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Co-culture of induced pluripotent stem cells with cardiomyocytes is sufficient to promote their differentiation into cardiomyocytes

by Axel J. Chu, Eric Jiahua Zhao, Mu Chiao, Chinten James Lim

Various types of stem cells and non-stem cells have been shown to differentiate or transdifferentiate into cardiomyocytes by way of co-culture with appropriate inducer cells. However, there is a limited demonstration of a co-culture induction system utilizing stem cell-derived cardiomyocytes as a stimulatory source for cardiac reprogramming (of stem cells or otherwise). In this study, we utilized an inductive co-culture method to show that previously differentiated induced pluripotent stem (iPS) cell-derived cardiomyocytes (iCMs), when co-cultivated with iPS cells, constituted a sufficient stimulatory system to induce cardiac differentiation. To enable tracking of both cell populations, we utilized GFP-labeled iPS cells and non-labeled iCMs pre-differentiated using inhibitors of GSK and Wnt signaling. Successful differentiation was assessed by the exhibition of spontaneous self-contractions, structural organization of α-actinin labeled sarcomeres, and expression of cardiac specific markers cTnT and α-actinin. We found that iCM-iPS cell-cell contact was essential for inductive differentiation, and this required overlaying already adherent iPS cells with iCMs. Importantly, this process was achieved without the exogenous addition of pathway inhibitors and morphogens, suggesting that ‘older’ iCMs serve as an adequate stimulatory source capable of recapitulating the necessary culture environment for cardiac differentiation.

Validation of an algorithm to evaluate the appropriateness of outpatient antibiotic prescribing using big data of Chinese diagnosis text

Por: Zhao · H. · Bian · J. · Wei · L. · Li · L. · Ying · Y. · Zhang · Z. · Yao · X. · Zhuo · L. · Cao · B. · Zhang · M. · Zhan · S.
Objective

We aimed to evaluate the validity of an algorithm to classify diagnoses according to the appropriateness of outpatient antibiotic use in the context of Chinese free text.

Setting and participants

A random sample of 10 000 outpatient visits was selected between January and April 2018 from a national database for monitoring rational use of drugs, which included data from 194 secondary and tertiary hospitals in China.

Research design

Diagnoses for outpatient visits were classified as tier 1 if associated with at least one condition that ‘always’ justified antibiotic use; as tier 2 if associated with at least one condition that only ‘sometimes’ justified antibiotic use but no conditions that ‘always’ justified antibiotic use; or as tier 3 if associated with only conditions that never justified antibiotic use, using a tier-fashion method and regular expression (RE)-based algorithm.

Measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the classification algorithm, using classification made by chart review as the standard reference, were calculated.

Results

The sensitivities of the algorithm for classifying tier 1, tier 2 and tier 3 diagnoses were 98.2% (95% CI 96.4% to 99.3%), 98.4% (95% CI 97.6% to 99.1%) and 100.0% (95% CI 100.0% to 100.0%), respectively. The specificities were 100.0% (95% CI 100.0% to 100.0%), 100.0% (95% CI 99.9% to 100.0%) and 98.6% (95% CI 97.9% to 99.1%), respectively. The PPVs for classifying tier 1, tier 2 and tier 3 diagnoses were 100.0% (95% CI 99.1% to 100.0%), 99.7% (95% CI 99.2% to 99.9%) and 99.7% (95% CI 99.6% to 99.8%), respectively. The NPVs were 99.9% (95% CI 99.8% to 100.0%), 99.8% (95% CI 99.7% to 99.9%) and 100.0% (95% CI 99.8% to 100.0%), respectively.

Conclusions

The RE-based classification algorithm in the context of Chinese free text had sufficiently high validity for further evaluating the appropriateness of outpatient antibiotic prescribing.

Association of magnesium intake with type 2 diabetes and total stroke: an updated systematic review and meta-analysis

Por: Zhao · B. · Zeng · L. · Zhao · J. · Wu · Q. · Dong · Y. · Zou · F. · Gan · L. · Wei · Y. · Zhang · W.
Objective

The detailed associations between type 2 diabetes (T2D) and total stroke and magnesium intake as well as the dose–response trend should be updated in a timely manner.

