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中药龟鹿二仙胶治疗膝骨关节炎的疗效和安全性:系统评价和荟萃分析。

The efficacy and safety of traditional Chinese medicine Guilu Erxian Jiao in the treatment of knee osteoarthritis: A systematic review and meta-analysis.

机构信息

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan.

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan; Program in Molecular Medicine, College of Life Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan.

出版信息

Complement Ther Clin Pract. 2022 Feb;46:101515. doi: 10.1016/j.ctcp.2021.101515. Epub 2021 Nov 23.

DOI:10.1016/j.ctcp.2021.101515
PMID:34837805
Abstract

OBJECTIVE

A systematic review was conducted to investigate the efficacy of Guilu Erxian Jiao (GEJ) in the treatment of knee osteoarthritis (OA).

METHODS

We searched PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese Electronic Periodical Services, and ClinicalTrials.gov to identify relevant randomized controlled trials or controlled clinical trials, from the inception of each source to April 20, 2021. Primary outcome included overall efficacy, pain score, and Lequesne index score; secondary outcome included adverse events. Methodological quality was assessed using the Cochrane risk of bias tool (RoB 1.0). The meta-analysis was performed based on a random-effects model due to anticipated clinical heterogeneity. The grading of overall evidence was assessed using the GRADE system. The study protocol was registered on PROSPERO (CRD42021233573).

RESULTS

Eight studies were included. Compared to controls, GEJ exhibited superior overall efficacy for treating OA (risk ratio (RR) = 1.20; 95% confidence interval (CI) = 1.06-1.35). Regarding pain score, there was no statistical difference between GEJ and controls (standardized mean difference (SMD) = 0.27; 95% CI = -0.91 - 1.46). No significant difference was found in Lequesne score between GEJ and controls (MD = -0.25; 95% CI = -0.52 - 0.01). No statistical difference in adverse reactions was observed between GEJ and controls (risk difference (RD) = -0.01; 95% CI = -0.05-0.03).

CONCLUSION

Our findings suggest that GEJ may have positive effects on overall efficacy in treating OA. However, there is insufficient evidence regarding pain score, Lequesne score, and knee joint function score.

摘要

目的

系统评价古力西尔胶囊(GEJ)治疗膝骨关节炎(OA)的疗效。

方法

我们检索了 PubMed、MEDLINE、EMBASE、Cochrane 中央对照试验注册库、中国电子期刊全文数据库和 ClinicalTrials.gov,以确定从每个来源的开始到 2021 年 4 月 20 日的相关随机对照试验或对照临床试验。主要结局包括总疗效、疼痛评分和 Lequesne 指数评分;次要结局包括不良反应。采用 Cochrane 偏倚风险工具(RoB 1.0)评估方法学质量。由于预期存在临床异质性,因此采用随机效应模型进行荟萃分析。使用 GRADE 系统评估总体证据等级。研究方案在 PROSPERO(CRD42021233573)上注册。

结果

纳入了 8 项研究。与对照组相比,GEJ 治疗 OA 的总疗效更优(风险比(RR)=1.20;95%置信区间(CI)=1.06-1.35)。关于疼痛评分,GEJ 与对照组之间无统计学差异(标准化均数差(SMD)=0.27;95%CI=-0.91 - 1.46)。GEJ 与对照组的 Lequesne 评分无显著差异(MD=-0.25;95%CI=-0.52 - 0.01)。GEJ 与对照组的不良反应发生率无统计学差异(风险差(RD)=-0.01;95%CI=-0.05-0.03)。

结论

我们的研究结果表明,GEJ 可能对治疗 OA 的总疗效有积极影响。然而,关于疼痛评分、Lequesne 评分和膝关节功能评分,证据不足。

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