Nishikawa T, Tsuda A, Tanaka M, Koga I, Uchida Y
Psychopharmacology (Berl). 1982;77(4):301-4. doi: 10.1007/BF00432759.
Prophylactic effects of psychotropic drugs on 55 schizophrenics in remission were evaluated for 3 years in a double-blind controlled study employing a cross-over design. Patients were randomly assigned to the following drugs orally administered twice a day: placebo; diazepam 15 mg; imipramine 50 mg; chlorpromazine 75 mg; and haloperidol 3 mg. The number of days of remission for each patient was recorded. Since only two patients received all five drug treatments, the data were analyzed using the number of days allocated to the "first assigned drugs" only and the cross-over aspect of the experimental design was disregarded. All patients treated with either the placebo, diazepam or imipramine relapsed within a year. On the other hand, four patients treated with chlorpromazine, or with haloperidol, were in remission for more than 1 year. Fifty percent of the patients relapsed within 16 days with placebo; 88 days with diazepam; 30 days with imipramine; 165 days with chlorpromazine; and 74 days with haloperidol. Within a year, only chlorpromazine significantly prolonged the remission state as compared to placebo and imipramine. At the end of the 3-year trial, both chlorpromazine and haloperidol significantly prolonged the remission state as compared to the other three drugs. These data suggest that neuroleptic treatment for a longer period is vitally important to prevent relapse even in schizophrenics in remission and that such a trial seems an efficient method for investigating the prophylactic effects of neuroleptics.
在一项采用交叉设计的双盲对照研究中,对55名处于缓解期的精神分裂症患者进行了为期3年的精神药物预防效果评估。患者被随机分配至以下每天口服两次的药物组:安慰剂;地西泮15毫克;丙咪嗪50毫克;氯丙嗪75毫克;以及氟哌啶醇3毫克。记录每名患者的缓解天数。由于只有两名患者接受了所有五种药物治疗,因此仅使用分配给“首次分配药物”的天数来分析数据,而忽略了实验设计的交叉方面。所有接受安慰剂、地西泮或丙咪嗪治疗的患者在一年内均复发。另一方面,四名接受氯丙嗪或氟哌啶醇治疗的患者缓解超过1年。使用安慰剂的患者50%在16天内复发;使用地西泮的为88天;使用丙咪嗪的为30天;使用氯丙嗪的为165天;使用氟哌啶醇的为74天。与安慰剂和丙咪嗪相比,在一年内只有氯丙嗪能显著延长缓解状态。在3年试验结束时,与其他三种药物相比,氯丙嗪和氟哌啶醇均能显著延长缓解状态。这些数据表明,即使对于处于缓解期的精神分裂症患者,长期使用抗精神病药物治疗对于预防复发至关重要,并且这样的试验似乎是研究抗精神病药物预防效果的有效方法。