Design

Systematic review and meta-analyses.

Data sources

PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov were rigorously searched from inception to 15 March 2019.

Eligibility criteria

Prospective cohort studies investigating these two diseases were included.

Data synthesis

Relative risk (RR) and 95% CI in random effects models as well as absolute risk (AR) were pooled to calculate the risk of T2D and stroke. Methodological quality was assessed by the Newcastle-Ottawa Scale.

Results

Forty-one studies involving 53 cohorts were included. The magnitude of the risk was significantly reduced by 22% for T2D (RR 0.78 (95% CI 0.75 to 0.81); p2 body mass index and those with ≥12-year follow-up; the reduced risk in Asians was not as notable as that in North American and European populations.

Conclusions

Magnesium intake has significantly inverse associations with T2D and total stroke in a dose-dependent manner. Feasible magnesium-rich dietary patterns may be highly beneficial for specific populations and could be highlighted in the primary T2D and total stroke prevention strategies disseminated to the public.

PROSPERO registration number

CRD42018092690.

Effect of resting heart rate on the risk of all-cause death in Chinese patients with hypertension: analysis of the Kailuan follow-up study

Por: Zhao · M. X. · Zhao · Q. · Zheng · M. · Liu · T. · Li · Y. · Wang · M. · Yao · S. · Wang · C. · Chen · Y.-M. · Xue · H. · Wu · S.
Objective

Previous studies have shown that an elevated heart rate is associated with a higher risk of cardiovascular events. This study aimed to prospectively examine the relationship between resting heart rate (RHR) and all-cause mortality in Chinese patients with hypertension.

Design

An observational, prospective and population-based cohort study.

Setting

The Kailuan cohort study was conducted in Tangshan City in northern China.

Participants

We enrolled 46 561 patients who did not receive beta-blocker treatment and were diagnosed with hypertension for the first time during an employee health examination in Kailuan Group in 2006 and 2008.

Outcome

The primary outcome of this study was all-cause mortality.

Methods

The patients in this study were followed for 9.25±1.63 years. All patients were followed up face to face every 2 years. According to the distribution of RHR in the study population, RHR was categorised into five groups on the basis of quintiles: Q1: RHR ≤68 beats per minute (bpm); Q2: RHR >68 and ≤72 bpm; Q3: RHR >72 and ≤76 bpm; Q4: RHR >76 and ≤82 bpm; Q5: RHR >82 bpm. Cox proportional hazards model, which was adjusted for traditional risk factors, was used.

Results

During follow-up, 4751 deaths occurred. After adjustment for potential confounders, restricted cubic spline regression showed that the risk of all-cause mortality increased with heart rate. In multivariate Cox regression analyses adjusted for age, sex and major covariates, the HR for all-cause mortality was 1.31 (95% CI 1.27 to 1.33) in the highest quintile group (Q5) compared with the lowest quintile group (Q1).

Conclusion

An increase in RHR is a long-term risk factor of all-cause mortality in Chinese patients with hypertension.

Trial registration number

ChiCTR-TNC-11001489.

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta‐analysis of randomised controlled trials

Abstract

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta‐analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: −30.33 days, [95% CI: −37.95, −22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.

Surgical site infection following operative treatment of open fracture: Incidence and prognostic risk factors

