N-乙酰半胱氨酸治疗儿童呼吸道感染疾病的临床研究OA北大核心CSTPCD
Clinical trial of N-acetylcysteine in the treatment of children with respiratory tract infection
目的 观察N-乙酰半胱氨酸在儿童呼吸道感染疾病中的应用效果.方法 将呼吸道感染患儿随机分为对照组和试验组,对照组在常规对症治疗的基础上静脉注射注射用头孢他啶30～100 mg·kg-1,q12 h;试验组在对照组治疗的基础上雾化吸入N-乙酰半胱氨酸溶液(0.3 g∶3 mL),qd;均治疗7 d.比较2组患儿的临床疗效、症状缓解时间、胸部X线片变化、肺功能[第1秒用力呼气容积(FEV1)、潮气量(VT)和呼气峰值流量(PEF)]、血清炎症因子、免疫功能,并进行安全性评价.结果 试验过程因脱落、失访共剔除28例,最终试验组和对照组分别纳入40和52例.治疗后,试验组和对照组的临床总有效率分别为92.50％(37例/40例)和76.92％(40例/52例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组与对照组发热消失时间分别为(2.96±0.65)和(4.83±0.81)d,咳嗽缓解时间分别为(5.58±1.08)和(7.45±1.24)d,气喘缓解时间分别为(3.23±0.54)和(4.72±0.75)d,肺部啰音消失时间分别为(4.66±0.72)和(5.94±0.87)d,FEV1 分别为(2.26±0.25)和(1.79±0.21)L,VT 分别为(13.76±1.32)和(10.27±1.17)mL·kg-1,PEF 分别为(5.78±0.68)％和(4.92±0.62)％,血清 C 反应蛋白(CRP)分别为(7.68±1.18)和(9.41±1.29)mg·L-1,白细胞介素-6(IL-6)分别为(18.76±3.24)和(22.75±3.85)ng·mL-1,肿瘤坏死因子 α(TNF-α)分别为(8.93±1.51)和(15.46±2.24)ng·mL-1,CD4+/CD8+分别为1.35±0.29和1.20±0.30.试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.05).试验组的药物不良反应有恶心3例,呕吐1例,腹泻1例;对照组的药物不良反应有呕吐3例,腹泻2例.试验组和对照组的药物不良反应发生率分别为12.50％(5例/40例)和9.62％(5例/52例),在统计学上差异无统计学意义(P＞0.05).结论 N-乙酰半胱氨酸联合头孢他啶治疗呼吸道感染疗效确切,可有效改善患儿肺功能,缓解气道炎症,提高免疫功能,且安全性良好.
Objective To observe the application effect of N-acetylcysteine in children with respiratory tract infection.Methods According to random number table method,children with respiratory tract infection were divided into control group and treatment group.The control group was given intravenous injection of ceftazidime(30-100 mg·kg-1,q12 h)on basis of routine symptomatic treatment,while treatment group was given aerosol inhalation of N-acetylcysteine solution(0.3 g∶3 mL,qd)on basis of control group.All patients were treated for 7 d.The clinical curative effect,remission time of symptoms,changes of chest X-ray,lung function[forced expiratory volume in 1 second(FEV1),tidal volume(VT),peak expiratory flow(PEF)],serum inflammatory factors,immune function and adverse drug reactions in the two groups were compared.Results In the trial,there were 28 cases excluded due to shedding and loss of follow-up,and there were 40 cases in treatment group and 52 cases in control group,respectively.After treatment,total clinical response rates in treatment group and control group were 92.50％(37 cases/40 cases)and 76.92％(40 cases/52 cases),the difference was statistically significant(P＜0.05).After treatment,disappearance time of fever in treatment group and control group were(2.96±0.65)and(4.83±0.81)d;remission time of cough were(5.58±1.08)and(7.45±1.24)d;remission time of asthma were(3.23±0.54)and(4.72±0.75)d;disappearance time of lung rales were(4.66±0.72)and(5.94±0.87)d;FEV1 were(2.26±0.25)and(1.79±0.21)L;VT were(13.76±1.32)and(10.27±1.17)mL·kg-1;PEF were(5.78±0.68)％and(4.92±0.62)％;levels of serum C-reactive protein(CRP)were(7.68±1.18)and(9.41±1.29)mg·L-1;levels of interleukin-6(IL-6)were(18.76±3.24)and(22.75±3.85)ng·mL-1;levels of tumor necrosis factor α(TNF-α)were(8.93±1.51)and(15.46±2.24)ng·mL-1;CD4+/CD8+were 1.35±0.29 and 1.20±0.30.There were statistically significant differences in the above indexes between the treatment group and the control group(all P＜0.05).In treatment group,there were 3 cases with nausea,1 case with vomiting and 1 case with diarrhea.In control group,there were 3 cases with vomiting and 2 cases with diarrhea.There was no significant difference in incidence of adverse drug reactions between treatment group and control group[12.50％(5 cases/40 cases)vs 9.62％(5 cases/52 cases),P＞0.05].Conclusion Curative effect of N-acetylcysteine combined with ceftazidime is significant in children with respiratory tract infection,which can effectively improve lung function,relieve airway inflammation and enhance immune function,with good safety.
宋金涛;赵永;戴红臣;李桂涛
阜阳市人民医院儿科,安徽阜阳 236000
药学
吸入用N-乙酰半胱氨酸溶液注射用头孢他啶呼吸道感染炎症反应免疫功能
N-acetylcysteine solution for inhalationceftazidime for injectionrespiratory tract infectioninflammatory responseimmune function
《中国临床药理学杂志》 2024 (020)
2915-2919 / 5
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