A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia
A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia
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DOI：
10.1056/nejmoa002028
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发表时间：
2002-01-03
影响因子：
158.5
通讯作者：
Brenner, R
中科院分区：
文献类型：
--
作者：
Csernansky, JG;Mahmoud, R;Brenner, R
背景：预防复发是精神障碍患者维持治疗的一个主要目标。我们对一种较新的非典型抗精神病药物利培酮和一种较旧的传统神经阻滞剂氟哌啶醇在精神分裂症和分裂情感性障碍患者的复发率方面进行了长期比较。
方法：在40个地点进行的一项双盲、前瞻性研究中，我们将病情稳定的慢性精神分裂症或分裂情感性障碍成年门诊患者随机分配接受利培酮或氟哌啶醇的灵活剂量治疗，为期至少一年。
结果：在397名接受随机分组的患者中，2名患者的数据被排除，因为他们没有接受研究药物；一个研究地点的所有30名患者的数据被赞助商杨森研究基金会排除，因为担心数据的完整性。利培酮组的中位治疗持续时间为364天，氟哌啶醇组为238天（P = 0.02）。在分析中保留的177名被分配到利培酮组和188名被分配到氟哌啶醇组的患者中，分别有44.1%和52.7%因复发以外的原因停止治疗。研究结束时复发风险的卡普兰 - 迈耶估计值在利培酮组为34%，在氟哌啶醇组为60%（P
（最后一个单词“P”似乎不完整，如果还有后续内容，请提供完整信息以便更准确地翻译。）
Background: Prevention of relapse is a major goal of maintenance treatment in patients with psychotic disorders. We performed a long-term comparison of a newer, atypical antipsychotic drug, risperidone, and an older, conventional neuroleptic drug, haloperidol, in terms of the rate of relapse in patients with schizophrenia and schizoaffective disorder.Methods: In a double-blind, prospective study at 40 sites, we randomly assigned adult outpatients in stable condition with chronic schizophrenia or schizoaffective disorder to receive treatment with flexible doses of either risperidone or haloperidol for a minimum of one year.Results: Of the 397 patients who underwent randomization, data from 2 were excluded because they did not receive study medication; data from all 30 patients from one site were excluded by the sponsor, the Janssen Research Foundation, because of concern about the integrity of the data. The median duration of treatment was 364 days in the risperidone group and 238 days in the haloperidol group (P=0.02). Of the 177 patients assigned to risperidone and the 188 assigned to haloperidol who remained in the analysis, 44.1 percent and 52.7 percent, respectively, discontinued treatment for reasons other than relapse. The Kaplan-Meier estimate of the risk of relapse at the end of the study was 34 percent for the risperidone group and 60 percent for the haloperidol group (P