哌拉西林钠他唑巴坦钠联合布地奈德雾化吸入治疗新生儿肺炎的临床研究

Clinical trial of piperacillin/tazobactam sodium combined with budesonide aerosol inhalation in the treatment of neonatal pneumonia

目的 观察哌拉西林钠他唑巴坦钠联合布地奈德雾化吸入治疗新生儿肺炎对临床症状改善、炎症因子水平的影响。方法 将新生儿肺炎患儿按随机数字表法分为对照组和试验组。对照组患儿静脉滴注哌拉西林钠他唑巴坦钠100 mg·kg^(-1),每8 h给药1次,连续治疗7~10 d;试验组在对照组治疗的基础上,雾化吸入布地奈德混悬液1 mg,每日2次,连续治疗7~10 d。比较2组患儿的临床疗效、临床症状改善情况、血清炎症因子及药物不良反应发生率。结果 试验过程中出现15例脱落病例,最终试验组和对照组分别纳入60例。治疗后,试验组的总有效率显著高于对照组(93.33%vs. 71.67%),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的发热消失时间分别为(4.36±1.02)和(5.42±1.28)d,咳嗽消失时间分别为(5.37±1.47)和(6.95±1.61)d,气喘消失时间分别为(3.20±0.98)和(4.68±1.05)d,肺部啰音消失时间分别为(6.53±1.14)和(8.93±1.39)d, C反应蛋白(CRP)水平分别为(9.27±2.34)和(13.49±2.86)mg·L^(-1),降钙素原(PCT)分别为(0.51±0.16)和(0.89±0.23)ng·mL^(-1),白细胞介素6(IL-6)分别为(72.36±12.52)和(88.57±13.65)pg·mL^(-1);试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。试验组发生恶心呕吐1例、皮疹2例、腹泻2例,总药物不良反应发生率为8.33%;对照组发生恶心呕吐1例、皮疹1例、腹泻1例,总药物不良反应发生率为5.00%,差异无统计学意义(P>0.05)。结论 哌拉西林钠他唑巴坦钠联合布地奈德雾化吸入治疗新生儿肺炎是安全有效的,其可有效降低CRP、PCT和IL-6水平。

Objective To investigate the effects of piperacillin/tazobactam sodium combined with budesonide aerosol inhalation on improvement of clinical symptoms and levels of inflammatory factors in neonatal pneumonia.Methods Newborns with pneumonia were randomly divided into control group and treatment group using a random number table method.Patients in the control group were administered piperacillin sodium tazobactam sodium at a dose of 100 mg·kg^(-1)via intravenous infusion once every 8 h,continuously for 7-10 days.Patients in the treatment group were treated with budesonide inhalation suspension at a dose of 1 mg twice a day by nebulization,in addition to the treatment regimen of the control group,for 7-10 days.The therapeutic efficacy,improvement of clinical symptoms,serum inflammatory factors,and incidence of adverse drug reactions were compared between the two groups.Results During the trial,15 dropout cases occurred,and finally 60cases were included in both the treatment and control groups,respectively.The total effective rate of treatment in the treatment group was higher than that in the control group(93.33%vs.71.67%),and the difference was statistically significant(P<0.05).The times for fever disappearance in the treatment and control groups were(4.36±1.02)and(5.42±1.28)days;cough disappearance were(5.37±1.47)and(6.95±1.61)days;wheezing disappearance were(3.20±0.98)and(4.68±1.05)days;lung rales disappearance were(6.53±1.14)and(8.93±1.39)days,respectively;after treatment,the levels of C-reactive protein(CRP)in the treatment and control groups were(9.27±2.34)and(13.49±2.86)mg·L^(-1),respectively;the levels of procalcitonin(PCT)were(0.51±0.16)and(0.89±0.23)ng·mL^(-1),respectively;and the level of interleukin-6(IL-6)were(72.36±12.52)and(88.57±13.65)pg·mL^(-1),respectively.The differences of the indicators between the treatment and control groups were all statistically significant(all P<0.05).In the treatment group,one case of nausea and vomiting,two cases of rash,and two cases of diarrhea occurred,with a total incidence rate of 8.33%;in the control group,one case of nausea and vomiting,one case of rash,and one case of diarrhea occurred,with a total incidence rate of 5.00%.There was no significant difference in the incidence of adverse drug reactions between the two groups(P>0.05).Conclusion Piperacillin/tazobactam sodium combined with budesonide aerosol inhalation is safe and effective in the treatment of neonatal pneumonia,which can effectively reduce levels of CRP,PCT and IL-6.