开郁宁与氟西汀治疗轻中度抑郁症的多中心随机双盲对照研究

发布时间：2018-05-05 02:23

本文选题：开郁宁 + 氟西汀　；参考：《中国新药杂志》2015年13期

【摘要】：目的:评价开郁宁片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、平行对照的实验设计。共纳入228例患者,随机分为开郁宁组114例、氟西汀组114例;疗程6周。以汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD)、汉密尔顿焦虑量表(Hamilton Anxiety Scale,HAMA)和临床大体印象量表(Clinical Global Impression,CGI)进行疗效评估。以不良事件发生率,血常规、尿常规、血生化、心电图检查及生命体征等进行安全性评估。结果:开郁宁组113例和氟西汀组111例纳入疗效统计分析。开郁宁组和氟西汀组治疗第6周末HAMD减分值的结转值分别为(12.4±4.2)分和(11.0±4.6)分,开郁宁组优于氟西汀组,差异有统计学意义(F=5.36,P=0.022);但两组符合方案的实测值分别为(12.7±3.7)分和(12.0±3.5)分,两组比较差异无统计学意义(F=2.06,P=0.153)。开郁宁组和氟西汀组有效率分别为81.4%(92/113)和70.3%(78/111),两组比较差异无统计学意义(P0.05)。开郁宁组和氟西汀组不良事件发生率分别为14.2%和18.7%,两组比较差异无统计学意义(P0.05)。开郁宁组与药物相关的不良事件主要表现为恶心(1.8%)。结论:开郁宁片治疗轻中度抑郁症安全有效。
[Abstract]:Objective: to evaluate the efficacy and safety of Kaiyuning tablet in the treatment of mild to moderate depression. Methods: a multi-center, randomized, double-blind and double-simulated, parallel-controlled design was used. A total of 228 patients were randomly divided into Kaiyuning group (114 cases) and fluoxetine group (114 cases) for 6 weeks. The efficacy was evaluated by Hamilton Depression scale, Hamilton Anxiety scale and Clinical General impression scale. Safety was evaluated by adverse events, blood routine, urine routine, blood biochemistry, electrocardiogram and vital signs. Results: 113 cases in Kaiyuning group and 111 cases in fluoxetine group were included in the statistical analysis of curative effect. At the end of the 6th week of treatment, the carryover values of HAMD in the Kaiyuning group and fluoxetine group were 12.4 卤4.2 and 11.0 卤4.6, respectively, which were better than those in the fluoxetine group, the difference was statistically significant, but the actual values of the two groups were 12.7 卤3.7 and 12.0 卤3.5, respectively. There was no statistical difference between the two groups. The effective rates of Kaiyuning group and fluoxetine group were 81.4 / 92 / 113) and 70.33 / 78 / 111 respectively. There was no significant difference between the two groups (P 0.05). The incidence of adverse events in Kaiyuning group and fluoxetine group were 14.2% and 18.7%, respectively. There was no significant difference between the two groups (P 0.05). The main adverse events related to drugs in Kaiyuning group were nausea 1.8%. Conclusion: Kaiyuning tablet is safe and effective in the treatment of mild and moderate depression.
【作者单位】：首都医科大学附属北京安定医院精神疾病诊断与治疗北京市重点实验室北京脑重大疾病研究院精神分裂症研究所;健民药业集团股份有限公司;第四军医大学西京医院;昆明医科大学第一附属医院;河北省第六人民医院;武汉市精神卫生中心;
【分类号】：R749.4

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