消栓肠溶胶囊治疗缺血性中风恢复期(气虚血瘀证)多中心、随机、双盲双模拟、平行对照临床试验

A Multi-center Randomized Controlled Trial on Xiao-shuan Enteric-coated Capsules for the treatment of ischemic stroke restoration stage(syndrome of blood stasis due to qi deficiency)

目的观察消栓肠溶胶囊对缺血性中风恢复期气虚血瘀证患者神经功能缺损程度、证候及安全性指标的影响,从而探讨其疗效。方法采用随机、双盲双模拟、阳性药平行对照及多中心临床试验的研究方法,治疗组324例给予消栓肠溶胶囊和复方地龙胶囊模拟剂,对照组107例给予消栓肠溶胶囊模拟剂和复方地龙胶囊,连续使用(28±1)d,并分别于用药前、用药(28±1)d、发病(90±2)d对患者的神经功能缺损程度和证候及安全性指标进行采集分析。结果 1治疗组与对照组神经功能缺损评分,治疗后均有降低,组内、组间比较差异均有统计学意义,且治疗组疗效优于对照组;2治疗组与对照组中医证候积分均降低,组内、组间差异有统计学意义,治疗组疗效优于对照组;32组治疗前后生命体征、血尿常规等理化检查未发现明显异常,未出现严重不良事件。结论消栓肠溶胶囊能显著改善缺血性中风气虚血瘀证患者神经功能缺损症状及气虚血瘀症状,其疗效优于复方地龙胶囊,具有较好的安全性。

Objective To observe the effect of Xiao-shuan Enteric-coated capsules in the treatment of convalescent cerebral infarction（syndrome of blood stasis due to qi deficiency）,and the effect will be observed.Methods Randomized,double-blind,double simulation,positive drug parallel contrast and multicenter clinical trial research methods was used in this study,325 patients in treatment group was given Xiao-shuan Enteric-coated capsules and compound Dilong capsule simulation agent,while 107 cases of the control group was given Xiao-shuan Enteric-coated capsule simulation agent and compound Dilong capsule,the medication was continuously used and the nerve function,Chinese medicine syndrome and security index before medication,（28 ± 1） d after medication and（90 ± 2） d after morbidity were collected.Results 1 The neurologic impairment between two groups and before-after treatment decreased significantiy,and the treatment group was superior to control group;2 TCM syndrome of both treatment group and control group decreased,and the differences between two groups and before-after treatment were significant,and the treatment group was superior to control group;3 Vital sign,blood routine and urine routines showed normal,and no adverse effect happened.Conclusion Xiao-shuan Enteric-coated capsules could significantly improve the nerve function and the syndrome of blood stasis due to qi deficiency,and the effect is superior to compound Dilong capsule and secure.