Abstract: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).