联合降阶梯方案治疗婴幼儿喘息临床研究
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摘要
目的观察联合降阶梯方案治疗婴幼儿喘息的有效性及安全性。方法采用分层随机、开放、平行对照试验,于2013年2月至2015年1月,从上海交通大学医学院附属新华医院等4家医院选择轻中度急性发作期的喘息患儿206例,分为观察组106例、对照组100例。(1)观察组采用联合降阶梯方案:醋酸泼尼松片,0.5 mg/(kg·d),晨顿服,疗程3 d;阿奇霉素干混悬剂,10 mg/(kg·d),1次/d,疗程3 d;妥洛特罗贴剂,0.5 mg/d,1次/d,疗程7 d;氯雷他定糖浆,3 mg/d,1次/d,疗程14 d;孟鲁司特钠,4 mg/d,1次/d,疗程28 d。给药途径为口服或外用。(2)对照组采用常规治疗方案:甲泼尼龙琥珀酸钠,1 mg/(kg·d),1次/d,疗程3 d;头孢类抗生素,用药剂量参照说明书,疗程3 d;口服氨溴特罗口服液,每次2.5~7.5 m L,每12 h 1次,疗程遵医嘱(药物连续服用不超过7 d);前两者为静脉给药。观察治疗前后症状、体征积分、疗效及喘息反复情况。结果治疗后7 d的分析结果显示,观察组、对照组的症状体征积分和下降均值分别为5.89、4.84,治疗总有效率分别为98.11%、92.00%(P<0.05)。治疗后28 d的分析结果显示,对照组、观察组的喘息反复发生率分别为24.00%、12.26%(P<0.05)。结论联合降阶梯方案治疗婴幼儿喘息(轻中度急性发作期)疗效优于常规治疗方案,且可减少喘息反复发作风险,临床应用安全。
Objective To evaluate the efficacy and safety of combined de-escalation therapy in the treatment of infant wheezing. Methods Stratified random,open,parallel control method was adopted. A total of 206 cases of infant wheezing(mild-to-moderate at acute exacerbation)were recruited from 4 clinical research centers from Feb. 2013 to Jan. 2015,and were divided into the experiment group(n=106)and the control group(n=100).(1)The experiment group was given the combined de-escalation therapy:prednisone acetate tablets 0.5 mg(/kg·d),QD for 3 d;azithromycin suspension 10 mg(/kg·d),QD for 3 d;tulobuterol tape 0.5 mg/d,QD for 7 d;loratadine syrup 3 mg/d,QD for 14 d;montelukast sodium 4 mg/d,QD for 28 d.The drugs were taken orally or used externally.(2)The control group was given the conventional therapy:methylprednisolone1 mg(/kg·d),QD for 3 d;cephalosporin(medication dosage referring to the drug instructions)for 3 d;ambrocol oral solution,2.5-7.5 mL each time,Q12 h(taken as prescribed but not more than 7 d). Both methylprednisolone and cephalosporin were administered by intravenous drip. Before and after treatment,observe the symptom and sign improvement,the treatment effect and the repeatedness of wheezing. Results After 7 d of treatment,the mean decreased value of symptom score was 5.89 in experiment group and 4.84 in control group;the total effective rate was 98.11% in experiment group and 92.00% in control group(P<0.05). After 28 d of treatment,the experiment group has lower rate of recurrent wheezing incidence(12.26%)thanthe control group(24.00%)(P<0.05). Conclusion The efficacy of combined de-escalation therapy for infant wheezing(mild-to-moderate at acute exacerbation)is superior to conventional therapy with good clinical safety. The combined de-escalation therapy may achieve good social and economic benefits by reducing the risk of recurrent wheezing
