The aim of this study was to systematically evaluate the quality of the clinical practice guidelines (CPGs) for diabetes mellitus published in China over the period of January 2007 to April 2017.
We searched the China National Knowledge Infrastructure, Chinese Biomedical Literature database, VIP database and WanFang databases and guideline websites for CPGs for diabetes mellitus published between January 2007 and April 2017 in China. Two reviewers independently screened the literature according to the inclusion and exclusion criteria and extracted data. We used the the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool (Canadian Institutes of Health Research, Ottawa, Canada) to evaluate the quality of the included guidelines, calculated the scores of each domain and evaluated the consistency among the assessors via use of the intragroup correlation coefficient. And then we compared the results with Chinese CPGs and international CPGs. We conducted a subgroup analysis based on different classification criteria and compared scores of each domain subgroup analyses.
A total of 98 guidelines were identified. The correlation coefficient within the group was 0.93, suggesting that the consistency between the evaluators was good. The scores of the six domains of AGREE II were described in median (IQR) as follows: scope and purpose 53.7 (50.0–59.7), stakeholder involvement 31.5 (27.3–37.0), rigour of development 19.1 (15.3–22.2), clarity of presentation 59.3 (50.0–64.8), applicability 18.1 (13.9–25.7) and editorial independence 0.0 (0.0–0.0). The mean score in each domain of quality of Chinese diabetes CPGs was lower than that of CPGs published worldwide but higher than the mean score of Chinese guidelines of all topics. A funding source, the updated version, organisation and publishers of the guidelines and target fields are all the factors influencing the quality of CPGs to a certain degree.
A large number of Chinese diabetes CPGs have been produced. Their quality remain unsatisfactorily low compared with CPGs worldwide, there is still room for improvement. Chinese guideline developers should pay more attention to the transparency of methodology, and use the AGREE II instrument to develop and report guidelines.
Nut consumption has been associated with a lower risk of type 2 diabetes, metabolic syndrome and insulin resistance. However, its effect on the risk of non-alcoholic fatty liver disease (NAFLD) is unknown. Therefore, we investigated the relationship between nut consumption and NAFLD risk.
We conducted a retrospective case-control study including 534 patients diagnosed with NAFLD and 534 controls matched by sex and age (±5 years) from the Affiliated Nanping First Hospital of Fujian Medical University in China.
Information on dietary intake was collected using a semiquantitative food frequency questionnaire and nut consumption was calculated. Nut consumption was categorised using quartiles based on the distribution of daily nut intake of the controls. Binary logistic regression models were used to estimate ORs and the 95% CIs for the association between nut consumption and NAFLD risk.
After adjusting for potential confounding variables, nut consumption was not associated with NAFLD risk in the overall sample. When the fully adjusted model was stratified by sex, a significant inverse association was found between high nut consumption and NAFLD only among the men in the highest quartile (OR=0.43; 95% CI 0.26 to 0.71; P trend = 0.01). The inverse association of nut consumption with NAFLD risk in men remained significant after controlling for other known or suspected risk factors for NAFLD.
Diets with a higher intake of nuts may be associated with a decreased risk of NAFLD, particularly in men.
The use of negative‐pressure wound therapy (NPWT) has displayed significant clinical benefits in the healing of infected wounds. However, the effects of NPWT on bacterial colonisation and infection of traumatic wounds has been controversial. The aim of this study is to evaluate the impact of NPWT treatment in rabbits with a contaminated full‐thickness wound on bacterial behaviour, including colony morphology, spatial distribution, fissional proliferation, and bacterial bioburden. Full‐thickness wounds were created on the back of rabbits, and were inoculated with bioluminescent Staphylococcus aureus. The wounds were treated with sterile gauze dressings and NPWT with continuous negative pressure (−125 mm Hg). Wound samples were harvested on days 0 (6 hours after bacterial inoculation), 2, 4, 6, and 8 at the centre of wound beds before irrigation. Scanning electron microscopy and transmission electron microscopy (TEM) analyses were performed to determine the characteristic bacteriology. Laser scanning confocal microscopy was performed to obtain bioluminescent images, which were used to observe spatial distribution of the GFP‐labelled S. aureus within the tissue and quantify the bacterial bioburden. NPWT resulted in sparse amounts of scattered bacteria on the wound surface or as sparsely spaced single colonies within the tissue. Wound bioburden on day 8 in the NPWT and gauze groups was 34.6 ± 5.5% and 141.9 ± 15.4% of the baseline values (N = 6), respectively (P < .0001). TEM showed a lack of S. aureus active fission within NPWT‐treated tissue. NPWT can impact S. aureus colony morphology and spatial distribution both on the surface and within wound tissue, and reduce S. aureus as early as 48 hours after therapy initiation. Additionally, NPWT inhibits bacterial fissional proliferation in microcolonies.
