西药联合丹龙口服液治疗轻、中度支气管哮喘急性发作期(热哮证)的随机、双盲、对照、多中心临床试验  

Treatment of Mild-to-moderate Bronchial Asthma( Heat Wheezing Syndrome) Patients at Acute Onset with Western Medicine Combined Danlong Oral Liquid: a Multi-center,Randomized Double-blinded,Positive-controlled Clinical Trial

作　　者：刘旻[1] 刘贵颖[1] 胡思源[1] 万丽玲[2] 蔡鸿彦[3] 徐艳玲[4] 毛兵[5] 朱慕云[6] 崔丽英[7] 孙健民[8] 

机构地区：[1]天津中医药大学第一附属医院呼吸科,天津300193 [2]江西中医学院附属医院呼吸科,南昌330006 [3]吉林省中西医结合医院呼吸科,长春130021 [4]辽宁中医药大学附属医院呼吸科,沈阳110032 [5]四川大学华西医院中西医结合科,成都610041 [6]江苏省苏北人民医院呼吸科,扬州225001 [7]内蒙古医学院附属医院呼吸科,呼和浩特010050 [8]山西医科大学第一医院中医科,太原030001

出　　处：《中国中西医结合杂志》2015年第5期529-533,共5页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的观察西药联合丹龙口服液治疗轻、中度支气管哮喘急性发作期(热哮证)的有效性和安全性。方法选择轻、中度支气管哮喘急性发作期(热哮证)患者480例,按3∶1随机分为试验组(360例)和对照组(120例),两组均维持原西药治疗,试验组予丹龙口服液,对照组予咳喘宁口服液,均口服,10 m L/次,3次/日,治疗7天,评价哮喘症状疗效、肺功能疗效、中医证候计分和及主症计分。结果哮喘症状疗效比较,控显率试验组(77.36%,246/318)高于对照组(56.07%,60/107);肺功能疗效比较,控显率试验组(74.28%,231/318)高于对照组(50.00%,51/107);中医证候计分治疗前后差值比较,试验组[(-11.26±4.70)分]优于对照组[(-9.21±5.09)分];中医主症计分治疗前后差值比较,试验组[(-6.58±3.08)分]优于对照组[(-5.16±3.45)分],差异均有统计学意义(P<0.01)。不良反应发生率,试验组为6/346例(1.73%),对照组为12/118例(10.17%),差异有统计学意义(P<0.05)。结论西药联合丹龙口服液治疗轻、中度支气管哮喘急性发作期(热哮证)优于咳喘宁口服液。Objective To observe the efficacy and safety of Danlong Oral Liquid （DOL） com- bined Western medicine （WM） in treating mild-to-moderate bronchial asthma patients （heat wheezing syndrome） at acute onset. Methods Totally 480 mild-to-moderate bronchial asthma patients （heat wheezing syndrome） at acute onset were randomly assigned to two groups in the ratio 3： 1, the treatment group （360 cases） and the control group （120 cases）. All patients received basic WM treatment. Patients in the treatment group took DOL, 10 mL each time, 3 times per day for 7 days in total, while those in the control group took Kechuanning Oral Liquid （KOL）, 10 mL each time, 3 times per day for 7 days in total. Efficacy for asthma symptoms, lung functions and scores of TCM syndrome and/or main symptoms were evaluated. Results The percentage of clinical control and significant effectiveness of asthma symptoms in the treatment group was significantly higher than that of the control group （77.36% vs 56.07%, P 〈0.01 ）. The percentage of clinical control and significant effectiveness of lung functions in the treat- ment group was significantly higher than that of the control group （74.28% vs 50.00%, P 〈0.01 ）. The anterior-posterior difference in scores of TCM syndrome was significantly superior in the treatment group than in the control group （ -11.26±4.70 vs -9.21±5.09, P 〈0.01 ）. The anterior-posterior difference in scores of main symptoms was significantly better in the treatment group than in the control group （ -6.58±3.08 vs -5.16±3.45, P 〈0.01 ）. The incidence of adverse reactions was significantly lower in the treatment group than in the control group [1. 73% （6/346 cases） vs 10.17% （12/118 cases）, P 〈 0.05]. Conclusion DOL combined WM was superior to KOL in treating mild-to-moderate bronchial asthma patients （heat wheezing syndrome） at acute onset.

关 键 词：支气管哮喘 急性发作 热哮证 丹龙口服液 

分 类 号：R562.25[医药卫生—呼吸系统]