中文摘要：

【目的】探讨补阳还五汤对膝骨性关节炎（KOA）气虚血瘀证患者西安大略和麦克马斯特大学骨关节炎调查量表（WOMAC）评分及关节液肿瘤坏死因子-α（TNF-α）、前列腺素E（_2PGE）2、基质金属蛋白酶-3（MMP-3）水平的影响。【方法】采用前瞻随机对照临床试验设计方法,根据患者的性别、年龄、病程、病情分级等一般情况,将108例病例按照分层随机化的方法,以1∶1的比例分成试验组和对照组,每组各54例。2组均给予玻璃酸钠关节腔内注射、盐酸氨基葡萄糖胶囊及双氯芬酸钠肠溶片口服等常规治疗方法治疗;同时,试验组给予补阳还五汤煎剂口服治疗,连续4周。分别观察2组受试对象治疗前、治疗后WOMAC评分及关节液TNF-α、PGE_2、MMP-3水平的变化。【结果】（1）治疗4周后,2组患者WOMAC评分及关节液TNF-α、PGE_2、MMP-3水平均较治疗前显著改善（P〈0.05）,且试验组的改善作用均优于对照组,组间比较,差异均有统计学意义（P〈0.01）。（2）安全性评价：试验期间,2组患者均无不良反应事件发生。【结论】补阳还五汤能够改善WOMAC评分,促进膝关节软骨下骨髓水肿的吸收,延缓软骨的破坏和退变,调节关节液TNF-α、PGE_2、MMP-3水平,是治疗膝骨性关节炎气虚血瘀证有效、安全的方剂之一,值得临床推广应用。

英文摘要：

Objective To evaluate the effect ofBuyangHuanwu Decoction（BHD） on Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） scores, and on tumor necrosis factor alpha（TNF-α）, prostaglandin E2（PGE2） and matrix metalloproteinase-3（MMP-3 ） levels in the joint fluid of knee osteoarthritis（KOA） patients with Qi deficiency and blood stasis syndrome. Methods The prospective, randomized, and controlled clinical trial was performed in 108 cases of KOA patients with Qi deficiency and blood stasis syndrome. According to the gender, age, course of the disease and disease classification, the patients were divided into trial group and control group at proportion of 1：1 following the method of stratified randomization. Both groups were treated with conventional treatment including intra-articular injection of sodium hyaluronate and oral use of glucosamine hydrochloride capsules and diclofenac sodium enteric-coated metformin hydrochloride tablets. And the trial group was simultaneously treated with BHD for 4 weeks. We observed the changes of outcome measures of WOMAC scores, and TNF-α, PGE2 and MMP-3 levels in joint fluid of the patients before and after treatment. Results （1） After treatment for 4 weeks, WOMAC scores, and TNF-α, PGE2 and MMP-3 levels in joint fluid of the two groups were obviously improved as compared with those before treatment（P 〈 0.05） , and the improvement of the trial group was superior to that of the control group, the differences being statistically significant between the two groups （P 〈 0.01 ）. （2）During the trial, no adverse event was found in the two groups. Conclusion BHD can improve WOMAC scores, relieve knee joint edema, delay the destruction and degeneration of cartilage, and regulate TNF-α, PGE2 and MMP-3 levels in joint fluid, which is an effective and safe recipe for the treatment of KOA patients with Qi deficiency and blood stasis syndrome, and shows good prospects in clinical application.