米氮平片联合帕罗西汀片治疗女性重度抑郁症的临床研究

Clinical trial of mirtazapine tablets combined with paroxetine tablets in the treatment of women with severe depression

目的观察米氮平片联合帕罗西汀片治疗女性重度抑郁症的临床疗效及安全性。方法将58例女性重度抑郁症患者随机分为对照组29例与试验组29例。对照组予以口服帕罗西汀初始剂量为20 mg qd,根据耐受情况调整剂量,最大剂量为50 mg qd;试验组在对照组治疗的基础上,予以口服米氮平起始剂量15mg qd,最大剂量为30 mg qd。2组患者均治疗6周。比较2组患者的临床疗效、5-羟色胺、多巴胺、去甲肾上腺素,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为82.76%(24/29例)和58.62%(17/29例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的5-羟色胺分别为(150.28±19.49),(124.29±15.59)pg·m L^(-1);多巴胺分别为(215.29±25.29),(248.39±29.29)μg·L^(-1);去甲肾上腺素(230.92±25.69),(255.39±26.77)pg·m L^(-1),差异均有统计学意义(P<0.05)。试验组的药物不良反应主要有食欲缺乏、头晕、便秘、乏力和多汗,对照组的药物不良反应主要有镇静嗜睡、食欲缺乏、口干和谷丙转氨酶升高。试验组和对照组的药物不良反应发生率分别为20.69%和24.14%,差异无统计学意义(P>0.05)。结论米氮平片联合帕罗西汀片治疗女性重度抑郁症的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of mirtazapine tablets combined with paroxetine tablets in the treatment of women with severe depression. Methods A total of 58 women with severe depression were randomly divided into control group and treatment group with 29 cases per group. Control group orally received the initial dose of paroxetine 20 mg qd,the maximum dose was 50 mg qd with adjusting for tolerability. Treatment group was orally given the initial dose of mirtazapine 15 mg qd,the maximum dose was 30 mg qd,on the basis of the control group. Two groups were treated for 6 weeks. The clinical efficacy,5- hydroxytryptamine（ 5- HT）,dobaamine,norepinephrine and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 82. 76%（ 24 /29 cases） and 58. 62%（ 17 /29 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： 5- HT were（ 150. 28 ± 19. 49）,（ 124. 29 ± 15. 59） pg·m L^-1; dobaamine were（ 215. 29 ± 25. 29）,（ 248. 39 ± 29. 29） μg·L^-1; norepinephrine were（ 230. 92 ± 25. 69）,（ 255. 39 ± 26. 77） pg·m L^-1,the differences were statistically significant（ P〈0. 05）. The adverse drug reactions in treatment group were loss of appetite,dizziness,constipation,fatigue and sweating,which in control group were sedative drowsiness,loss of appetite,dry mouth and elevated alanine aminotransferase. The incidences of adverse drug reactions in treatment and control groups were 20. 69% and 24. 14% without significant difference（ P〈0. 05）. Conclusion Mirtazapine tablets combined with paroxetine tablets have a definitive clinical efficacy in the treatment of women with severe depression,without increasing the incidence of adverse drug reactions.