To investigate anticoagulant adherence and its associated factors, including demographics, clinical variables, atrial fibrillation (AF) severity, knowledge, satisfaction with services, perceived barriers, perceived benefits, symptom severity and self-efficacy in patients with AF.
This is a cross-sectional study.
A convenient sample of patients with AF were recruited from cardiology clinics of two teaching hospitals in Taiwan.
Data were collected using the study questionnaires, including the AF-related symptom subscale of the AF Severity Scale, the Knowledge of Warfarin Anticoagulation Treatment Scale, the Satisfaction Scale about Service and Warfarin Treatment, the perceived benefits subscale of the Beliefs about Anticoagulation Survey, the Concerns about Anticoagulation Therapy Scale, The Self-efficacy for Appropriate Medication Use Scale and the short-form Adherence to Refills and Medications Scale.
A total of 151 patients with AF participated in the study; 53 treated with warfarin and 98 treated with novel oral anticoagulants (NOACs). The difference in adherence to warfarin (mean=8.6; SD=1.6) and NOACs (mean=8.9; SD=2.0) was statistically insignificant. Multiple linear regression analysis showed that perceived barriers (β=0.18, p=0.017) and self-efficacy (β=–0.48, p(2,149)=38.11, p
We found no better adherence to NOACs compared with warfarin. Patients with greater self-efficacy and perceived fewer barriers showed better adherence to anticoagulation therapy.
To estimate the prevalence and influencing factors of physical activity (PA) and sedentary behaviour (SB) in rural areas of China.
A multistage, stratified cluster sampling method was used to obtain samples in the general population of Henan province in China.
38 515 participants aged 18–79 years were enrolled from the Henan Rural Cohort Study for the cross-sectional study.
The International Physical Activity Questionnaire was used to assess the levels of PA and SB. Multiple logistic regression analysis was used to calculate ORs and 95% CIs of potential influencing factors with physical inactivity.
The age-standardised prevalence of light PA and sitting >7.5 hours per day were 32.74% and 26.88% in the general Chinese rural adults, respectively. Gender differences were: 34.91%, 29.76% for men and 31.75%, 25.16% for women, respectively. The prevalence of participants with both light PA and sitting >7.5 hours per day was 13.95%. Education at least junior middle school, divorced/widowed/unmarried, RMB1000> per capita monthly income ≥RMB500, sitting >7.5 hours per day were negatively associated with light PA. For sitting >7.5 hours per day, the negative factors were being men, divorced/widowed/unmarried, heavy smoking, Fishery products, vegetable and fruits intake .
Physical inactivity and SB were high in rural China. There is an increased need to promote a healthy lifestyle to the rural population.
The Henan Rural Cohort Study has been registered with the Chinese Clinical Trial Register.
Registration number: ChiCTR-OOC-15006699. http://www.chictr.org.cn/showproj.aspx?proj=11375
To examine the effects of a transtheoretical model‐based WeChat health education program on self‐management in hemodialysis patients in China.
A longitudinal experimental intervention study.
Patients (n=120) who underwent hemodialysis from December 2015 ‐ November 2017 were recruited and randomly allocated to either group 1 (who received a 3‐month WeChat health education immediately after randomization) or group 2 (who was combined with group 1 and received the same intervention at the 5th month after enrollment in the study). Self‐management, knowledge and self‐efficacy were assessed at baseline (T0), 3‐month after enrollment in the study (T1), 21‐month after enrollment in the study (T2).
