables could potentially result in improved outcomes for wound healing among this particular group of patients.

Exploration of wound‐related complications post‐kidney transplantation

Abstract

An essential intervention for patients with end-stage renal disease is kidney transplantation. Nonetheless, patient outcomes are substantially affected by complications associated with postoperative wounds. The purpose of this research was to determine the prevalence, risk factors and repercussions of wound-related complications among kidney transplant recipients. A cross-sectional observational study was undertaken at Qilu Hospital of Shandong University Department of Organ Transplantation, China. Included in the study were 118 patients who had undergone kidney transplantation during the specified time period. Medical record evaluations, questionnaires and patient interviews were utilized to collect data, with an emphasis on demographics, transplant information, postoperative care and wound complications. Infection, dehiscence, lymphocoele, delayed wound healing, seroma formation and haematoma were classified as complications. The presence of comorbidities, age over 50 and living donor transplants were identified as significant risk factors for postoperative complications. The most prevalent complications observed were delayed wound healing (21.2%) and infections (16.9%) (p < 0.05). Antibiotics were found to be effective in managing infections, while prolonged conservative management was necessary for delayed wound healing. Prominent complications that recurred were infections and wound healing delays. No statistically significant correlation was observed between gender, BMI and prior transplants with the occurrence of complications (p > 0.05). The research highlighted the significance of taking into account patient-specific variables, including age and concurrent medical conditions, when conducting post-kidney transplantation treatment. The results supported the use of individualized strategies in postoperative care, particularly for populations at high risk, in order to reduce the incidence and severity of complications associated with wounds in pursuit to enhancing clinical practices and formulating focused intervention strategies to improve patient outcomes following transplantation.

A cross‐sectional study quantifies the independent contribution of nurses and midwives in child health outcomes

Abstract

Introduction

As the largest profession within the healthcare industry, nursing and midwifery workforce (NMW) provides comprehensive healthcare to children and their families. This study quantified the independent role of NMW in reducing under-5 mortality rate (U5MR) worldwide.

Design

A retrospective, observational and correlational study to examine the independent role of NMW in protecting against U5MR.

Methods

Within 266 “countries”, the cross-sectional correlations between NMW and U5MR were examined with scatter plots, Pearson's r, nonparametric, partial correlation and multiple regression. The affluence, education and urban advantages were considered as the potential competing factors for the NMW–U5MR relationship. The NMW–U5MR correlations in both developing and developed countries were explored and compared.

Results

Bivariate correlations revealed that NMW negatively and significantly correlated to U5MR worldwide. When the contributing effects of economic affluence, urbanization and education were removed, the independent NMW role in reducing U5MR remained significant. NMW independently explained 9.36% U5MR variance. Multilinear regression selected NMW as a significant factor contributing an extra 3% of explanation to U5MR variance when NMW, affluence, education and urban advantage were incorporated as the predicting variables. NMW correlated with U5MR significantly more strongly in developing countries than in developed countries.

Conclusion

NMW, indexing nursing and midwifery service, was a significant factor for reducing U5MR worldwide. This beneficial effect explained 9.36% of U5MR variance which was independent of economic affluence, urbanization and education. The NMW may be a more significant risk factor for protecting children from dying under 5 years old in developing countries. As a strategic response to the advocacy of the United Nations to reduce child mortality, it is worthy for health authorities to consider a further extension of nurses and midwives' practice scope to enable communities to have more access to NMW healthcare services.

Optimal treatment of asymptomatic patients with severe aortic stenosis: protocol of a prospective, multicentre, registry study

Por: Xia · C. · Li · Y.-M. · Xiong · W. · Ma · L. · Xiong · T.-Y. · Zhao · Z.-G. · Peng · Y. · Wei · J. · Feng · Y. · Chen · M.
Introduction

Decisions regarding the optimal timing of intervention for asymptomatic aortic stenosis (AS) are controversial. The study aims to identify potential risk factors for asymptomatic patients with severe AS that are associated with worse prognosis and to evaluate the benefits of early interventions for asymptomatic patients presenting with one or more additional risk factors.

Methods and analysis

This is a non-interventional, prospective, open-label, multicentre registry study across China. A total of 1000 patients will be enrolled and categorised as symptomatic or asymptomatic. The primary endpoint is the occurrence of all-cause mortality, stroke, acute myocardial infarction and heart failure-related hospitalisation at 1-year follow-up. In asymptomatic severe AS patients presenting with one or more risk factors, the occurrence rate of the primary endpoint between those who undergo transcatheter aortic valve replacement (TAVR) and those who do not will be compared. We will also compare the occurrence rate of the primary endpoint for asymptomatic severe AS patients with additional risk factors who undergo TAVR with those presenting with symptoms. This study is believed to provide additional evidence to help clinicians identify and refer severe AS patients who are asymptomatic but present with additional risk factors for early intervention of TAVR.

