补肾健脾活血法治疗 2 型糖尿病骨质疏松症的疗效和安全性的系统评价和荟萃分析方案。
The efficacy and safety of traditional Chinese medicine's tonifying-kidney, strengthening-spleen, and invigorating-blood circulation (Bushen-Jianpi-Huoxue) principle for type 2 diabetes mellitus with osteoporosis: A protocol for systematic review and meta-analysis.
机构信息
The Third Clinical Medical College.
Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine.
出版信息
Medicine (Baltimore). 2021 Mar 26;100(12):e25197. doi: 10.1097/MD.0000000000025197.
BACKGROUND
Type 2 diabetes mellitus (T2D) and osteoporosis (OP) often coexist, and both are systemic metabolic diseases and seriously increase the risk of fragility fracture. However, there is no specific Western medicine for the treatment of T2D with OP (T2DOP). As reported in clinical and experimental studies, traditional Chinese medicine (TCM) based on principle of tonifying-kidney, strengthening-spleen, and invigorating blood circulation (Bushen-Jianpi-Huoxue) (BSJPHX) has significant efficacy against T2DOP. This protocol will be designed for a systematic review and meta-analysis to assess the efficacy and safety of TCM BSJPHX principle in the treatment of T2DOP.
METHODS
All relevant randomized controlled trials (RCTs) related to TCM therapies conducted in BSJPHX principle for T2DOP will be searched in the 8 electronic databases: PubMed, Cochrane Library, Wed of Science, EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Biomedical Literatures Database (CBM), Chinese Scientific Journal Database (VIP), Wanfang Database, from inception to October 2020. The main outcomes will contain: fasting blood glucose (FPG), 2 hours postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), serum calcium, bone mineral density (BMD), TCM syndrome integral, and the additional outcomes will consist of visual analog scale (VAS), and adverse events. Two reviewers will independently carry out literature search, data selection and synthesis, and literature quality assessment. In case of any dispute, it will be settled by group discussion. Assessment of risk of bias, reporting bias, and data synthesis would be performed with Review Manager software (Rev-Man 5.3).
RESULT
This study will collate and summarize the various current evidences of TCM BSJPHX principle for T2DOP.
CONCLUSION
This study will offer convincing evidence for judging the efficacy and safety of TCM BSJPHX principle for T2DOP.
PROSPERO REGISTRATION NUMBER
CRD42020218877.
背景
2 型糖尿病（T2DM）和骨质疏松症（OP）常并存，两者均为全身性代谢性疾病，严重增加脆性骨折风险。然而，对于 T2DM 伴 OP（T2DOP），尚无特定的西药治疗方法。临床和实验研究报道，基于补肾健脾活血（BSJPHX）原则的中药对 T2DOP 具有显著疗效。本方案将设计为系统评价和荟萃分析，以评估中药 BSJPHX 原则治疗 T2DOP 的疗效和安全性。
方法
将检索 8 个电子数据库（PubMed、Cochrane 图书馆、Web of Science、EMBASE、中国知网（CNKI）、中国生物医学文献数据库（CBM）、中国科学引文数据库（VIP）、万方数据库）中所有关于中药治疗 T2DOP 的 BSJPHX 原则相关的随机对照试验（RCT），检索时间为建库至 2020 年 10 月。主要结局指标包括空腹血糖（FPG）、餐后 2 小时血糖（2hPG）、糖化血红蛋白（HbA1c）、血清钙、骨密度（BMD）、中医证候积分，次要结局指标包括视觉模拟评分（VAS）和不良事件。由 2 位评价员独立进行文献检索、数据选择和综合、文献质量评价。如有分歧，通过小组讨论解决。采用 Review Manager 软件（RevMan 5.3）评估偏倚风险、报告偏倚和数据综合。
结果
本研究将整理和总结目前中药 BSJPHX 原则治疗 T2DOP 的各种证据。
结论
本研究将为判断中药 BSJPHX 原则治疗 T2DOP 的疗效和安全性提供有说服力的证据。
注册编号
CRD42020218877。
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