There were significant group effects on self‐efficacy; time effects on partnership, self‐care, emotion management with total self‐management; interaction effects on problem‐solving and emotion management within total self‐management according to the two‐way repeated measures ANCOVA. Further between‐group comparisons indicated that patients in group 1 had better self‐management than those in group 2 at T1. Within‐group comparisons demonstrated that, compared with the baseline values, group 1 had significantly improved self‐management at T1; however, group 2 had improved self‐management at T2.
The transtheoretical model‐based WeChat health education program had a potentially positive effect on improving the self‐management of hemodialysis patients.
Self‐management is often difficult yet crucial for hemodialysis patients. This study indicated that the transtheoretical model‐based WeChat health education resulted in improved self‐management in hemodialysis patients and can be implemented in continuing care during the interdialysis period to improve self‐management in patients.
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Despite the publication of hundreds of trials on gout and hyperuricemia, management of these conditions remains suboptimal. We aimed to assess the quality and consistency of guidance documents for gout and hyperuricemia.
Systematic review and quality assessment using the appraisal of guidelines for research and evaluation (AGREE) II methodology.
PubMed and EMBASE (27 October 2016), two Chinese academic databases, eight guideline databases, and Google and Google scholar (July 2017).
We included the latest version of international and national/regional clinical practice guidelines and consensus statements for diagnosis and/or treatment of hyperuricemia and gout, published in English or Chinese.
Two reviewers independently screened searched items and extracted data. Four reviewers independently scored documents using AGREE II. Recommendations from all documents were tabulated and visualised in a coloured grid.
Twenty-four guidance documents (16 clinical practice guidelines and 8 consensus statements) published between 2003 and 2017 were included. Included documents performed well in the domains of scope and purpose (median 85.4%, range 66.7%–100.0%) and clarity of presentation (median 79.2%, range 48.6%–98.6%), but unsatisfactory in applicability (median 10.9%, range 0.0%–66.7%) and editorial independence (median 28.1%, range 0.0%–83.3%). The 2017 British Society of Rheumatology guideline received the highest scores. Recommendations were concordant on the target serum uric acid level for long-term control, on some indications for urate-lowering therapy (ULT), and on the first-line drugs for ULT and for acute attack. Substantially inconsistent recommendations were provided for many items, especially for the timing of initiation of ULT and for treatment for asymptomatic hyperuricemia.
Methodological quality needs improvement in guidance documents on gout and hyperuricemia. Evidence for certain clinical questions is lacking, despite numerous trials in this field. Promoting standard guidance development methods and synthesising high-quality clinical evidence are potential approaches to reduce recommendation inconsistencies.
To investigate the relationship between gay app use and HIV testing among men who have sex with men (MSM).
Serial cross-sectional study.
A newly well-developed city in China.
4935 MSM were recruited through offline sampling methods from 2015 to 2017.
The primary outcome is the difference in HIV testing between app and non-app users.
2872 (58.2%) and 2159 (43.7%) participated MSM had been tested for HIV within lifetime and the past year, respectively. Compared with non-app-using MSM, app-using MSM had a significantly higher prevalence of HIV testing within lifetime (adjusted OR (AOR): 1.48, 95% CI 1.27 to 1.72) and the past year (AOR: 1.36, 95% CI 1.18 to 1.57). App-using MSM were more likely to take an HIV test at the Centers for Disease Control and Prevention (AOR: 1.48, 95% CI 1.24 to 1.76) and community-based organisations (AOR: 1.71, 95% CI 1.44 to 2.03), but less often at gay venues (AOR: 0.49, 95% CI 0.37 to 0.63). Meanwhile, app-using MSM were more likely to take self-testing (AOR: 1.61, 95% CI 1.21 to 2.14). Predictors of HIV testing in the past year were: having an education level of college or higher (AOR: 1.29, 95% CI 1.01 to 1.65), being self-identified as a homosexual (AOR: 1.23, 95% CI 1.02 to 1.46), being recruited through clinic-based sampling (AOR: 1.30, 95% CI 1.06 to 1.60), using gay app (AOR: 1.49, 95% CI 1.21 to 1.83), engaging in group sex (AOR: 1.64, 95% CI 1.23 to 2.19), having received HIV-related service (AOR: 5.49, 95% CI 4.57 to 6.60), having a high level of HIV-related knowledge (AOR: 1.33, 95% CI 1.10 to 1.61) and high-risk perception (AOR: 2.95, 95% CI 1.40 to 6.23).
