微量元素与健康研究

目的 本研究旨在系统评价黑骨藤追风活络胶囊联合西药治疗类风湿关节炎的疗效与安全性，为临床应用提供依据。方法 通过检索中国知网、万方数据库、中文科技期刊数据库、SinoMed、PubMed及Web of Science,收集截至2025年12月发表的相关随机对照试验(RCTs)。两名研究者对文献进行筛选与数据提取，并利用Cochrane偏倚风险评估工具对纳入研究的方法学质量进行评价，采用RevMan 5.4软件对数据进行Meta分析。结果 最终纳入5篇RCTs,涉及362例类风湿关节炎患者，其中试验组180例，对照组182例。Meta分析结果显示，黑骨藤追风活络胶囊联合西药总有效率显著高于单独使用西药(RR=1.21,95%CI:1.10～1.33,P=0.0001),但试验组不良反应与对照组差异无统计学意义(RR=0.29,95%CI:0.12～0.70,P=0.51)。结论 黑骨藤追风活络胶囊联合西药优于单独使用西药，能提高临床总有效率，保障临床安全。但因临床研究数量较少，且质量有待提高，未来可规范临床试验过程，提高证据质量，为临床应用提供证据支持。

Objective To systematically evaluate the efficacy and safety of Heiguteng Zhuifeng Huoluo Capsules combined with Western medicine in the treatment of rheumatoid arthritis(RA) and to provide evidence for their clinical use.Methods China National Knowledge Infrastructure(CNKI), Wanfang Data, Chinese Science and Technology Journal Database(VIP), SinoMed, PubMed, and Web of Science were systematically searched for relevant randomized controlled trials(RCTs) published through December 2025. Two reviewers independently screened the literature and extracted data. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias tool. Meta-analysis was performed using RevMan 5.4.Results Five RCTs involving 362 patients with RA were included, with 180 patients in the intervention group and 182 in the control group. Meta-analysis showed that Heiguteng Zhuifeng Huoluo Capsules combined with Western medicine resulted in a significantly higher overall response rate than Western medicine alone(RR=1.21, 95% CI: 1.10-1.33, P=0.0001). For adverse reactions, the reported pooled effect estimate was RR=0.29(95% CI: 0.12-0.70, P=0.51), with no statistically significant difference reported between the intervention and control groups.Conclusion Heiguteng Zhuifeng Huoluo Capsules combined with Western medicine may improve the overall clinical response in patients with RA compared with Western medicine alone. However, given the limited number of available studies and concerns regarding their methodological quality, these findings should be interpreted with caution. Further well-designed, high-quality RCTs are warranted to strengthen the evidence base for clinical application.