元七骨痛酊治疗膝骨关节炎(筋脉瘀滞证)多中心随机对照临床试验

Treatment of Knee Osteoarthritis(Tendon and Vessel Stasis Syndrome) Patients with Yuanqigutong Tincture:a Multi-center,Randomized and Positive-controlled Clinical Trial

目的:评价元七骨痛酊治疗膝骨关节炎(筋脉瘀滞证)的有效性和安全性。方法:采用前瞻性、多中心、随机、阳性药平行对照临床研究方法,纳入200例膝骨关节炎(筋脉瘀滞证)患者,分为试验组与对照组各100例。试验组和对照组患者分别给予元七骨痛酊、骨友灵搽剂,外搽于患处,每次2~5mL,每日3次,疗程2周。评价疾病综合疗效、中医证候评分、单项症状和起效时间。结果:综合疗效比较,试验组患者总有效率为92.0%,对照组总有效率为78.0%,组间临床疗效比较差异具有统计学意义(P<0.01),试验组疗效明显优于对照组;经过治疗,试验组患者积分下降(8.91±4.1441),对照组患者积分下降(6.88±3.4061),差异具有统计学意义(P<0.01);单项症状中"从座位站立、最大行走距离、日常活动(不包括在不平路行走)",试验组患者改善程度显著优于对照组,差异具有统计学意义(P<0.05)。两组患者均无不良反应发生。结论:元七骨痛酊治疗膝骨关节炎(筋脉瘀滞证)疗效确切,优于骨友灵搽剂,且未发现不良反应,值得临床推广应用。

Objective：To evaluate the efficacy and safety of Yuanqigutong tincture in knee osteoarthritis（tendon and vessel stasis syndrome）. Methods：200 patients were involved in a prospective, multi-center, randomized and positive parallel-controlled clinical trial. 100 patients were enrolled in the yuanqigutong tincture group,while another 100 patients were enrolled in the guyouling lini- ment group. Two drugs were used externally and 2~SmL per time and three times a day. The course of treatment was 2 weeks. The disease comprehensive effect,scores of traditional Chinese Medicine syndromes, single symptom and onset time were evaluated. Re- suits： The total effective rates of disease comprehensive effect of treated group and control group were 92.0 ~/60 and 78.0 %, and the efficacy of two groups was significant difference statistically（P^0.01 ）. The scores of decline of traditional Chinese Medicine Syn- drome of treated group and control group were 8.91 ± 4. 1441 and 6.88 ± 3. 4061, and the efficacy of two groups was significant difference statistically （P〈 0. 01 ）. The individual symptoms ＇ efficacy of two groups were significant difference statistically （P〈 0.05）, and these symptoms included standing from the seat, maximum walking distance and daily activities which exclude walking on rough road. The two groups had no obvious side-effect. Conclusion： Yuanqigutong tincture was effective as a treatment of knee osteoarthritis（tendon and vessel stasis syndrome） and had no adverse reaction. Yuanqigutong tincture was superior to guyouling liniment in improving disease comprehensive effect and score of traditional Chinese Medicine syndrome.