李长红 魏琴 魏思璐 冯艳广 王慧娟

【摘 要】目的：观察体外冲击波疗法联合口服益肾蠲痹丸治疗膝骨关节炎的临床疗效及安全性。方法：将334例膝骨关节炎患者随机分为治疗组和对照组，每组167例。治疗组给予体外冲击波疗法联合口服益肾蠲痹丸治疗，对照组给予萘普生口服治疗。2组均以6个月为1个疗程。观察2组临床疗效，治疗前及治疗5周、3个月、6个月后采用视觉模拟评分法（VAS）评估2组受试者的膝关节疼痛，WOMAC骨關节炎指数评估受试者的功能。结果：治疗6个月后，治疗组显效74例，好转86例，无效7例，总有效率为95.81%；对照组显效57例，好转74例，无效36例，总有效率为78.44%。2组比较，差异有统计学意义（P < 0.01）。治疗5周、3个月、6个月后，2组VAS评分和WOMAC骨关节炎指数较治疗前均有改善（P < 0.05），且治疗组改善优于对照组（P < 0.05）。结论：采用体外冲击波疗法联合口服益肾蠲痹丸能快速缓解膝关节疼痛和改善功能，具有较好的远期疗效，且不良反应发生率较低。

【关键词】 骨关节炎，膝；体外冲击波；益肾蠲痹丸；临床疗效；安全性

【ABSTRACT】Objective：To observe the clinical efficacy and safety of extracorporeal shock wave combined with Yishen Juanbi Wan（益肾蠲痹丸）in the treatment of knee osteoarthritis.Methods：Three hundred and thirty-four patients with knee osteoarthritis were randomly divided into a treatment group and a control group，with 167 casesin each.The treatment group was given extracorporeal shock wave therapy combined with Yishen Juanbi Wan，while the control group was orally given Naproxen.The two groups were treated with 6 months as a course.The clinical efficacy of the two groups was observed.After five weeks，three months and six months of treatment，the visual analogue scale（VAS）was used to evaluate the knee pain of both groups and the WOMAC was used to evaluate the bone function of subjects.Results：After six months of treatment for the treatment group，74 cases were markedly improved，86 cases were improved，7 cases had no improvement，and the total effective rate was 95.81%.In the control group，57 cases were markedly improved，74 cases were improved，36 cases were ineffective，and the total effective rate was 78.44%.The difference between the two groups was statistically significant（P < 0.01）.After 5 weeks，3，6 months of treatment，the VAS scores and WOMAC osteoarthritis index in the two groups were improved compared with those before treatment（P < 0.05），and the treatment group was better than the control group（P < 0.05）.Conclusion：Extracorporeal shock wave combined with Yishen Juanbi Wan can quickly relieve knee pain and improve its function，with a better and long-term effect and a low incidence rate of adverse reaction.

【Keywords】 osteoarthritis，knee；extr-acorporeal shock wave；Yishen Juanbi Wan（益肾蠲痹丸）；pain；clinical efficacy；safety

骨关节炎（osteoarthritis，OA）是以关节软骨局灶病变、软骨下骨肥厚反应和关节边缘骨赘形成为特征的慢性关节疾病。OA表现为关节疼痛、僵硬、肥大及活动受限[1-2]，属中医学“骨痹”范畴。近年来，随着老年人口的增加[3]，本病发病率也明显升高，60岁以上人群患病率可达50%，

75岁以上的人群则达80%，本病致残率可高达53%[4]；女性多于男性，并且膝骨关节炎（knee os teoarthritis，KOA）所占比例甚高，60岁以上人群的患病率可达42%[5]。

目前，国内外治疗KOA包括减少关节的负重、镇痛和抗炎药物、糖皮质激素、双膦酸盐、双醋瑞因、氨基葡萄糖等，但治疗效果并不理想。近年来，体外冲击波（ESWT）治疗KOA，在减轻膝关节疼痛和改善功能方面引起了极大的关注。国内外的动物实验也表明，冲击波对OA的治疗有显著疗效，能够迅速缓解关节疼痛并恢复关节功能，远期具有延缓OA退行性变的作用[6-7]。……