Damodaran Ishwary, Hui Koh Ong, Nordin Amer Siddiq Amer, Yee Anne, Gill Jesjeet Singh, Francis Benedict, Azhar Fatin Liyana, Sulaiman Ahmad Hatim
Hospital Bentong, Jalan Tras, Bentong 28700, Malaysia.
Department of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, Malaysia.
Healthcare (Basel). 2020 Dec 3;8(4):533. doi: 10.3390/healthcare8040533.
Clozapine remains as the gold standard for the management of treatment resistant schizophrenia. Nevertheless, mortality and morbidity associated with Clozapine is partly contributed by its adverse effect of constipation in view of its prominent anticholinergic properties. Despite the evidence that approximately 60% of patients on Clozapine will experience constipation, there is no proper guideline as to the best laxative in the treatment of Clozapine induced constipation. Hence this study was conducted to evaluate the efficacy and safety of Prucalopride and Lactulose in the treatment of Clozapine induced constipation. This was a four week, prospective, open-label head to head comparison study between Prucalopride and Lactulose in the treatment of Clozapine induced constipation. Male and female patients on Clozapine between the age of 18-60 with an established diagnosis of treatment resistant schizophrenia with ≤2 spontaneous complete bowel movement per week were recruited in this study. Eligible patients were assigned into two groups. Patients received Prucalopride 2 mg once daily or Lactulose 10 g once daily for four weeks. Efficacy was analyzed in 58 patients. The proportion of patient with ≥3 spontaneous complete bowel movement (SCBM) was higher in the Prucalopride 2 mg group, reaching significance at Week 4 with -value of ( = 0.029). The proportion of patient with ≥3 SCBM at Week 1 was 71.4% in the Prucalopride 2 mg group and 60% in the Lactulose 10 g group. The proportion of patient with ≥3 SCBM at Week 4 was 85.7% in the Prucalopride 2 mg group and the proportion remained at 60% in the Lactulose 10 g group. The improvement in the dissatisfaction and treatment satisfaction subscales of the patient assessment of constipation-quality of life (PAC-QOL) were higher in the Prucalopride 2 mg group compared to the Lactulose 10 g group. The common adverse events associated with Prucalopride 2 mg were abdominal pain and loose stools which was transient and subsided within a few days. Over four weeks, in this population of patients with Clozapine induced constipation, Prucalopride 2 mg significantly improved the bowel movement and it was safe.
氯氮平仍然是难治性精神分裂症治疗的金标准。然而，鉴于氯氮平具有显著的抗胆碱能特性，其便秘副作用在一定程度上导致了相关的死亡率和发病率。尽管有证据表明约60%服用氯氮平的患者会出现便秘，但对于治疗氯氮平所致便秘的最佳泻药尚无恰当的指南。因此，本研究旨在评估普芦卡必利和乳果糖治疗氯氮平所致便秘的疗效和安全性。这是一项为期四周的前瞻性、开放标签的头对头比较研究，比较普芦卡必利和乳果糖治疗氯氮平所致便秘的效果。本研究招募了年龄在18至60岁之间、确诊为难治性精神分裂症且每周自发完全排便次数≤2次的服用氯氮平的男性和女性患者。符合条件的患者被分为两组。患者分别接受每日一次2毫克普芦卡必利或每日一次10克乳果糖治疗，为期四周。对58名患者进行了疗效分析。每日2毫克普芦卡必利组中每周自发完全排便次数≥3次的患者比例更高，在第4周达到显著水平，P值为（P = 0.029）。在第1周，每日2毫克普芦卡必利组中每周自发完全排便次数≥3次的患者比例为71.4%，每日10克乳果糖组为60%。在第4周，每日2毫克普芦卡必利组中每周自发完全排便次数≥3次的患者比例为85.7%，而每日10克乳果糖组这一比例仍为60%。与每日10克乳果糖组相比，每日2毫克普芦卡必利组患者便秘生活质量评估（PAC-QOL）中不满和治疗满意度子量表的改善情况更好。与每日2毫克普芦卡必利相关的常见不良事件为腹痛和腹泻，这些症状是短暂的，在几天内就会消退。在这一氯氮平所致便秘的患者群体中，经过四周时间，每日2毫克普芦卡必利显著改善了排便情况，且安全性良好。