Abstract

Considering the high incidence of postoperative complications of open fracture, management of this injury is an intractable challenge for orthopaedist, and surgical site infection (SSI) is the devastate one. Screening for high‐risk patients and target them with appropriate interventions is important in clinical practice. The aim of this study was to identify modifiable factors that were associated with SSI following operative treatment of open fractures. This retrospective, multicentre study was conducted at three hospitals. A total of 2692 patients with complete data were recruited between June 2015 and July 2018. Demographic characteristics, operation relative variables, additional comorbidities, and biochemical indexes were extracted and analysed. Receiver operating characteristic analysis was performed to detect the optimum cut‐off value for some variables. Univariate and multivariate logistic analysis models were performed, respectively, to identify the independent risk factors of SSI. The overall incidence of SSI was 18.6%, with 17.0% and 1.6% for superficial and deep infection, respectively. Results of univariate and multivariate analyses showed the following: fracture type, surgical duration > 122 minutes, anaesthesia time > 130 minutes, intraoperative body temperature < 36.4°C, blood glucose (GLU) > 100 mg/dL, blood platelet (PLT) < 288 × 109, and white blood cells (WBC) > 9.4 × 109 were independent risk factors of postoperative wound infection following operative treatment of open fractures. Six modifiable factors such as surgical duration > 122 minutes, anaesthesia time > 130 minutes, intraoperative body temperature < 36.4°C, GLU > 100 mg/dL, PLT < 288 × 109, and WBC > 9.4 × 109 play an important role in the prevention of SSI, and these factors should be optimized perioperatively.

Changes in pregnancy-related serum biomarkers early in gestation are associated with later development of preeclampsia

by Shiying Hao, Jin You, Lin Chen, Hui Zhao, Yujuan Huang, Le Zheng, Lu Tian, Ivana Maric, Xin Liu, Tian Li, Ylayaly K. Bianco, Virginia D. Winn, Nima Aghaeepour, Brice Gaudilliere, Martin S. Angst, Xin Zhou, Yu-Ming Li, Lihong Mo, Ronald J. Wong, Gary M. Shaw, David K. Stevenson, Harvey J. Cohen, Doff B. Mcelhinney, Karl G. Sylvester, Xuefeng B. Ling

Background

Placental protein expression plays a crucial role during pregnancy. We hypothesized that: (1) circulating levels of pregnancy-associated, placenta-related proteins throughout gestation reflect the temporal progression of the uncomplicated, full-term pregnancy, and can effectively estimate gestational ages (GAs); and (2) preeclampsia (PE) is associated with disruptions in these protein levels early in gestation; and can identify impending PE. We also compared gestational profiles of proteins in the human and mouse, using pregnant heme oxygenase-1 (HO-1) heterozygote (Het) mice, a mouse model reflecting PE-like symptoms.

Methods

Serum levels of placenta-related proteins–leptin (LEP), chorionic somatomammotropin hormone like 1 (CSHL1), elabela (ELA), activin A, soluble fms-like tyrosine kinase 1 (sFlt-1), and placental growth factor (PlGF)–were quantified by ELISA in blood serially collected throughout human pregnancies (20 normal subjects with 66 samples, and 20 subjects who developed PE with 61 samples). Multivariate analysis was performed to estimate the GA in normal pregnancy. Mean-squared errors of GA estimations were used to identify impending PE. The human protein profiles were then compared with those in the pregnant HO-1 Het mice.

Results

An elastic net-based gestational dating model was developed (R2 = 0.76) and validated (R2 = 0.61) using serum levels of the 6 proteins measured at various GAs from women with normal uncomplicated pregnancies. In women who developed PE, the model was not (R2 = -0.17) associated with GA. Deviations from the model estimations were observed in women who developed PE (P = 0.01). The model developed with 5 proteins (ELA excluded) performed similarly from sera from normal human (R2 = 0.68) and WT mouse (R2 = 0.85) pregnancies. Disruptions of this model were observed in both human PE-associated (R2 = 0.27) and mouse HO-1 Het (R2 = 0.30) pregnancies. LEP outperformed sFlt-1 and PlGF in differentiating impending PE at early human and late mouse GAs.

Conclusions

Serum placenta-related protein profiles are temporally regulated throughout normal pregnancies and significantly disrupted in women who develop PE. LEP changes earlier than the well-established biomarkers (sFlt-1 and PlGF). There may be evidence of a causative action of HO-1 deficiency in LEP upregulation in a PE-like murine model.

