中药注射液治疗类风湿关节炎的网状Meta分析

Network Meta-analysis of Chinese medicine injections in treatment of rheumatoid arthritis

系统评价中药注射液治疗类风湿关节炎的疗效和安全性。计算机检索PubMed、Cochrane Library、EMbase、Web of Science、中国知网(CNKI)、万方(Wanfang)、维普(VIP)和中国生物医学文献服务系统(SinoMed),搜索建库至2022年2月16日所发表的中药注射液治疗类风湿关节炎的随机对照试验(RCT),采用RevMan 5.3、Stata 15.0软件进行数据分析。最终纳入53项RCTs,包括4 280例患者。试验组共涉及11种中药注射液:丹参川芎嗪注射液、丹参酮Ⅱ磺酸钠注射液、丹红注射液、灯盏细辛注射液、骨瓜提取物注射液、红花注射液、鹿瓜多肽注射液、鹿瓜多肽注射液+丹参酮Ⅱ磺酸钠注射液、疏血通注射液、正清风痛宁注射液、复方丹参注射液、血必净注射液。网状Meta分析疗效排序结果显示:(1)改善临床总有效率方面,累计概率排名曲线下面积(SUCRA)排序为西医常规联合血必净注射液>联合骨瓜提取物注射液>联合复方丹参注射液>联合丹参川芎嗪注射液>联合红花注射液>联合正清风痛宁注射液>联合丹红注射液>联合鹿瓜多肽注射液>联合丹参酮Ⅱ磺酸钠注射液>联合灯盏细辛注射液;(2)改善红细胞沉降率(ESR)方面,SUCRA排序为西医常规联合血必净注射液>联合疏血通注射液>联合红花注射液>联合丹参酮Ⅱ磺酸钠注射液>联合骨瓜提取物注射液>联合丹红注射液>联合鹿瓜多肽注射液>联合灯盏细辛注射液>联合鹿瓜多肽注射液+丹参酮Ⅱ磺酸钠注射液>联合丹参川芎嗪注射液>联合正清风痛宁注射液;(3)改善类风湿因子(RF)方面,SUCRA排序为西医常规联合鹿瓜多肽注射液>联合丹参酮Ⅱ磺酸钠注射液>联合鹿瓜多肽注射液+丹参酮Ⅱ磺酸钠注射液>联合骨瓜提取物注射液>联合丹参川芎嗪注射液>联合正清风痛宁注射液>联合丹红注射液>联合灯盏细辛注射液;(4)改善C反应蛋白(CRP)方面,SUCRA排序为西医常规联合血必净注射液>联合丹参酮Ⅱ磺酸钠注射液>联合鹿瓜多肽注射液+丹参酮Ⅱ磺酸钠注射液>联合红花注射液>联合丹参川芎嗪注射液>联合灯盏细辛注射液>联合骨瓜提取物注射液>联合鹿瓜多肽注射液>联合正清风痛宁注射液>联合丹红注射液;(5)改善晨僵时间方面,SUCRA排序为西医常规联合疏血通注射液>联合鹿瓜多肽注射液>联合灯盏细辛注射液>联合血必净注射液>联合骨瓜提取物注射液>联合正清风痛宁注射液>联合丹红注射液>联合丹参酮Ⅱ磺酸钠注射液>联合红花注射液;(6)改善关节疾病活动度评分(DAS28)方面,SUCRA排序为西医常规联合鹿瓜多肽注射液+丹参酮Ⅱ磺酸钠注射液>联合鹿瓜多肽注射液>联合正清风痛宁注射液>联合红花注射液>联合骨瓜提取物注射液>联合灯盏细辛注射液。安全性方面,试验组不良反应/事件少于对照组。结果表明,在西医常规治疗的基础上,联合中药注射液可提高类风湿关节炎的临床效果。但鉴于不同治疗措施间纳入的质量、研究数量存在较大差异,中药注射液的SUCRA排序结果还有待今后开展高质量的多中心、大样本、随机双盲试验加以佐证。

