氨磺必利治疗乙醇所致精神障碍的临床疗效及安全性评价

Clinical efficacy and safety of amisulpride in treatment of patients with mental disorders due to alcohol

目的探讨氨磺必利治疗乙醇所致精神障碍的临床疗效与安全性。方法将120例乙醇所致精神障碍患者随机分为试验组60例和对照组60例。试验组予以口服氨磺必利,起始剂量100 mg·d-1;对照组予以口服奋乃静,起始剂量4 mg·d-1。2组均在2周内调整到合适剂量,观察治疗8周。用阳性与阴性症状量表(PANSS)和不良反应量表(TESS)比较2组患者的临床疗效和不良反应发生率。结果在治疗后第2,4,8周末,试验组的总有效率明显优于对照组(P<0.05)。治疗后,2组患者的PANSS评分均较治疗前显著降低(P<0.01)。除阳性症状外,试验组各时点降分幅度均大于对照组(P<0.05或P<0.01)。试验组不良反应发生率和合并用药率均低于对照组(均P<0.01)。结论氨磺必利治疗乙醇所致精神障碍的临床疗效确切,安全性高,可作为治疗乙醇所致精神障碍的首选抗精神病药。

Objective To explore the clinical efficacy and safety of domestic amisulpride in treatment of patients with mental disorders due to alcohol. Methods One hundred twenty patients with mental disorders due to use of alcohol were choosed and randomly assigned to treatment group and control group,each group was 60 cases. Treatment group was treated with amisulpride 100 mg·d-1for the starting dose. Control group was treated with perphenazine 4 mg · d-1for the starting dose. Two groups were adjusted to the appropriate dose in two weeks,and observed for 8 weeks. To compare the clinical efficacy and adverse drug reactions by positive and negative syndrome scale（ PANSS） and treatment emergent symptom scale（ TESS）. Results The clinical efficacy in the treatment group was significantly better than that in control group in the2 nd,4thand 8thweekend after treatment（ P〈0. 05）. The scores of the PANSS in the both groups after treatment were significantly lower than before（ P〈0. 01）. Except the positive factor of PANSS,the decrease ranges of the scores in treatment group was significantly greater than those in the control group（ P〈0. 05 or P〈0. 01）. The incidence of adverse drug reactions and the rate of drug combination in the treatment group was significantly lower than those in the control group（ P〈0. 01）.Conclusion Domestic amisulpride is rather effective and safe intreatment of patients with mental disorders due to use of alcohol. Therefore,it can be the preferred antipsychotic drugs.