Development and validation of a sensitive LC-MS/MS method for the quantitation of IMB-YH-4py5-2H, an antituberculosis candidate, and its application to the pharmacokinetic study

by Sen He, Hong-Tong Chen, Rui Zhao, Xin-Xin Hu, Tong-Ying Nie, Xin-Yi Yang, Cong-Ran Li, Xi Lu, Xiu-Kun Wang, Xue Li, Yun Lu, Guo-Qing Li, Jing Pang, Xue-Fu You

(E)-N,N-dimethyl-4-oxo-4-(4-(pyridin-4-yl)phenyl)but-2-enamide hydrochloride (IMB-YH-4py5-2H) is a novel Protein Kinase B (PknB) inhibitor with potent activity against Mycobacterium tuberculosis strains. In the present study, a sensitive and specific liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated to determine IMB-YH-4py5-2H in rat plasma. Sample pretreatment was achieved by liquid-liquid extraction with ethyl acetate, and separation was performed on an XTerra MS C18 column (2.1×50 mm, 3.5 μm) with gradient elution (methanol and 0.1% formic acid) at a flow rate of 0.3 mL/min. Detection was performed in multiple reaction monitoring (MRM) mode. Linear calibration curves were obtained over a concentration range of 1−100 ng/mL. The intra-day and inter-day precisions were lower than 8.46%, and the accuracies ranged from -8.71% to 12.36% at all quality control levels. The extraction recoveries were approximately 70%, and the matrix effects were negligible. All quality control samples were stable under different storage conditions. The validated method was successfully applied to a preclinical pharmacokinetic study in Sprague-Dawley rats. IMB-YH-4py5-2H demonstrated improved pharmacokinetic properties (higher exposure level) compared with its leading compound. IMB-YH-4py5-2H was also distributed throughout the lung pronouncedly, especially inside alveolar macrophages, indicating its effectiveness against lower respiratory infections.

Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

Por: Ma · T.-t. · Yang · Z. · Zhu · S. · Zhao · J.-h. · Li · Y. · Sun · F.-y. · Zhao · N. · Xiong · Z.-y. · Xiong · Z.-b. · Dong · J.
Introduction

Restless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).

Methods and analysis

This is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.

Ethics and dissemination

The study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.

Trial registration number

NCT03817554

Predicting value of white cell count and total bilirubin on clinical outcomes in patients with ST-elevation myocardial infarction following percutaneous coronary intervention: a cohort study

Por: Tuxun · M. · Zhao · Q. · Xiang · Y. · Liu · F. · Shan · C.-F. · Zhou · X.-R. · Song · N. · Waisiding · A. · Zhang · X.-H. · Aihemaiti · G. · Yang · Y.-N. · Li · X.-M.
Objectives

A combined equation based on white cell count (WCC) and total bilirubin (TB) was assessed for its ability to predict adverse clinical outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention (PCI).

Design

A single-centre, prospective cohort study.

Setting

The First Affiliated Hospital of Xinjiang Medical University.

Method

A total of 615 patients with STEMI postprimary PCI were enrolled. WCC and TB were collected at admission. Logistic regression was used to determine the combined equation. The primary endpoints were in-hospital mortality and major adverse cardiovascular events (MACE), which composed of cardiac death, cardiac shock, malignant arrhythmia (ventricular tachycardia, ventricular fibrillation), severe cardiac insufficiency, non-fatal myocardial infarction, angina pectoris readmission, severe cardiac insufficiency (cardiac III–IV level), stent restenosis and target vessels revascularisation during the hospitalisation and 36 months follow-up period.

Result

77 patients occurred in MACE during the hospitalisation (17 in-hospital mortality). WCC and TB were taken as an independent variables to make a category of logistic regression analysis of in-hospital MACE, the logistic regression model was: logit (P)=–8.00+0.265 WCC+0.077 TB, the combination of WCC and TB was more valuable on evaluating the in-hospital mortality (area under the curve 0.804, 95% CI 0.678 to 0.929, p

Conclusion

The combination of WCC and TB is an independent predictor for in-hospital outcomes in patients with STEMI than single detection.

