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·药物与临床·

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 Δ

1＊
包 黎 ，张 静 ，刘 伟 [1.武汉市精神卫生中心公卫（院感）科，武汉 430022；2.武汉市精神卫生中心检验
3 #
2
科，武汉 430022；3.武汉市精神卫生中心精神科二病区，武汉 430022]
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
3
2
1
BAO Li ，ZHANG Jing ，LIU Wei（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
Δ 基金项目：湖北省科技计划项目（No.2018CFB334）；武汉市医
treatment of MDD， but clinical efficacy of trazodone
学科研项目（No.WG19D08）
combined with venlafaxine is better.
＊主管护师。研究方向：精神疾病患者的营养与护理干预。
KEYWORDS Major depressive disorder； Trazodone；
E-mail：baoli234123@163.com
Venlafaxine；Efficacy；Safety
# 通信作者：主治医师。研究方向：精神卫生。E-mail：liuwei5@
163.com

·2008 · China Pharmacy 2021 Vol. 32 No. 16 中国药房 2021年第32卷第16期