瘀肾合治方药辅助治疗膝骨性关节炎的文献研究与分析

Adjuvant treatment by TCM prescription of Shenyu Hezhi approach in knee osteoarthritis: A systematic review of literature

目的:系统评价瘀肾合治方药辅助治疗膝骨性关节炎(KOA)的临床疗效及安全性。方法:计算机检索中国知网(CNKI)、维普(VIP)、万方及中国生物医学文献数据库及国外Pub Med、EMbase、MEDLINE、Cochrane Library等数据库;手工检索广州中医药大学图书馆馆藏期刊,检索时限截至2017年7月;搜集瘀肾合治方药辅助治疗KOA相关随机对照(RCT)研究文献。参照Cochrane系统评价方法进行文献筛选、资料提取及方法学质量测评;采用软件Rev Man 5.3进行Meta分析,并结合软件GRADEpro?GDT对本研究证据质量进行评价。结果:共纳入17项RCT研究文献,合计1 607例患者;Meta分析结果提示:(1)疗效评价:瘀肾合治方药辅助治疗KOA临床总有效率高于对照组;在骨性关节炎量表WOMAC总评分、疼痛、关节僵硬与生理功能评分以及肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)、超敏C-反应蛋白(hs-CRP)等指标的改善方面均优于对照组(P<0.01);(2)安全性评价:两组尚未存在严重不良反应事件报道;(3)证据分级:参考GRADE证据等级评估分析,本系统评价其测评级别提示"低质量或"极低质量"。结论:现有证据表明,瘀肾合治方药辅助治疗KOA疗效确切,不良反应较少,可以有效改善KOA症状;但由于本研究存在一定局限性,仍需高质量临床研究予以佐证。

Objective: To evaluate the clinical efficacy and safety of TCM Shenyu Hezhi approach(SHA) in the treatment of knee osteoarthritis(KOA). Methods: Databases including China National Knowledge Infrastructure(CNKI), VIP, Wanfang Database, Pub Med, EMbase, MEDLINE, and Cochrane Library were extensively searched with computer for randomized controlled trials(RCTs) involving SHA adjunctive treatment for KOA until July 2017. Also, the correlated periodicals were manually retrieved. Potential literature was independently screened, followed with data extraction and methodological quality assessment based on Cochrane criteria. Meta-analysis was conducted using Rev Man 5.3 software, and the evidence quality grading evaluation for this systematic review was performed using GRADEpro? GDT software. Results: Seventeen trials including 1 607 patients were analyzed. The results of Meta-analyses showed that:(1)The evaluation of curative effect: the patients receiving SHA adjunctive treatment showed significantly higher total effective rate while compared to the control group. Furthermore, there were additive benefits by SHA adjunctive treatment in terms of response changes for WOMAC scales(involving total scoring, scoring of pain, joint stiffness and physiological function), tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), hypersensitive C-reactive protein(hs-CRP) and other indexes while in comparison with the control group(P<0.01).(2)safety evaluation: No serious adverse events were reported.(3)evidence classification: The quality level of GRADE classification indicated ‘low quality' or ‘very low quality'. Conclusions: We concluded that there is supporting evidence that SHA adjuctive treatment showed benefits with few adverse reactions and relative better effect of KOA symptoms improvement. Due to certain limitations of this study, further high-quality studies are necessary to verify the conclusions.