The Clinical Research On Compound Macrostem Onion Capsule For Patients In Acute Exacerbation Of Chronic Bronchitis (the Pattern Of Phlegm-Heat Stagnation In Lung)

Objective To investigate the clinical effect and security of Compound Macrostem Onion Capsule on acute exacerbation of chronic bronchitis caused by phlegm-heat stagnated in lung, and to explore the mechanism of this capsule.Methods Random, double-blind, comparative parallelly designs were taken。24 cases of acute exacerbation of chronic bronchitis caused by phlegm-heat stagnated in lung were observed which were randomly and averagely divided into treatment group and control group. With clinical expressions and auxiliary routine blood tests, liver and kidney function tests, chest X-rays, these patients were diagnosised as acute exacerbation of chronic bronchitis caused by phlegm-heat stagnated in lung。Treatment group were treated with Compound Macrostem Onion Capsule 4, tid, while control group were treated with 2 Qinbaohong Zhike Capsule and 2 analogue capsule, tid。Both groups took medicines orally. The period of treatment was 10 days. The symptoms and signs were observed at the 1st day before treatment and the 10st after treatment. The correlative examinations were taken both before and after treatment. Use SPSS statistic software to handle all indexes of experiment and comparative groups. Wilcoxon Mann-Whitney test was used to contrast clinical effective rate and unhealth reaction rate。Result There were 12 patients evaluated in Compound Macrostem Onion Capsule group, and 12 patients evaluated in Qinbaohong Zhike Capsule group。According to evaluation standard of drug’s effect, 3 patients were recovery, 5 patiens were excellence and 3 patients were effective in treatment group, excellence rate was 66.67% and clinical total effective rate was 91.67%. No patient were recovery, 9 patients were excellence and 2 patients were effective in Qinbaohong Zhike Capsule group, excellence rate was 75% and clinical effective rate was 91.67%. The difference of clinical total effect rate between two groups was tested by Wilcoxon Mann-Whitney test, the difference had no statistics significance(P＞0.05). There were obvious improved in symptoms, sings, TCM ZHENG between pretherapy and post-treatment in each group, and there was no statistics significance in cough, asthma, sings and score of TCM ZHENG between tow groups was tested by Wilcoxon Mann-Whitney test. But there was statistics significance in relieve time or recovery time of stethocatharsis (P＜0.05), and Compound Macrostem Onion Capsule group is better than Qinbaohong Zhike Capsule group. One adverse reaction was found in Compound Macrostem Onion Capsule group.Conclusion This study adopted randomized, comparative parallelly, double-blind method to evaluate clinical effection and safety inside body of 24 patients, who were diagnosed acute exacerbation of chronic bronchitis(the pattern of phlegm-heat stagnation in lung). The diagnosis was definite by clinical expressions and auxiliary checks. The result shows there is no obvious difference between clinical effection, symptoms, sings, TCM ZHENG, cough, asthma of Compound Macrostem Onion Capsule and Qinbaohong Zhike Capsule. They both have notable effection. Compound Macrostem Onion Capsule is better than Qinbaohong Zhike Capsule in relieve time or recovery time of stethocatharsis. One adverse reaction was found in Compound Macrostem Onion Capsule group, and it’s safe must be tested again.