Narang Manish, Shah Dheeraj, Akhtar Hina
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, University College of Medical Sciences (University of Delhi) and Guru Teg Bahadur Hospital, Delhi, India. Correspondence to: Dr Dheeraj Shah, Associate Professor, Department of Pediatrics, UCMS and GTB Hospital, Dilshad Garden, Delhi 110 095, India.
Indian Pediatr. 2015 Oct;52(10):847-51. doi: 10.1007/s13312-015-0730-y.
To evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain.
Double blind, randomized placebo-controlled trial.
Pediatric Gastroenterology clinic of a teaching hospital.
132 children (age 4-12 y) with recurrent abdominal pain (Apley Criteria) randomized to receivedrotaverine (n=66) or placebo (n=66) orally.
Children between 4-6 years of age received 10 mL syrup orally (20 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks while children >6 years of age received one tablet orally (40 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks.
Primary: Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days. Secondary: Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects.
Reduction in number of episodes of abdominal pain [mean (SD) number of episodes 10.3 (14) vs 21.6 (32.4); P=0.01] and lesser school absence [mean (SD) number of school days missed 0.25 (0.85) vs 0.71 (1.59); P=0.05] was noticed in children receiving drotaverine in comparison to those who received placebo. The number of pain-free days, were comparable in two groups [17.4 (8.2) vs 15.6 (8.7); P=0.23]. Significant improvement in parental satisfaction score was noticed on Likert scale by estimation of mood, activity, alertness, comfort and fluid intake. Frequency of adverse events during follow-up period was comparable between children receiving drotaverine or placebo (46.9% vs 46.7%; P=0.98).
Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.
评估盐酸屈他维林治疗儿童复发性腹痛的疗效和安全性。
双盲、随机、安慰剂对照试验。
一家教学医院的儿科胃肠病诊所。
132名4至12岁复发性腹痛儿童（符合阿普利标准），随机分为口服盐酸屈他维林组（n = 66）和安慰剂组（n = 66）。
4至6岁儿童口服10毫升糖浆（20毫克盐酸屈他维林或安慰剂），每日3次，共4周；6岁以上儿童口服1片（40毫克盐酸屈他维林或安慰剂），每日3次，共4周。
主要指标：使用药物/安慰剂4周期间的疼痛发作次数和无痛天数。次要指标：研究期间缺课天数、家长满意度（采用李克特量表）以及预期不良反应的发生情况。
与接受安慰剂的儿童相比，接受盐酸屈他维林的儿童腹痛发作次数减少[平均（标准差）发作次数10.3（14）对21.6（32.4）；P = 0.01]，缺课天数减少[平均（标准差）缺课天数0.25（0.85）对0.71（1.59）；P = 0.05]。两组的无痛天数相当[17.4（8.2）对15.6（8.7）；P = 0.23]。通过评估情绪、活动、警觉性、舒适度和液体摄入量，李克特量表显示家长满意度得分有显著改善。接受盐酸屈他维林或安慰剂的儿童在随访期间不良事件的发生率相当（46.9%对46.7%；P = 0.98）。
盐酸屈他维林是治疗儿童复发性腹痛的一种有效且安全的药物。
