氟哌啶醇与奥氮平治疗精神分裂症疗效和安全性的随机对照研究

The efficacy and adverse effects of haloperidol and olanzapine:a randomized controlled study

目的比较氟哌啶醇与奥氮平治疗精神分裂症的疗效及安全性。方法将符合精神分裂症诊断标准的住院患者按照1:2比例随机分为氟哌啶醇(n=120)和奥氮平治疗组(n=252),进行为期6周的治疗观察;于基线及治疗2、4、6周末评定阳性和阴性症状量表(positive and negative syndrom scale,PANSS),锥体外系副反应量表(rating scale for extrapyramdal side effects,RSESE)、静坐不能评定量表(barnes akathisia rating scale,BARS)和异常不自主运动量表(abnormal involuntary movement scale,AIMS);计算体质量指数(body mass index,BMI);基线及治疗4、6周末测定空腹血糖、血脂和肝功能等指标。结果氟哌啶醇组与奥氮平组基线PANSS总分差异无统计学意义;第6周末氟哌啶醇组PANSS总分低于奥氮平组(53.31±1.64 vs.58.05±1.02),减分率高于后者(60.63±2.86%vs.52.45±1.80%),均P<0.05;两组有效率(66.7%vs.62.7%)差异无统计学意义。第6周末氟哌啶醇组BMI较基线的变化值(0.08±0.20 kg/m2vs.0.91±0.12 kg/m2)、谷丙转氨酶异常病例数比例(16.98%vs.28.07%)均低于奥氮平组(P<0.05);第4周末氟哌啶醇组甘油三酯较基线的变化值低于奥氮平组(0.24±0.12 mmol/L vs.0.57±0.07 mmol/L),P<0.05。氟哌啶醇组锥体外系不良反应发生率(73.3%)明显高于奥氮平组(10.71%),P<0.05。结论在精神分裂症急性期,氟哌啶醇治疗有效率与奥氮平相当,对体重、血脂、转氨酶的影响较小,但锥体外系不良反应发生率较高。

Objective To compare the efficacy and adverse effects of haloperidol and olanzapine in treatment of patients with schizophrenia. Methods A randomized, multi-center, controlled clinical trial was conducted. Pa- tients with schizophrenia were randomly assigned into haloperidol （n = 120） and olanzapine （n = 252） groups to re- ceive monotherapy with either drug alone for 6 weeks. The positive and negative syndrome scale （PANSS）, body mass index （BMI）, rating scale for extrapyramdal side effects （RSESE）, barnes akathisia rating scale （BARS） and abnormal involuntary movement scale （AIMS） were assessed at baseline, 2, 4, and 6 weeks following treatment. Moreover, a series of parameters including blood glucose, lipid metabolism and hepatic functions were detected atsame time points. Results There were no significant difference in PANSS scores between two groups at baseline. At the end of 6 weeks, the PANSS score of were lower in haloperidol group than in olanzaping group （53.31±1.64 vs. 58.05±1.02） whereas the reduction rates of PANSS in were higher in haloperidol group than in olanzapine group （60.63 ±2.86% vs. 52.45±1.80%）, P 〈 0.05. The difference at effective rates was no statistically significant be- tween these two groups （66.7% vs. 62.7%）. The BMI changes （0.08±0.20 kg/m2 vs. 0.91±0.12 kg/m^2） and thepercentage of cases with abnormal alanine aminotransferase level in haloperidol group were lower than that in olanzap- ine group at the 6 weeks （16.98% vs. 28.07%）; the changes of triglyeride in haplopeidol were lower than that in olanzapine group at the 4 weeks with P 〈 0.05 （0.24±0.12 mmol/L vs. 0.57 ±0.07 mmol/L）. The incidence rate of extrapyramidal symptoms were higher in haloperidol group than in olanzapine group （73.3% vs 10.71%,P 〈 0.05）. Conclusion These results demonstrate that haploperidol is as effective as olanzapine in treatment for schizophrenia. Olanzapine can significantly increase body weight and adverse metablic effects whereas haloperidol can cause higher incidence of extrapyramidal syndrome （EPS）. The double-blind, fixed low dose studies on haloperidol with a larger sample size are needed to confirm the results of our study.