Anticoagulation regimens during pregnancy in patients with mechanical heart valves: a protocol for a systematic review and network meta-analysis

Por: He · S. · Zou · Y. · Li · J. · Liu · J. · Zhao · L. · Yang · H. · Su · Z. · Ye · H.
Introduction

Pregnancy in patients with mechanical heart valves (MHVs) is associated with high maternal complications and fetal complications.Anticoagulation treatments serve to decrease their venous clotting risk. Although some anticoagulation regimens have been used for patients during pregnancy with MHVs, no one is definitively superior among different regimens in recent studies. For a better understanding of the clinical treatment which anticoagulation regimen is more effective and safer during the pregnancy in patients with MHVs, a Bayesian network meta-analysis is necessary.

Methods and analysis

This protocol has been reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Related studies until April 2019 will be searched in the following databases: PubMed, Embase,SinoMed and the using the OVID interface to search for evidence-based medicine reviews. A clinical trial registry (www.ClinicalTrials.gov) was also searched for unpublished trials. Both experimental studies (randomised clinical trials) and observational studies (cohort studies, case–control studies and case series studies) will be included in this study. Quality assessment will be conducted using Cochrane Collaboration’s tool or Newcastle-Ottawa Scale based on their study designs. The primary outcomes of interest will be the frequencies of serious maternal and fetal events. The additional outcomes of interest will be adverse maternal events, mode of delivery and adverse fetal events. Pairwise and network meta-analysis will be conducted using R (V.3.4.4, R Foundation for Statistical Computing, Vienna, Austria) and Stata (V.14, StataCorp). The ranking probabilities will be estimated at each possible rank for each anticoagulation regimen using the surface under the cumulative ranking curve. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed.

Ethics and dissemination

Either ethics approval or patient consent is not necessary, because this study will be based on literature. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42019130659

Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial

Por: Zhang · H. · Feng · Y. · Zhao · J. · Chen · R. · Chen · X. · Yin · X. · Cheng · W. · Li · D. · Li · J. · Huang · X. · Li · J. · Liu · J. · Liu · J. · Liu · Y. · Tan · Z. · Zhao · W. · Huang · H. · Li · D. · Yu · Y. · Wang · M. · Qin · R.
Introduction

Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomised controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis

TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay.

Ethics and dissemination

The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.

Trial registration number

NCT03138213

Effectiveness of horticultural therapy in people with dementia: A quantitative systematic review

Abstract

Aims and objectives

To evaluate the effectiveness of horticultural therapy on cognitive function, agitation, positive emotion and engagement in people with dementia.

Background

The number of people with dementia is increasing rapidly, and nonpharmacological interventions such as horticultural therapy have been recommended as the first choice for these patients. Horticultural therapy involves participatory and ornamental horticultural therapy. Many original studies have examined the effectiveness of horticultural therapy in the last two decades. However, these studies vary in types of interventions, outcomes and measurement.

Design

A quantitative systematic review and meta‐analysis.

Methods

This systematic review was conducted under PRISMA guidelines. Randomised controlled trials (RCTs) and quasi‐experimental studies involving horticultural therapy for people with dementia were included. Risk of bias was assessed by the Cochrane's and Joanna Briggs Institute's tool. Reference lists and a relevant journal were searched. Meta‐analyses were conducted using RevMan 5.3. PubMed, CINAHL, Embase, BIOSIS Previews, Web of Science Core Collection, China National Knowledge Infrastructure, Wanfang, SinoMed, Cochrane Library and ProQuest Health & Medical Complete were searched. Studies from database inception to 1 July 2019 were included.

Results

This systematic review included 14 studies (4 RCTs and 10 quasi‐experimental studies) involving 411 people with dementia. The results of meta‐analyses indicated that significant differences were found in the effectiveness of participatory horticultural therapy on total score of cognitive function, agitation, positive emotion and engagement, but not in the effectiveness of ornamental horticultural activities on agitation and positive emotion.

Conclusions

The existing evidence supports the effectiveness of participatory horticultural therapy on cognitive function, agitation, positive emotion and engagement. Future high‐quality original studies are needed to draw more robust conclusions.