Ethics and dissemination

The study protocol has been approved by the local ethics committee of each participating site: West China Hospital, Sichuan University; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Second Hospital of Hebei Medical University; Tianjin Chest Hospital; and First Affiliated Hospital of Nanchang University. All participants will provide written informed consent. Study results will be published through academic conferences and peer-reviewed journals.

Trial registration

This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853.

Differentiating attack-defense performance for starting and bench players during the Tokyo Olympics men’s basketball competition

by Wenping Sun, ChenSoon Chee, LianYee Kok, FongPeng Lim, Shamsulariffin Samsudin

This study aimed to explore the differences in attack-defense performance between the top and bottom teams for starting and bench players during the Tokyo Olympics men’s basketball competition, to determine the relationship between the attack-defense performance of starting and bench players and the final competition rankings, as well as with each performance indicator. The rank-sum ratio (RSR) comprehensive evaluation was employed to describe the attack-defense performance of starting and bench players. Additionally, an independent sample t-test, Spearman Rho Correlation, and Pearson Correlation were conducted to test the differences and relationships between the various variables at a 0.05 level of significance, respectively. The results indicated that the top four teams showed significant differences in the attack-defense performance of their starting players compared to the bottom four teams (p = 0.021), mainly in terms of 3-point shooting percentage (p = 0.042) and free throw shooting percentage (p = 0.044). Besides that, the attack-defense ranks of both starting players (p = 0.004, r = 0.757) and bench players (p = 0.020, r = 0.658) had a significant correlation with the final rankings. Points per game, 2-point field goal percentage, and assists had a statistically significant (pr

Intervention of muscle-building and antifrailty exercise combined with Baduanjin for frailty of different functional levels: study protocol for a randomised controlled trial

Por: Xu · S. · Gong · Z. · Wang · F. · Cao · M. · Liu · J. · Chen · C. · Zhang · N. · Kang · J. · Xu · C. · Peng · N.
Introduction

Frailty has been currently considered as a multidimensional concept, including physical, cognitive and social frailty. Frailty has also been associated with a range of adverse events, which might increase the risks of disability, falls, fractures, delirium and death. Increasing evidence has shown that multicomponent exercise training can improve physical and cognitive function, delay or reverse frailty. However, there is still a lack of exercise intervention programmes for the frail older adults in China. This trial aims to investigate the effects of the muscle-building and antifrailty exercise combined with Baduanjin on the physical function of frail older adults, as well as the effectiveness and safety of the intervention.

Methods and analysis

This study is a prospective randomised controlled trial. A total of 192 patients, aged 70 years or older, who are diagnosed as prefrailty or frailty based on the Fried criteria will be included. Prior written and informed consent will be obtained from every subject. These subjects will be randomly assigned to the exercise intervention group (n=96) and the control group (n=96). The exercise intervention group will undergo different exercise programmes for different levels of physical function. They will perform the muscle-building and antifrailty exercise three times per week for 30–60 min for 24 weeks. The control group will implement health education on frailty and maintain the old lifestyle without any intervention.

The primary outcomes include the change in frailty and functional capacity, assessed according to the Fried Scale and the Short Physical Performance Battery. Secondary outcomes include the changes in body composition, Activities of daily living, Mini-Mental State Examination, The Geriatric Depression Scale-15 and the haematological indicators.

Ethics statement

The study has been approved by the Medical Ethics Committee of the PLA General Hospital (approval no.: S2022-600-02).

Trial registration number

ChiCTR2300070535.

Association between alcohol consumption and risk of hyperuricaemia among adults: a large cross-sectional study in Chongqing, China

Por: Chen · S. · Ding · R. · Tang · X. · Chen · L. · Luo · Q. · Xiao · M. · Ding · X. · Peng · B.
Objective

To investigate the relationship between alcohol consumption and hyperuricaemia (HUA), we conducted a study based on a large population.

Setting

Cross-sectional study.

Participants

A total of 20 833 participants aged 30–79 years were enrolled in the China Multi-Ethnic Cohort, Chongqing region.

Outcomes

The serum level of uric acid, fasting blood glucose and blood lipids were tested. Basic demographic statistics such as age, gender, marital status, education level, family annual income and the detail information of alcohol consumption were collected using a standardised questionnaire.

