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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 被引量:11

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
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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.
出处 《中国中西医结合杂志》 CAS CSCD 北大核心 2015年第5期529-533,共5页 Chinese Journal of Integrated Traditional and Western Medicine
关键词 支气管哮喘 急性发作 热哮证 丹龙口服液 bronchial asthma acute attack heat wheezing syndrome Danlong Oral Liquid
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