Relevance to clinical practice

The results support the use of participatory horticultural therapy for improving cognitive function, agitation, positive emotion and engagement of people with dementia.

A randomized controlled trial of the Effects of a telehealth educational intervention on medication adherence and disease activity in rheumatoid arthritis patients 远距照护教育干预对类风湿性关节炎患者用药依从性和疾病活动性影

Abstract

Aims

To examine the effects of a tailored telehealth educational intervention on medication adherence and disease activity in discharged patients with rheumatoid arthritis (RA).

Design

An un‐blinded randomized controlled trial.

Methods

A total of 92 eligible patients were recruited from January 2015–December 2015. Participants were randomly assigned to either the intervention (N = 46) or control group (N = 46). The intervention group received four educational sessions delivered through a telephone across a 12‐week intervention. The content of the education mainly included: subject's knowledge about disease; treatment goals; the importance of taking medication correctly; side effect management; remembering to take medication. The control group received only standard care including discharge instructions. Outcome measures included medication adherence and disease activity.

Results

The intervention group had significantly higher medication adherence compared with the control group at 12th and 24th week. There was no significant difference between two groups in disease activity at 12th and 24th week.

Conclusions

The telephone‐delivered tailored educational intervention effectively improved medication adherence among discharged patients with rheumatoid arthritis. However, no significant benefits of the intervention on disease activity were detected.

Impact

Good medication adherence in rheumatoid arthritis patients contributes to controlling symptom and inflammation, preventing the progressive structural damage. This study demonstrated that the telehealth educational intervention could improve patients' medication adherence but did not have a direct impact on clinical condition in the short‐term. The intervention for discharged patients with rheumatoid arthritis can be integrated into the clinical setting by the nursing staff as follow‐up care.

Trial registration number: ChiCTR‐IPR‐14005722.

目的

探讨针对性的远距照护教育干预对类风湿性关节炎(RA)出院患者用药依从性和疾病活动性的影响。

设计

非盲随机对照试验。

方法

自2015年1月至2015年12月期间共招募92名符合条件的患者。将参与者随机分为两组:干预组(N=46)和对照组(N=46)。干预组在为期12周的干预措施中通过电话共接受了4次照护教育。教育内容主要包括:受试者疾病知识指导;治疗目标;正确服药的重要性;副作用管理;记住服药。而对照组仅接受标准护理,包括出院指导。结果指标包括用药依从性和疾病活动性。

结果

干预组在第12周和第24周的用药依从性明显高于对照组。两组在第12周和第24周的疾病活动性无显著差异。

结论

通过电话进行的针对性的教育干预可有效提高类风湿性关节炎出院患者的用药依从性。然而,尚未发现干预对疾病活动性有显著影响。

影响

类风湿性关节炎患者良好的用药依从性有助于控制症状和炎症,防止出现进行性结构损伤。本项研究表明,远距照护教育干预可提高患者的服药依从性,但短期内对临床状况无直接影响。针对类风湿性关节炎出院患者的干预可由护理人员纳入临床环境作为后续护理。试验注册号:ChiCTR‐IPR‐14005722。

Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review

Por: Zhao · Q. · Shen · J. · Lu · J. · Li · F. · Jiang · Q. · Wang · Y.
Introduction

Aliskiren is a newly developed medicine. As one of the effective renin–angiotensin–aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy.

Methods and analysis

A comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger’s test to evaluate if the reporting bias existed.

Ethics and dissemination

Ethical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.

PROSPERO registration number

CRD42019142141.

