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首页> 外文期刊>The New England journal of medicine >Clozapine alone versus clozapine and risperidone with refractory schizophrenia.
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Clozapine alone versus clozapine and risperidone with refractory schizophrenia.

机译：单独使用氯氮平与氯氮平和利培酮合并难治性精神分裂症。

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BACKGROUND: The treatment of schizophrenia with multiple antipsychotic drugs is common, but the benefits and risks are not known. METHODS: In a randomized, double-blind study, we evaluated patients with schizophrenia and a poor response to treatment with clozapine. The patients continued to take clozapine and were randomly assigned to receive eight weeks of daily augmentation with 3 mg of risperidone or with placebo. This course of treatment was followed by an optional 18 weeks of augmentation with risperidone. The primary outcome was reduction in the total score for severity of symptoms on the Positive and Negative Syndrome Scale (PANSS). The secondary outcomes included cognitive functioning. RESULTS: A total of 68 patients were randomly assigned to treatment. In the double-blind phase, the mean total score for the severity of symptoms decreased from baseline to eight weeks in both the risperidone and the placebo groups. There was no statistically significant difference in symptomatic benefit between augmentation with risperidone and placebo: 9 of 34 patients receiving placebo and 6 of 34 receiving risperidone responded to treatment (P=0.38). The mean difference in the change in PANSS scores from baseline to eight weeks between those receiving risperidone and those receiving placebo was 0.1 (95 percent confidence interval, -7.3 to 7.0). The verbal working-memory index showed a small decline in the risperidone group and a small improvement in the placebo group (P=0.02 for the comparison between the two groups in the change from baseline). The increase in fasting blood glucose levels was mildly greater in the risperidone group than in the placebo group (16.2 vs. 1.8 mg per deciliter [0.90 vs. 0.10 mmol per liter], P=0.04). The incidence and severity of other side effects did not differ between the two groups. CONCLUSIONS: In this short-term study, the addition of risperidone to clozapine did not improve symptoms in patients with severe schizophrenia. (ClinicalTrials.gov number, NCT00272584).
机译：背景：使用多种抗精神病药治疗精神分裂症很普遍，但其益处和风险尚不清楚。方法：在一项随机，双盲研究中，我们评估了精神分裂症患者和氯氮平治疗反应不良的患者。患者继续服用氯氮平，并被随机分配接受三周利培酮或安慰剂每日八周强化治疗。在此疗程后，可选用利培酮增加18周。主要结果是阳性和阴性综合征量表（PANSS）的症状严重程度总分降低。次要结果包括认知功能。结果：共68例患者被随机分配接受治疗。在双盲阶段，利培酮和安慰剂组的症状严重程度的平均总分从基线降低到八周。利培酮和安慰剂之间的症状获益在统计学上无显着差异：34名接受安慰剂的患者中有9名接受利培酮的患者中有6名对治疗有反应（P = 0.38）。接受利培酮治疗者与接受安慰剂治疗者之间从基线到八周的PANSS评分变化的平均差异为0.1（95％置信区间为-7.3至7.0）。言语工作记忆指数显示利培酮组有轻微下降，安慰剂组有小改善（两组比较，从基线变化而言，P = 0.02）。利培酮组的空腹血糖水平较安慰剂组轻度增加（分别为16.2 vs. 1.8 mg /分升[0.90 vs. 0.10 mmol / l]，P = 0.04）。两组之间其他副作用的发生率和严重程度没有差异。结论：在这项短期研究中，在氯氮平中加入利培酮不能改善严重精神分裂症患者的症状。 （ClinicalTrials.gov编号，NCT00272584）。

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