加味当归四逆汤配合温针灸治疗膝骨性关节炎的随机对照研究

目的:评价加味当归四逆汤配合温针灸治疗膝骨性关节炎(OA)患者的临床疗效。方法:将95例膝骨性关节炎(OA)患者采用随机数字表法分为治疗组48例和对照组47例。治疗组服用加味当归四逆汤并配合温针灸治疗,对照组服用塞来昔布胶囊。2组均以1周为1疗程,治疗4个疗程后进行疗效评价。结果:治疗组总有效率为95.83%(95%CI=85.30%~99.46%);对照组为89.36%(95%CI=76.61%~96.42%);两组综合疗效比较(u=1.845 1,P=0.065 2),差异接近临界状态。两组治疗后VAS评分参数比较,差异无统计学意义。两组治疗后WOMAC评分比较(t=-4.566 4,P0.01),差异具有统计学意义。且两组在观察期间各项实验室检测指标均未见明显不良反应。结论:加味当归四逆汤配合温针灸治疗膝骨性关节炎优于塞来昔布的证据尚不够确定,其收益为OR=0.37(95%CI=0.07~1.96),NNT=16(95%CI=6.03~39.01)。

The Randomized Controlled Study on Modified Danggui Sini Decoction Combined with Warming Acupuncture for the Treatment of Knee Osteoarthritis

Objective： To evaluate the clinical efficacy of modified danggui sini decoction combined with warming acupuncture for knee osteoarthritis （OA）. Methods： 95 cases patients with OA were randomized into two groups, i.e. the treatment group with 48 cases and the control group with 47 cases. The treatment group were received modified danggui sini decoction combined with warming acupunctur, and the control group were received celecoxib capsule. For two groups, one week constituted one treatment course, and the therapeutic effect and the safety were evaluated and compared after 4 treatment courses. Results： The total effective rate was 95.8% （95% CI = 85.30% - 99.46% ） in the treatment group; and 85.3% （95% CI = 76. 61% - 96. 42% ） in the control group ; and compared the integrated efficacy of two groups （ u = 1. 845 1, P = 0. 065 2）, the differences close to the critical state. After treatment of 2 groups, compared VAS score parameter, the difference was not statistically significant, whlie compared WOMAC scores （ t = - 4. 566 4, P 〈 0. 01 ） , the difference was statistically significant. During the observation period, for all laboratory indexes of two groups no adverse reactions were seen. Conclusion： The evidence, that in the treatment of knee osteoarthritis modified danggui sini decoction combined with warming acupuncture was better than celecoxib capsule, is insufficient to determine. Its benenfit was OR = 0.37 （95% CI =0. 07 - 1.96）, NNT = 16 （95% CI =6.03 -39.01）.