Gay app use was significantly associated with increased HIV testing among MSM hard to reach by traditional outreach. Therefore, it is imperative to expand HIV testing among non-app-using MSM. Continued efforts, innovative strategies and increased resource are highly needed to realise the first ‘90’ target.
In this study, we aimed to present the epidemiological characteristics of elevated blood pressure among middle and high school students aged 12–17 years in Jiangsu Province.
Hypertension, which is considered a rare disease in children, is an important early precursor to long-term cardiovascular damage, and elevated blood pressure in childhood is a strong predictor of hypertension in adulthood.
Physical examination and questionnaire investigation among children aged 12–17 years in Jiangsu Province were conducted from 2017 to 2018.
Physical measurements included height, weight, blood pressure and history of menarche/first spermatorrhoea. Questionnaire investigation included family type, delivery mode, lifestyle habits and psychological test.
In our study we investigated 17 791 middle and high school students, consisting of 8701 female students and 9090 male students. The prevalence of screening elevated blood pressure among students aged 12–17 years was 20.0% (95% CI 19.2% to 20.9%) for female students and 22.3% (95% CI 21.5% to 23.2%) for male students. The prevalence of screening elevated blood pressure for urban male middle and high school students was higher than that of elevated blood pressure for rural male middle and high school students. However, similar phenomenon cannot be observed among female students. For both male and female students, body mass index (BMI), obesity/overweight and menarche/first spermatorrhoea can be a risk factor contributing to elevated blood pressure, and sleep time and regional distribution might be important factors that need to be investigated in depth.
We found a relatively high prevalence of screening elevated blood pressure among students aged 12–17 years for both female and male students in Jiangsu Province. The risk factors can be BMI, obesity/overweight and menarche/first spermatorrhoea.
This study examines the incidence and spatial clustering of phenylketonuria (PKU) in China between 2013 and 2017.
Data from the Chinese Newborn Screening Information System were analysed to assess PKU incidence with 95% CIs by province, region and disease severity. Spatial clustering of PKU cases was analysed using global and local spatial autocorrelation analysis in the geographic information system.
The database contained 4925 neonates with confirmed PKU during the study period, corresponding to an incidence of 6.28 (95% CI: 6.11 to 6.46) per 100 000 neonates screened. Incidence was highest in the provinces of Gansu, Ningxia and Qinghai, where it ranged from 19.00 to 28.63 per 100 000 neonates screened. Overall incidence was higher in the northern part of the country, where classical disease predominated, than in the southern part, where mild disease predominated. PKU cases clustered spatially (global Moran’s I=0.3603, Z=5.3097, p
China shows an intermediate PKU incidence among countries, and incidence differs substantially among Chinese provinces and between northern and southern regions. Our results suggest the need to focus efforts on screening, diagnosing and treating PKU in high-incidence provinces.
To adapt the Child Food Neophobia Scale (CFNS) cross-culturally for use among 12-36-month-old Chinese toddlers and to perform a preliminary assessment of its construct validity and reliability.
Food neophobia is the fear of eating new or unfamiliar foods, which affects the type and quality of individual dietary intake, especially during early childhood. However, measurements of child food neophobia have rarely been reported in China due to a lack of reliable and valid measurements.
The CFNS was translated and adapted into a Chinese version (CFNS-CN) through a forward translation, reconciliation, a back translation, expert review and pretesting. The construct validity and reliability of the CFNS-CN were tested in 390 caregivers of 12–36 months old Chinese toddlers through convenience sampling in Changsha Maternal and Child Health Care Hospital, Hunan Province, China. The internal consistency, confirmatory factor analysis (CFA) and reliability were estimated.
The kappa coefficients indicated moderate to perfect agreement between the test and retest, and Cronbach’s α coefficient was 0.91. A normal 2/df, CMIN/DF=3.302, Comparative Fit Index, CFI=0.993, Tucker-Lewis Index, TLI=0.986 and root mean square error of approximation, RMSEA=0.077 were found. The CFA results showed that the model indicators were acceptable. High food neophobia was observed in 25.1% of individuals.
