[关键词]
[摘要]
目的 运用网状Meta分析评价各类中成药治疗2型糖尿病(type 2 diabetes mellitus,T2DM)合并脑卒中的疗效。方法 2名研究员独立检索4大中文数据库(中国知网、万方、维普、中国生物医学文献数据库)和4大英文数据库(PubMed、Web of Science、Embase、Cochrane Library),选取建库至2023年5月31日收录的中成药治疗T2DM合并脑卒中的随机对照试验(randomized controlled trials,RCTs),并进行数据提取与整理,按照Cochrane 5.3偏倚风险评估方法进行质量评价,应用R软件进行网状Meta分析。结果 最终共纳入25篇文献,包括脑心通胶囊、芪冬瘫复胶囊、通脉降糖胶囊、通心络胶囊以及银丹心脑通软胶囊5种中成药。在改善临床总有效率方面,与常规西医治疗相比,联合5种中成药疗效更佳,且通心络胶囊联合常规西医治疗>脑心通胶囊联合常规西医治疗>芪冬瘫复胶囊联合常规西医治疗>通脉降糖胶囊联合常规西医治疗>银丹心脑通软胶囊联合常规西医治疗;在改善美国国立卫生研究院卒中量表(National Institutes of Health stroke scale,NIHSS)评分方面,与常规西医治疗相比,联合2种中成药疗效更佳,且脑心通胶囊联合常规西医治疗>银丹心脑通软胶囊联合常规西医治疗;在提高日常生活活动能力(ability of daily living activities,ADL)方面,与常规西医治疗相比,联合脑心通胶囊效果最佳;常规西医治疗的基础上联合口服中成药可以减少不良反应发生。结论 常规西医治疗的基础上,加用中成药可有效改善NIHSS,提高T2DM合并脑卒中患者的日常生活能力,且安全性良好,脑心通胶囊联合常规西医治疗可能是T2DM合并脑卒中的最佳干预措施。此外,不同的中成药作为治疗组的RCT研究在数目和质量上存在差异,故仍需要大样本、高质量的RCT研究用于不同中成药在疗效评价上的进一步验证。
[Key word]
[Abstract]
Objective To evaluate the efficacy of various Chinese patent medicines in the adjuvant treatment of type 2 diabetes mellitus (T2DM) with stroke by network meta-analysis. Methods Two researchers independently searched four English databases (PubMed, Web of Science, Embase, Cochrane Library) and four Chinese databases (CNKI, Wanfang, VIP, CBM). Randomized controlled trials (RCTs) of Chinese patent medicine in the treatment of T2DM complicated with stroke were selected from the establishment of the database to May 31, 2023. The data were extracted and sorted out. The quality was evaluated according to the Cochrane 5.3 bias risk assessment method. R software was used for network Meta-analysis. Results A total of 25 literatures were included, including Naoxintong Capsule (脑心通胶囊, NXT), Qidong Tanfu Capsule (芪冬瘫复胶囊, QDTF), Tongmai Jiangtang Capsule (通脉降糖胶囊, TMJT), Tongxinluo Capsule (通心络胶囊, TXL) and Yindan Xinnaotong Soft Capsule (银丹心脑通软胶囊, YDXNT). In terms of improving the total clinical effective rate, compared with conventional western medicine treatment, the combination of five kinds of Chinese patent medicines were more effective, and TXL combined with conventional western medicine treatment > NXT combined with conventional western medicine treatment > QDTF combined with conventional western medicine treatment > TMJT combined with conventional western medicine treatment > YDXNT combined with conventional western medicine treatment; In terms of improving National Institutes of Health stroke scale (NIHSS) score, compared with conventional western medicine treatment, the combination of two Chinese patent medicines were more effective, and NXT combined with conventional western medicine treatment > YDXNT combined with conventional western medicine treatment; In terms of improving the ability of daily living activities (ADL), compared with conventional western medicine treatment, the combined NXT had the best effect; On the basis of conventional western medicine treatment combined with oral Chinese patent medicines could reduce the incidence of adverse reactions. Conclusion On the basis of conventional western medicine treatment, the addition of Chinese patent medicines can effectively improve NIHSS and improve the daily living ability of patients with T2DM complicated with stroke, and the safety is good. No adverse reactions were observed. NXT combined with conventional western medicine treatment may be the best intervention for T2DM complicated with stroke. In addition, there are differences in the number and quality of RCT studies of different Chinese patent medicines as treatment groups, so large-sample and high-quality RCT studies are still needed for further verification of the efficacy evaluation of different Chinese patent medicines.
[中图分类号]
R285.64
[基金项目]
国家中医药管理局2021歧黄学者支持项目(国家中医药人教函 [2022] 6);谢雁鸣全国名老中医药专家传承工作室建设项目(国家中医药人教函 [2022] 75)