| Objective:This clinical research is to observe Bufei Decoction-Liuwei Dihuang pill in the treatment of copd stabilization lungs kidney Qi-Yin deficiency in the clinical curative effect,evaluation of TCM syndrome integral,pulmonary function and symptom assessment and the number of exacerbations in hospital,and analyze the safety index and adverse reactions,to explore the effectiveness of the combination of Chinese and western treatment of copd stabilization and security.Methods:Using the method of randomized controlled trial,84 subjects who met the test requirements were screened and randomly divided into experimental group and control group.The control group was treated with triple inhalation(Budesonide/Formoterol and Tiotropium),and the experimental group was treated with triple inhalation plus Bufei Decoction-Liuwei Dihuang Pill.The drug treatment observation period was 12 weeks,and the follow-up period was 1 year.The changes of TCM syndrome score,FEV1,FVC,CAT score,CCQ score,m MRC grade and hospitalization times of acute exacerbation were observed and recorded.Safety indexes were monitored and adverse reactions were recorded.Results:In the process of this experiment,some cases were shed or removed,and finally,36cases in the experimental group and 35 cases in the control group were included in the statistical analysis,a total of 71 cases.Before the start of treatment,two groups of patients in the gender,age distribution,body mass index,smoking status,progression,FEV1%pred on the basic characteristics such as comparison,there was no statistically significant difference(P>0.05),two groups of patients with TCM syndrome integral,FEV1 and FVC,CAT scores,CCQ score,m MRC stage,in the past 1 year,number of exacerbations in hospital compare,there was no statistically significant difference(P>0.05),the comparability between the two groups.12weeks after treatment,the total effective rate of the experimental group was 94.44%,the total effective rate of the control group was 74.28%,the experimental group was better than the control group(P<0.05);Compared with the traditional Chinese medicine syndromes such as shortness of breath,cough and sputum,perspiration,easy to catch a cold,tinnitus,dizziness and dizziness,the improvement in the two groups was better than before,and the improvement in the experimental group was better than that in the control group(P<0.05).The improvement of FEV1 in experimental group was better than that in control group[experimental group0.22±0.04L,control group 0.10(0.06,0.12)L;P<0.01],and the improvement of FVC in experimental group was better than that in control group[experimental group 0.25(0.20,0.27)L,control group 0.13(0.09,0.18)L;P<0.01].CAT score,CCQ score and m MRC score were all improved compared with before treatment,and the experimental group was better than the control group(P<0.01).After one year of follow-up,the hospitalization frequency of acute exacerbation in the experimental group was improved compared with that before treatment(P<0.01),while there was no difference in the control group before and after treatment(P>0.05).During the observation period of treatment,abdominal distension reaction occurred in 2cases in the experimental group,and the symptoms were mild.In the control group,1 case presented hoarseness,and the patient was advised to strengthen gargling after using Symbicort Turbuhaler and then relieved spontaneously.No abnormal safety indicators caused by this drug were observed in the two groups of patients.Conclusion:Bufei decoction-Liuwei Dihuang pill combined with western medicine has good clinical efficacy,safety and tolerability in the treatment of lung and kidney qi-Yin deficiency in the stable phase of COPD. |