The CFNS-CN showed good internal consistency reliability and construct validity. The CFNS-CN may become an effective tool for assessing food neophobia in Chinese toddlers.
This trial was pre-registered at the China Clinical Trial Registration Center under registration number ChiCTR1800015890.
To assess the efficacy and safety of green-light laser photoselective vaporisation of the prostate (PVP) compared with transurethral resection of the prostate (TURP) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Systematic review and meta-analysis, conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement.
PubMed, EMBASE, the Cochrane Library until October 2018.
Randomised controlled trials and prospective studies comparing the safety and efficacy of PVP versus TURP for LUTS manifesting through BPH.
Perioperative parameters, complications rates and functional outcomes including treatment-related adverse events such as International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), postvoid residual (PVR), quality of life (QoL) and International Index of Erectile Function (IIEF).
22 publications consisting of 2665 patients were analysed. Pooled analysis revealed PVP is associated with reduced blood loss, transfusion, clot retention, TUR syndrome, capsular perforation, catheterisation time and hospitalisation, but also with a higher reintervention rate and longer intervention duration (all p
PVP is an effective alternative, holding additional safety benefits. PVP has equivalent long-term IPSS, Qmax, QoL, PVR, IIEF efficacy and fewer complications. The main drawbacks are dysuria and reintervention, although both can be managed with non-invasive techniques. The additional shortcoming is that PVP does not acquire histological tissue examination which removes an opportunity to identify prostate cancer.
To document the factors, and their pathways, that influence healthcare and antibiotics use following reported gastrointestinal illnesses in Anhui province, China.
This study uses cross-sectional design, descriptive statistical analysis, pathway mapping and multivariate logistic regression modelling.
Households in 12 villages in Anhui province, China.
A total of 3659 residents who: (1) held a registered rural residence and were actually living in the sampled villages when this study was conducted; (2) were aged 18 years and older and (3) were willing to participate and able to answer the survey questions.
Planned and measured variables included the occurrence of gastrointestinal illness, professional care seeking and antibiotic use due to the illness and factors influencing these measures.
Of the 3659 informants, 29.0% reported gastrointestinal illness episodes in the past year. Of these episodes, 50.2% led to professional care seeking and 65.4% of antibiotic use. Multivariate logistic modelling identifies that: (1) reported gastrointestinal illnesses were more frequent in north compared with middle (OR 0.569, 95% CI 0.472 to 0.686) and south (OR 0.588, 95% CI 0.492 to 0.702) Anhui, and were positively associated with age (B=0.123, p
Reported gastrointestinal illnesses are quite prevalent in the sample population and a large proportion of these have resulted in professional care and antibiotics use. The factors associated with the reported illnesses and pathways of healthcare and antibiotic use, as identified in this study, should inform future research and intervention efforts.
The importance of health-related quality of life (HRQoL) is increasing and many healthcare authorities recommend the use of measures that account for both mortality and morbidity. This study will determine, for the first time in Romania, value sets for EuroQoL-five-dimensions-3-level (EQ-5D-3L) and EQ-5D-5L questionnaires and their population norms (study 1). It will also compare the HRQoL (measured with EQ-5D-5L) of Roma communities in Romania with that of the general population (study 2).
Cross-sectional studies of face-to-face interviews conducted in representative samples of the Romanian general population and Romanian Roma communities. 1614 non-institutionalised adults older than 18 years will be interviewed using a computer-assisted interview for study 1. Participants will complete EQ-5D-3L and 5L, 13 composite time trade-off tasks (cTTO), 7 discrete choice experiment questions (DCE) and sociodemographic questions. For study 2, 606 non-institutionalised self-identified Roma people older than 18 years will be interviewed using a pencil-and-paper interview. Participants will complete EQ-5D-5L and the same sociodemographic questions as for study 1. The 3L value set will be estimated using econometric models and the cTTO data. cTTO and DCE data will be used for the 5L value set. Population norms will be reported by age and gender. The ORs for reporting different levels of problems and the most common health states in the population will be estimated. For study 2, t-tests and analysis of variance will be used to explore differences between groups in HRQoL and for each EQ-5D.
