世界中医药

目的：评价哮喘急性发作期中医综合治疗方案的疗效和安全性，并总结出优势和特色。方法：采用随机、对照、多中心、大样本的方法进行临床试验研究360例，分冷哮、热哮两个证候，其中冷哮180例，试验组90例，对照组90例；热哮180例，试验组90例，对照组90例，试验组分别应用“喘嗽宁片”“喘息康颗粒”，并加外用咳喘膏贴剂，根据实际需求适当加用万托林吸入；对照组采用常规西药治疗方案。试验结束后进行哮喘疾病综合疗效、中医证候疗效评价，万托林使用天数及次数，肺功能、ECP、PEF变异率指标评价。治疗期疗程为10 d。结果：1）冷哮、热哮2组在疾病疗效愈显率及总有效率方面试验组均较对照组好，但差异无统计学意义，综合试验组与综合对照组愈显率比较差异有统计学意义，P<0.05；2）冷哮、热哮组、综合试验组中医证候疗效愈显率及总有效率组间差异无统计学意义，P>0.05，但试验组痊愈及显效的例数明显多于对照组；3）冷哮、热哮2组在万托林使用天数和次数均少于对照组，但组间比较无统计学意义；4）冷哮试验组FEV1%、FEV1、PEFR、FVC治疗前后有明显差异，对照组FEV1%、FEV1、PEFR治疗前后有明显统计学意义，热哮试验组FEV1%治疗前后，对照组FEV1%、PEFR、FVC、FEV1治疗前后有明显统计学意义，2组组间比较无统计学意义（P>0.05）。结论：中西医结合治疗哮喘急性发作期（冷哮、热哮）疗效显著且安全可靠。

English Summary:

To evaluate effect and safety of comprehensive treatment protocol of Chinese medicine for acute exacerbation of asthma, and to sum up its advantages and characteristics. Methods： A randomized, controlled, multi-center clinical trial was conducted with large samples. The recruited 360 patients included 180 cases of heat wheezing syndrome and 180 cases of cold wheezing syndrome. Heat wheezing patients were divided into treatment group (n=90) and control group (n=90); Cold wheezing patients were also divided into treatment group (n=90) and control group (n=90). Patients in both treatment groups were applied “Kesouning tablets”, “Chuankangxi granules” and external administration of Xiaoke ointment patch, as well as Ventolin inhalation depending on situations; both control groups gave patients conventional western medicine. After treatment, patients were given evaluations on comprehensive effect of asthma, TCM syndromes, Ventolin application days and times, pulmonary function, ECP, PEF variation rate index. Course of the treatment period was 10 days. Results： 1)Both treatment groups of cold wheezing and heat wheezing patients showed better results in remarkably effective rate and total effective rate compared with their own control groups, but there was no statistically significant difference. While taking treatment groups and control groups as two big groups, the remarkably effective rate and total effective rate of treatment group showed significant differences from that of the control group (P<0.05); 2)Remarkably effective rate and total effective rate from the aspect of Chinese medicine syndrome showed no significant differences between the treatment groups and control groups no matter compared among cold wheezing patients, heat wheezing patients or all the patients (P>0.05). However, there were more remarkably effective and total effective cases in the treatment groups; 3)Ventolin usage were less in both treatment groups compared with their own control groups. 4)ECP, PEF mutation rate, pulmonary function all showed significant improvement after treatment. Conclusion： Integrated Chinese and Western medicine shows reliable effectiveness and safety to treat acute exacerbation of asthma (wheezing cold, heat wheezing).

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