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氢溴酸东莨菪碱治疗氯氮平所致唾液分泌过多的双盲、随机、安慰剂对照交叉试验。

Hyoscine for clozapine-induced hypersalivation: a double-blind, randomized, placebo-controlled cross-over trial.

机构信息

Department of Psychiatric Emergency Services, Shalvata Mental Health Center, Hod Hasharon.

Department of Psychiatry, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Int Clin Psychopharmacol. 2019 Mar;34(2):101-107. doi: 10.1097/YIC.0000000000000251.

DOI:10.1097/YIC.0000000000000251
PMID:30614850
Abstract

Clozapine is the only evidence-based antipsychotic for treatment-resistant schizophrenia. However, it has considerable side effects, limiting its usability and reducing patients' adherence. One of the most common and distressing side effects is hypersalivation, which can be debilitating, stigmatizing and potentially dangerous through its association with aspiration pneumonia. There is a paucity of evidence guiding possible treatment strategies for hypersalivation. This study aims to examine the efficacy of hyoscine (scopolamine) for clozapine-induced hypersalivation. Fourteen inpatients diagnosed with treatment-resistant schizophrenia, treated with clozapine and suffering from hypersalivation were randomized to receive hyoscine 0.3 mg and placebo daily for 4 weeks each in a randomized, double-blind, placebo-controlled cross-over trial. The primary outcome was improvement in the Toronto Nocturnal Hypersalivation Scale. The secondary outcomes were change in the mass of the pillowcase, anxiety, depression and quality of life. Hypersalivation improved significantly with hyoscine over placebo when measured by the Toronto Nocturnal Hypersalivation Scale (odds ratio=0.21, 95% confidence interval: 0.16-0.28, P<0.001). No significant difference was observed in any of the secondary outcomes. This study showed a beneficial effect of hyoscine over placebo for clozapine-induced hypersalivation.

摘要

氯氮平是唯一一种有循证医学证据支持的治疗难治性精神分裂症的抗精神病药物。然而,它有相当多的副作用,限制了它的可用性,并降低了患者的依从性。最常见和最令人痛苦的副作用之一是过度流涎,这可能使人衰弱,使人感到耻辱,并可能因与吸入性肺炎有关而变得危险。目前指导过度流涎可能治疗策略的证据很少。本研究旨在研究氢溴酸东莨菪碱(scopolamine)治疗氯氮平引起的过度流涎的疗效。14 名被诊断为治疗抵抗性精神分裂症的住院患者,服用氯氮平并伴有过度流涎,随机分为两组,每组 7 人,分别接受氢溴酸东莨菪碱 0.3mg 和安慰剂,每天一次,持续 4 周,采用随机、双盲、安慰剂对照交叉试验。主要结局是多伦多夜间过度流涎量表的改善。次要结局是枕套质量的变化、焦虑、抑郁和生活质量。用多伦多夜间过度流涎量表测量,与安慰剂相比,氢溴酸东莨菪碱显著改善了过度流涎(比值比=0.21,95%置信区间:0.16-0.28,P<0.001)。在任何次要结局中均未观察到显著差异。本研究显示氢溴酸东莨菪碱对氯氮平引起的过度流涎有优于安慰剂的疗效。

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