二甲双胍治疗氯氮平所致体质量增加的疗效和安全性分析

目的初步探讨二甲双胍对治疗氯氮平所致体质量增加的疗效及其安全性。方法采用随机、双盲、前瞻性对照研究,选取67例住院难治性精神分裂症女性患者,按照随机数字表法分为干预组(氯氮平联合二甲双胍治疗,n=33)和对照组(氯氮平联合安慰剂,n=34),并在0和8周末进行体质量、体重指数(body max index,BMI)、阳性与阴性症状量表(positive and negative syndrome scale,PANSS)和不良反应量表进行盲法测定和评估,并采用意向性分析。结果治疗8周末,干预组的体质量和BMI低于对照组(62.7±5.9vs 65.9±5.2和24.1±1.2vs 24.8±1.1),差异均有统计学意义(P0.05)。治疗8周后,除阴性症状外(7.3±0.8vs 7.7±1.1),干预组在PANSS总分(31.2±2.1vs 33.32±2.7)、阳性症状(7.2±0.6vs 7.5±0.8)和一般精神病理得分(16.7±1.1vs 18.2±1.7)均低于对照组,差异均有统计学意义(P0.05)。干预组最常见的不良反应为恶心5例(15%),2组不良反应差异无统计学意义(P0.05)。结论二甲双胍一定程度上能有效减轻氯氮平所致的体质量增加,疗效佳、安全性好,但临床推广应用需进一步探讨。

Analysis of efficacy and safety of adjunctive metformin on increased body mass induced by clozapine

Objective To evaluate the efficacy and safety of adjunctive metformin on increased body mass induced by clozapine.Methods Our study was a randomized-controlled,double blind and prospective research.A total of 67 patients with schizophrenia were randomly divided into the intervention group(clozapine combined with metformin,n=33)and the control group(clozapine combined with placebo,n=34).Body weight,body max index(BMI),positive and negative syndrome scale(PANSS)and adverse drug reactions(ADRs)scale were used in two groups at 0 and 8 weeks.Furthermore,intention-to-treat(ITT)was used in all the analyses.Results At 8 weeks,the intervention group presented lower scores regarding body weight and BMI than the control group(62.7±5.9 vs.65.9±5.2 and 24.1±1.2 vs.24.8±1.1,all P<0.05).Furthermore,apart from negative symptom scores(7.3±0.8 vs.7.7±1.1),PANSS total scores,positive scores and general psychopathology scores were significant less in the intervention group when compared with those in the control group at 8 weeks with statistical differences(31.2±2.1 vs.33.32±2.7,7.2±0.6 vs.7.5±0.8 and 16.7±1.1 vs.18.2±1.7,respectively).Nausea regarded as the most common ADR occurred in five cases(15%)in the intervention group.No significant difference was found as for the total number of cases undergoing side effects between two groups(P>0.05).Conclusion It is effective and safe that adjunctive metformin to some extents reduces body mass induced by clozapine in patients with schizophrenia,whose application to clinical practice needs further investigation.