Weissbluth M, Christoffel K K, Davis A T
J Pediatr. 1984 Jun;104(6):951-5. doi: 10.1016/s0022-3476(84)80506-5.
We performed a prospective, randomized, double-blind, placebo-controlled clinical trial of dicyclomine hydrochloride using specific diagnostic criteria for infantile colic: spells of unexplained irritability, agitation, fussiness or crying lasting greater than or equal to 3 hours/day, occurring greater than or equal to 3 days/week, and continuing for greater than or equal to 3 weeks. Dicyclomine eliminated colic in 15 of 24 (63%) infants, whereas placebo was effective in six of 24 (25%) (corrected X2 = 5.42, P = 0.02). The study also addressed the hypothesis that parental distress caused by infantile colic affects subsequent temperament and sleep patterns. The data fail to document easier temperaments or longer sleep durations at 4 months in infants whose colic ceased during treatment.
我们采用针对婴儿腹绞痛的特定诊断标准，开展了一项关于盐酸双环胺的前瞻性、随机、双盲、安慰剂对照临床试验：不明原因的烦躁、激动、哭闹或啼哭发作持续时间≥3小时/天，每周发作≥3天，且持续≥3周。双环胺使24例婴儿中的15例（63%）腹绞痛消失，而安慰剂仅使24例中的6例（25%）有效（校正X2 = 5.42，P = 0.02）。该研究还探讨了这样一个假设，即婴儿腹绞痛引起的父母焦虑会影响其随后的气质和睡眠模式。数据未能证明在治疗期间腹绞痛停止的婴儿在4个月时气质更温和或睡眠时间更长。
