| ObjectiveObservation for the assessment of Feikang Granules in the treatment of chronic obstructive pulmonary disease patients in plateau period with both lung and kidney deficiency syndrome of the TCM syndrome score,times and degree of acute exacerbation,pulmonary function,quality of life and 6MWD,to further evaluate the clinical effect of Feikang Granules on stable phase of COPD.MethodsIn this study,meet the inclusion criteria of chronic obstructive pulmonary disease stability of patients with both lung and kidney deficiency syndrome were randomly divided into Feikang Granules treatment group and control group.The control group according to the patient’s condition to conventional treatment of Western medicine.Feikang Granules treatment group which treated with Feikang Granules and routine treatment of Western medicine.The course of treatment was 6 months.The change of the TCM syndrome score,times and degree of acute exacerbation,pulmonary function,St.George Respiratory Questionnaire(SGRQ)and Six minutes walking distance(6MWD)were respectively observed before treatment,after treatment in the third month and the sixth month between the two groups.Results1.There were no statistically significant difference in the general clinical data including age,gender,course and severity of illness between the two groups of patients at baseline under the SPSS 21.0.2.The effect on the clinical symptoms:Repeated measures of variance analysis showed that the time trend of cough,fatigue,soreness and weakness of waist and knees and total score between the two groups were statistically significant(P<0.05).After 3 months of treatment,the symptom score and total scores of Feikang treatment group were lower than before treatment,the difference was significant(P<0.016).After 6 months of treatment,all symptoms scores of Feikang treatment group except spontaneous sweating were significantly lower than before treatment(P<0.016).There was also significantly difference between 3 months of treatment and 6 months of treatment in the score of expectoration,shortness of breath,fatigue and soreness and weakness of waist and knees(P<0.016).In addition to cough and fatigue symptoms,the rest of the symptom after 3 months of treatment of the control group were significantly lower than before treatment(P<0.016).All the symptoms after 6 months of treatment were lower than before treatment(P<0.016).There only the scores of expectoration,colds and total score were significantly difference in the control group between 3 months of treatment and 6 months of treatment(P<0.016).Comparison between groups at different time points,the results showed that after 3 months of treatment,the score of cough,fatigue and syndrome score in the Feikang treatment group were lower than the control group,the difference was statistically significant(P<0.016).After 6 months of treatment,the score of cough,fatigue,soreness and weakness of waist and knees and syndrome score in the Feikang treatment group were lower than the control group,the difference was statistically significant(P<0.016).3.The effect on the clinical efficacy:After 3 months of treatment,Feikang treatment group’ s total efficiency was 68.97%and the control group’ s total efficiency was 13.79%.After 6 months of treatment,Feikang treatment group’s total efficiency was 93.10%and control group’s total efficiency was 51.72%.Although both groups were able to improve the TCM syndromes of patients(P<0.05),the comparison between the two groups at the same time point showed that the Feikang group was superior to the control group(P<0.05).4.The effect on the lung function:Repeated measures of variance analysis showed that there was no significant difference in the time trend of FEV1,FEV1%,FEV1/FVC between the two groups(P>0.05).There was a uptrend to FEV1,FEV1%and FEV1/FVC of the Feikang treatment group after treatment,but there were not significant difference as compared with before treatment.The change trend of the parameters in the control group was not obvious,but there was no significant difference between the two groups.5.The effect on the times and degree of acute exacerbation:After the treatment,the times of acute exacerbation of Feikang treatment group was significantly lower than the control group(P<0 05).The degree of acute exacerbation before or after treatment had no differences between two groups(P>0.05).6.The effect on the quality of life:Repeated measures of variance analysis showed that there was no significant difference in the time trend of respiratory symptoms,limited activity,disease influence and SGRQ total integral between the two groups(P>0.05).Comparison between groups at each time point,the result showed that there was no significant difference between the two groups at the end of the treatment for 3 months(P>0.016),and the scores of Feikang treatment group were significantly lower than those of the control group after the treatment for the last 6 months(P<0.016).The Feikang treatment group after treatment in patients with respiratory symptoms,limited activity,disease influence and SGRQ total integral has the remarkable difference compared with before treatment(P<0.016).The difference was statistically significant between the 6 months of treatment and the treatment for 3 months.The scores of the control group were improved at 3 months and at the end of the treatment for 6 months,the difference was statistically significant(P<0.016).There was no significant difference between the treatment of 6 months and the treatment for the 3 months(P>0.016).7.The effect on the 6 minutes walking distance:Repeated measures of variance analysis showed that there was no significant difference in the time trend of 6MWD between the two groups(P>0.05).The 6MWD in the Feikang treatment group was significantly improve after 3 months of treatment and the treatment for 6 months(P<0.016).Additionally,the treatment of 6 months in Feikang treatment group was significantly lower than that of the treatment for 3 months(P<0.016).However,the control group increased only 6 months after treatment(P<0.016).Conclusions1.The treatment of Feikang granule jointed by traditional western medicine can significantly improve the clinical symptoms of chronic obstructive pulmonary disease patients in plateau period with both lung and kidney deficiency syndrome,especially in the aspect of cough,fatigue and soreness and weakness of waist and knees,alleviate more obviously.2.Feikang granule can obviously improve patients’ quality of life and reduce the impact of disease on patients.3.Feikang granule to a certain extent can delay the decline of lung function,reduce the numbers of acute exacerbation and improve the ability of daily activities. |
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