骨康胶囊联合透明质酸钠治疗膝骨性关节炎Meta分析

Meta Analysis on the Treatment of Knee Osteoarthritis by Gukang Capsule Combined with Sodium Hyaluronate

目的:现有研究表明骨康胶囊联合透明质酸钠对膝骨性关节炎疗效显著,且安全性较高,但仍缺乏循证依据。通过大数据分析,系统评价骨康胶囊联合透明质酸钠治疗膝骨性关节炎的临床效果。方法:检索英文(PubMed、Embase、the Cochrane Library)数据库、中文(中国知网、万方、VIP、CBM)等数据库中有关骨康胶囊联合透明质酸钠治疗膝骨性关节炎的临床随机对照试验(randomized control trials,RCTs),检索时间为各数据库从建库到2020年10月20日。由2位研究者根据纳入和排除标准筛选文献,对纳入文献进行数据提取和质量评价,采用RevMan5.3软件对所纳入的研究数据进行Meta分析。结果:最终纳入9篇文献,777例患者。实验组采用骨康胶囊联合透明质酸钠治疗,对照组采用透明质酸钠或透明质酸钠加氨基葡萄糖治疗。Meta分析结果显示,实验组临床总有效率优于对照组(OR=4.55,95%CI(2.73,7.58),P<0.00001);实验组Lequesne评分改善较对照组明显[MD=-3.44,95%CI(-3.83,-3.05),P<0.00001];实验组VAS评分较对照组降低更为明显[MD=-1.54,95%CI(-1.97,-1.10),P<0.00001];实验组治疗KOA的hs-CRP评分较对照组降低更为明显[MD=-2.10,95%CI(-2.51,-1.68),P<0.00001];实验组治疗KOA的TNF-α评分较对照组降低更为明显[MD=-116.63,95%CI(-151.17,-82.10),P<0.00001];实验组治疗KOA的IL-1β评分较对照组降低更为明显[MD=-4.28,95%CI(-6.54,-2.03),P<0.0002],实验组不良反应发生率与对照组无统计学差异[OR=0.58,95%CI(0.33,1.02),P=0.06>0.05]。结论:骨康胶囊联合透明质酸钠治疗膝骨关节炎疗效显著,较单纯透明质酸钠或透明质酸钠联合氨基葡萄糖治疗更有优势,且安全性较高。但由于纳入研究文献的质量偏低,该疗法仍需进行多中心、高质量、大样本的临床随机对照研究加以佐证。

Objective:Through data analysis,systematically evaluate the clinical effect of Gukang capsule combined with sodium hyaluronate in the treatment of knee osteoarthritis.Methods:It performed a randomized control trials(RCTs)for the treatment of knee osteoarthritis with Gukang capsule combined with sodium hyaluronate in a database like PubMed,Embase,Cochrane Library in Chinese(WanFang,VIP,CBM).The data was retrieved from each database from the date it was built to October 20,2020,Two researchers selected the literature according to the inclusion and exclusion criteria,extracted and evaluated the data from the included literature,and Meta analysis was conducted on the included data using RevMan 5.3 software.Results:9 literatures were finally included.777 patients in the experimental group were treated with Gukang capsule combined with sodium hyaluronate,while the control group was treated with sodium hyaluronate or sodium hyaluronate plus glucosamine.Meta analysis results showed that the total clinical effective rate of the experimental group was better than that of the control group(OR=4.55,95%CI(2.73,7.58),P<0.00001);The improvement of Lequesne score in the experimental group was significantly better than that in the control group[MD=-3.44,95%CI(-3.83,-3.05),P<0.00001].VAS score in the experimental group was significantly lower than that in the control group[MD=-1.54,95%CI(-1.97,-1.10),P<0.00001].The reduction of hs-CRP in KOA in the experimental group was more significant than that in the control group[MD=-2.10,95%CI(-2.51,-1.68),P<0.00001].The reduction of TNF-αin KOA in the experimental group was more significant than that in the control group[MD=-116.63,95%CI(-151.17,-82.10),P<0.00001].The KOA in the experimental group was significantly lower than that in the control group[MD=-4.28,95%CI(-6.54,-2.03),P<0.0002],and there was no significant difference in the incidence of adverse reactions between the experimental group and the control group[OR=0.58,95%CI(0.33,1.02),P=0.06].Conclusion:Bone kang capsule in combination with sodium hyaluronate treat knee osteoarthritis is pure sodium hyaluronic acid or sodium hyaluronate combined with glucosamine has more advantages,and a significant curative effect,high security,but because in the quality of the research literature on the low side,the treatment would still need a multicenter large randomized controlled clinical study on high quality sample for them.