孟鲁司特钠联合干扰素α1b治疗小儿喘息性支气管炎的临床疗效

Clinical effect of montelukast sodium combined with interferon α1bin treatment of pediatric asthmatic bronchitis

目的探讨孟鲁司特钠联合干扰素α1b治疗小儿喘息性支气管炎(AB)的临床效果。方法选择2013年4月至2014年4月于武汉市第八医院诊治的80例小儿AB患者为研究对象,按照入院顺序单、双号,将其随机分为实验组(n=40)和对照组(n=40)。入选患儿均符合小儿AB临床诊断标准。同时排除伴有药物过敏史及肝、肾功能不全者。实验组患儿采用孟鲁司特钠联合干扰素α1b方案治疗,对照组采用常规方案治疗。对两组患儿的治疗有效率、满意率及住院时间等进行统计学分析。本研究遵循的程序符合武汉市第八医院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象监护人的知情同意,并与之签署临床研究知情同意书。两组患儿性别、年龄及病程等一般临床资料比较,差异均无统计学意义(P>0.05)。结果实验组治疗有效率、满意率分别为95.0%与97.5%,显著优于对照组的80.0%与77.5%,且差异均有统计学意义(χ2=4.114,7.314,P<0.05);实验组患儿住院时间、喘憋症状消失时间、发热消失时间及哮鸣音消失时间分别为(12.8±6.7)d,(1.6±1.1)d,(1.7±0.1)d及(5.5±1.5)d,均显著短于对照组的(15.5±5.8)d,(7.8±2.5)d,(3.3±1.0)d及(9.2±3.2)d,两组上述观察指标分别比较,差异均有统计学意义(t=4.28,5.78,5.55,12.31,P<0.05)。实验组治疗相关不良反应发生率为0,低于对照组的5%,但差异无统计学意义(χ2=0.51,P>0.05)。结论目前,小儿AB发病率较高,临床上采用孟鲁司特钠联合干扰素α1b治疗效果理想,但是否值得临床推广应用,尚需多中心、大样本随机对照研究进一步证实。

Objective To study clinical effect of montelukast sodium combined with interferon α1b in treatment of pediatric asthmatic bronchitis （AB）. Methods From April 2013 to April 2014,a total of 80 cases of children with AB who hospitalized in the Eighth Hospital of Wuhan City were admitted as research objects. According to their odd and even number of admission, they were randomly divided into experimental group （n=40） and control group （n=40）. All the patients were in accordance with the clinical diagnostic criteria of AB, and the patients who had the history of drug allergy, liver and renal insufficiency were excluded. In experimental group, the patients were treated with montelukast sodium combined with interferon α1b, while control group was treated with routine method. The treatment effective rate, satisfaction degree and hospitalization time, etc. between two groups were statistically analyzed. The procedure that this study followed met the ethical standards made by Institutional Review Board of the Eighth Hospital of Wuhan City in Hebei Province and approved by the committee. Grouping had the consent of guardians of study subjects and clinical study letter of consent was signed. The differences in age, gender ratio, course of disease and other general clinical data of the patients between two groups were not statistically significant （P〉0.05）. Results The effective rate and the treatment satisfaction of guardians of study subjects in experimental group were 95.0% and 97.5% which were significantly better than 80.0% and 77.5 % of control group, there were significant differences between two groups（X^2 = 4.114,7. 314; P〈 0.05）. The hospitalization time, wheezing symptoms disappearance time, fever disappearing time and wheeze disappearing time of experimental group were （12.8±6.7） d ,（1.6±1.1） d,（1.7±0.1） and （5.5±1.5） d which were significance shorter than those （15.5±5.8） d, （7.8±2.5） d ,（3.3±1.0） d and （9.2±3.2） d in control group, respectively , and there were significant differences between two groups （t = 4.28,5.78, 5.55,12.31;P〈0.05） . The incidence rate of adverse reactions after treatment in experimental group and control group were 0 and 5% respectively, and there was no statistical significance between them （X^2 = 0.51 ,P〉0.05） . Conclusions At present, the incidence rate of AB in children is high, and the treatment effect of strategy of montelukast sodium combined with interferon alb is ideal. Whether montelukast sodium combined with interferon alb in treating pediatric AB is worthy of clinical promotion and application or not, it still needs to be further confirmed by randomized controlled trials of multiple centers and large samples.