仲香胶囊治疗腰椎间盘突出症(气滞血瘀证)的临床研究

Clinic Research of Zhongxiang Capsule for Treatment of Lumbar Disc Herniation(Syndrome of Qi-stagnation and Blood Stasis)

目的:评价仲香胶囊治疗腰椎间盘突出症(气滞血瘀证)的安全性及有效性。方法:随机、双盲、阳性药平行对照、多中心研究方法进行仲香胶囊的Ⅲ期临床试验。纳入受试者437例:其中试验组328例,对照组109例,其中试验组服用仲香胶囊,对照组服用腰痛宁胶囊,疗程3周,观察其临床疗效和安全性。结果:疾病疗效:试验组总有效率89.9%,对照组总有效率87.2%,总有效率两组差异无统计学意义(P>0.05);试验组总显效率39%,对照组总显效率22%,总显效率试验组优于对照组(P<0.05)。单项症状体征疗效分析:下肢麻木、腰部压痛、腰部活动不利和直腿抬高试验两组间比较均有统计学意义(P<0.05)。起效时间指标分析:两组间差异无统计学意义(P>0.05)。FAS分析与PPS分析结果相同。不良事件和不良反应分析:试验组有4例(1.2%)发生不良事件,均为不良反应,对照组有2例(1.8%)不良事件,其中1例为不良反应,不良事件发生率和不良反应发生率两组间差异无统计学意义(P>0.05)。结论:仲香胶囊治疗腰椎间盘突出症(气滞血瘀证)安全有效。

Objective:To evaluate the efficacy and safety of ZhongXiang capsule for the treatment of lumbar disc herniation(syndrome of qi stagnation and blood stasis).Methods:PhaseⅢclinical trial of ZhongXiang capsule was carried out by randomized,double-blind,positive drug parallel controlled and multi-center research methods in 437patients.Patients were divided into two groups,with the test group taking ZhongXiang capsule and the control group Yaotongning capsule.After 3-week treatment,the efficacy and safety of salvianolate were evaluated.Results:The total efficiency rate was 89.9%in the test group,and 87.2%in the control group(P>0.05).The total effective rate was 39%in the test group,and 22%in the control group(P<0.05).Statistical analysis of individual symptoms and signs indicated that conditions of lower limb numbness,waist tenderness,waist straightness and leg raising test in the test group were better than those of the control group(P<0.05).No statistically significant difference was found between two groups concerning analysis of the onset time.All results of FAS were the same as those of PPS.Adverse events occurred in4patients(1.2%)in the test group,all of which were adverse reactions.2adverse events were found(1.8%)with 1adverse reaction in the control group.No statistically significant difference was found between two groups.Conclusion:Zhong Xiang capsule is safe and effective for the treatment of lumbar disc herniation(syndrome of qi stagnation and blood stasis).