Oral propranolol for treatment of the subgroups of essential tremor: a systematic review and meta-analysis protocol

Por: Zhang · M. · Li · W. · Hu · L. · Chen · L. · Yang · L. · Zhang · T. · Shen · H. · Peng · Y. · Gao · S. · Chen · Z. · Wang · T. · Zhao · Z.
Introduction

Essential tremor (ET), a tremor disorder, is one of the most common movement disorders. Only oral drugs (propranolol, primidone, topiramate, etc)are still the first-line treatment recommended by the Food and Drug Administration. Propranolol is thought to potentially reduce upper limb action tremor. However, it has a poor effect on axial tremor symptoms, such as essential head tremor and voice tremor. Studies have shown that tremor severity develops over time, possibly producing other clinical tremors and neurological soft signs (such as memory loss, gait abnormalities, balance disorders, etc), which further increases the difficulty of treating tremors. However, some recent studies provide emerging evidence for oral propranolol on subgroups of ET, which is based on the anatomical distribution of ET (lower extremities, head, sound, tongue, etc). This systematic review aims to synthesise these new data to improve the efficacy of propranolol in ET subgroups.

Methods and analysis

We will search for randomised controlled trials from the PubMed, MEDLINE, EMBASE, Cochrane Library, UptoDate and PEDro databases from inception to June 2019. All data will be extracted independently by two reviewers and compared at the end of the review. The two reviewers will screen the study quality, and the Cochrane Collaboration’s tool in Review Manager (RevMan) V.5.3.3 will be used to evaluate risk of bias. Our primary outcome will be the functional disability component related to tremors, as measured by the Fahn-Tolosa-Marin Tremor Rating Scale subscales B and C. Secondary outcomes will include severity of tremors and quality of life. Narrative and meta-analytical syntheses are planned.

Ethics and dissemination

Published aggregated data will be used in this review analysis and therefore no ethical approval is required. The results will be published in peer-reviewed journals, and proliferation activities will include diverse social stakeholders, non-academic groups and patients.

PROSPERO registration number

CRD42018112580

Acupuncture for emotional disorders in patients with migraine: a systematic review protocol

Por: Sun · N. · Sun · M. · Li · Z. · Sun · R.-R. · Zhao · L. · Chen · J. · Liang · F.-r.
Introduction

Migraine is the second-leading cause of years lived with disability worldwide. The high prevalence of migraine-related emotional disorders is often overlooked. Acupuncture is often used to treat both migraine and emotional disorders. This systematic review protocol aims to analyse whether acupuncture is effective for treating emotional disorders in patients with migraine.

Methods and analysis

Nine databases will be searched from inception to may 2019: cochrane central register of controlled trials, medline, embase, allied and complementary medicine database, cinahl, china national knowledge infrastructure, chinese biomedical literature database, vip database and wanfang database. Randomised controlled trials (rcts) of acupuncture therapy for migraine with emotional functioning outcomes, which were reported in chinese or english, will be included. The primary outcome is the change in emotional functioning. Study selection, data extraction and assessment of the risk of bias will be performed independently by two or more reviewers. Revman software (v.5.3) will be used to perform the assessment of the risk of bias and data synthesis.

Ethics and dissemination

Ethics approval is not be needed because the data will not contain individual patient data, and there are no concerns about privacy. The results of this meta-analysis will be disseminated through publication in a peer-reviewed journal or relevant conference.

Trial registration number

CRD42019139433.

All-cause mortality following low-dose aspirin treatment for patients with high cardiovascular risk in remote Australian Aboriginal communities: an observational study

Por: Zhao · Y. · Jeyaraman · K. · Burgess · P. · Connors · C. · Guthridge · S. · Maple-Brown · L. · Falhammar · H.
Objectives

To evaluate the benefit and risk of low-dose acetylsalicylic acid (aspirin) in patients from remote Aboriginal communities in the Northern Territory, Australia.

Design

Retrospective cohort study using primary care and hospital data routinely used for healthcare. Aspirin users and non-users were compared before and after controlling confounders by matching. Marginal structural models (MSM) were applied to ascertain the benefit and risk.

Setting

The benefit and harm of aspirin were investigated in patients aged ≥18 years from 54 remote Aboriginal communities.

Participants

None had a previous cardiovascular event or major bleeds. Patients on anticoagulants or other antiplatelets were excluded.

Intervention

Aspirin at a dose of 75–162 mg/day.

