伸筋接骨胶囊改善骨折(气滞血瘀证)的随机、双盲、多中心平行对照Ⅲ期临床研究

A Multicentered,Double-Blind Randomized Parallel Controlled Trials of Shenjin Jiegu Capsule in Improvement of Fracture of Syndrome of Qidepression and Blood Stasis

目的:在Ⅱ期临床试验基础上,进一步客观评价伸筋接骨胶囊改善骨折气滞血瘀证的安全性及有效性。方法:符合骨折(气滞血瘀证)受试者474例进入临床试验,采用骨折挫伤胶囊为对照,随机、双盲、多中心平行对照临床试验设计方法,每次4粒,每日3次。连服4～6周为1个疗程。结果:(1)试验组显效率为90.8%,总有效率为99.7%(n=316);对照组显效率为87.3%,总有效率为99%(n=102);扣除中心效应,显效率和总有效率,两组比较差异无统计学意义(P>05)。(2)试验组和对照组中医证候积分均有疗后低于疗前(P<0.01)。而两组疗后积分比较组间无差异(P>0.05)。(3)中医症状单项疗效比较,试验组疼痛与肿胀消失时间均低于对照组(P<01)。(4)试验组不良事件及不良反应率分别为2.20%,2.00%,对照组为3.40%,3.40%。两组比较未显示出统计学差异。结论:伸筋接骨胶囊可有效促进骨折愈合,改善中医证候疗效不劣于骨折挫伤胶囊,并在改善骨折早期出现的疼痛、肿胀等症状方面具有一定的优势,且具有较好的安全性。

Objective：Based on the PhaseⅡ clinical trial,a further objective evaluation of Shenjin Jiegu Capsule for treating fractures of syndrome of Qi depression and blood stasis was made.Methods：474 cases were subjects in clinical trials,Guzhe Cuoshang Capsule was used as control.A multicentered,double-blind,randomized parallel controlled trial was designed,4 pills,3 times a day.4~6 weeks was a course of treatment.Results：（1）The effective rate in Shenjin Jiegu Capsule group was 90.8%,in control group was 87.3%;and no significant dirrerences were observed between the two groups（P0.05）.The total effective rate in experimental group was 99.7%,in control group was 99%,there was no significant dirrerences in two groups（P0.05）.（2）TCM syndrome score after treatment in experimental and control groups were lower than that before treatment（P0.01）.The two points after treatment had no differences between groups（P0.05）.（3）Comparison of efficacy of TCM individual symptoms,pain and swelling lost time in the experimental group were lower than those in the control group.（4）Analysis of adverse events and adverse reactions：the incidence of the adverse events in experimental group was 2.2%,and the incidence of adverse reaction was also 2.0%.In the control group,the incidence of the adverse events was 3.4%,and the incidence of the adverse reaction was 3.4%.The incidence of adverse events and adverse reaction rates between the two groups showed no significant difference（P0.05）.Conclusion：Shenjin Jiegu Capsule can effectively promote the efficacy of TCM,and the effect is not inferior to Guzhe Cuoshang Capsule.And it has certain advantages on improving the early stage of fracture pain,swelling and other symptoms and has better security.