连花清咳片治疗小儿急性支气管炎痰热壅肺证有效性和安全性的随机、开放、平行对照、多中心临床观察  

Randomized,Open,Parallel Controlled,Multi-center Study for Efficacy and Safety of Lianhua Qingke Tablets in Treatment of Acute Bronchitis in Children with Syndrome of Phlegm-heat Obstructing Lung

作　　者：李楠 耿少怡[2] 王小芳 张晓伟 贾丽霞[4] 康荣珍 杜向军 吴立春 张琳琳 LI Nan;GENG Shaoyi;WANG Xiaofang;ZHANG Xiaowei;JIA Lixia;KANG Rongzhen;DU Xiangjun;WU Lichun;ZHANG Linlin(Shijiazhuang Maternal and Child Health Care Hospital,Shijiazhuang 050000,China;Hebei Province Hospital of Traditional Chinese Medicine(TCM),Shijiazhuang 050000,China;Shijiazhuang Hospital of TCM,Shijiazhuang 050000,China;The Third Hospital of Shijiazhuang,Shijiazhuang 050011,China;Jinzhou People's Hospital,Shijiazhuang 052200,China;The Hospital of Zanhuang County,Shijiazhuang 051230,China;The Hospital of Yuanshi County,Shijiazhuang 051130,China)

机构地区：[1]石家庄市妇幼保健院,石家庄050000 [2]河北省中医院,石家庄050000 [3]石家庄市中医院,石家庄050000 [4]石家庄市第三医院,石家庄050011 [5]晋州市人民医院,石家庄052200 [6]赞皇县医院,石家庄051230 [7]元氏县医院,石家庄051130

出　　处：《中国实验方剂学杂志》2024年第10期90-94,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药多学科交叉创新团队项目(ZYYCXTD-D-202206)。

摘　　要：目的:评价连花清咳片治疗小儿急性支气管炎痰热壅肺证的临床有效性和安全性。方法:采用随机、开放、平行对照、多中心临床研究的方法,将急性支气管炎痰热壅肺证患儿随机分配到观察组和对照组,对照组采用常规基础治疗,观察组在常规基础治疗上联用连花清咳片,疗程7 d。比较两组患儿疾病疗效、中医证候疗效、症状消失时间、咳嗽消失时间并对安全性进行评价。结果:该研究共纳入248例患儿(观察组和对照组各124例)。治疗7 d,观察组疾病疗效总有效率为96.8%(120/124),对照组为90.3%(112/124),观察组优于对照组(Z=-5.034,P<0.01)。观察组中医证候疗效总有效率为97.6%(121/124),对照组为93.5%(116/124),观察组优于对照组(χ^(2)=-5.326,P<0.01)。观察组症状体征计分和及中医证候计分和在服药3 d、服药7 d时,均显著低于对照组(P<0.01);观察组症状消失时间、咳嗽消失时间均短于对照组(P<0.01)。两组均未发生与药物相关的不良反应。结论:连花清咳片治疗小儿急性支气管炎痰热壅肺证临床疗效显著,可明显缩短病程、缓解咳嗽症状,改善中医证候,且安全性良好,值得临床应用及推广。Objective:To evaluate the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis in children with the syndrome of phlegm-heat obstructing lung.Method:A randomized,open,parallel controlled,and multi-center clinical study was conduted.Children with acute bronchitis(syndrome of phlegm-heat obstructing lung)were randomly assigned to an observation group and a control group.The control group received routine basic treatment,and the observation group was treated with Lianhua Qingke Tablets on the basis of routine basic treatment.After 7 days of treatment,the clinical efficacy,TCM efficacy,time to symptom disappearance,time to cough disappearance,and clinical safety were compared between the two groups.Result:A total of 248 children were included(124 in the observation group and 124 in the control group).After 7 days of treatment,the total response rate in terms of clinical efficacy in the observation group was 96.8%(120/124),which was higher than that(90.3%,112/124)in the control group(Z=-5.034,P<0.01).The total response rate in terms of TCM syndrome in the observation group was 97.6%(121/124),which was higher than that(93.5%,116/124)in the control group(χ^(2)=-5.326,P<0.01).The scores of physical signs and TCM symptoms in the observation group were lower than those in the control group at the time of taking medicine for 3 days and 7 days(P<0.01).The time to symptom disappearance and the time to cough disappearance in the observation group were shorter than those in the control group(P<0.01).Drug-related adverse reactions occurred in neither group.Conclusion:Lianhua Qingke tablets demonstrate a definite effect on acute bronchitis in children with the syndrome of phlegm-heat blocking lung.The tablets can significantly shorten the course of disease and relieve cough and TCM symptoms,with high safety,which is worthy of clinical application and promotion.

关 键 词：急性支气管炎 连花清咳片 临床疗效 安全性 

分 类 号：R2-0[医药卫生—中医学] R22R242R287R563