Outcome measures

Endpoints were all-cause, cardiovascular mortality and incidences of cardiovascular events and major bleeds.

Results

8167 predominantly Aboriginal adults were included and followed between July 2009 and June 2017 (aspirin users n=1865, non-users n=6302, mean follow-up 4 years with hospitalisations 6.4 per person). Univariate analysis found material differences in demographics, prevalence of chronic diseases and outcome measures between aspirin users and non-users before matching. After matching, aspirin was significantly associated with reduced all-cause mortality (HR=0.45: 95% CI 0.34 to 0.60; p

Conclusion

Aspirin was associated with reduced all-cause mortality. Bleeding risk was less compared with survival benefits. Aspirin should be considered for primary prevention in Aboriginal people with high cardiovascular risk.

Effects of photoelectric therapy on proliferation and apoptosis of scar cells by regulating the expression of microRNA‐206 and its related mechanisms

Abstract

Human skin fibroblast (HSF) cells were irradiated with different energy lasers to detect cell proliferation, apoptosis, and expression of microRNA‐206 and protein, and to further summarise the therapeutic effect of laser on scar cells. Human scar cell line HSF cells were cultured in three groups. The control group was not irradiated by laser, the low‐energy group was irradiated by 10 J/cm2 laser, and the high‐energy group was irradiated by 20 J/cm2 laser. After irradiation, HSF cells were cultured for 20 hours. Cell proliferation was detected by MTT assay. Cell cycle and apoptosis were detected by flow cytometry. Transwell migration assay was used to detect cell migratory ability. Reverse transcription polymerase chain reaction (RT‐PCR) was used to detect miR‐206 and mTOR gene levels. The levels of MMP‐9, Bax, Bcl‐2, cyclin D1, and mTOR signalling pathway proteins were detected by Western blotting assays. The results showed that after laser irradiation, the proliferation of cells decreased, and the difference between the control group and the experimental group was significant (P < .05). The higher the energy was, the greater the upregulation of apoptosis was. Apoptosis and cell migration increased (P < .05). The expressions of microRNA‐206, MMP‐9, and Bax were upregulated, while the expressions of mTOR, Bcl‐2, and cyclin D1 were downregulated. To sum up, laser irradiation can significantly inhibit the proliferation of HSF cells, affect cell cycle, and increase cell apoptosis and migratory ability.

Surgical site infection following traumatic orthopaedic surgeries in geriatric patients: Incidence and prognostic risk factors

Abstract

Geriatric population is increasing rapidly worldwide, and fragility fracture and complication following orthopaedic surgery in elderly people have now become major challenges for surgeons. Further studies are required to identify potentially modifiable factors associated with surgical site infection (SSI) in geriatric patients. This retrospective, multicenter study was conducted at four level I hospitals in China. During the 31‐month study period, a total of 2341 patients (65 years or older) underwent orthopaedic surgery and complete data were recorded from September 2015 to April 2018. Demographics information, medications and additional comorbidities, surgery‐related variables, and laboratory indexes were extracted and analysed. Receiver‐operating characteristic analysis was performed to detect the optimum threshold of continuous variables. Independent risk factors of SSI were identified by univariate and multivariate analyses. Finally, 63 patients suffered from wound infection within the follow‐up period, indicating a 2.7% incidence rate of SSI. Statistical results showed that open injury (odds ratio [OR], 9.5; 95% confidence interval [CI], 5.4‐16.7), American Society of Anesthesiologists classified III‐IV score (OR, 2.2; 95% CI, 1.3‐3.8), surgical duration of >132 minutes (OR, 2.9; 95% CI, 1.1‐5.0), serum albumin (ALB) of <36.4 mg/L (OR, 2.0; 95% CI, 1.6‐3.4), and blood glucose (GLU) of >118 mg/dL (OR, 3.1; 95% CI, 1.1‐5.3) were independent risk factors of postoperative SSI. With the application of sensitive and modifiable variables such as surgical duration and the levels of ALB and GLU, more geriatric patients with sub‐high risk of postoperative SSI could be identified.

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