[关键词]
[摘要]
目的 对中成药治疗绝经后骨质疏松症的系统评价/Meta分析进行再评价,以期为中成药的临床实践和决策提供证据支持。方法 运用计算机检索中国知网、中国生物医学数据库、万方、维普、Embase、PubMed、Cochrane Library数据库,检索时限均为建库至2023年6月20日,收集中成药治疗绝经后骨质疏松症的系统评价/Meta分析。通过建立文献重叠矩阵,计算校正后重叠面积(corrected covered area,CAA)评价原始文献重复率;采用系统评价的偏倚风险工具(risk of bias in systematic reviews,ROBIS)对纳入文献的偏倚风险评估进行评价;运用,AMSTAR-2评价工具对纳入文献进行方法学质量评价,运用PRISMA 2020声明对中成药治疗绝经后骨质疏松症系统评价/Meta分析的文献报告质量进行综合评估。另外,运用GRADE对所有纳入文献的结局指标进行质量分级。结果 共纳入6种中成药及其10篇系统评价/Meta分析,AMSTAR-2方法学质量评价结果显示纳入研究均为极低质量。PRISMA 2020报告质量评价结果显示纳入研究得分为18~30,其中8篇为中等质量,2篇为低质量。GRADE分析结果显示2项证据级别为中级,23项为低级,16项为极低级。ROBIS工具分析显示3项研究为低偏倚风险,7项研究为高偏倚风险。CCA为0.453,表示原始文献重复率较低。结论 目前中成药治疗绝经后骨质疏松症在改善骨密度、疼痛程度等方面的有效性与安全性良好,但这一发现受到文献方法学使用和质量报告等级较低的限制,建议未来研究严格按照相关规范进行系统评价,以获得更高质量的临床证据。
[Key word]
[Abstract]
Objective To re-evaluate systematic reviews/meta-analyses (SRs/Mas) of traditional Chinese medicine (TCM) treatments for postmenopausal osteoporosis (PMOP), aiming to provide evidence-based support for clinical practice and decision-making in TCM. Methods Computer searches were conducted in CNKI, CBM, Wanfang, VIP, Embase, PubMed, and Cochrane Library from inception to June 20, 2023, to collect SRs/MAs focusing on TCM treatment for PMOP. A literature overlap matrix was established to calculate the Corrected Covered Area (CCA) to assess the duplicate rate among original studies. The Risk of Bias in Systematic Reviews (ROBIS) tool was employed to evaluate bias risk in the included literature. Methodological quality assessment of the included literature was conducted using the AMSTAR-2 tool, and the overall reporting quality of SRs/MAs on TCM treatment for PMOP was assessed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 (PRISMA 2020) statement. Additionally, the grading of recommendations assessment, development, and evaluation (GRADE) approach was utilized to grade the quality of outcome indicators from all included studies. Results A total of six types of TCM and 10 SRs/MAs were included. Methodological quality assessment using AMSTAR-2 revealed that all included studies were of extremely low quality. PRISMA 2020 reporting quality assessment showed scores ranging from 18 to 30, with eight studies of moderate quality and two studies of low quality. GRADE assessment indicated two pieces of evidence at a moderate level, 23 at a low quality level, and 16 at an extremely low quality level. The ROBIS tool revealed three studies with low bias risk and seven studies with high bias risk. CCA was 0.453, suggesting a relatively low rate of duplication among the original literature. Conclusion Presently, TCM treatment for PMOP shows effectiveness in improving bone density, pain levels, etc., while demonstrating good safety. However, this finding is constrained by the low methodological utilization and low reporting quality levels of the literature. Future research is advised to strictly adhere to relevant standards in conducting systematic reviews to attain higher-quality clinical evidence.
[中图分类号]
R285.64
[基金项目]
国家重点研发计划项目(2018YFC2002500);国家自然科学基金面上项目(82274232);广东省基础与应用基础研究基金区域联合基金项目(2022B1515120022);广东省科技计划项目-广东省中医药信息化重点实验室(2021B1212040007);张荣华广东省名中医传承工作室建设项目