比较氨磺必利与利培酮治疗精神分裂症的疗效与安全性

Comparison the clinical effects and safety of amisulpride and risperidone in the treatment of schizophrenia

目的比较氨磺必利与利培酮治疗精神分裂症的疗效和安全性。方法60例精神分裂症患者随机分为试验组和对照组(均n=30)。试验组,以阳性症状为主则口服氨磺必利400～1200 mg·d-1,以阴性症状为主则口服氨磺必利片50～300 mg·d-1;对照组口服利培酮2～6 mg,观察6周。于治疗前及治疗第2,4,6周末,用阳性和阴性症状量表(PANSS)、临床总体印象量表(CGI)和药物不良反应评定量表(TESS)评定2组的疗效及安全性。结果试验组与对照组6周末有效率分别为82.8%,93.1%;痊愈率分别为37.9%,44.8%。在治疗的各时间点CGI比较2组差异无统计学意义(P>0.05)。阴性症状为主患者,试验组(n=12)与对照组(n=7)6周末的有效率和治愈率比较差异无统计学意义。2组安全性相当(P>0.05)。结论对治疗精神分裂症有效性和安全性,氨磺必利与利培酮相当。

Objective To compare the efficacy and safety of amisulpride and risperidone in the treatment of schizophrenia. Methods A total of 60 schizophrenics were randomized into trial group （ n = 30） and control group （ n = 30）. Patients in the trial group dominated by negative symp-toms taking amisulpride（400-1200 mg·d^-1）, and dominated by nega-tive symptoms taking amisulpride tablets（50-300 mg·d^-1）. The pa-tients in control group taking risperidone （2-6 mg） ;all for 6 weeks. The clinical effects were evaluated by positive and negative syndrome scale （PANSS） and CGI. And side effects were assessed by TESS at the time 2,4 and 8 weeks before and after treatment. Results The cure rate in trial group was 37.9% and efficacy rate was 82. 8% after 6 weeks treat- ment. While 44. 8% and 93.1% in control group. There were no statis-tical different between two groups （ P 〉 0.05）. There was no significant difference in safety between the two groups. Conclusion The efficacy and safety rate of amisulpride and risperidone in the treatment of schizo-phrenia are the same.