切换至 "中华医学电子期刊资源库"
高级检索
中华临床医师杂志(电子版)

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
全文 ( ) 下载PDF ( ) 导出引用
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/OL]. 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/OL]. 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
1
Mathers C, Fat D, Organization W, et al. The Global Burden of Disease: 2004 Update Geneva, Switzerland: World Health Organization [M]. published by the Harvard School of Public Health on behalf of the World Health Organization and the World Bank :2008.
2
Artigas F. Developments in the field of antidepressants, where do we go now? [J]. Eur Neuropsychopharmacol, 2015, 25(5): 657-670.
3
Ionescu D F, Papakostas G I. Experimental medication treatment approaches for depression [J]. Transl Psychiatry, 2017, 7(3): e1068.
4
Huang C Y, Yang S Y, Mojtabai R, et al. Trends of polypharmacy and prescription patterns of antidepressants in Asia [J]. J Clin Psychopharmacol, 2018, 38(6): 598-603.
5
Blier P, Ward H E, Tremblay P, et al. Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study [J]. Am J Psychiatry, 2010, 167(3): 281-288.
6
Chen P. Optimized treatment strategy for depressive disorder [J]. Adv Exp Med Biol, 2019, 1180: 201-217.
7
Rush A J, Trivedi M H, Wisniewski S R, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report [J]. Am J Psychiatry, 2006, 163(11): 1905-1917.
8
Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review [J]. Can J Psychiatry, 2010, 55(3): 126-35.
9
张作记. 行为医学量表手册 [M]. 北京: 中华医学电子音像出版社, 2001: 225-227, 285-287.
10
Mcgahuey CA, Gelenberg AJ, Laukes CA, et al. The Arizona sexual experience scale (ASEX): reliability and validity [J]. J Sex Marital Ther, 2000, 26(1): 25-40.
11
Jaeger J. Digit symbol substitution test: the case for sensitivity over specificity in neuropsychological testing [J]. J Clin Psychopharmacol, 2018, 38(5): 513-519.
12
Wang G, Si TM, Li L, et al. Cognitive symptoms in major depressive disorder: associations with clinical and functional outcomes in a 6-month, non-interventional, prospective study in China [J]. Neuropsychiatr Dis Treat, 2019, 15: 1723-1736.
13
Sumiyoshi T, Watanabe K, Noto S, et al. Relationship of cognitive impairment with depressive symptoms and psychosocial function in patients with major depressive disorder: Cross-sectional analysis of baseline data from PERFORM-J [J]. J Affect Disord, 2019, 258: 172-178.
14
Health N. TESS (treatment emergent symptom scale-write-in) [J]. Psychopharmacology Bulletin, 1985, 21:1069-1072.
15
Lin J, Su Y, Wang C, et al. Effects of tandospirone augmentation in major depressive disorder patients with high anxiety: a multicenter, randomized, parallel-controlled, open-label study [J]. J Psychiatr Res, 2018, 99: 104-110.
16
Yamada K, Yagi G, Kanba S. Clinical efficacy of tandospirone augmentation in patients with major depressive disorder: a randomized controlled trial [J]. Psychiatry Clin Neurosci, 2003, 57(2): 183-187.
17
Chen H, Lin Q, Lin T, et al. A controlled study of the efficacy and safety of tandospirone citrate combined with escitalopram in the treatment of vascular depression: A pilot randomized controlled trial at a single-center in China [J]. J Psychiatr Res, 2019, 114: 133-140.
18
Fukumoto K, Fogaça M V, Liu R J, et al. Medial PFC AMPA receptor and BDNF signaling are required for the rapid and sustained antidepressant-like effects of 5-HT(1A) receptor stimulation [J]. Neuropsychopharmacology, 2020, 45(10): 1725-1734.
19
