曲唑酮联合文拉法辛治疗重度抑郁症疗效与安全性的随机对照研究

包黎; 张静; 刘伟

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曲唑酮联合文拉法辛治疗重度抑郁症疗效与安全性的随机对照研究

更新时间：2022-06-21

- 曲唑酮联合文拉法辛治疗重度抑郁症疗效与安全性的随机对照研究
- Randomized Controlled Trials of Efficacy and Safety of Trazodone Combined with Venlafaxine in the Treatment of Major Depressive Disorder
- 中国药房 2021年32卷第16期
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- 纸质出版日期：2021，
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包黎, 张静, 刘伟. 曲唑酮联合文拉法辛治疗重度抑郁症疗效与安全性的随机对照研究[J]. 中国药房, 2021,32(16).

BAO Li, ZHANG Jing, LIU Wei. Randomized Controlled Trials of Efficacy and Safety of Trazodone Combined with Venlafaxine in the Treatment of Major Depressive Disorder[J]. China Pharmacy, 2021,32(16).
包黎, 张静, 刘伟. 曲唑酮联合文拉法辛治疗重度抑郁症疗效与安全性的随机对照研究[J]. 中国药房, 2021,32(16). DOI：

BAO Li, ZHANG Jing, LIU Wei. Randomized Controlled Trials of Efficacy and Safety of Trazodone Combined with Venlafaxine in the Treatment of Major Depressive Disorder[J]. China Pharmacy, 2021,32(16). DOI：

摘要

目的：比较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75mg，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25mg，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。

Abstract

OBJECTIVE：To compare th e 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 V enlafaxine 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.

关键词

重度抑郁症曲唑酮文拉法辛疗效安全性

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