开郁宁治疗轻中度抑郁症的安慰剂对照研究

Double-blind controlled trial of Kaiyuning tablet and placebo in the treatment of mild to moderate depressive episodes

目的:评价开郁宁治疗轻中度抑郁症的疗效及安全性。方法:采用多中心、随机、双盲双模拟、平行对照的方法将149例抑郁症患者分为开郁宁组(75例)和安慰剂组(74例),疗程6周。以治疗前后汉密尔顿抑郁量表(HAMD)、中医证候量化分级表减分值评估疗效;以不良事件发生率、血常规、尿常规、血生化、心电图检查等评估安全性。结果:纳入结转疗效分析意向治疗(ITT)的患者及实测疗效分析符合方案(PP)的患者开郁宁组分别为72例和60例,安慰剂组分别为73例和56例。疗程结束后开郁宁组HAMD及中医证候量化分级表的减分值在ITT患者中(F=17.72,18.08)及PP患者中(F=14.66,13.90)明显高于安慰剂组(P均<0.01)。开郁宁组有效率[51.4%(ITT),58.3%(PP)]明显高于安慰剂组[21.9%(ITT),25.0%(PP)](χ2=13.56,13.17;P均<0.05);不良事件发生率开郁宁组(4.2%)和安慰剂组(6.9%)比较差异无统计学意义。结论:开郁宁治疗轻中度抑郁发作安全有效。

Objective： To evaluate the efficacy and safety of Kaiyuning tablet on mild to moderate depres- sive episodes. Method： Using muhicenter, randomized, double-blind, double simulation, parallel-group method, 149 patients were randomly divided into Kaiyuning group （75 cases） and placebo group （n =74）. The course was 6 weeks. The efficacy was evaluated with the reducing scores of Hamilton depression scale （ HAMD ）, Chinese medicine syndrome quantitative classification scale after treatment. The safety and tolerabili- ty were assessed by the incidence of adverse events, hematology, clinical chemistry, urinalysis, electrocardio- gram. Results： Intent-to-treat （ITr） patients using carry forward curative effect analysis and per-protocol （PP） patients using efficacy analysis of measured values in Kaiyuning group was 72 cases and 60 cases respec- tively ; was 73 cases and 65 eases respectively in the placebo group. The reducing scores of HAMD and Chinese medicine syndrome quantitative classification scale in Kaiyuning group in ITY patients （ F = 17.72,18.08 ） and PP patients （ F = 14.66,13.90） were significantly higher than those in the placebo group （ all P 〈 0.01 ）. Effi- ciency in Kaiyuning group [51.4% （ITF）,58.3% （PP）] were significantly higher than those in the placebo group [21.9% （ITT）, 25.0% （PP）] ）（ all P 〈0.05 ）. Incidence of adverse events between Kaiyuning group （4. 2% ） and the placebo group （6.8%） showed no statistical significance. Conclusion：Kaiyuning tablet is a safety and efficacy antidepressant.