| Objective: To evaluate the clinical synergistic effect of Baihe Gujin Decoction on acute non-tuberculosis Mycobacteria lung disease(Syndrome of lung-kidney yin deficiency),by observing the clinical symptom score,the changes of lung lesions and the improvement of pulmonary function before and after treatment based on the non-tuberculosis Mycobacteria lung disease Foundation plus Baihe Gujin Decoction.Methods:1.The clinical data:By using the design principle of random-controlled,30 patients which up to the non-tuberculosis Mycobacteria lung disease diagnostic standards were divided into two groups: the traditional Chinese medicine group and the not taking traditional Chinese medicine group,15 cases in each group.The baseline data were comparable between two groups.2.Drug usage:(1)Traditional Chinese medicine: Taking Baihe Gujin Decoction 3 times at everyday morning,noon and evening,one pair a day.Insist on taking for two weeks then stop a week,a total of nine weeks(3 months).(2)The basic treatment program of anti-NTM lung disease:It is based on expert consensus and NTM for drug sensitivity test in vitro to make suitabling for the subjects′treatment.To evaluate the efficacy after insist on using for 3 months,then continue treatment.(3)Treatment: the traditional Chinese medicine group : anti-NTM lung disease basic treatment + Baihe Gujin Decoction.The not served traditional Chinese medicine group: anti-NTM lung disease basic treatment.To observe the changes of symptoms,lesions and pulmonary function before and after treatment.3.Monitoring project: Monitoring of Efficacy: the magnitude estimation of clinical symptoms,chest CT,pulmonary function before and after treatment;Safety monitoring: vital signs,blood routine,urine routine,stool routine,liver and kidney function,adverse events.4.The results and analysis method of statistics Statistic analysis would use the SPSS21.0 statistical analysis software for calculation.All statistical tests were two-sided,and when the P value was less than or equal to 0.05 would be considered to have the statistical significance.Result:1.Comparison of Clinical symptom score: There were significant difference between two groups before and after treatment,P<0.05).The traditional Chinese medicine group is superior to the not served traditional Chinese medicine group.2.Evaluation of pulmonary function: There were significant difference between two groups before and after treatment,P<0.05),The traditional Chinese medicine group is superior to the not served traditional Chinese medicine group.3.Result evaluation of chest CT: there were no different between two group before and after treatment,(P>0.05),the two groups get the same effect.4.Adverse reactions: The two groups had no serious adverse reactions.Conclusion: Baihe Gujin Decoction has synergistic effect on improving clinical symptoms and pulmonary function in patients with non-tuberculosis mycobacteria(Syndrome of lung-kidney yin deficiency). |