防风祛痹丸治疗痰瘀痹阻兼气血两虚证痛风慢性期随机对照双盲多中心Ⅱ期临床研究

目的]评价防风祛痹丸治疗痰瘀痹阻兼气血两虚证痛风慢性期的疗效和安全性.方法]采用随机双盲、双模拟、安慰剂和别嘌呤醇对照、多中心临床试验设计,分为试验药组、阳性药组、安慰剂组三组,分别予以防风祛痹丸+别嘌呤醇模拟剂、别嘌呤醇片+防风祛痹丸模拟剂、防风祛痹丸模拟剂+别嘌呤醇模拟剂,疗程均为6周.以关节疼痛VAS评分、血尿酸水平、关节功能、中医证候积分、痛风急性发作次数观察疗效,以不良事件和实验室检查观察安全性.结果]共220例完成试验,用药4、6周后试验药组的关节疼痛VAS评分及减分值、血尿酸水平和中医证候积分均较安慰剂组、阳性药组显著下降(P＜0.05),治疗6周后试验药组关节功能改善优于阳性药组、安慰剂组(P＜0.01),痛风发作次数差异无统计学意义(P＞0.05).试验过程中未出现严重不良反应.结论]防风祛痹丸治疗痰瘀痹阻兼气血两虚证痛风慢性期具有较好疗效,安全性较好.

Fangfengqubi Pill in Treatment of Chronic Gout with Syndrome of Blockage of Phlegm and Blood Stasis Combined Qi-blood Deficiency

Objective] To evaluate the safety and efficacy of Fangfengqubi pill in the treatment of chronic gout with syndrome of blockage of phlegm and blood stasis combined qi-blood deficiency.Methods]This study was a double-blind,double-dummy,randomized and parelled placebo and allopurinol controlled,multi-center phase 2 clinical trail.The subjects of treatment group were administered orally with 6g Fangfengqubi pills and 100mg allopurinol dummy（tid）,the subjects of allopurinol group were administered orally with 100mg allopurinol and 6g Fangfengqubi pills dummy（tid）,the subjects of placebo group were administered orally with 6g Fangfengqubi pills dummy and 100mg allopurinol dummy（tid） for 6 weeks.Visual analogue scales（VAS） of joint pain,blood uric acid,joint function,efficacy of TCM syndrome,and flare frequency of gout were employed to evaluate the effectiveness,adverse events and related laboratory examinations were employed to evaluate the safety.Results] Two hundred and forty subjects participated in the trials（120 in the treatment group,60 in the allopurinol group,60 in the placebo group）.All of them were in the Full Analysis Se（t FAS） and the Safety Se（t SS）,220 subjects completed the trial excluding 20 subjects.The VAS and its decreased score,blood uric acid level and efficacy of TCM syndrome in the treatment group were significantly less than the allopurinol group and the placebo group after 4 and 6 weeks treatment,the improvement of joint function in the treatment group was significantly better than the allopurinol group and the placebo group after 6 weeks treatment.The difference of the flare frequency in 3 groups was not significant.No serious adverse event occurred in all groups.Conclusion] Fangfengqubi pill is effective and safe in the treatment of chronic gout with syndrome of blockage of phlegm and blood stasis combined qi-blood deficiency.