草乌甲素片治疗骨关节炎效果和安全性评价

目的 观察草乌甲素片治疗骨关节炎的临床疗效和安全性.方法 本研究采用开放式对照法,将114例骨关节炎患者分为2组：试验组57例,口服草乌甲素片0.4 mg,3次/d;对照组57例,口服双氯芬酸钠片25 mg,3次/d.2组疗程均为2周.疗效判断指标为服药前后患者对自己的总体评价变化、医生对患者总体情况的评价变化、患者关节压痛数变化、关节肿胀数变化以及美国西部安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分变化,同时观察不良反应发生情况.结果 用药后2周,对照组自评视觉模拟评分（VAS）试验前为（66±13）,试验后为（33±13）,差异有统计学意义（P＜0.01）;试验组患者自评VAS评分试验前为（67±15）,试验后为（39 ± 13）,差异有统计学意义（P＜0.01）;医生VAS评分均有明显改善对照组试验前为（66±12）,试验后为（33±12）,试验组试验前为（67±15）,试验后为（39±12）]（P＜0.01）;且试验组不劣于对照组.对照组关节压痛数试验前为2.0（1.0,4.0）,试验后为0.0（0.0,1.0）;试验组关节压痛数试验前为2.0（0.0,3.0）,试验后为0.0（0.0,1.0）;对照组关节肿胀数试验前为8.0（5.0,10.0）,试验后为2.0（1.0,3.0）;试验组关节肿胀数试验前为7.0（5.0,10.0）,试验后为2.0（1.0,4.0）;对照组WOMAC评分试验前为（31±13）,试验后为（14±7）;试验组WOMAC评分试验前为（33±17）,试验后为（14±8）.2组患者关节压痛数、关节肿胀数以及WOMAC评分均有明显改善（P＜0.01）,2组间差异无统计学意义（P＞0.05）.结论 草乌甲素片治疗骨关节炎疗效确切,不劣于双氯芬酸钠片.

Efficacy and safety of bulleyaconitine A on patients with osteoarthritis

Objective To assess the efficacy and safety of bulleyaconitine A on patients with osteoarthritis.Methods In this open-controlled trial,a total of 114 patients with osteoarthritis were assigned to bulleyaconitine A （n =57,at dose of 0.4 mg,three daily） or diclofenac （n =57,at dose of 25 mg,three daily） for two weeks.Total patient-self assay,total doctor assay,number of tenderness for joins,number of edeme for joins and the western ontario and McMaster universities osteoarthritis index （WOMAC） score were assessed.Results In diclofenac group,VAS score for patient was （33 ± 13） after two weeks of treatment and it was （66 ± 13） before drug use（P 〈 0.01） in bulleyaconitine A group.VAS score for patient was （39 ± 13） after two weeks and it was （67 ± 15） before treatment（P 〈0.01）.There was significant improvement of VAS score in both groups （P 〈 0.01）.Bulleyaconitine A showed noninferiority to diclofenac.Before drug use,the number of tenderness for joins was 2.0 （1.0,4.0） ; after drug use it was 0.0 （0.0,1.0） in diclofenac group.Before drug use,the number of tenderness for joins was 2.0（0.0,3.0） ; after drug use it was 0.0（0.0,1.0） in Bulleyaconitine A group.Before drug use,the number of edeme for joins was 8.0（5.0,10.0） ; after drug use,it was 2.0 （1.0,3.0） in diclofenac groups.Before drug use,the number of edeme for joins was 7.0 （5.0,10.0） ;after drug use,it was 2.0 （1.0,4.0） in bulleyaconitine A group.Before drug use,WOMAC score was （31 ± 13） ; after drug use,it was （14 ±7） in diclofenac group.Before drug use,WOMAC score was （33 ± 17） ; after drug use,it was （14 ± 8） in bulleyaconitine A group.There was improvement of tenderness and edema of joins and WOMAC score in both groups（P 〈 0.01）.Conclusion Bulleyaconitine A has confirmed efficacy and is non-inferior to diclofenac.