目的 系统评价芍甘附子汤联合西药治疗类风湿关节炎（RA）的有效性和安全性。方法 检索PubMed、EMbase、Cochrane Library、Web of science、CNKI、Wangfang、VIP和SinoMed,检索时间从建库至2023-12,检索芍甘附子汤联合西药治疗RA的RCT研究,治疗组接受芍甘附子汤联合西药治疗,对照组接受西药治疗。文献筛选和数据提取由两位研究者独立进行,评价的结局指标包括有效性、安全性、中医证候积分、类风湿关节炎疾病活动性评分（DAS28评分）、关节压痛数量、关节肿胀数量、晨僵持续时间、红细胞沉降率（ESR）及C-反应蛋白（CRP）。应用Review Manager 5.4进行文献偏倚风险评价。应用R-Studio 4.3.2进行Meta分析、敏感性分析和发表偏倚分析。结果 纳入11篇文献,患者851例,其中治疗组427例,对照组424例。Meta分析结果显示,治疗组总有效率比对照组提高18.00%,差异有统计学意义（RD=0.18,95%CI：0.13~0.24,P<0.01）。不良反应发生率比对照组下降3.00%,但差异无统计学意义（RD=-0.03,95%CI：-0.08~-0.02,P=0.27）。治疗组在中医证候积分（SMD=-3.58,95%CI：-4.67~-2.40）、DAS28评分（MD=-0.67,95%CI：-1.07~-0.26）、关节压痛数量（MD=-1.41,95%CI：-2.27~-0.55）、关节肿胀数量（MD=-1.05,95%CI：-1.16~-0.93）、晨僵持续时间（MD=-18.80,95%CI：-21.92~-15.69）、ESR（MD=-5.56,95%CI：-7.35~-3.77）、CRP（MD=-2.77,95%CI：-4.30~-1.25）均优于对照组,差异均有统计学意义（P<0.05）。本研究纳入文献质量偏低,不存在显著发表偏倚。结论 芍甘附子汤联合西药治疗RA的有效性优于单用西药治疗,同时可以改善临床症状及炎症指标,且不良反应发生率未增加。
Abstract
Objective To systematically evaluate the efficacy and safety of Shaogan Fuzi decoction combined with western medicine in the treatment of rheumatoid arthritis（RA）. Methods A comprehensive literature search was conducted across PubMed,Embase,Cochrane Library,Web of Science,CNKI,Wanfang,VIP,and SinoMed databases from their inception through December 2023.RCT studies of Shaogan Fuzi decoction combined with western medicine for RA were retrieved. The treatment group received Shaogan Fuzi decoction combined with western medicine, while the control group received only western medicine. Literature screening and data extraction were performed independently by two reviewers. The primary outcomes assessed included efficacy,safety,Traditional Chinese Medicine（TCM）syndrome scores,RA disease activity score (DAS28 score),tender joint count,swollen joint count,duration of morning stiffness,erythrocyte sedimentation rate（ESR）,and C-reactive protein（CRP）. The risk of bias of the literature was evaluated using Review Manager 5.4. Meta-analysis,sensitivity analysis,and publication bias assessments were conducted using R-Studio 4.3.2. Results Eleven articles met the inclusion criteria,involving 851 patients,with 427 in the treatment group and 424 in the control group. Meta-analysis results revealed an 18.00% statistically significant improvement in overall treatment efficacy in the treatment group compared to the control group （RD=0.18,95%CI：0.13~0.24,P<0.01）. The incidence of adverse events was slightly lower in the treatment group by 3.00% （RD=-0.03,95%CI：-0.08~-0.02,P=0.27）, but the difference was not statistically significant. The treatment group demonstrated significant improvements across multiple secondary outcomes,including TCM syndrome scores （SMD=-3.58,95%CI：-4.67~-2.40）, DAS28 scores （MD=-0.67,95%CI：-1.07~-0.26）, tender joint count （MD=-1.41,95% CI：-2.27~-0.55）, swollen joint count（MD=-1.05,95%CI：-1.16~-0.93）, duration of morning stiffness （MD=-18.80,95%CI：-21.92~-15.69）, ESR （MD=-5.56,95%CI：-7.35~-3.77）, and CRP levels （MD=-2.77,95%CI：-4.30~-1.25）. Although the quality of the included literature was generally low,no significant publication bias was identified. Conclusions The combination of Shaogan Fuzi decoction with western medicine appears to be more effective than western medicine alone in the treatment of RA,offering additional benefits in symptom relief and inflammation control without increasing the incidence of adverse events.
关键词
类风湿关节炎 /
芍甘附子汤 /
有效性 /
安全性 /
Meta分析
Key words
rheumatoid arthritis /
Shaogan Fuzi decoction /
efficacy /
safety /
Meta-analysis
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基金
黑龙江省中医药科研课题（ZHY2024-021）; 哈尔滨市科技计划项目（ZC2023ZJ004022）
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