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中华临床医师杂志(电子版) ›› 2022, Vol. 16 ›› Issue (08) : 725 -731. doi: 10.3877/cma.j.issn.1674-0785.2022.08.004

心身医学·临床研究

文拉法辛初始联合坦度螺酮治疗重性抑郁障碍的临床研究
胡艳1, 汪卫华2,†(), 纪菊英3, 周蓉3, 刘羽3, 隋云川3, 赵汉清3, 刘康3, 胡一帆3   
  1. 1. 213003　江苏常州，安徽医科大学无锡临床学院心理科
    2. 213003　江苏常州，安徽医科大学无锡临床学院心理科；213003　江苏常州，联勤保障部队第904医院全军精神医学中心心理科
    3. 213003　江苏常州，联勤保障部队第904医院全军精神医学中心心理科
  • 收稿日期:2022-06-17 出版日期:2022-08-15
  • 通信作者: 汪卫华
  • 基金资助:
    厅市共建中枢神经系统药物四川省重点实验室开发课题(210024-01SZ)

Clinical effects of venlafaxine initially combined with tandospirone for treatment of major depressive disorder

Yan Hu1, Weihua Wang2,†(), Juying Ji3, Rong Zhou3, Yu Liu3, Yunchuan Sui3, hanqing Zhao3, Yifan Hu3   

  1. 1. Department of Psychology, Wuxi Clinical College, Anhui Medical University, Jiangsu 213003, China
    2. Department of Psychology, Wuxi Clinical College, Anhui Medical University, Jiangsu 213003, China; Department of Cardiology, Psychiatric Center of PLA, No. 904 Hospital of The PLA Joint Logistic Support Force, Changzhou 213003, China
    3. Department of Cardiology, Psychiatric Center of PLA, No. 904 Hospital of The PLA Joint Logistic Support Force, Changzhou 213003, China
  • Received:2022-06-17 Published:2022-08-15
  • Corresponding author: Weihua Wang
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引用本文：

胡艳, 汪卫华, 纪菊英, 周蓉, 刘羽, 隋云川, 赵汉清, 刘康, 胡一帆. 文拉法辛初始联合坦度螺酮治疗重性抑郁障碍的临床研究[J]. 中华临床医师杂志(电子版), 2022, 16(08): 725-731.

Yan Hu, Weihua Wang, Juying Ji, Rong Zhou, Yu Liu, Yunchuan Sui, hanqing Zhao, Yifan Hu. Clinical effects of venlafaxine initially combined with tandospirone for treatment of major depressive disorder[J]. Chinese Journal of Clinicians(Electronic Edition), 2022, 16(08): 725-731.

目的

探讨文拉法辛初始联合坦度螺酮治疗重性抑郁障碍患者的疗效、副反应及对患者性功能和认知功能的影响。

方法

选取2021年3月至2021年12月就诊于联勤保障部队第904医院心理科的患者，从中挑选符合入组条件的重性抑郁障碍患者90例，按随机数字表法分成单药组（文拉法辛联合安慰剂，43例）和联合组（文拉法辛联合坦度螺酮，47例）。分别于治疗前（基线）、治疗后第1、2、4、6周末进行汉密尔顿抑郁量表（HAMD-17）、汉密尔顿焦虑量表（HAMA）、亚利桑那性体验量表（ASEX）、数字符号转换测验（DSST）、认知功能缺陷自评问卷（PDQ-D）、药物副反应量表（TESS）评估。

结果

联合组治疗后第1、2、4、6周末HAMD-17、HAMA评分均较治疗前下降（P均＜0.05），单药组治疗后第2、4、6周末HAMD-17、HAMA评分较治疗前下降（P均＜0.05）；联合组治疗后第1、2、4、6周末HAMD-17、HAMA评分均低于单药组（P均＜0.05）。联合组治疗后第4、6周末ASEX评分较治疗前下降（P均＜0.05），单药组治疗前后ASEX评分差异无统计学意义（P均＞0.05）；联合组治疗后第4、6周末ASEX评分均低于单药组，差异有统计学意义（P均＜0.05）。联合组治疗后第4、6周末DSST、PDQ-D评分与治疗前有显著性差异（P均＜0.05），单药组治疗前后DSST、PDQ-D评分差异无统计学意义（P均＞0.05）；联合组治疗后第6周末DSST评分高于单药组（t=-2.160，P均＜0.05），联合组治疗后第4、6周末PDQ-D评分低于单药组（t=2.842、4.298，P均＜0.05）。（4）2组不良反应发生率差异无统计学意义（χ2=0.621，P=0.523）。

结论

文拉法辛初始联合坦度螺酮治疗重性抑郁障碍患者能够提高疗效，缩短起效时间，安全性良好，并且能够改善性功能及认知功能。

关键词: 重性抑郁障碍, 文拉法辛, 坦度螺酮, 初始联合, 疗效, 性功能, 认知功能
Objective

To evaluate the efficacy and side effects of venlafaxine initially combined with tandospirone in the treatment of patients with major depressive disorder, as well as the effects on sexual and cognitive functions.

Methods

A total of 90 depression patients who visited the Department of Cardiology of the No. 904 Hospital of The PLA Joint Logistic Support Force from March 2021 to December 2021 were selected. These patients, who met the enrollment criteria, were selected and randomly divided into either a monotherapy group (43 cases) or a combination therapy group (47 cases) using the random number table method. The monotherapy group was treated with venlafaxine combined with placebo, and the combination group was treated with venlafaxine combined with tandospirone. The patients were evaluated with the Hamilton Rating Scale for Depression (HAMD-17), Hamilton Anxiety Scale (HAMA), Arizona Sexual Experience Scale (ASEX), Digit Symbol Substitution Test (DSST), Perceived Deficit Questionnaire for Depression (PDQ-D), and Treatment Emergent Symptom Scale (TESS) at baseline and 1, 2, 4, and 6 weeks after treatment. Paired t-test and independent sample t-test were used to compare the differences in efficacy, sexual function, and cognitive function between the two groups, and the chi-square test was used to compare the differences in the incidence of drug side effects.