Objective To evaluate the efficacy and safety of combined de-escalation therapy in the treatment of infant wheezing. Methods Stratified random,open,parallel control method was adopted. A total of 206 cases of infant wheezing(mild-to-moderate at acute exacerbation)were recruited from 4 clinical research centers from Feb. 2013 to Jan. 2015,and were divided into the experiment group(n=106)and the control group(n=100).(1)The experiment group was given the combined de-escalation therapy:prednisone acetate tablets 0.5 mg(/kg·d),QD for 3 d;azithromycin suspension 10 mg(/kg·d),QD for 3 d;tulobuterol tape 0.5 mg/d,QD for 7 d;loratadine syrup 3 mg/d,QD for 14 d;montelukast sodium 4 mg/d,QD for 28 d.The drugs were taken orally or used externally.(2)The control group was given the conventional therapy:methylprednisolone1 mg(/kg·d),QD for 3 d;cephalosporin(medication dosage referring to the drug instructions)for 3 d;ambrocol oral solution,2.5-7.5 mL each time,Q12 h(taken as prescribed but not more than 7 d). Both methylprednisolone and cephalosporin were administered by intravenous drip. Before and after treatment,observe the symptom and sign improvement,the treatment effect and the repeatedness of wheezing. Results After 7 d of treatment,the mean decreased value of symptom score was 5.89 in experiment group and 4.84 in control group;the total effective rate was 98.11% in experiment group and 92.00% in control group(P<0.05). After 28 d of treatment,the experiment group has lower rate of recurrent wheezing incidence(12.26%)thanthe control group(24.00%)(P<0.05). Conclusion The efficacy of combined de-escalation therapy for infant wheezing(mild-to-moderate at acute exacerbation)is superior to conventional therapy with good clinical safety. The combined de-escalation therapy may achieve good social and economic benefits by reducing the risk of recurrent wheezing
引文
[1]Bouzas ML,SoléD,Cardoso MR,et al.Wheezing in infants:frequency,clinical characteristics and treatment[J].J Pediatr(Rio J),2012,88(4):361-365.
[2]Lima JA,Fischer GB.Prevalence of and risk factors for wheezing in the first year of life[J].J Bras Pneumol,2010,36(5):525-531.
[3]Chong Neto HJ,Rosário NA,Grasselli EA,et al.Recurrent wheezing in infants:epidemiological changes[J].J Pediatr(Rio J),2011,87(6):547-550.
[4]高苗苗,林芊,鲍一笑.联合降阶梯方案治疗婴幼儿喘息疗效及安全性研究[J].中国实用儿科杂志,2012,3(3):202-205.
[5]胡亚美,江载芳.诸福棠实用儿科学[M].7版.北京:人民卫生出版社,2011:1172.
[6]中华医学会儿科学分会呼吸学组,《中华儿科杂志》编辑委员会.儿童支气管哮喘诊断与防治指南[J].中华儿科杂志,2008,46(10):745-753.
[7]中华医学会呼吸病学分会哮喘学组.咳嗽的诊断与治疗指南(2009版)[J].中华结核和呼吸杂志,2009,32(6):407-413.
[8]中华中医药学会.中医儿科常见病诊疗原则[S].北京:中国中医药出版社,2012.
[9]全国儿科哮喘协作组,中国疾病预防控制中心环境与健康相关产品安全所.第三次中国城市儿童哮喘流行病学调查[J].中华儿科杂志,2013,51(10):729-735.
[10]中华医学会儿科学分会呼吸学组,《中华儿科杂志》编辑委员会.儿童支气管哮喘诊断与防治指南(2016年版)[J].中华儿科杂志,2016,54(3):167-181.
[11]嵇若旭,李京阳,鲍一笑,等.短程小剂量口服激素在婴幼儿喘息急性期联合降阶梯治疗方案中的作用研究[J].儿科药学杂志,2014,20(3):9-12.
[12]Lin SJ,Yan DC,Lee WI,et al.Effect of azithromycin on natural killer cell function[J].Int Immunopharmacol,2012,13(1):8-14.
[13]Nagaoka K,Yanagihara K,Harada Y,et al.Macrolides inhibit fusobacterium nucleatum-induced MUC5AC production in human airway epithelial cells[J].Antimicrob Agents Chemother,2013,57(4):1844-1849.
[14]Stokholm J,Chawes BL,Vissing NH,et al.Azithromycin for episodes with asthma-like symptoms in young children aged 1-3years:a randomised,double-blind,placebo-controlled trial[J].Lancet Respir Med,2016,4(1):19-26.