Results

After controlling for potential confounders, compared with participants who never consumed alcohol, participants who drank 3–5 days per week had the highest risk of HUA (OR: 1.51, 95% CI: 1.25 to 1.82) and those who drank alcohol harmfully had the highest risk of HUA (OR: 1.81, 95% CI: 1.41 to 2.32). In addition, we found that those who drank moderately had no significant association with risk of HUA. However, among men, compared with participants who never consumed alcohol, those who drank moderately was also a risk factor of HUA (OR: 1.23, 95% CI: 1.03 to 1.46) and those who drank alcohol harmfully had the highest risk of HUA (OR: 2.13, 95% CI: 1.64 to 2.78). Compared with participants who drank alcohol moderately, the OR (95% CI) for those who drank alcohol harmfully had the highest risk of HUA was 1.88 (1.42 to 2.48), and the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.22 (1.12 to 1.33). Among men, compared with participants who drank alcohol moderately, those who drank alcohol harmfully had the highest risk of HUA (OR: 1.93, 95% CI: 1.45 to 2.57), as well as the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.24 (1.13 to 1.35).

Conclusion

This study suggested that the frequency and degree of alcohol consumption may be the risk factors for HUA, especially in males.

The efficacy of electroacupuncture in among early diabetic patients with lower limb arteriosclerotic wounds

Abstract

Diabetic foot ulcers are the prevalent complication of diabetes mellitus, frequently culminating in arteriosclerosis of the lower extremities and consequent development of chronic wounds. The effectiveness of electroacupuncture (EA) as therapeutic intervention for promoting wound healing in this particular group of patients has been comprehensively assessed in this study. A randomized controlled trial involving 380 early diabetic patients with arteriosclerotic lesions of the lower limbs was conducted. Standard wound care plus EA was administered to the treatment group, while standard wound care alone was administered to the control group. The principal outcome assessed was the reduction in lesion size following the 8-week treatment period. Pain scores, recuperation time, and quality of life (QoL) evaluations constituted secondary outcomes. In comparison to the control group, the treatment group exhibited a significantly greater reduction in wound size (p < 0.05). The treatment group exhibited significantly reduced pain scores and significantly higher QoL scores (p < 0.05). The duration of recovery did not vary substantially among the groups (p > 0.05). Electroacupuncture thus appeared to be an effective adjunctive treatment for early diabetic patients with lower limb arteriosclerotic lesions, promoting pain relief and quality of life. Additional investigation is necessary to validate these results and delve into the underlying mechanisms of action.

Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)

Por: Zhang · J. · Hu · X. · Jiang · J. · Lu · D. · Guo · L. · Peng · X. · Pan · Y. · He · W. · Li · J. · Zhou · H. · Huang · J. · Jiang · F. · Pu · J. · Cheng · Z. · Yang · B. · Ma · J. · Chen · P. · Liu · Q. · Song · D. · Lu · L. · Li · S. · Fan · Y. · Meng · Z. · Tang · L. · Shin · E.-S. · Tu · S. · Koo · B.-
Introduction

Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.

Method and analysis

The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm22 and plaque burden>70%. The primary endpoint is a composite of all-cause death, myocardial infarction and revascularisation at 12 months after randomisation. We will test the non-inferiority of the angiography-derived FFR-guided strategy compared with the IVUS-guided decision for PCI and the stent optimisation strategy.

The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.

Ethics and dissemination

FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.

Trial registration number

NCT04397211.

Effects of the different intensities of task-oriented training on the upper extremity motor function and self-care ability of stroke survivors: study protocol for a multiarm parallel-group randomised controlled trial in a tertiary hospital in China

Por: Liu · S. · Zhang · K. · Li · X. · Li · C. · Peng · M.
Introduction

Although task-oriented training (TOT) may provide added therapeutic value to stroke survivors, current TOT guidance offers insufficient advice on standardisation, particularly choices of intensity, for clinical practice. Therefore, this study aims to explore the effects of different intensities of TOT on motor function and self-care ability of stroke survivors.

Methods and analysis

This randomised controlled clinical trial will recruit 72 participants from a tertiary hospital, diagnosed with decreased self-care ability and upper limb motor dysfunction post-stroke. All participants will be randomly assigned to one of three experimental groups or the control group to undergo intervention for 8 weeks. The participants in the control group (n=18) will receive traditional occupational therapy, while those in the experimental groups will receive different intensities of TOT (50%, 75% and 100% intensity for groups A, B and C, respectively). This protocol designed a more innovative and optimised TOT programme to explore the optimal intensity of TOT on stroke survivors. The primary outcome is Canadian Occupational Performance Measure, and the secondary outcomes include Modified Barthel Index, Wolf Motor Function Test and Motor Activity Log.

