舒肝解郁胶囊剂量加倍治疗中度抑郁症的随机、双盲、平行对照、多中心临床研究

Efficacy and safety of double doses of SHUGANJIEYU capsules in treating moderate depressive disorder:a multicenter,random,double-blind,and parallel-controlled trial

目的评价舒肝解郁胶囊剂量加倍治疗中度抑郁症的疗效和安全性。方法采用随机、双盲、平行对照、多中心临床试验方法,募集中度抑郁症患者随机分为高剂量组和常规剂量组。高剂量组采用舒肝解郁胶囊(每粒0.36 g)强化治疗,每日2次、每次4粒,常规剂量组为舒肝解郁胶囊与外观和舒肝解郁胶囊一致的模拟剂各2粒,每日2次,两组均连续治疗56 d。以汉密尔顿抑郁量表17项(Hamilton depression scale,HAMD-17)和汉密尔顿焦虑量表(Hamilton anxiety scale,HAMA)评价疗效,安全性评价采用患者不良事件和实验室检查。结果共纳入高剂量组和常规剂量组各120例患者。经过56 d治疗,以HAMD-17考察,高剂量组痊愈率为84.2%,常规剂量组为63.3%,两组差异有统计学意义(P<0.05)。治疗14 d后,高剂量组HAMD-17减分率高于常规剂量组[(35.4%±17.0%)vs.(27.1%±16.0%)],治疗56 d,高剂量组减分率仍高于常规剂量组[(79.0%±18.9%)vs.(65.9%±23.1%)],差异具有统计学意义(P<0.01)。两组中位起效时间均为14 d,组间差异无统计学意义(P>0.05)。以HAMA考察,治疗56 d高剂量组焦虑症状痊愈率达93.3%,总分下降72.5%,常规剂量组焦虑症状痊愈率77.5%,总分下降64.4%,两组间差异均有统计学意义(P<0.05)。两组不良反应发生率(17.5%vs.11.7%)差异无统计学意义(P>0.05)。结论舒肝解郁胶囊对中度抑郁症的抑郁症状和伴随的焦虑症状有较好疗效,剂量加倍能加快抑郁症状缓解速度,提高近期症状改善幅度,安全性尚可。

Objective To explore the efficacy and safety of double dosage of SHUGANJIEYU capsule on moderate depression. Methods The study was conducted by a multicenter, random, double-blind and parallel-controlled trial. Trial group received SHUGANJIEYU capsules 4# twice a day. Control group got two SHUGANJIEYU capsules and two simulated ones twice a day. The study lasted 56 days （8 weeks） for both groups. Primary efficacies were evaluated by the total score and score changed rate of Hamilton depression scale-17 （HAMD-17）and Hamilton anxiety scale （HAMA） as well safety by reported adverse events and laboratory tests for patients. Results One hundred twenty patients were recruited in trial group and 120 patients in control group. After a 8-week treatment, the remission ratio was 84.2% and 63.3% for the trial group and the control group, respectively according to the HAMD-17. The difference in the remission ratio was significant （P〈0.05）. Furthermore, the reduction rate of the total scores of HAMD-17 was 35.4% and 27.1% for the trial group and the control group at the 14th day of treatment, respectively, whereas 79.0% and 65.9% for the trial group and the control group at the 56th day. The reduction ratio was significantly higher in trial group than control group （P〈0.01）. The median time to response was 14 days in both groups. Based on the HA- MA, the remission ratio was 93.3% and 77.5% for the trial group and the control group respectively after 8 weeks and the difference in the remission ratio was significant between the two groups （P〈0.05）. Incidences of adverse effect were not significantly different between the two groups （17.5% vs. 11.7%, P〉0.05）. Conclusion SHUGANJIEYU capsule exhibits a good therapeutic effect on the depressive symptoms and anxiety symptoms in patients with moderate depres- sion. Double doses of SHUGANJIEYU capsule can increase the effect of SHUGANJIEYU and accelerates SHUGANJIEYU-induced improvement of depression symptoms with an acceptable safety.