包黎 张静 刘伟

中图分类号 R749.05 文献标志码 A 文章编号 1001-0408（2021）16-2008-04

DOI 10.6039/j.issn.1001-0408.2021.16.15

摘 要 目的：比較曲唑酮联合文拉法辛和单用文拉法辛用于重度抑郁症（MDD）的疗效与安全性。方法：将2018年9月-2020年9月于我院住院治疗的160例MDD患者按随机数字表法分为对照组（80例）和观察组（80例）。对照组患者给予盐酸文拉法辛缓释片75 mg，口服，每天上午1次;观察组患者在对照组治疗的基础上给予盐酸曲唑酮片25 mg，口服，每天2次;两组患者均根据疗效和耐受情况调整用药剂量。比较两组患者治疗前后汉密尔顿抑郁量表24项（HAMD-24）评分、蒙哥马利-阿斯伯格抑郁量表（MADRS）评分和匹兹堡睡眠质量指数（PSQI）评分，比较其临床疗效，并记录不良反应发生情况。结果：共有12例患者脱落，最终纳入148例患者，其中对照组73例、观察组75例。治疗前，两组患者的HAMD-24、MADRS、PSQI评分比较，差异均无统计学意义（P>0.05）。治疗1、3、5、8周后，两组患者的HAMD-24评分、MADRS评分均显著低于同组治疗前，且观察组显著低于同组对照组（P<0.05）;观察组患者的PSQI评分均显著低于同组治疗前及同期对照组（P<0.05），而对照组患者治疗前后PSQI评分比较差异均无统计学意义（P>0.05）。观察组患者的总有效率（96.00%）显著高于对照组（86.30%）（P<0.05）。两组患者的不良反应总发生率比较，差异无统计学意义（P>0.05）。结论：曲唑酮联合文拉法辛和单用文拉法辛治疗MDD均有显著疗效且安全性相当，但曲唑酮联合文拉法辛的疗效更优。

关键词 重度抑郁症;曲唑酮;文拉法辛;疗效;安全性

Randomized Controlled Trials of Efficacy and Safety of Trazodone Combined with Venlafaxine in the Treatment of Major Depressive Disorder

BAO Li1，ZHANG Jing2，LIU Wei3（1. Dept. of Infection Management， Wuhan Mental Health Center， Wuhan 430022， China;2. Dept. of Laboratory Medicine， Wuhan Mental Health Center， Wuhan 430022， China; 3. No. 2 Medical Unit， Wuhan Mental Health Center， Wuhan 430022， China）

ABSTRACT   OBJECTIVE： To compare the clinical efficacy and safety of trazodone combined with venlafaxine and venlafaxine in the treatment of major depressive disorder （MDD）. METHODS： Totally 160 patients with MDD who were treated in our hospital from Sept. 2018 to Oct. 2020 were all enrolled and divided into control group （80 cases） and observation group （80 cases） according to random number table. Control group was treated with Venlafaxine hydrochloride sustained-release tablets 75 mg orally， once every morning. Observation group was additionally treated with Trazodone hydrochloride tablets 25 mg orally， twice a day， on the basis of control group. The dosage was adjusted according to the efficacy and tolerance. Hamilton depression scale 24 （HAMD-24）， Montgomery-Asperger depression scale （MADRS） and Pittsburgh sleep quality index （PSQI） were compared between 2 groups before and after treatment. Clinical efficacies were compared and the occurrence of ADR were recorded. RESULTS： A total of 12 patients were expelled， and 148 patients were eventually included， involving 73 cases in control group and 75 cases in observation group. Before treatment， there was no significant differences in HAMD-24， MADRS or PSQI scores between 2 group （P>0.05）. After 1， 3， 5 and 8 weeks of treatment， HAMD-24 and MADRS scores of 2 groups were significantly lower than before treatment， and the observation group was significantly lower than the control group （P<0.05）. PSQI scores of observation group were significantly lower than before treatment and control group during the same period （P<0.05）， while there was no significant difference in PSQI scores of control group before and after treatment （P>0.05）. The total response rate of observation group （96.00%） was significantly higher than control group （86.30%） （P<0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P>0.05）. CONCLUSIONS： Trazodone combined with venlafaxine and venlafaxine alone both have good efficacy and similar safety in the treatment of MDD， but clinical efficacy of trazodone combined with venlafaxine is better.

KEYWORDS   Major depressive disorder; Trazodone; Venlafaxine; Efficacy; Safety

重度抑郁症（major depressive disorder，MDD）是临床上最常见的精神疾病之一，其主要临床特征为情绪抑郁并伴有心理和营养变化，如情绪低落、悲观自负、难以维持精神集中、睡眠和/或食欲障碍、疲劳等，严重者甚至会有自杀的想法和行为[1]。药物是治疗MDD的一线方法[2]。其中，曲唑酮是一种四环类非典……