Results

HAMD-17 and HAMA scores at 1, 2, 4, and 6 weeks were significantly lower than the baseline values in the combination group (P＜0.05), while HAMD-17 and HAMA scores at 2, 4, and 6 weeks were significantly lower than the baseline values in the monotherapy group (P＜0.05); the HAMD-17 and HAMA scores of the combination group were significantly lower than those of the monotherapy group at 1, 2, 4, and 6 weeks (P＜0.05). The ASEX scores at 4 and 6 weeks were significantly lower than the baseline value in the combination group (P＜0.05), but there was no significant difference in the ASEX scores before and after treatment in the monotherapy group (P＞0.05); the ASEX scores of the combination group were significantly lower than those of the monotherapy group at 4 and 6 weeks (P＜0.05). The DSST and PDQ-D scores at 4 and 6 weeks in the combination group were significantly different from the baseline values (P＜0.05), but there was no significant difference in the DSST and PDQ-D scores before and after treatment in the monotherapy group (P＞0.05); the DSST score of the combination group was significantly higher than that of the monotherapy group at 6 weeks (t=-2.160, P＜0.05), and the PDQ-D score of the combination group was significantly lower than that of the monotherapy group at 4 and 6 weeks (t=2.842 and 4.298, respectively, P＜0.05). There was no evident difference in the incidence of adverse reactions between the two groups (χ2=0.621, P=0.523).

Conclusion

Compared with venlafaxine, the initial combination of venlafaxine with tandospirone in the treatment of patients with major depressive disorder can improve the efficacy, shorten the onset of action, have a good safety profile, and improve sexual and cognitive function.

Key words: Major depressive disorder, Tandospirone, Venlafaxine, Initial combination, Efficacy, Sexual function, Cognitive function
表1 2组患者一般资料比较
一般资料 单药组（n=43） 联合组（n=47） t/χ2/Z值 P值
性别［例（%）］ 0.702 0.402
男 12（27.9） 17（36.2）
女 31（72.1） 30（63.8）
年龄（岁，
x¯±s
）		 34.05±9.17 35.57±10.75 -0.722 0.472
婚姻［例（%）］ 0.266 0.875
未婚 17（39.5） 20（42.6）
已婚 24（55.8） 24（51.1）
离异 2（4.7） 3（6.4）
受教育程度［例（%）］ 2.041 0.360
初中 18（41.9） 24（51.1）
高中至大专 19（44.2） 14（29.8）
大学及以上 6（14.0） 9（19.1）

住院次数［次，M（P25，P75）］

病程［月，M（P25，P75）］

 1（1，1） 1（1，2） -1.425 0.154
24（12，48） 24（5，60） -0.468 0.640
文拉法辛剂量（mg，
x¯
±s）		 151.16±31.79 148.94±26.56 0.362 0.718
表2 2组HAMD-17、HAMA评分比较（分，
xˉ
±s）
组别 HAMD-17评分 HAMA评分
基线 第1周末 第2周末 第4周末 第6周末 基线 第1周末 第2周末 第4周末 第6周末
单药组（n=43） 26.98±5.48 26.05±5.15 19.12±4.84* 12.48±5.00* 9.38±3.17* 23.37±7.17 22.09±5.07 16.15±4.70* 12.05±4.01* 8.41±2.55*
联合组（n=47） 26.70±4.85 23.19±4.79△ 16.77±4.37△ 10.11±2.76△ 6.84±3.10△ 24.43±6.83 19.13±5.11△ 14.19±3.15△ 10.04±3.44△ 6.58±2.88△
t值 0.252 2.725 2.400 2.661 3.705 -0.714 2.758 2.257 2.498 3.065
P值 0.801 0.008 0.019 0.010 ＜0.001 0.477 0.007 0.027 0.014 0.003
表3 2组ASEX评分比较（分，
xˉ
±s）
组别 ASEX评分
基线 第1周末 第2周末 第4周末 第6周末
单药组（n=43） 19.40±3.92 18.65±3.12 18.32±2.70 18.38±3.21 19.15±4.01
联合组（n=47） 19.64±4.17 18.70±3.46 17.62±3.82 15.67±3.16△ 16.18±4.12△
差值及95%CI -0.24（-1.94~1.46） -0.05（-1.43~1.33） 0.70（-0.72~2.12） 2.70（1.33~4.07） 2.98（1.20~4.75）
t值 -0.284 -0.073 0.979 3.924 3.341
P值 0.777 0.942 0.330 <0.001 0.001
表4 2组DSST、PDQ-D评分比较（分，
xˉ
±s）
组别 DSST评分 PDQ-D评分
基线 第1周末 第2周末 第4周末 第6周末 基线 第1周末 第2周末 第4周末 第6周末
单药组（n=43） 41.33±9.70 42.37±9.72 43.27±9.92 43.35±9.92 42.60±9.55 32.95±12.40 31.42±8.75 33.37±9.32 32.60±8.38 32.36±10.00
联合组（n=47） 40.00±13.05 41.02±12.38 41.19±12.23 45.85±12.32△ 47.80±12.36△ 32.66±12.92 29.19±11.49 30.26±8.11 27.52±8.16△ 24.04±7.70△
t值 0.543 0.572 0.867 -1.025 -2.160 0.110 1.027 1.673 2.842 4.298
P值 0.589 0.569 0.388 0.308 0.034 0.913 0.307 0.098 0.006 ＜0.001
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