Khorana Meera, Chankajorn Woranate, Kanjanapattanakul Wiboon, Kirawittaya Tawatchai, Horpaopan Sunthorn, Chotigeat Uraiwan, Sangtawesin Waraporn
Neonatology Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand.
J Med Assoc Thai. 2003 Aug;86 Suppl 3:S590-5.
To evaluate the effect of cisapride on corrected QT (QTc) interval in neonates at the Queen Sirikit National Institute of Child Health.
A prospective study was performed to see the effects of cisapride on QTc interval in 20 neonates between 1st July 2001 and 31st January 2002. QTc interval was determined just before, 48 hours, 7 days and 15 days after the start of treatment with cisapride. QTc interval was calculated by averaging QT/square root(RR) values obtained from 5 consecutive beats in lead II of the EKG. Baseline electrolyte and calcium levels were drawn on all infants before treatment of cisapride. Drug dose ranged from 0.1-0.2 mg/kg every 6 to 8 hours.
Twenty infants were enrolled in the survey but complete data was obtained on 18 infants only. QTc interval of > 0.45 seconds was not found in any neonate. There was no significant difference of QTc interval before and 48 hours, 7 days and 15 days after cisapride administration (p = 0.861). There were also no statistically significant effects of age at starting cisapride, weight, gestational age and dose on QTc interval (p = 0.581, 0.65, 0.8, and 0.497). There were no adverse effects such as diarrhea or jaundice during the study.
Term and preterm infants using cisapride at the doses of 0.4-0.8 mg/kg/day did not develop QTc prolongation, arrhythmias or adverse effects. In the absence of risk factors, cisapride may be safe for use in neonates.
评估西沙必利对诗丽吉王后国家儿童健康研究所的新生儿校正QT（QTc）间期的影响。
进行一项前瞻性研究，以观察2001年7月1日至2002年1月31日期间西沙必利对20例新生儿QTc间期的影响。在开始使用西沙必利治疗前、治疗后48小时、7天和15天测定QTc间期。QTc间期通过平均心电图II导联连续5次心跳获得的QT/√RR值来计算。在使用西沙必利治疗前，对所有婴儿进行基线电解质和钙水平检测。药物剂量为每6至8小时0.1 - 0.2毫克/千克。
20例婴儿纳入调查，但仅18例婴儿获得完整数据。未在任何新生儿中发现QTc间期>0.45秒。西沙必利给药前、给药后48小时、7天和15天的QTc间期无显著差异（p = 0.861）。开始使用西沙必利时的年龄、体重、胎龄和剂量对QTc间期也无统计学显著影响（p = 0.581、0.65、0.8和0.497）。研究期间未出现腹泻或黄疸等不良反应。
足月儿和早产儿使用剂量为0.4 - 0.8毫克/千克/天的西沙必利未出现QTc延长、心律失常或不良反应。在没有危险因素的情况下，西沙必利用于新生儿可能是安全的。
