国产与进口头孢他啶治疗新生儿呼吸窘迫综合征合并肺炎临床随机对照研究

Domestic and Import Ceftazidime Treatment of Neonatal Respiratory Distress Syndrome Combined with Pneumonia of Newborn: a Clinical Randomized Controlled Trial

目的：评价国产与进口头孢他啶治疗新生儿呼吸窘迫综合征（NRDS）合并肺炎（PN）的效果与安全性。方法：选取2011年10月至2014年10月我院NICU收治的NRDS合并PN患儿106例,按随机数字表法分为国产组和进口组各53例,分别应用国产和进口头孢他啶抗感染,初始治疗均以100 mg/（kg·d）剂量溶于0.9%氯化钠注射液30～50 m L,分2次静脉滴注,每12 h一次。观察两组患儿的症状体征变化、辅助通气情况、需调整为头孢哌酮/舒巴坦钠或碳青霉烯类抗感染的情况、抗菌药物疗程、抗菌药物费用、临床转归、不良反应和细菌学指标等。结果：头孢他啶治疗总有效率为60.38%（64/106）,国产组和进口组的有效率分别为52.83%（28/53）和67.92%（36/53）,细菌清除率分别为11.11%和18.75%。两组的住院时间、持续正压通气（CPAP）或机械通气时间、头孢他啶使用时间、头孢哌酮/舒巴坦钠或碳青霉烯类使用时间、病死率比较差异均无统计学意义（P均〉0.05）。国产组和进口组的抗菌药物疗程分别为（25.41±6.32）d和（20.11±5.74）d,抗菌药物费用分别为（2 337.20±698.30）元和（2 558.70±921.60）元,国产组抗菌药物疗程长于进口组（P〈0.01）,但抗菌药物费用低于进口组（P〈0.01）。两组均无明显不良反应发生。两组的主要致病菌为肺炎克雷伯菌肺炎亚种,且为产ESBLs菌,其对头孢他啶耐药率为100%。结论：NRDS合并PN致病菌对头孢他啶耐药率较高,临床初始治疗不建议首选头孢他啶抗感染。

Objective： To evaluate the efficacy and safety of domestic and import cefiazidime on neonatal respiratory distress syndrome （NRDS） combined with pneumonia of newborn （PN）. Methods： From Oct, 2011 to Oct, 2014, 106 cases of NRDS combined with PN were divided randomly into two groups： the domestic group was given domestic ceftazidime 100 mg/（ kg·d） by intravenous drip 2 times every day and the import group was given import ceftazidime 100 mg/（ kg · d） by intravenous drip 2 times every day. The symptoms, signs, assisted ventilation, adjustment into sulbactam/cefoperazone （sulperazone） or carbapenems, duration of antimicrobial agents administration, cost of antimicrobial agents, clinical outcome, adverse reactions, and bacteriology indexes were observed. Results： The total efficacy of ceftazidime on NRDS combined with PN among 106 cases was 60.38%, the efficacy of domestic and import ceftazidime was 52.83% and 67.92%, respectively. There were no significant difference between the two groups with the durations of staying in the hospital, CPAP or mechanical ventilation, duration of ceftazidime, duration of sulperazone or carbapenems and the fatality rate. The bacterial clearance of the domestic group and the import group was 11.11% and 18.75%, respectively. The duration of domestic and import was （25.41±6.32） d and （20.11±5.74） d, the cost of antibiotics was （2,337.20±698.30） yuan and （2,558.70±921.60） yuan. The cost of antimicrobial agents on the domestic group was lower than that on the import group （P〈0.01）. No significant adverse reaction was observed in both two groups. The main pathogenic bacterium was ESBLs, which was resistant to ceftazidime 100%. Conclusion： The resistance of pathogenic bacteria of NRDS combined with PN is rather high, and the curative effect is not good. Ceftazidime should not be the first suggested for serious infection on NRDS combined with PN.