Ethics and dissemination

The Second Affiliated Hospital of Hainan Medical University Ethics Committee approved the medical and ethical protocol for this study (LW2022015). All participants will sign an informed consent form. The results will be presented in scientific conferences and published in peer-reviewed journals.

Trial registration number

ChiCTR2200056390.

Predictive factors of poor outcome and mortality among anterior ischaemic stroke patients despite successful recanalisation in China: a secondary analysis of the CAPTURE trial

Por: Li · G. · Sun · Y. · Liu · T. · Yang · P. · Peng · Y. · Chen · W. · Zhang · L. · Chu · J. · Kuai · D. · Wang · Z. · Wu · W. · Xu · Y. · Zhou · B. · Geng · Y. · Yin · C. · Li · J. · Wang · M. · Peng · X. · Xiao · Y. · Li · M. · Zhang · X. · Liu · P. · Wang · N. · Zhang · Y.
Objectives

This work aimed to analyse the risk factors for poor outcomes and mortality among patients with anterior large vessel occlusion (LVO) ischaemic stroke, despite successful recanalisation.

Setting and participants

This study conducted a secondary analysis among patients who underwent successful recanalisation in the CAPTURE trial. The trial took place between March 2018 and September 2020 at 21 sites in China. The CAPTURE trial enrolled patients who had an acute ischaemic stroke aged 18–80 years with LVO in anterior circulation.

Interventions

Thrombectomy was immediately performed using Neurohawk or the Solitaire FR after randomisation in CAPTURE trial. Rescue treatment was available for patients with severe residual stenosis caused by atherosclerosis.

Primary and secondary outcome measures

The primary goal was to predict poor 90-day survival or mortality within 90 days post-thrombectomy. Univariate analysis, using the 2 test or Fisher’s exact test, was conducted for each selected factor. Subsequently, a multivariable analysis was performed on significant factors (p≤0.10) identified through univariate analysis using the backward selection logistic regression approach.

Results

Among the 207 recruited patients, 79 (38.2%) exhibited poor clinical outcomes, and 26 (12.6%) died within 90 days post-thrombectomy. Multivariate analysis revealed that the following factors were significantly associated with poor 90-day survival: age ≥67 years, internal carotid artery (ICA) occlusion (compared with middle cerebral artery (MCA) occlusion), initial National Institutes of Health Stroke Scale (NIHSS) score ≥17 and final modified Thrombolysis in Cerebral Infarction (mTICI) score 2b (compared with mTICI 3). Additionally, the following factors were significantly associated with mortality 90 days post-thrombectomy: initial NIHSS score ≥17, ICA occlusion (compared with MCA occlusion) and recanalisation with more than one pass.

Conclusions

Age, NIHSS score, occlusion site, mTICI score and the number of passes can be independently used to predict poor 90-day survival or mortality within 90 days post-thrombectomy.

Trial registration number

NCT04995757.

Experiences and management needs of endocrine therapy-related symptoms in patients with breast cancer: a systematic review and qualitative evidence synthesis protocol

Por: Wang · L. · Wei · T. · Liu · J. · Peng · S. · Chen · J. · Hu · M. · Li · X.
Introduction

Patients with breast cancer and endocrine therapy-related symptoms often experience pain, self-denial, anxiety, fear of recurrence and despair, which can be extremely physically and psychologically traumatising for the patients. Failure to receive effective support and management reduces adherence to medications, leading to a higher risk of relapse and mortality. Clearly, it is paramount to identify what support these patients may need and how to meet their symptom management needs. This paper outlines a protocol to synthesise qualitative evidence on endocrine therapy symptom experiences, management expectations and preferences of patients with breast cancer.

Methods and analysis

The following databases were searched in November 2023 with no date restriction applied: The Cochrane Library, PubMed, Embase, Web of Science, Scopus, CINAHL and OpenGrey. Published studies on qualitative or mixed-method on symptom experiences and management needs during endocrine therapy in patients with breast cancer will be retrieved. We will also search for reference lists and perform a forward citation search. Before inclusion in this review, two reviewers will independently apply the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research to ensure methodological validity. Any disagreements regarding the evaluation of the articles will be resolved through discussion with or by a third reviewer. Data will be extracted using the standardised data extraction tool EndNote20 for unified management, assessment, and review of information. The common sense model of self-regulation will guide data extraction and synthesis. The final synthesised findings will be graded according to the GRADE-CERQual approach to establish confidence.

