散寒止痛外用贴膏治疗膝骨关节炎寒湿痹阻证的临床研究  

Treatment of cold-dampness obstruction syndrome of knee osteoarthritis with Sanhan Zhitong Plaster

作　　者：何晓瑾[1] 潘立群[1] 姜伟华[1] 徐峰[1] 江鸿杰[1] 景海波[1] 

机构地区：[1]南京中医药大学第一临床医学院,江苏210046

出　　处：《北京中医药大学学报（中医临床版）》2013年第2期9-14,共6页Journal of Beijing University of Traditional Chinese Medicine

基　　金："十一五"国家科技支撑计划项目(No.2008BAI53B017)

摘　　要：目的观察评价散寒止痛外用贴膏治疗膝骨关节炎寒湿痹阻证旳临床疗效及安全性。方法将4个研究中心纳入的膝骨关节炎578例按2∶2∶1比例随机分配成试验A组233例(复方南星止痛膏)、阳性药对照B组230例(伤湿解痛膏)、安慰剂对照C组115例(丙烯酸酯压敏胶胶布),给予敷贴药物治疗,每日1次,连用6d为1个周期。比较3组治疗前后膝关节疼痛的治愈率、有效率,WOMAC骨关节炎指数、中医证候积分、用药后的不良反应。结果以全分析集和符合方案数据分析集的数据进行分析,按膝关节疼痛视觉模拟评分法观察,A组疗效最好;WOMAC骨关节炎指数3组治疗前后随时间变化的趋势有统计学意义;以全分析集的数据分析,中医证候疗效A组最好。无与试验药物有关的严重不良反应发生。结论散寒止痛外用贴膏治疗膝骨关节炎寒湿痹阻证是安全有效的。Objective To observe the curative effect and safety of Sanhan Zhitong Plaster in the treatment of cold-dampness obstruction syndrome of knee osteoarthritis （KOA）. Methods KOA patients （n=578） from 4 research centers were divided, accordind to a proportion of 2： 2： 1, into group A （n=233, treated with Fufang Nanxing Zhitong Plaster）, group B （n=230, treated with Shangshi Jietong Plaster） and group C （n=115, treated with acrylics pressure-sensitive adhesive plaster）, once a day for 6 days. The cure rate, effective rate, Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC）, integrals of TCM syndromes and adverse effects after medication were compared among three groups before and after treatment. Results All data were analyzed by using Full Analysis Set （FAS） and Per-Protocol population （PP）. The curative effect was the best in group A after knee pain scoring with Visual Analogue Scale （VAS）. The change tendency of WOMAC had statistical significance in three groups before and after treatment. The curative effect on TCM syndromes was the best in group A after data analysis with FAS. There were no serious adverse reactions observed related to experimental medicinal. Conclusion Sanhan Zhitong Plaster is safe and effective in the treatment of cold-dampness obstruction syndrome of KOA

关 键 词：外用贴膏 膝骨关节炎 散寒止痛 随机双盲对照试验 多中心研究 

分 类 号：R255.6[医药卫生—中医内科学]