This study aims to systematically evaluate the efficacy and safety of Chinese medicine injections in the treatment of rheumatoid arthritis. Specifically, randomized controlled trial(RCT) in the treatment of rheumatoid arthritis with Chinese medicine injections was retrieved from PubMed, EMbase, Cochrane Library, Web of Science, Wanfang, CNKI, VIP, and SinoMed(from inception to February 16, 2022). RevMan 5.3 and Stata 15.0 were employed for data analysis. Finally, 53 RCTs, involving 4 280 patients were included. The experimental groups involved the following injections: including Danshen Chuanxiongqin Injection, Tanshinone ⅡSodium Sulfonate Injection, Danhong Injection, Dengzhan Xixin Injection, Gugua Extract Injection, Honghua Injection, Lugua Polypeptide Injection, Lugua Polypeptide Injection + Tanshinone ⅡSodium Sulfonate Injection, Shuxuetong Injection, Zhengqing Fengtongning Injection, Compound Danshen Injection, and Xuebijing Injection. The network Meta-analysis showcased the following trends.(1) As for improving total clinical effective rate, the surface under the cumulative ranking curve(SUCRA) followed the order of conventional treatment of western medicine combined with Xuebijing Injection > combined with Gugua Extract Injection > combined with Compound Danshen Injection > combined with Danshen Chuanxiongqin Injection > combined with Honghua Injection > combined with Zhengqing Fengtongning Injection > combined with Danhong Injection > combined with Lugua Polypeptide Injection > combined with Tanshinone ⅡSodium Sulfonate Injection > combined with Dengzhan Xixin Injection.(2) As for improving erythrocyte sedimentation rate(ESR), SUCRA followed the order of conventional treatment of western medicine combined with Xuebijing Injection > combined with Shuxuetong Injection > combined with Honghua Injection > combined with Tanshinone ⅡSodium Sulfonate Injection > combined with Gugua Extract Injection > combined with Danhong Injection > combined with Lugua Polypeptide Injection > combined with Dengzhan Xixin Injection > combined with Lugua Polypeptide Injection + Tanshinone ⅡSodium Sulfonate Injection > combined with Danshen Chuanxiongqin Injection > combined with Zhengqing Fengtongning Injection.(3) As for improving rheumatoid factor(RF), SUCRA followed the order of conventional treatment of western medicine combined with Lugua Polypeptide Injection > combined with Tanshinone ⅡSodium Sulfonate Injection > combined with Lugua Polypeptide Injection + Tanshinone ⅡSodium Sulfonate Injection > combined with Gugua Extract Injection > combined with Danshen Chuanxiongqin Injection > combined with Zhengqing Fengtongning Injection > combined with Danhong Injection > combined with Dengzhan Xixin Injection.(4) As for improving C-reactive protein(CRP), SUCRA followed the order of conventional treatment of western medicine combined with Xuebijing Injection > combined with Tanshinone ⅡSodium Sulfonate Injection > combined with Lugua Polypeptide Injection + Tanshinone ⅡSodium Sulfonate Injection > combined with Honghua Injection > combined with Danshen Chuanxiongqin Injection > combined with Dengzhan Xixin Injection > combined with Gugua Extract Injection > combined with Lugua Polypeptide Injection > combined with Zhengqing Fengtongning Injection > combined with Danhong Injection.(5) As for alleviating morning stiffness, SUCRA followed the order of conventional treatment of western medicine combined with Shuxuetong Injection > combined with Lugua Polypeptide Injection > combined with Dengzhan Xixin Injection > combined with Xuebijing Injection > combined with Gugua Extract Injection > combined with Zhengqing Fengtongning Injection > combined with Danhong Injection > combined with Tanshinone ⅡSodium Sulfonate Injection > combined with Honghua Injection.(6) As for improving disease activity score(DAS28), SUCRA followed the order of conventional treatment of western medicine combined with Lugua Polypeptide Injection + Tanshinone ⅡSodium Sulfonate Injection > combined with Lugua Polypeptide Injection > combined with Zhengqing Fengtongning Injection > combined with Honghua Injection > combined with Gugua Extract Injection > combined with Dengzhan Xixin Injection. The experimental groups had lower incidence of adverse reactions than the control group. The results of network Meta-analysis suggest that on the combination of conventional treatment of western medicine with Chinese medicine injections can improve the efficacy on rheumatoid arthritis. However, in view of the great differences in the quality and number of studies included for different therapies, the SUCRA of Chinese medicine injections need to be further verified with high-quality multi-center, large-sample, randomized double-blind trials.