关节消痛合剂治疗膝骨关节炎的疗效及安全性研究  

Efficacy and safety of GJXTHJ in the treatment of patients with knee osteoarthritis

作　　者：叶卫国[1] 麦海棠[1] 叶沛光[1] 

机构地区：[1]东莞市人民医院药剂科,广东东莞523018

出　　处：《临床医药实践》2010年第6X期695-698,共4页Proceeding of Clinical Medicine

摘　　要：目的:观察关节消痛合剂治疗膝关节骨关节炎疗效及安全性。方法:70例膝骨关节炎患者随机分为治疗组36例,对照组34例。治疗组给予关节消痛合剂20 mL/次,3次/d,对照组给予布洛芬缓释胶囊,600 mg/次,2次/日,总疗程12 w。在治疗前及治疗后2、4、12 w,运用WOMAC量表进行疗效评估并观察不良反应。结果:治疗后两组患者的WOMAC积分均明显下降,不同时间点的测量数据间差异有统计学意义(P=0.000)。两组患者的WOMAC疼痛积分有统计学意义(P=0.018),治疗组的积分高于对照组。单独效应上对照组患者的疼痛积分在治疗后第2、4周显著低于治疗组(P=0.032、P=0.035),而在治疗12 w后两组患者的疼痛积分之间没有统计学意义(P=0.113)。两组患者的僵硬积分及功能积分没有统计学意义(P=0.141、P=0.089)。两种药物的时间及分组交互效应均无统计学意义。治疗组不良事件发生率为2.7%,对照组不良反应发生率为23.5%。均为消化道不良反应,对照组还出现两例肝功能异常。结论:关节消痛合剂与布洛芬缓释胶囊对膝骨关节炎均有良好疗效,远期疗效与布洛芬缓释胶囊相当,且在安全性上优于布洛芬缓释胶囊。关节消痛合剂是治疗膝骨关节炎的理想药物。Objceive:To evaluate the efficacy and safety of Guan-Jie-Xiao-Tong-He-Ji(GJXTHJ) in the treatment of patients with knee osteoarthritis(OA).Methods:A total of 70 patients with knee OA hospitalized in the DongGuan people’s hospital were enrolled in this randomised control trial.Patients were randomized to GJXTHJ group(n=36) and ibuprofen group(n=34).GJXTHJ was taken orally 20ml 3 times per day in GJXTHJ group,ibuprofen was taken orally 600mg twice per day in ibuprofen group.WOMAC was used to assess the knee indices and observe the incidence of adverse effect at 0,2,4,12 weeks after administration.Results:After treatment,WOMAC indices of both groups of patients decreased significantly at each time points of this trial(P=0.000).WOMAC pain indices of two groups are significant difference(P = 0.018),indices of GJXTHJ group higher than ibuprofen group.At the first 2,4 weeks after administration,the WOMAC pain indices of control group were significantly lower than the GJXTHJ treatment group(P = 0.032,P = 0.035).At 12 weeks,the WOMAC pain indices of the two groups were no significant difference(P = 0.113).WOMAC stiffness and function indices were no significant difference(P = 0.141,P = 0.089).The incidence of adverse events of GJXTHJ group is 2.7%,ibuprofen group is 23.5%.There were two cases of abnormal liver function in ibuprofen group.Conclusion:Both group are obviouslv effective in the treatment of patients with knee OA.Ibuprofen has faster action,but the long-term effect were no significant difference between two groups.GJXTHJ is the ideal drug in knee OA treatment.

关 键 词：骨关节炎 关节消痛合剂 药物评价 

分 类 号：R684.3[医药卫生—骨科学]