[15]朱亚菊,林芊,华丽,等.布地奈德混悬液联合妥洛特罗贴剂治疗婴幼儿反复喘息的疗效及安全性研究[J].上海交通大学学报(医学版),2011,31(12):1729-1732.
[16]范飞,鲍一笑,华丽,等.婴幼儿喘息急性期联合降阶梯治疗方案中氯雷他定的作用[J].中国实用儿科杂志,2013,28(4):274-277.
[17]Pelkonen ASl,Malmstr?m K,Sarna S,et al.The effect of montelukast on respiratory symptoms and lung function in wheezy infants[J].Eur Respir J,2013,41(3):664-670.
[18]蔡昀庭,鲍一笑,范飞,等.婴幼儿喘息急性期联合降阶梯治疗方案中孟鲁司特的作用研究[J].儿科药学杂志,2013,19(7):6-10.
[2]Lima JA,Fischer GB.Prevalence of and risk factors for wheezing in the first year of life[J].J Bras Pneumol,2010,36(5):525-531.
[3]Chong Neto HJ,Rosário NA,Grasselli EA,et al.Recurrent wheezing in infants:epidemiological changes[J].J Pediatr(Rio J),2011,87(6):547-550.
[4]高苗苗,林芊,鲍一笑.联合降阶梯方案治疗婴幼儿喘息疗效及安全性研究[J].中国实用儿科杂志,2012,3(3):202-205.
[5]胡亚美,江载芳.诸福棠实用儿科学[M].7版.北京:人民卫生出版社,2011:1172.
[6]中华医学会儿科学分会呼吸学组,《中华儿科杂志》编辑委员会.儿童支气管哮喘诊断与防治指南[J].中华儿科杂志,2008,46(10):745-753.
[7]中华医学会呼吸病学分会哮喘学组.咳嗽的诊断与治疗指南(2009版)[J].中华结核和呼吸杂志,2009,32(6):407-413.
[8]中华中医药学会.中医儿科常见病诊疗原则[S].北京:中国中医药出版社,2012.
[9]全国儿科哮喘协作组,中国疾病预防控制中心环境与健康相关产品安全所.第三次中国城市儿童哮喘流行病学调查[J].中华儿科杂志,2013,51(10):729-735.
[10]中华医学会儿科学分会呼吸学组,《中华儿科杂志》编辑委员会.儿童支气管哮喘诊断与防治指南(2016年版)[J].中华儿科杂志,2016,54(3):167-181.
[11]嵇若旭,李京阳,鲍一笑,等.短程小剂量口服激素在婴幼儿喘息急性期联合降阶梯治疗方案中的作用研究[J].儿科药学杂志,2014,20(3):9-12.
[12]Lin SJ,Yan DC,Lee WI,et al.Effect of azithromycin on natural killer cell function[J].Int Immunopharmacol,2012,13(1):8-14.
[13]Nagaoka K,Yanagihara K,Harada Y,et al.Macrolides inhibit fusobacterium nucleatum-induced MUC5AC production in human airway epithelial cells[J].Antimicrob Agents Chemother,2013,57(4):1844-1849.
[14]Stokholm J,Chawes BL,Vissing NH,et al.Azithromycin for episodes with asthma-like symptoms in young children aged 1-3years:a randomised,double-blind,placebo-controlled trial[J].Lancet Respir Med,2016,4(1):19-26.
[15]朱亚菊,林芊,华丽,等.布地奈德混悬液联合妥洛特罗贴剂治疗婴幼儿反复喘息的疗效及安全性研究[J].上海交通大学学报(医学版),2011,31(12):1729-1732.
[16]范飞,鲍一笑,华丽,等.婴幼儿喘息急性期联合降阶梯治疗方案中氯雷他定的作用[J].中国实用儿科杂志,2013,28(4):274-277.
[17]Pelkonen ASl,Malmstr?m K,Sarna S,et al.The effect of montelukast on respiratory symptoms and lung function in wheezy infants[J].Eur Respir J,2013,41(3):664-670.
[18]蔡昀庭,鲍一笑,范飞,等.婴幼儿喘息急性期联合降阶梯治疗方案中孟鲁司特的作用研究[J].儿科药学杂志,2013,19(7):6-10.