Fukumoto K, Iijima M, Funakoshi T, et al. 5-HT(1A) receptor stimulation in the medial prefrontal cortex mediates the antidepressant effects of mGlu2/3 receptor antagonist in mice [J]. Neuropharmacology, 2018, 137: 96-103.
20
Huang X, Yang J, Yang S, et al. Role of tandospirone, a 5-HT1A receptor partial agonist, in the treatment of central nervous system disorders and the underlying mechanisms [J]. Oncotarget, 2017, 8(60): 102705-102720.
21
Clayton AH, El Haddad S, Iluonakhamhe JP, et al. Sexual dysfunction associated with major depressive disorder and antidepressant treatment [J]. Expert Opin Drug Saf, 2014, 13(10): 1361-1374.
22
Oosting RS, Chan JS, Olivier B, et al. Differential effects of vilazodone versus citalopram and paroxetine on sexual behaviors and serotonin transporter and receptors in male rats [J]. Psychopharmacology (Berl), 2016, 233(6): 1025-1034.
23
万争艳, 李宁. 枸橼酸坦度螺酮治疗抗抑郁药所致性功能障碍的临床疗效 [J]. 神经损伤与功能重建, 2019, 14(01): 49-50.
24
Clayton AH, Gommoll C, Chen D, et al. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial [J]. Int Clin Psychopharmacol, 2015, 30(4): 216-23..
25
Rosenblat J D, Kakar R, Mcintyre R S. The cognitive effects of antidepressants in major depressive disorder: a systematic review and meta-analysis of randomized clinical trials [J]. Int J Neuropsychopharmacol, 2015, 19(2).
26
Glikmann-Johnston Y, Saling MM, Reutens DC, et al. Hippocampal 5-HT1A receptor and spatial learning and memory [J]. Front Pharmacol, 2015, 6: 289.
27
Uehara T, Matsuoka T, Sumiyoshi T. Tandospirone, a 5-HT1A partial agonist, ameliorates aberrant lactate production in the prefrontal cortex of rats exposed to blockade of N-methy-D-aspartate receptors; toward the therapeutics of cognitive impairment of schizophrenia [J]. Front Behav Neurosci, 2014, 8: 291.
28
中国神经科学学会精神病学基础与临床分会抑郁障碍研究联盟. 伴焦虑痛苦特征抑郁症的临床诊治专家共识 [J]. 精神医学杂志, 2021, 34(1): 74-78.
[1] 张启龙, 柳亿, 卢会丽, 罗慧, 李成林, 王菁, 王辉. 奥妥珠单抗治疗磷脂酶A2受体相关膜性肾病的疗效与安全性：单中心回顾性分析[J/OL]. 中华危重症医学杂志(电子版), 2024, 17(05): 379-384.
[2] 王杰, 袁泉, 王玥琦, 乔佳君, 谭春丽, 夏仲元, 刘守尧. 溃疡油在糖尿病足溃疡治疗中的应用效果及安全性观察[J/OL]. 中华损伤与修复杂志(电子版), 2024, 19(06): 480-484.
[3] 聂生军, 王钰, 王毅, 鲜小庆, 马生成. 复方倍他米松局部注射联合光动力疗法治疗小型瘢痕疙瘩的临床疗效观察[J/OL]. 中华损伤与修复杂志(电子版), 2024, 19(05): 404-410.
[4] 莫淇舟, 苏劲, 黄健, 李健维, 李思宁, 柳建军. 智能控压输尿管软镜碎石吸引取石术在直径10～25 mm上尿路结石中的应用[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2024, 18(05): 497-502.
[5] 李义亮, 苏拉依曼·牙库甫, 麦麦提艾力·麦麦提明, 克力木·阿不都热依木. 机器人与腹腔镜食管裂孔疝修补术联合Nissen 胃底折叠术短期疗效分析[J/OL]. 中华疝和腹壁外科杂志(电子版), 2024, 18(05): 512-517.
[6] 周艳, 李盈, 周小兵, 程发辉, 何恒正. 不同类型补片联合Nissen 胃底折叠术修补食管裂孔疝的疗效及复发潜在危险因素[J/OL]. 中华疝和腹壁外科杂志(电子版), 2024, 18(05): 528-533.
[7] 王小琴, 汪丽, 崔建英. 无张力疝修补术治疗慢性肾功能衰竭合并腹股沟疝患者的疗效[J/OL]. 中华疝和腹壁外科杂志(电子版), 2024, 18(05): 538-542.
[8] 詹济玮, 蔡柳春, 温琼娜, 郭石生, 温春妹, 温鹤明. 布地格福联合噻托溴铵治疗AECOPD 的临床分析[J/OL]. 中华肺部疾病杂志(电子版), 2024, 17(05): 823-826.
[9] 魏孔源, 仵正, 王铮, 黎韡. 机器人胰腺中段切除后远端胰腺消化道不同重建方式初探[J/OL]. 中华腔镜外科杂志(电子版), 2024, 17(05): 295-300.
[10] 梁艳娉, 列诗韵, 王艺穗, 吴晓瑛, 林颖. 基于内镜操作细节记录系统构建胃底静脉曲张内镜下组织胶注射术的标准化管理方案[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(05): 705-709.
[11] 陈杰, 武明胜, 李一金, 李虎, 向源楚, 荣新奇, 彭健. 低位直肠癌冷冻治疗临床初步分析[J/OL]. 中华结直肠疾病电子杂志, 2024, 13(06): 494-498.
[12] 史彬, 司远. 益气和络方联合缬沙坦治疗气阴两虚兼血瘀证IgA 肾病的疗效观察[J/OL]. 中华肾病研究电子杂志, 2024, 13(06): 306-312.
[13] 韩俊岭, 王刚, 马厉英, 连颖, 徐慧. 维生素D 联合匹维溴铵治疗腹泻型肠易激综合征患者疗效及对肠道屏障功能指标的影响研究[J/OL]. 中华消化病与影像杂志(电子版), 2024, 14(06): 560-564.
[14] 阳跃, 庹晓晔, 崔子豪, 欧阳四民, 林海阳, 胡景宇, 胡银, 李涛, 赵景峰, 郝岱峰, 冯光. 改良“阅读者”皮瓣修复骶尾部压疮的疗效[J/OL]. 中华临床医师杂志(电子版), 2024, 18(08): 751-755.
[15] 克地尔牙·马合木提, 胡波, 杨琼, 闫素, 胡岚卿, 高沛沛, 姚恩生. 依达拉奉右莰醇对急性脑梗死后认知功能障碍的疗效观察[J/OL]. 中华脑血管病杂志(电子版), 2024, 18(05): 459-466.
阅读次数
全文


摘要

版权所有 中华医学会 中华医学电子音像出版社有限责任公司  京ICP备14006079号-1  网络出版服务许可证：(署)网出证(京)字第075号