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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 efficacy and safety of diclofenac sodium suppository (DSS) for rectal administration of hyperthermia in infants and young children, and provide a basis for rational use of antipyretic drugs. Methods: A total of 336 patients with acute bronchial pneumonia and fever who were hospitalized in Suizhou MCH from September 2012 to August 2015 were selected as randomized controlled trials (RCT) and divided into DSS group 168 patients in the acetaminophen suppository (PCS) group were given rectal administration of DSS 0.5 mg / kg and PCS 10 mg / kg respectively, and anti-infective and symptomatic supportive treatment were given according to the condition. Using the monitor to monitor the two groups of children’s vital signs in a row, the onset time of antipyretic effect after the first administration was recorded, the body temperature decreased to normal time and the body temperature maintained normal time. Children with recurrent or persistent high fever are given repeated doses every 6 hours. Observed after administration of 24 h after the clinical adverse reactions and laboratory tests and so on. Results: There were 15 cases and 17 cases lost in the DSS group and the PCS group, 153 cases and 151 cases were included in the observation test. The onset time of antipyretic effect after the first administration in the two groups were (35.18 ± 3.06) min and (45.34 ± 3.52) min, respectively, and the body temperature decreased to (2.86 ± 0.66) h and (4.20 ± 0.68) h The normal time was (8.22 ± 0.58) h and (6.70 ± 0.54) h, respectively, with relapse fever, sustained high fever and repeated medication within 24 h. There was significant difference between the two groups (P <0.01). The incidences of nervous system, circulatory system, digestive system and skin adverse reactions in DSS group and PCS group were significantly different at 24 h after drug administration (P <0.01). The incidences of essential vital signs and abnormal laboratory tests were significantly different between the two groups The difference was statistically significant (P <0.05). Conclusion: Rectal administration of DSS can effectively relieve the clinical adverse reactions of hyperthermia, nervous system, digestive system and skin in infants and young children. However, hypothermia, poor circulation, acid-base imbalance and electrolyte imbalance may occur even as the preferred antipyretic drug Use with caution.