齐哌西酮与氟哌啶醇治疗精神分裂症的疗效和安全性比较

目的：验证齐哌西酮治疗精神分裂症的疗效及安全性。方法：采用随机、双盲、双模拟、平行对照研究。治疗d 1～4,试验组每日早餐后服齐哌西酮20 mg及氟哌啶醇安慰剂1片,对照组每日早餐后服氟哌啶醇2 mg及齐哌西酮安慰剂1片；治疗d 5～42,试验组每日早、晚餐后服齐哌西酮20 mg及氟哌啶醇安慰剂1片,对照组每日早、晚餐后服氟哌啶醇2 mg及齐哌西酮安慰剂1片。疗程6 wk。结果：完成6 wk治疗的精神分裂症病人共57例,其中试验组(齐哌西酮组)29例,对照组(氟哌啶醇组)28例。治疗结束时,2组PANSS和BPRS评分较入组时均显著减低(P＜0.05)；PANSS总减分率：齐哌西酮组为(66±s 28)%,氟哌啶醇组为(66±26)%；临床总有效率：齐哌西酮组66%,氟哌啶醇组71%,2组疗效差异无显著意义(P＞0.05)。2组的不良反应发生率差异无显著意义,齐哌西酮组失眠的发生率显著高于氟哌啶醇组(P＜0.05)。结论：国产齐哌西酮治疗精神分裂症有明显疗效,未见明显不良反应。

Safety and efficacy of ziprasidone and haloperidol in patients with schizophrenia

AIM:To evaluate the efficacy and safety of ziprasidone in treating the patients with schizophrenia.METHODS:Randomized,double-blind,placebo-controlled trial was conducted from 2003 to 2004.Sixty patients were randomly assigned to the experimental group and the control group.The experimental group was treated with ziprasidone(20 mg)and haloperidol placebo,and the control group was treated with haloperidol(2 mg)and ziprasidone placebo after breakfast during the first four days of treatment period.In the following days,the experimental group was treated with ziprasidone(20 mg)and haloperidol placebo,and the control group was treated with haloperidol(2 mg)and ziprasidone placebo after breakfast and dinner.The treat- ment period was six weeks.RESULTS:Fifty-seven patients completed the trial,29 patients in the experimental group and 28 patients in the control group.Compared with baseline,the scores of PANSS and BPRS in endpoint were significantly reduced in both groups(P＜0.05).The decreasing rates on PANSS were(66±s 28)% in experimental group and(66±26)% in control group.There was no significant difference(P＞0.05)of re- sponse rate(RR)between experimental group(66%)and control group(71%).There was no significant dif- ference of incidence rate(IR)between two groups,but insomnia in experimental group was significantly fewer than that in control group(P＜0.05).CONCLUSION:Ziprasidone has distinct efficacy in treating the acute on- set of schizo-phrenia without obvious adverse reactions.