“缩泉丸和五苓散治疗氯氮平引起的精神分裂症患者唾液分泌过多的临床疗效评估”研究方案

背景：氯氮平引起的唾液分泌过多在精神分裂症患者中的发病率很高,不但影响患者外观及人际交往,也会影响患者的生命质量,常是患者不愿意继续服药的原因。本研究拟评估传统中药方剂缩泉丸和五苓散对氯氮平引起的唾液分泌增多的治疗作用。方法与设计：本研究采用前瞻性、双盲、随机、安慰剂对照试验设计,共预计从台湾中部一所医学中心精神部门纳入45名受试者,随机分配至缩泉丸组、五苓散组及安慰剂组。患者根据其所在组接受不同的治疗,缩泉丸或五苓散或安慰剂口服10g,每日两次,共8周。使用流涎严重度量表评分、夜间流涎量表评分及唾液腺造影的结果作为主要结局指标;临床总体印象量表评分、阳性与阴性症状量表评分、异常不自主运动量表评分、锥体外系副反应量表及中医体质量表评分作为次要结局指标。讨论：通过本试验研究,希望能够证实缩泉丸和五苓散对于氯氮平引起的精神分裂症患者唾液分泌增多有一定的疗效,并能通过改善患者的精神状态而提高其生命质量。临床试验注册：Clinical Trials.gov（Indentifier：NCT01045720）。

Treatment effects of traditional Chinese medicines Suoquan Pill and Wuling Powder on clozapine-induced hypersalivation in patients with schizophrenia: study protocol of a randomized,placebo-controlled trial

Background: It is reported that 30% to 80% schizophrenia patients suffered from hypersalivation when taking clozapine. Some investigations of the use of formulas of traditional Chinese medicine (TCM) to treat clozapine-induced hypersalivation suggested their potential treatment effects. In these formulas, Suoquan Pill (SQP) and Wuling Powder (WLP) were suggested to have therapeutic effects in improving clozapine-induced hypersalivation. Methods and design: A prospective, double-blind, randomized, placebo-controlled study will be conducted to test the therapeutic effects of SQP and WLP in relieving hypersalivation in patients taking clozapine. A total of 45 patients will be enrolled into this study with 15 in each treatment group. Patients will receive medication according to their assigned group. Either SQP 10 g per oral dose twice daily, WLP 10 g per oral dose twice daily or placebo powder 10 g per oral dose twice daily will be prescribed to the patients for 8 weeks. The Drooling Severity Scale, Nocturnal Hypersalivation Rating Scale and sialoscintigraphy will be used as the primary outcome measures; the Clinical Global Impressions Severity, the Positive and Negative Syndrome Scale, the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale and the TCM constitutional scale will be used as the secondary outcome measures Discussion: It is hypothesized that SQP and WLP will have a beneficial effect in controlling clozapine-induced hypersalivation symptoms. It may also improve the life quality of psychotic patients by improving their mental status. Trial registration: ClinicalTrials. gov (Identifier: NCT01045720).