妥洛特罗贴剂联合马来酸氯苯那敏片治疗慢性咳嗽儿童患者的临床研究  

Clinical trial of tulobuterol patch combined with chlorpheniramine maleate tablets in the treatment of children with chronic cough

作　　者：李果 仇午娴 王淑静 陈洁 童晓 LI Guo;QIU Wu-xian;WANG Shu-jing;CHEN Jie;TONG Xiao(Department of Pediatrics,Affiliated Hospital of Jiangnan University/Wuxi Third People’s Hospital,Wuxi 214000,Jiangsu Province,China)

机构地区：[1]江南大学附属医院/无锡第三人民医院儿科,江苏无锡214000

出　　处：《中国临床药理学杂志》2020年第19期2986-2988,2992,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省杰出青年学者自然科学基金资助项目(1808085J28)。

摘　　要：目的观察妥洛特罗贴剂联合马来酸氯苯那敏片治疗慢性咳嗽儿童患者的临床疗效及安全性。方法将80例慢性咳嗽患儿随机分为对照组和试验组,每组40例。对照组给予0.35 mg·kg^-1氯苯那敏,分3次口服;试验组在对照组治疗的基础上,于20:00~21:00给予妥洛特罗贴剂,1~3岁者每次0.5 mg,3~9岁者每次1 mg,9岁以上者每次2 mg。2组患儿均连续治疗2周。比较2组患儿的临床疗效,咳嗽评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92.50%(37例/40例)和75.00%(30例/40例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的日间咳嗽评分分别为(0.51±0.21)和(0.78±0.28)分,夜间咳嗽评分分别为(0.41±0.22)和(0.72±0.27)分,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有黏贴部位瘙痒、心悸和疲劳,对照组发生的药物不良反应有心悸和疲劳。试验组和对照组的总药物不良反应发生率分别为10.00%和5.00%,差异无统计学意义(P>0.05)。结论妥洛特罗贴剂联合马来酸氯苯那敏片治疗小儿慢性咳嗽的临床疗效确切,其能显著减轻患儿的咳嗽症状,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of tulobuterol patch combined with chlorpheniramine maleate tablets in the treatment of children with chronic cough.Methods Eighty children with chronic cough were randomly divided into control and treatment group with 40 cases per group.Control group was given 0.35 mg·kg^-1 chlorpheniramine,oral administration,tid.Treatment group was given tolobuterol patch at 20:00 and 21:00 in the evening,and the dose of 1-3,3-9 and>9 years old were 0.5,1.0 and 2.0 mg per time,respectively,on the basis of control group.Two groups were treated for 2 weeks.The clinical efficacy,cough scores and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 92.50%(37 cases/40 cases)and 75.00%(30 cases/40 cases)with significant difference(P<0.05).After treatment,the daytime cough scores of treatment and control groups were(0.51±0.21)and(0.78±0.28),the night cough scores of those two groups were(0.41±0.22)and(0.72±0.27),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were itching on the adhesive site,palpitation and fatigue,while those in control group were palpitation and fatigue.The incidences of total adverse drug reactions in the treatment and control groups were 10.00%and 5.00%without significant difference(P>0.05).Conclusion Tulobuterol patch combined with chlorpheniramine maleate tablets has a definitely clinical efficacy in the treatment of children with chronic cough,which can significantly reduce the cough,without increasing the incidence of adverse drug reactions.

关 键 词：妥洛特罗贴剂 马来酸氯苯那敏片 慢性咳嗽 安全性评价 

分 类 号：R974.2[医药卫生—药品]