Suppes T, Webb A, Paul B, Carmody T, Kraemer H, Rush A J
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas 75235-9070, USA.
Am J Psychiatry. 1999 Aug;156(8):1164-9. doi: 10.1176/ajp.156.8.1164.
Case series and follow-up studies suggest that clozapine may have mood-stabilizing properties in addition to antipsychotic action in patients with schizoaffective disorder, bipolar type, and bipolar I disorder, but the generalizability of these findings is limited. This article describes a randomized, open study of clozapine add-on therapy versus treatment as usual for patients with treatment-resistant illness and a history of mania.
Thirty-eight patients meeting the DSM-IV criteria for schizoaffective or bipolar disorder that was deemed treatment-resistant were randomly assigned to clozapine add-on treatment (N = 19) or treatment as usual (no clozapine) (N = 19) and followed up for 1 year. Patients received monthly ratings on the Brief Psychiatric Rating Scale, Clinical Global Impression scale, Bech-Rafaelsen Mania Scale, Hamilton Depression Rating Scale, Scale for the Assessment of Positive Symptoms, Scale for the Assessment of Negative Symptoms, Abnormal Involuntary Movement Scale, and a 40-item side effect checklist. Differences between treatment groups were assessed according to a pattern-mix random-regression model. An additional analysis compared group differences in rating scale scores against relative time in the study.
Significant between-group differences were found in scores on all rating scales except the Hamilton depression scale. Total medication use over 1 year significantly decreased in the clozapine group. No significant differences between groups in somatic complaints were noted. The subjects with nonpsychotic bipolar I disorder who received clozapine showed a degree of improvement similar to that of the entire clozapine-treated group. Clozapine dose was significantly higher for the patients with schizoaffective illness than for those with bipolar disorder.
The results of this study support clozapine's independent mood-stabilizing property. They demonstrate that clozapine use was associated with significant clinical improvement relative to treatment as usual.
病例系列研究和随访研究表明，氯氮平除了对分裂情感性障碍、双相 I 型障碍和双相 II 型障碍患者具有抗精神病作用外，可能还具有心境稳定特性，但这些研究结果的普遍性有限。本文描述了一项针对难治性疾病且有躁狂病史患者的氯氮平附加疗法与常规治疗的随机开放性研究。
38 名符合 DSM-IV 标准的难治性分裂情感性或双相情感障碍患者被随机分配至氯氮平附加治疗组（N = 19）或常规治疗组（不使用氯氮平）（N = 19），并随访 1 年。患者每月接受简明精神病评定量表、临床总体印象量表、贝克-拉法尔森躁狂量表、汉密尔顿抑郁评定量表、阳性症状评定量表、阴性症状评定量表、异常不自主运动量表以及一份 40 项副作用清单的评估。根据模式混合随机回归模型评估治疗组之间的差异。另一项分析比较了量表评分的组间差异与研究中的相对时间。
除汉密尔顿抑郁量表外，所有量表评分在组间均存在显著差异。氯氮平组 1 年的总用药量显著减少。两组在躯体不适方面未发现显著差异。接受氯氮平治疗的非精神病性双相 I 型障碍患者的改善程度与整个氯氮平治疗组相似。分裂情感性疾病患者的氯氮平剂量显著高于双相情感障碍患者。
本研究结果支持氯氮平具有独立的心境稳定特性。结果表明，与常规治疗相比，使用氯氮平与显著的临床改善相关。
