帕罗西汀联合氨磺必利治疗躯体形式障碍的临床研究

Paroxetine combined with amisulpride in the treatment of somatoform disorders

目的：评价小剂量氨磺必利联合帕罗西汀治疗躯体形式障碍患者的临床疗效和安全性。方法67例躯体形式障碍的患者随机分为试验组33例和对照组34例。试验组：帕罗西汀起始剂量为20 mg· d-1，一周内调整至20～60 mg· d-1；氨磺必利起始剂量为50 mg· d-1，1周内调至100～150 mg· d-1。对照组：帕罗西汀起始剂量为20 mg· d-1，1周内调至20～60 mg· d-1，疗程6周。2组患者入组时，第2，4，6周进行汉密尔顿抑郁量表（HAMD-17）、汉密尔顿焦虑量表（ HAMA ）及症状自评量表（ SCL -90）评定。结果入组时，试验组HAMD，HAMA，SCL-90分别为（19.52±2.98），（22.64±3.42），（3.01±0.72），对照组分别为（20.38±3.25），（21.87±3.31），（2.82±0.68），差异无统计学意义（P＞0.05），治疗6周后，试验组 HAMD，HAMA，SCL -90分别为（8.36±2.67），（9.38±2.23），（1.20±0.52），对照组分别为（11.33±3.02），（11.62±2.66），（1.67±0.59）。第2周开始，试验组HAMD 较对照组显著降低（ P ＜0.05）；试验组HAMA和SCL-90躯体化因子得分在第4周时较对照组显著降低（ P＜0.05），第6周时差异更显著。试验组不良反应发生率为33.33％，对照组为26.47％，2组差异无统计学意义（ P＞0.05），2组均无明显严重或不可耐受的不良反应产生。结论小剂量氨磺必利联合帕罗西汀治疗躯体形式障碍，可加快症状缓解，提高治疗效果，无明显的不良反应产生。

Objective To assess the clinical efficacy and safety of paroxetine combined with low dosage of amisulpride on the treatment of somatoform disorders. Methods A total of 67 somatoform disorders patients were randomly divided into treatment group （ n=33 ） and control group（ n =34 ） .Patients in the treatment group were given paroxetine combined with amisulpride treatment , paroxetine 20 mg· d-1 initially and adjusted to 20 -60 mg· d-1 within 1 week; amisulpride 50 mg· d-1 initially and adjusted to 100 -150 mg· d-1 within 1 week. And patients in the control group were given paroxetine as the same schedule of treatment group combined with placebo .The HAMD, HAMA and SCL-90 score were used to evaluate the symptoms before and at the time of 2, 4 and 6 weeks after treatment .Results The HAMD, HAMA and SCL -90 score were （ 19.52 ±2.98 ） , （ 22.64 ±3.42 ） and （3.01 ±0.72） in treatment group and （20.38 ±3.25）,（21.87 ±3.31） and （ 2.82 ±0.68 ） in control group without statistical difference （P〉0.05）.After6weekstreatment,thescorewere（8.36±2.67）,（9.38±2.23）,（1.20±0.52）intreatment group and （11.33 ±3.02）, （11.62 ±2.66）, （1.67 ±0.59） in control group with statistical difference （P〈0.05）. The HAMD score was significantly decreased in the treatment group compared with control group 2 weeks after treatment （ P〈0.05 ） .The HAMA and SCL-90 score in treatment group showed significant differences after 4 weeks treatment and especially 6 weeks later compared with control group （P〈0.05）.The total incidence of adverse drug reactions was 33.33% in the treatment group and 26.47% in the control group with no difference （ P 〉0.05 ） . Conclusion Paroxetine combined with low dosage of amisulpride can improve the symptom quickly for the treatment of somatoform disorders , without increasing adverse reactions .