Ethics approval was given by the National Bioethics Committee of Medicines and Medical Devices Romania and Newcastle University’s Research Ethics Committee. Results will be published in peer-reviewed journals, presented at scientific conferences and on the project’s website. The EQ-5D-5L anonymised datasets will be deposited in a centralised repository. Two public workshops with local authorities, physicians and patients’ associations will be held.
Ethnic, demographic, lifestyle, genetic and environmental factors influence lipids and apolipoproteins. The aim of this study was to establish age-specific and gender-specific reference intervals for non-fasting lipids and apolipoproteins in healthy Chinese children and adolescents.
This study followed the Clinical and Laboratory Standards Institute EP28-A3c guidelines. Non-fasting samples were collected from 7260 healthy Chinese children and adolescents, and they were analysed using the Olympus AU5400 analyser for: triglycerides, total cholesterol (TC), high-density lipoprotein cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 and apolipoprotein B (ApoB). The age-related and gender-related reference intervals were partitioned using the Harris-Boyd method. The non-parametric method was used to establish the lower limit (2.5th percentile) and the upper limit (97.5th percentile) for the reference intervals. The 90% CIs for the lower and upper limits were also calculated.
Based on the Harris-Boyd method, gender partitions were required for TC, LDL-C and ApoB. Age differences were observed for all analytes. Paediatric reference intervals were established for non-fasting lipids and apolipoproteins based on a large population of healthy children and adolescents.
Previously used reference intervals did not take age and gender into account. These age-specific and gender-specific reference intervals established in this study may contribute to improved management and assessment of paediatric diseases.
Mother-to-child transmission (MTCT) is one of the main transmission routes of HIV, and the probability of MTCT can be dramatically reduced with comprehensive interventions. In southwest and western regions in China, the level of development in rural areas is relatively backwards and retains some original features, which also increases the difficulty of controlling infectious diseases. The Liangshan Prefecture started the prevention of MTCT programme in 2009. However, the implementation of the programme is not ideal, and the coverage of HIV testing is still low. Many Yi (local major ethnicity) women did not take antenatal care (ANC) and just gave birth to their babies at home for a variety of reasons.
Women with pregnancy history in the last 5 years were recruited from two townships based on cluster sampling. Face-to-face interviews were conducted to collect data. Descriptive analysis was performed to describe demographic characteristics, history of pregnancy and ANC uptake, knowledge of and attitudes towards ANC. Multivariable analysis was used to identify factors associated with uptake of ANC.
Among 538 women who completed the questionnaires, 77.9% knew that ANC was necessary during and after pregnancy. However, only 24.2% actually accessed ANC. Almost all women (94.6%) expressed their willingness to receive ANC for pregnancy but barriers towards actual uptake of ANC existed including shyness, lack of independence and unavoidable cost. Multivariate analysis showed that no experience of living outside of Zhaojue for more than 6 months, higher number of births, not knowing the necessity of ANC during pregnancy and not knowing the government’s promotion policies for ANC were associated with lack of ANC uptake.
Although ethnic minority women in rural Liangshan expressed strong intention to use ANC, actual uptake of ANC was low. Knowledge of ANC and HIV prevention for MTCT should be improved among this population, and efforts should be made to help them overcome barriers to accessing ANC.
Identifying the patients who are at risk for contrast-induced acute kidney injury (CI-AKI), which is defined as an increase in serum creatinine after exposure to contrast media, is a critical step in targeted prevention strategies. The absolute and relative importance of individual risk factors have not been systematically evaluated, let alone the new, controversial and modifiable risk factors of CI-AKI.
On 1 July 2019, a search was performed on MEDLINE, Embase and the Cochrane Database of Systematic Reviews. We will perform a systematic review and meta-analysis to assess the important risk factors for developing CI-AKI, including those new, modifiable factors, which are considered controversial. The secondary endpoint will be all-cause mortality. Two authors will then independently screen studies that meet the criteria for inclusion, consulting with a third author to resolve any dispute. The quality of the included studies will be assessed according to the Newcastle-Ottawa scale.
Ethics approval in this systematic review and meta-analysis protocol is not needed. We will disseminate the findings of this systematic review and meta-analysis via publications in peer-reviewed journals.
As the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.
This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.
This study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.