双氯芬酸钠栓治疗婴幼儿高热临床疗效与安全性研究  

Efficacy and Safety of Diclofenac Sodium Suppository in Infants with High Fever

作　　者：吴俊超[1] 杨静清[1] 宋道斌[1] 邬随焕 刘厚层 江广春 李艳[1] 汪晖[2] Wu Junchao Yang Jingqing Song Daobing Wu Suihuan Liu Houceng Jiang Guangchun Li Yan Wang Hui(Suizhou Maternal and Child Health Hospital, Hubei Suizhou 441300, China Wuhan University, Hubei Wahan 430071, China)

机构地区：[1]随州市妇幼保健院,湖北随州441300 [2]武汉大学,湖北武汉430071

出　　处：《儿科药学杂志》2017年第2期8-12,共5页Journal of Pediatric Pharmacy

基　　金：随州市医学科研基金重点项目;编号2015SMR053

摘　　要：目的:观察双氯芬酸钠栓(DSS)直肠给药治疗婴幼儿高热的临床疗效与安全性,为合理选用解热药物提供依据。方法:选取2012年9月至2015年8月在随州市妇幼保健院住院的336例急性支气管肺炎伴高热的婴幼儿为随机对照试验(RCT)研究对象,采用随机数字表法分为DSS组和对乙酰氨基酚栓(PCS)组各168例,分别给予DSS 0.5 mg/kg和PCS 10 mg/kg直肠给药,同时根据病情给予抗感染及对症支持治疗。使用监护仪连续动态监测两组患儿基本生命体征,记录首次给药后解热起效时间、体温降至正常时间及体温维持正常时间等。复发高热或持续高热的患儿每6 h重复给药一次。观察给药24 h时后各系统临床不良反应及实验室检查情况等。结果:DSS组和PCS组各失访15例和17例,纳入观察试验者为153例和151例。两组首次给药后解热起效时间分别为(35.18±3.06)min和(45.34±3.52)min,体温降至正常时间分别为(2.86±0.66)h和(4.20±0.68)h,体温维持正常时间分别为(8.22±0.58)h和(6.70±0.54)h,复发高热、持续高热和24 h内多次用药,两组比较差异有统计学意义(P<0.01)。给药24 h时DSS组和PCS组神经系统、循环系统、消化系统和皮肤不良反应发生率比较差异有统计学意义(P<0.01);基本生命体征和实验室检查指标异常发生率两组比较差异有统计学意义(P<0.05)。结论:DSS直肠给药可有效解除婴幼儿高热,神经系统、消化系统和皮肤临床不良反应少,但偶可发生体温过低、循环不良、酸碱失衡和电解质紊乱等,作为首选解热药需谨慎使用。Objective： To observe the clinical curative effect and security of diclofenac sodium suppository（ DSS） for infants with high fever,provide a basis for selection of antipyretic drugs. Methods： Three hundreds and thirty-six infants of acute infantile bronchitis with high fever in Suizhou Maternal and Child Health Hospital from September 2012 to August 2015 were selected as the research objects. All children were divided into DSS group and acetaminophen suppository（ PCS） group by the random number table method,each group had168 cases. Respectively given DSS 0. 5 mg / kg and PCS 10 mg / kg rectal administration,used the monitor continuous dynamic monitoring two groups of children with basic vital signs,recorded the antipyretic onset time after the first dosing,the time of body temperature dropped to normal and maintain normal,and so on. Recurrence and maintain fever of children repeated administration every 6 hours.The clinical adverse reactions and results of laboratory examination after dosing in 24 hours were observed. Results： There were 15 cases lost to follow-up in DSS group and 17 cases in PCS group,so 153 cases to be observed in DSS group and 151 cases in PCS group.Antipyretic onset time after the first dosing were（ 35. 18± 3. 06） min and（ 45. 34 ± 3. 52） min,body temperature drop to normal time were（ 2. 86±0. 66） h and（ 4. 20±0. 68） h,maintain normal temperature time were（ 8. 22±0. 58） h and（ 6. 70±0. 54） h,there were significant differences between two groups（ P 〈 0. 01）. There were differences about nervous system,circulatory system,digestive system,and the skin of clinical incidence of poor performance after dosing in 24 h between two groups（ P 〈 0. 01）,and there were differences about basic vital signs and laboratory examination incidence of adverse events between two groups（ P〈0. 05）. Conclusion：DSS rectum to medicine can efficiently relieve the high fever of infants,and clinical incidence of the nervous system,digestive system and skin are

关 键 词：双氯芬酸钠栓 婴幼儿 有效性 安全性 随机对照试验 

分 类 号：R720.5[医药卫生—儿科]