复方南星止痛膏治疗寒湿瘀阻型骨关节炎249例临床研究

Clinical study on"Compound Nanxing Pain Paste" in treating 249 cases of osteoarthritis of cold dampness and blood stasis

目的评价复方南星止痛膏治疗寒湿瘀阻型骨关节炎(OA)的临床疗效及其安全性。方法采用随机、平行对照、多中心临床试验方法将327例骨关节炎患者分为治疗组和对照组,分别采用复方南星止痛膏和麝香追风膏外敷治疗,疗程6天。观察两组关节疼痛VAS评分和缓解时间,中医证候积分和疗效,药物不良反应。结果治疗后两组VAS评分均明显下降(P<0.01),治疗组治疗前后VAS评分差值大于对照组(P<0.01);两组关节疼痛缓解时间有统计学差异(P<0.05);治疗后两组中医证候积分均明显下降(P<0.05),治疗组治疗前后中医证候积分差值大于对照组(P<0.05);两组中医证候总有效率有统计学差异(P<0.05);两组均未见明显的不良反应。结论复方南星止痛膏治疗寒湿瘀阻型骨关节炎有效、安全。

Objective To evaluate the clinical effects and safety of ＂Compound Nanxing Pain Paste＂ in the treatment of osteoarthritis of cold dampness and blood stasis.Methods By randomized,parallel control and multi-central clinical trials,327 subjects were divided into treatment group and control group,and treated respectively by ＂Compound Nanxing Pain Paste＂ and ＂Shexiang Zhuifeng Paste＂,with a course of 6 days.The VAS score and relief time of joint pain,symptoms score and efficacy,and side effects were observed.Results After treatment,the VAS scores were reduced evidently in both groups（P0.01）,with more significant reduction in the treatment group than in the control group（P0.01）;there was a difference in the pain relief time between the two groups（P0.05）;the symptoms scores were reduced in both groups（P0.05）,with more significant reduction in the treatment group than in the control group（P0.05）;there was a significant difference in the symptoms efficacy between the two groups（P0.05）;no remarkable side effects were found in both groups.Conclusion ＂Compound Nanxing Pain Paste＂ is effective and safe in the treatment of osteoarthritis of cold dampness and blood stasis.