可欣舒治疗轻、中度抑郁症(肝郁脾虚证)Ⅲ期临床试验

A phaseⅢclinical trial of Kexinshu in treatment of mild or moderate depression with syndrome of liver stagnation-spleen deficiency

目的评价可欣舒治疗轻、中度抑郁症(肝郁脾虚证)的有效性和安全性。方法采用随机、双盲、氟西汀平行对照、剂量固定的多中心试验。入选455例,随机分为试验组(可欣舒片4.5g·d^(-1))和对照组(盐酸氟西汀片10mg·d^(-1)),观察6wk。采用17项汉密尔顿抑郁量表(HAMD-17)、疗效指数、中医证候评价疗效,以实验室相关检查和不良反应发生率评价安全性。结果纳入全分析集(FAS)448例(试验组336例,对照组112例),纳入安全性分析集455例(试验组341例,对照组114例)。2组治疗2、4、6 wk末HAMD-17评分与基线相比均显著下降(P<0.05),2组间各时间点总分和减分值均无显著差异(P>0.05)。试验组和对照组的疗效指数分别为(2.7±1.1)和(2.3±1.2),有非常显著差异(P<0.01)。试验组中医证候的愈显率和总有效率分别为44.6%和83.3%,对照组为39.3%和81.2%,2组间无显著差异(P>0.05)。试验组不良反应口干(34.2%vs.4.7%)、食欲减退或厌食(20.2%vs.4.1%)的发生率显著低于对照组(P<0.01)。结论可欣舒治疗轻、中度抑郁症(肝郁脾虚证)有效、安全,不良反应发生率较低。

AIM To evaluate the efficacy and safety of Kexinshu tablet in the treatment of mild or moderate depression with syndrome of liver stagnation-spleen deficiency. METHODS A randomized, doubleblind, fluoxetine-paralled controlled, multicenter trial was conducted. Total 455 patients were randomized into two groups in the six-week treatment： trial group （Kexinshu 4.5 g·d^-1） and control group （fluoxetine hydrochloride 10 mg·d^-1）. Hamilton＇s depression scale （HAMD-17） , efficacy index and traditional Chinese medicine （TCM） syndrome were employed to evaluate the effectiveness, related laboratory examinations and adverse reactions rates were employed to evaluate the safety. RESULTS There were 448 patients in Full Analysis Set （336 in the trial group, 112 in the control group） and 455 patients in Safe Set （341 in the trial group, 114 in the control group）. Compared with the baseline, the HAMD-17 scores were reduced significantly in both groups at the end of 2, 4, and 6 wk （P 〈 0.05）, and there was no significant difference between the two groups （P 〉 0.05）. The efficacy indexes in the trial group and control group were 2.7 ± 1.1 and 2.3 ± 1.2 respectively with significant difference （P 〈 0.01 ）. The curative-markedly effective rates and total effective rates of TCM syndrome were 44.6% and 83.3% in the trial group, and 39.3% and 81.2% in the control group respectively, with no significant difference between them （P 〉 0.05） . The incidence rates of adverse reactions of dry mouth （34.2% vs. 4.7%） and appetite decreases or anorexia （20.2% vs. 4.1%） in the trial group were lower than those in the control group （P 〈 0.01 ） . CONCLUSION Kexinshu is effective and safe in treatment of mild or moderate depression with syndrome of liver stagnation-spleen deficiency, and it has lighter adverse reactions.