苗医弩药针疗法治疗膝骨关节炎的有效性和安全性

Efficacy and safety of Nu-based acupuncture therapy in treatment of knee osteoarthritis

目的初步评价苗医弩药针疗法治疗膝骨关节炎(中医为寒痹,苗医为冷骨风)的安全性及临床疗效。方法采用随机、多中心、平行对照的临床研究方法,各临床中心同步按照入选标准共纳入297例。并随机均分为治疗组、安慰剂组和针灸组,治疗组采用随症取5~6个穴位,用弩药液涂擦膝关节周围,以按揉法和点压法按摩所选穴位,待患者感觉膝关节局部有热感10~15 min后穴位常规消毒,以无菌的梅花针沾弩药液点刺所选穴位,每个穴位点刺3~5次,并在点刺部位使用竹罐拔罐,10~15 min后取罐。安慰剂组采用安慰剂代替弩药液,选穴及方法同治疗组。针灸组采用选取其他穴位常规针刺,用灸法或温针灸法。研究疗程为10 d。观察各组临床疗效、膝关节疼痛VAS评分、主要临床症状改善率、起效时间、消失时间及安全性指标的变化以及WOMAC评分情况。结果治疗组治愈率为18.33%,显效率为59.16%,总有效率为83.33%,优于安慰剂组(0、1.47%、19.12%)和针灸组(15.25%、50.84%、82.76%)(P<0.05),且PP分析与FAS分析结果基本一致;三组膝关节疼痛VAS评分治疗前后比较,差异有统计学意义(P<0.05);而治疗后组间休息痛、晨僵、行走痛、站立痛等主要临床症状的改善率及消失时间比较,差异有统计学意义(P<0.05);治疗组与安慰剂组、针灸组WOC评分相比,差异有统计学意义(P<0.05);未发现所采用治疗方法的不良反应。结论苗医弩药针疗法治疗膝骨关节炎安全、有效。

Objective in treating knee osteoarthritis(i.e.cold arthralgia in Chinese medicine and cold bone wind in Miao medicine).MethodsRandomized,multicenter and parallel controlled clinical research method was used.A total of 297 cases included in each clinical center according to the inclusion criteria were randomly divided into treatment group,placebo group and acupuncture group.In the treatment group,5~6 acupoints in the patients were selected according to the symptoms,and they were massaged according to kneading method and point pressing method after the Nu solution was daubed among the knee joint.When the patients felt that the knee joint was hot for 10~15 minutes,the acupoints were pricked with sterile plum-blossom needle dipped in Nu solution,3~5 times for each acupoint,followed by bamboo cupping for 10~15 minutes.The placebo control group was treated with placebo instead of Nu solution,and the standard for selecting acupoints and manipulation methods were the same as in the treatment group.The acupuncture control group was given routine acupuncture at other acupoints,moxibustion or warm acupuncture.The course of treatment was 10 days.Clinical efficacy,VAS score of knee pain,improvement rate of main clinical symptoms,change of onset time,disappearance time,safety index and WOMAC score were observed across the two groups.Results were all significantly higher than the placebo and acupuncture groups(18.33%,0,15.25%;59.16%,1.47%,50.84%;83.33%,19.12%,82.76%,P<0.05).The VAS scores of knee pain in the three groups were significantly different before and after treatment(P<0.05).After treatment,the improvement rate and disappearance time of main clinical symptoms such as rest pain,morning stiffness,walking pain and standing pain were significantly different between groups(P<0.05).Compared with placebo group and acupuncture group,the WOC score of the treatment group was significantly different(P<0.05).No adverse reactions in the treatment group were found.ConclusionNu-based acupuncture therapy is safe and effective in treating knee osteoarthritis.