| Objective:This study observed the clinical treatment effect of the chronic duration(lung and spleen Qi-deficiency)of asthma,to evaluate its clinical efficacy and safety,so as to provide new ideas and new methods for the clinical treatment of the chronic duration of asthma.Methods:Collect 70 patients who meet the inclusion criteria,randomly divided into control and observation group,the control group gave the treatment with the powder for inhalation of Salmeterol Xinafoate and Fluticasone Propionate(Seretide),the observation group gave Shenqi Bufei prescription on the base of the control group.After one month,observe two groups of patients before and after treatment by TCM syndrome scores,Asthma Control Test(ACT)scores,lung function,fractional nitricoxide concentrationin exhaled breath(Fe NO),peripheral blood eosinophil counts(EOS),and follow-up in three months after treatment to observe the situation of acute attack.The liver function and kidney function were observed before and after the treatment,and the adverse reactions occurring during the treatment were recorded to assess its safety.Results:1.The overall efficiency was 91.18% for the observation group,and 72.73% for the control group.The overall efficiency of the observation group was significantly better than that of the control group(P<0.05).2.After treatment,The total score of TCM syndrome of the observation group was(11.44±7.15),and the control group was(16.45±7.27).The total score of TCM syndrome in the two groups improved significantly compared with that before treatment(P<0.05),and the total score of TCM syndrome in the observation group improved more significantly compared with the control group(P<0.05).The individual points of major symptoms in the two groups were also improved compared with that before treatment(P<0.05),and the observation group improved more significantly in wheezing,cough,sputum,and fatigue symptoms(P<0.05),but there was no significant difference in the comparison of chest tightness and self-sweating symptoms(P>0.05).The individual points of second symptoms in the observation groups were improved compared with those before treatment(P<0.05).The symptom of loose stool in the control group was not improved significantly compared with that before treatment(P>0.05).The observation group had more significant improvement in symptoms of anemophobia,easy-cold and less eating compared with the control group(P<0.05),but there was no significant difference in the comparison of abdominal distension between the two groups(P>0.05).3.After treatment,the ACT score increased significantly in both groups compared with before(P<0.05)and more significantly increased in the observation group compared to the control group(P<0.05).4.After treatment,lung function(FEV1%pred,FEV1/FVC)was significantly improved in both groups compared with before(P<0.05),and more significant improvement in the observation group compared with the control group(P<0.05).5.After treatment,the Fe NO levels were significantly reduced in both groups compared with before(P<0.05),and more significantly reduced in the observation group compared to the control group(P<0.05).6.After treatment,the peripheral blood EOS level was significantly reduced in both groups compared with before(P<0.05).Although the mean peripheral blood EOS count in the observation group was lower than that in the control group,there was no statistical difference between the two groups(P>0.05).7.At three-month follow-up after treatment,the rate of acute attack was 3.23% in the observation group and 25% in the control group.The acute attack rate of the observation group was significantly lower than that of the control group(P<0.05).8.Safety indicators:There were no obvious abnormalities in liver and kidney function before and after the treatment.During the treatment,one patient in the control group developed dry throat and hoarseness.Considering the adverse reactions after using Seretide,the symptoms were gradually relieved after treatment.No other adverse effects were observed.Conclusion:The treatment of Shenqi Bufei prescription and Seretide in asthma patients with chronic persistent(lung and spleen Qi-deficiency)can effectively relieve patients’ symptoms,improve asthma control,improve lung function,and reduce the number of acute attacks,reduce Fe NO level and peripheral blood EOS level.In terms of relieving patients’ symptoms,improving asthma control and lung function,reducing the number of acute attacks and reducing Fe NO levels,the efficacy of Shenqi Bufei prescription and Seretide was significantly better than that of Seretide alone.It shows that Shenqi Bufei prescription can improve the efficacy,and have good safety,which is worthy of clinical application. |