仙灵骨葆胶囊针对膝骨关节炎疗效及安全性系统评价与荟萃分析

Systematic Evaluation and Meta-analysis of the Efficacy and Safety of Xianling Gubao Capsule(仙灵骨葆胶囊)in the Treatment of Knee Osteoarthritis

目的评估中成药仙灵骨葆胶囊(XLGBC)与常规药物相比的益处和危害,为临床膝骨关节炎的治疗提供循证依据。方法通过检索中国知网数据库(CNKI)、万方数据库、PubMed数据库、Cochrane图书馆和中国生物医学数据库(sinoMed)有关仙灵骨葆胶囊与非甾体抗炎药、透明质酸、葡萄糖胺或中医治疗膝关节骨关节炎的前瞻性随机对照试验(RCTS)。检索时间均从建库至2023年4月。由2名研究员采用“Cochrane偏倚风险评估工具”独立进行文献筛选、数据提取及文献质量评估,并使用RevMan 5.4.1软件对结局指标进行分析。结果最终共纳入39项研究,共计4236例患者。仙灵骨葆胶囊联合常规药物或中医治疗的治愈率[RR:1.48;95%置信区间(95%Cl):1.36,1.61;P=0.02,I 2=38%]、有效率(RR:1.18;95%Cl:1.14,1.21;P=0.07,I 2=28%)、Lequesne评分(MD:-2.22,95%CI:-2.38,-2.05;P<0.0001,I 2=91%)、JOA评分(MD:5.63,95%CI:0.92,10.33;P<0.0001,I 2=97%)均显著高于单纯常规治疗,并且能降低VAS评分(MD:-1.41,95%CI:-1.78,-1.05;P<0.00001,I 2=98%)、WOMAC评分(MD:-10.46,95%CI:-16.54,-4.37;P<0.0001,I 2=97%)以及Lysholm评分(MD:16.07,95%CI:11.58,20.57;P<0.0001,I 2=98%),提高患者生活质量SF-36评分(MD:8.66,95%CI:4.11,13.20;P=0.13,I 2=57%),下调血清肿瘤坏死因子-α(TNF-α)水平(SMD:-2.00,95%CI:-3.31,-0.70;P<0.00001,I 2=98%),且不良反应发生率低(RR:0.52;95%Cl:0.38,0.72;P=0.01,I 2=49%)。结论仙灵骨葆胶囊单独使用或联合其他疗法均能有效缓解膝骨关节炎患者疼痛,改善关节功能,极大提高患者生活质量,为临床膝骨关节炎综合治疗提供了新思路。

Objective This meta-analysis aims to assess the effectiveness and safety of Chinese medicine Xianling Gubao Capsule(仙灵骨葆胶囊,XLGBC)combined with conventional drugs in the treatment of knee osteoarthritis(KOA).Methods A meta-analysis of clinical randomized controlled trials(RCTs)on XLGBC treatment was carried out in KOA patients.The database included PubMed,Cochrane Library,Chinese Biomedical database(sinoMed),China National Knowledge Infrastructure(CNKI),and WanFang database.The search time was from the establishment of the database to April 2023.Literature screening,data extraction and literature quality assessment were conducted independently by two researchers,and the outcome indicators were analyzed using RevMan 5.4 software.Results Thirty-nine articles analyzed in this study involved 4326 patients.XLGBC used alone or used with other interventions affects cure rate(RR:1.48;95%Cl:1.36,1.61;P=0.02,I 2=38%)and total effective rate(RR:1.18;95%Cl:1.14,1.21;P=0.07,I 2=28%)significantly.Lequesne score(MD:-2.22,95%CI:-2.38,-2.05;P<0.0001,I 2=91%),JOA score(MD:5.63,95%CI:0.92,10.33;P<0.0001,I 2=97%)were significantly higher than conventional treatment alone,and could decrease VAS scores(MD:-1.41,95%CI:-1.78,-1.05;P<0.00001,I 2=98%),the WOMAC score(MD:-10.46,95%CI:-16.54,-4.37;P<0.0001,I 2=97%)and Lysholm score(MD:16.07,95%CI:11.58,20.57;P<0.0001,I 2=98%),improve patients'quality of life SF-36 score(MD:8.66,95%CI:4.11,13.20;P=0.13,I 2=57%),down-regulate serum TNF-αlevel(SMD:-2.00,95%CI:-3.31,-0.70;P<0.00001,I 2=98%),and the incidence of adverse reactions were lower(RR:0.52;95%Cl:0.38,0.72;P=0.01,I 2=49%).Conclusion This systematic review shows that XLGBC appears to be safe and has a beneficial effect on the quality of life and pain relief when used alone or in combination with conventional medications in knee osteoarthritis patients.