瘀血痹片(胶囊)联合基础疗法治疗慢性肌肉骨骼疼痛的有效性与安全性的Meta分析  

Meta-Analysis on Efficacy and Safety of Yuxuebi Tablets(Capsules)Combined with Basic Therapy in the Treatment of Chronic Musculoskeletal Pain

作　　者：刘莹 张国鑫 王文丽 黄奥晴 朱春燕 林娜[1] LIU Ying;ZHANG Guoxin;WANG Wenli;HUANG Aoqing;ZHU Chunyan;LIN Na(Institute of Chinese Materia Medica,China Academy of Chinese Medical Science,Beijing 100700,China)

机构地区：[1]中国中医科学院中药研究所,北京100700

出　　处：《中国医院用药评价与分析》2025年第3期319-324,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家“重大新药创制”科技重大专项(No.2019ZX09731-002);中国中医科学院中药研究所技术研发项目(No.20210701,No.20231019)。

摘　　要：目的:对瘀血痹片(胶囊)联合基础疗法治疗慢性肌肉骨骼疼痛(CMP)的临床疗效与安全性进行系统评价。方法:检索PubMed、Web of Science、Embase、the Cochrane Library、中国知网、维普数据库、万方数据库和中国生物医学文献数据库中的瘀血痹片(胶囊)治疗CMP的临床随机对照试验(RCT),时间截至2024年8月4日。将符合纳入标准的文献采用Cochrane风险评估工具进行质量评价,使用RevMan 5.3软件进行Meta分析。结果:最终纳入8篇RCT研究,共854例患者。Meta分析结果显示,与单纯采用基础疗法比较,瘀血痹片(胶囊)联合基础疗法能够显著提高患者的治疗总有效率(OR=3.31,95%CI=2.13~5.13,P<0.00001);降低视觉模拟评分法评分,缓解疼痛(MD=-2.07,95%CI=-2.52~-1.62,P<0.00001);提高Lysholm评分,增强关节功能(MD=9.37,95%CI=7.10~11.64,P<0.00001);提高日常生活活动评分,改善日常生活质量(MD=15.16,95%CI=9.79~20.52,P<0.00001);抑制血清炎症因子白细胞介素1(MD=-0.54,95%CI=-0.83~-0.26,P=0.0001)、白细胞介素8(MD=-20.92,95%CI=-21.93~-19.91,P<0.00001)、肿瘤坏死因子α(MD=-16.74,95%CI=-22.60~-10.87,P<0.00001)、C反应蛋白(MD=-5.83,95%CI=-8.59~-3.08,P<0.0001),差异均有统计学意义。在治疗安全性方面,两组治疗方案不良反应发生率的差异无统计学意义(RR=0.63,95%CI=0.21~1.90,P=0.41)。结论:瘀血痹片(胶囊)联合基础疗法干预CMP的疗效优于单纯基础疗法,但由于纳入研究较少,文献质量偏低,仍需要开展大样本、高质量的RCT研究以增加证据强度。OBJECTIVE:To systematically review the clinical efficacy and safety of Yuxuebi tablets(capsules)combined with basic therapy in the treatment of chronic musculoskeletal pain(CMP).METHODS:PubMed,Web of Science,Embase,the Cochrane Library,CNKI,VIP,Wanfang Data,and CBM were retrieved to clinical randomized controlled trials(RCT)of Yuxuibi tablets(capsules)in the treatment of CMP as of Aug.4th,2024.Cochrane risk assessment tool was used to evaluate the quality of literature that met the inclusion criteria,and RevMan 5.3 software was used for Meta-analysis.RESULTS:A total of 8 RCT were enrolled,including 854 cases of patients.Meta-analysis showed that compared with basic therapy alone,Yuxuebi tablets(capsules)combined with basic therapy could significantly improve the total effective rate(OR=3.31,95%CI=2.13-5.13,P<0.00001),reduce the visual analog score and relieve pain(MD=-2.07,95%CI=-2.52--1.62,P<0.00001),increase the Lysholm score and enhance the joint function(MD=9.37,95%CI=7.10-11.64,P<0.00001),increase the ADL score and improve the quality of daily life(MD=15.16,95%CI=9.79-20.52,P<0.00001),inhibit the serum inflammatory cytokines interleukin 1(MD=-0.54,95%CI=-0.83--0.26,P=0.0001),interleukin 8(MD=-20.92,95%CI=-21.93--19.91,P<0.00001),tumor necrosis factorα(MD=-16.74,95%CI=-22.60--10.87,P<0.00001),C-reactive protein(MD=-5.83,95%CI=-8.59--3.08,P<0.0001),the differences were statistically significant.In terms of treatment safety,there was no significant difference in the incidence of adverse drug reactions between two groups(RR=0.63,95%CI=0.21-1.90,P=0.41).CONCLUSIONS:The efficacy of Yuxuebi tablets(capsules)combined with basic therapy in the intervention of CMP is better than that of basic therapy alone.However,due to the limited included studies and low literature quality,it is still necessary to carry out large-sample and high-quality RCT to increase the strength of evidence.

关 键 词：瘀血痹片(胶囊) 慢性肌肉骨骼疼痛 类风湿关节炎 膝骨关节炎 META分析 

分 类 号：R971.1[医药卫生—药品] R932[医药卫生—药学]