目的 对中医药治疗重症肌无力(myasthenia gravis,MG)的Meta 分析或系统评价进行再评价。方法 计算机检索 Medline、EMbase、The Cochrane Library(2018 年11期)、CBM、CNKI、万方等 6 个数据库,检索时限均为从建库至2018年11月20日。采用 AMSTAR 工具评价纳入系统评价的方法学质量,并基于 GRADE 方法对系统评价纳入的结局指标进行证据质量分级。结果 共纳入9个相关系统评价或 Meta 分析,包含42个结局指标。AMSTAR 工具评价结果显示,11 个条目中,存在问题最多的是条目 1“是否提供了前期设计方案”(9个均未提供),其次是条目 11“是否说明相关利益冲突”(7个未说明)。GRADE 分级结果显示： 11个结局指标为极低质量,27个为低质量,仅有4个结局指标证据质量为中等,导致降级最主要因素为局限性(42个结局指标),其次为不精确(19 个结局指标)和不一致(18个结局指标)。结论 基于系统评价再评价结果,中医药治疗重症肌无力具有一定疗效,鉴于当前针对中医药治疗重症肌无力系统评价的方法学质量总体中等以及系统评价再评价制作过程影响,该研究存在一定局限性,因此,目前所获得的支持证据强度有待进一步提升,以期为临床医生提供更高级的临床证据。
Objective To evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) about traditional Chinese medicine for myasthenia gravis. Methods We comprehensively searched PubMed, EMbase, The Cochrane library (Issue 11, 2018), CBM, CNKI and WanFang Data to collect SRs of traditional Chinese medicine for myasthenia gravis from the establishment time of databases to November 20th, 2018. The AMSTAR tool was applied for methodological quality assessment of included studies, and the GRADE system was applied for evidence quality assessment of included outcomes of SRs. Results A total of 9 SRs involving 42 outcomes were included. The results of assessment using AMSTAR showed that, among 11 items, there were the most problems concerning Item 1 “Was an ‘a prior’ design provided?” (none of the 9 SRs provided it); followed by Item 11 “Were potential conflict of interest included?” (7 SRs didn’t described it). The results of grading showed that, 11 outcomes were graded as “low” quality ,27 outcomes were graded as “very low” quality,only 4 outcomes were graded as ”moderate quality”. The main factors contributed to downgrading evidence quality were limitations (42 outcomes), followed by imprecision (19 outcomes), and inconsistency (18 outcomes). Conclusion Based on the results of systematic evaluation and re-evaluation, TCM has a certain curative effect on the treatment of myasthenia gravis. In view of the current moderate methodological quality of TCM treatment for myasthenia gravis and the impact of systematic evaluation and re-evaluation process, this study has certain limitations. Therefore, the strength of the evidence currently supported needs to be further improved in order to provide clinicians with more advanced clinical evidence.
国家中医药管理局中医药标准制修订项目“重症肌无力中医治疗指南修订研究”（NO.SATCM—2015—BZ〔043〕）；吉林省科技厅科技发展项目“治疗重症肌无力新药芪参地黄颗粒的产业化开发”(NO.20180311025YY)；吉林省中医药科技项目“基于数据挖掘对痿病（重症肌无力）中医临床治疗经验整理研究”（NO.2018045）；吉林省中医药科技项目“参芪龙颗粒”对叠氮钠诱导线粒体损伤模型影响的研究”，（NO.2017213）；长春中医药大学 “橘井杯”学术科研创新项目“吉林地区重症肌无力患者生活质量与中医证候相关性研究”，（NO. YK201802）