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醋酸珠氯噻醇肌肉注射与口服氟哌啶醇液治疗精神分裂症急性加重期的双盲对照研究

A double-blind controlled study of intramuscular zuclopenthixol acetate and liquid oral haloperidol in the treatment of schizophrenic patients with acute exacerbation.

作者信息

Chouinard G, Safadi G, Beauclair L

机构信息

Psychiatric Research Centre, Louis-H. Lafontaine Hospital, University of Montreal, Québec, Canada.

出版信息

J Clin Psychopharmacol. 1994 Dec;14(6):377-84.

PMID:7884017
Abstract

We carried out a 9-day double-blind clinical trial comparing intramuscular zuclopenthixol acetate with liquid oral haloperidol in the treatment of 40 newly admitted schizophrenic patients with acute exacerbation. A parallel-group design was used with stratification by sex. Zuclopenthixol acetate (50 to 150 mg) was given intramuscularly every 3 days, whereas liquid haloperidol (10 to 30 mg daily) was given orally three times a day, with supplementary doses of each medication given under double-blind conditions when needed for agitation. No other sedative drugs, including benzodiazepines, were administered. The mean daily dose was 18.9 mg for haloperidol as compared with a mean dose per 3 days of 117.6 mg for zuclopenthixol. The two treatments were found to be equally efficacious on the Brief Psychiatric Rating Scale and Clinical Global Impression Scale. Both drugs induced similar extrapyramidal side effects. However, more tremors were associated with zuclopenthixol as was a tendency for tardive dyskinesia to be unmasked at the end of the injection interval. Sedation was higher with zuclopenthixol acetate than with haloperidol. Serum creatinine phosphokinase levels were not significantly increased after zuclopenthixol injections. The results of this trial suggest that zuclopenthixol acetate given intramuscularly every second to third day offers an alternative to conventional liquid oral haloperidol in the management of acute schizophrenia.

摘要

我们进行了一项为期9天的双盲临床试验,比较了醋酸珠氯噻醇肌肉注射与液体口服氟哌啶醇治疗40例新入院的急性加重期精神分裂症患者的疗效。采用平行组设计,并按性别分层。醋酸珠氯噻醇(50至150毫克)每3天肌肉注射一次,而液体氟哌啶醇(每日10至30毫克)每日口服三次,必要时在双盲条件下给予每种药物补充剂量以控制激动症状。未使用包括苯二氮䓬类在内的其他镇静药物。氟哌啶醇的日均剂量为18.9毫克,而醋酸珠氯噻醇每3天的平均剂量为117.6毫克。在简明精神病评定量表和临床总体印象量表上,发现两种治疗方法同样有效。两种药物引起的锥体外系副作用相似。然而,醋酸珠氯噻醇相关的震颤更多,且在注射间隔结束时有一种迟发性运动障碍被暴露的趋势。醋酸珠氯噻醇的镇静作用比氟哌啶醇更强。醋酸珠氯噻醇注射后血清肌酸磷酸激酶水平没有显著升高。该试验结果表明,每2至3天肌肉注射一次醋酸珠氯噻醇在急性精神分裂症的治疗中可作为传统液体口服氟哌啶醇的替代方法。

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