摘要
目的研究真实世界小儿肺热咳喘颗粒治疗呼吸系统疾病患儿的临床用药特征、有效性及安全性。方法选取医院信息系统(HIS)中使用小儿肺热咳喘颗粒治疗呼吸系统疾病患儿,分析其临床用药特征、治疗效果及安全性。结果使用小儿肺热咳喘颗粒治疗儿童呼吸系统疾病的病例共157例,其中男性91例(57.96%),女性66例(42.04%),平均年龄4.1岁,其中3~6岁患儿居多;平均住院时长为5.7 d。西医诊断频次排前5位的分别为支气管肺炎(31.48%)、支气管炎(22.22%)、肺炎(11.57%)、急性上呼吸道感染(5.10%)和惊厥(4.63%)。中医诊断155条,其中中医主病排前5位的分别为肺炎喘嗽病(61.29%)、咳嗽病(25.16%)、急喉喑(3.87%)、感冒(3.23%)和急惊风(2.58%);中医辨证分布排名前5位的分别是风热闭肺证(62.58%)、风热犯肺证(25.16%)、风热感冒证(3.23%)、风热外侵证(2.58%)和风热动风证(2.58%)。<3岁患儿单次用药剂量在1~4 g,3~7岁患儿单次用药剂量在2~8 g,>7岁患儿单次用药剂量在4~8 g;连续用药时间<3 d的患儿占38.85%,连续用药时间3~7 d的患儿占54.78%且占比最多,连续用药时间>7 d的患儿占6.37%。合并使用西药排名靠前的药物包括盐酸氨溴索注射液、吸入用布地奈德混悬液、注射用头孢曲松钠、硫酸特布他林雾化液、吸入用异丙托溴铵溶液等;合并使用中药排名靠前的药物包括痰热清注射液、热毒宁注射液、双黄连口服液、金振口服液、肺力咳合剂等。小儿肺热咳喘颗粒常见合并2种西药组合包括氨溴索+布地奈德、布地奈德+氨溴索、布地奈德+特布他林、氨溴索+头孢曲松钠、布地奈德+头孢曲松钠等。小儿肺热咳喘颗粒合并3种西药关联分析发现,小儿肺热咳喘颗粒常见合并组合包括布地奈德+(特布他林,氨溴索)、氨溴索+(特布他林,布地奈德)、氨溴索+(头孢曲松钠,布地奈德)、布地奈德+(头孢曲松钠,氨溴索)、氨溴索+(异丙托溴铵,布地奈德)等。157例住院患儿中治愈者128例(81.53%),好转者29例(18.47%);其中有8例患儿使用小儿肺热咳喘颗粒后出现了不同程度的肝酶水平升高,4例患儿使用小儿肺热咳喘颗粒后出现了不同程度的肌酐水平异常,诺氏评估量表法评分均为2分,均判定为可能有关。结论真实世界研究结果为小儿肺热咳喘颗粒治疗儿童呼吸系统疾病提供了指导,弥补了小儿肺热咳喘颗粒说明书信息不完善的问题,为临床医生的合理用药提供参考信息。
Objective To study the clinical medication characteristic,efficacy and safety of Xiaoer Feire Kechuan Granule in treatment of children with respiratory disease in the real world.Methods The children with respiratory disease using Xiaoer Feire Kechuan Granule was selected from hospital information system(HIS).The clinical medication characteristic,treatment effect and safety were analyzed.Results A total of 157 cases of pediatric respiratory system diseases were treated with Xiaoer Feire Kechuan Granule,including 91 males(57.96%)and 66 females(42.04%),with an average age of 4.1 years,most of which were 3-6 years old,and the average length of hospital stay was 5.7 d.The top 5 western medical diagnoses were bronchopneumonia(31.48%),bronchiolitis(22.22%),pneumonia(11.57%),acute upper respiratory tract infection(5.10%)and convulsion(4.63%).There were 155 traditional Chinese medicine diagnoses,among which the top 5 main diseases were pneumonia and wheezing(61.29%),cough(25.16%),acute hoarseness(3.87%),cold(3.23%),and acute infantile convulsions(2.58%);the top 5 syndromes of traditional Chinese medicine differentiation were wind-heat blocking lung syndrome(62.58%),wind-heat invading lung syndrome(25.16%),wind-heat cold syndrome(3.23%),wind-heat external invasion syndrome(2.58%)and wind-heat dynamic wind syndrome(2.58%).A single dose of 1-4 g for children<3 years old,2-8 g for children 3-7 years old,and 4-8 g for children>7 years old.The proportion of children with<3 d of continuous medication was 38.85%,the proportion of children with 3-7 d of continuous medication was 54.78%and the highest,and the proportion of children with>7 d of continuous medication was 6.37%.The top-ranked combinations of western drugs included ambroxol hydrochloride injection,budesonide suspension for inhalation,ceftriaxone sodium for injection,terbutaline sulfate solution for nebulization,ipratropium bromide solution for inhalation,etc;and the top-ranked combinations of traditional Chinese medicines included Tanreqing injection,Reduning injection,Shuanghuanglian oral liquid,Jinzhen oral liquid,and Feili cough mixture.Xiaoer Feire Kechuan Granule were commonly combined with two western drug combinations,including ambroxol+budesonide,budesonide+ambroxol,budesonide+terbutaline,ambroxol+ceftriaxone sodium,budesonide+ceftriaxone sodium,etc.The association analysis of pediatric lung-heat cough and asthma granules combined with 3 western drugs found that the common combination combinations of Xiaoer Feire Kechuan Granule included budesonide+(terbutaline,ambroxol),ambroxol+(terbutaline,budesonide),ambroxol+(ceftriaxone sodium,budesonide),budesonide+(ceftriaxone sodium,ambroxol),ambroxol+(ipratropium bromide,budesonide),etc.Among the 157 hospitalized children,128 cases(81.53%)were cured and 29 cases(18.47%)were improved;among them,8 cases of pediatric patients showed varying degrees of elevated liver enzyme levels and 4 cases of pediatric patients showed varying degrees of abnormal creatinine levels after using Xiaoer Feire Kechuan Granule,with a score of 2 points on the Norris Rating Scale,all of which were judged to be possibly related.Conclusion These real world results provide direction for Xiaoer Feire Kechuan Granule in treatment of children with respiratory disease and provide reference for rational use of medicine by clinician.These real world results also compensated for the imperfect drug label of Xiaoer Feire Kechuan Granule.
作者
王明芳
刘宝枚
庄乾君
张艳
王金玉
WANG Ming-fang;LIU Bao-mei;ZHUANG Qian-jun(Department of Pharmacy,Rizhao Hospital of Traditional Chinese Medicine,Rizhao 276800,China)
出处
《中国现代药物应用》
2025年第5期156-161,共6页
Chinese Journal of Modern Drug Application
基金
山东中医药学会临床药学科研专项基金项目(项目编号:SDACM202214),项目名称:小儿肺热咳喘颗粒(口服液)治疗儿童呼吸系统疾病真实世界的研究及临床综合评价。
关键词
真实世界
小儿肺热咳喘颗粒
儿童
呼吸系统疾病
临床用药特征
Real world
Xiaoer Feire Kechuan Granule
Children
Respiratory disease
Clinical medication characteristics
作者简介
通讯作者:王明芳。