Ethics and dissemination

This systematic review addressed previously published studies without personally identifiable participant information. Ethical approval from the research committee was not required. The findings of this systematic review will be disseminated to various key stakeholders and published in peer-reviewed journals.

PROSPERO registration number

CRD42023406987

Polyethylene glycol precipitation is an efficient method to obtain extracellular vesicle-depleted fetal bovine serum

by Peng Wang, Onno J. Arntz, Johanna F. A. Husch, Van der Kraan P. M., Jeroen J. J. P. van den Beucken, Fons A. J. van de Loo

Mesenchymal stromal/stem cell derived-extracellular vesicles (MSC-EVs) have gained interest as drug delivery nanoparticles, having immunoregulatory and potentiating tissue repair property. To maintain growth of MSCs and obtain pure MSC-derived EVs, the culture media should contain fetal bovine serum (FBS) devoid of EVs, as the presence of FBS EVs confounds the properties of MSC-EVs. Therefore, we tested three methods: 18h ultracentrifugation (UC) and ultrafiltration (UF), which are common FBS EV depletion methods in current MSC-EV research, and polyethylene glycol (PEG) precipitation to obtain three EV depleted FBS (EVdFBS) batches, and compared them to FBS and commercial (Com) EVdFBS on human adipose stem cell (hADSC) growth, differentiation, enrichment of EVs in hADSC supernatant and their biological function on collagen metabolism. Our comparative study showed UC and UF vary in terms of depletion efficiency and do not completely deplete EVs and affects the growth-promoting quality of FBS. Specifically, FBS EV depletion was comparable between PEG (95.6%) and UF (96.6%) but less by UC (82%), as compared to FBS. FBS protein loss was markedly different among PEG (47%), UF (87%), and UC (51%), implying the ratio of EV depletion over protein loss was PEG (2.03), UF (1.11), and UC (1.61). A significant decrease of TGFβ/Smad signaling, involving in MSC growth and physiology, was observed by UF. After 96 hours of exposure to 5% FBS or 5% four different EVdFBS cell growth media, the osteogenesis ability of hADSCs was not impaired but slightly lower mRNA expression level of Col2a observed in EVdFBS media during chondrogenesis. In consistent with low confluency of hADSCs observed by optical microscope, cell proliferation in response to 5% UF EVdFBS media was inhibited significantly. Importantly, more and purer ADSCs EVs were obtained from ADSCs cultured in 5% PEG EVdFBS media, and they retained bioactive as they upregulated the expression of Col1a1, TIMP1 of human knee synovial fibroblast. Taken together, this study showed that PEG precipitation is the most efficient method to obtain EV depleted FBS for growth of MSCs, and to obtain MSC EVs with minimal FBS EV contamination.

Effect of wound infiltration of dexmedetomidine in lumbar spine surgery on postoperative wound pain: A meta‐analysis

Abstract

In a meta-study, we evaluated the effectiveness and security of the combination of topical anaesthetic and dexmedetomidine in the treatment of postoperative pain in patients with lumbar disease. Four databases were systematically searched for possible related articles. Only English-language research was taken into account on the Internet. Furthermore, we only took into account the studies that were published prior to 2023. Only those that fulfilled the eligibility criteria were considered: (1) in adults who were about to undergo spine operation, (2) dexmedetomidine combined with local anaesthesia, (3) Visual Analog Scale scores at 4 and 24 h after the event and (4) this was a randomized or nonrandomized, controlled study. The meta-analysis was carried out with Revman 5.3 software. A ROBINS-I-based instrument was used to evaluate controlled studies. All trials were synthesized by computing the end results with either a fixed or a random effect model, which was dependent on statistical diversity. Five trials showed a marked reduction in wound pain at 4 h after the operation in patients who were treated with dexmedetomidine for lumbar spinal surgery (MD, −0.81; 95% CI, −1.24, −0.35; p = 0.0005). In the case of lumbar spinal operations, the addition of dexmedetomidine to the postoperative treatment resulted in a marked reduction in the pain at 24 h post-operation (MD, −0.64; 95% CI, −0.79, −0.48; p < 0.0001). The quality of the data we evaluated was ‘moderate’ to ‘good’; thus, we have limited confidence in the impact estimation, and the actual impact might be significantly different from what we had expected. Additional studies should concentrate on practices that are well known to cause severe postoperative pain, especially for cases where the improvement of pain management may lead to substantial clinical benefits in terms of reduction of morbidity or cost-effectiveness in terms of quicker healing and release.

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