| 1.Research backgroundPseudomonas aeruginosa(PA)is the most common colonizing bacteria in patients with bronchiectasis.Low immune function and the long-term and irregular use of antibiotics has caused PA to be a relatively common drug-resistant bacteria,and it is difficult to completely remove it once it is colonized.Compared with patients without PA colonization,patients with bronchiectasis chronically infected by PA have a worse quality of life,more severe clinical symptoms,faster decline in lung function,higher levels of airway inflammatory factors,and more extensive and severe radiological involvement.Acute exacerbations and hospitalizations are more frequent,and all-cause mortality is higher.They have more frequent exacerbations and hospitalizations,and higher all-cause mortality.Repeated acute exacerbation is one of the clinical features of bronchiectasis,and it is also an important event in the clinical course of the disease.PA colonization is an independent risk factor for frequent acute exacerbations and increased hospitalizations in patients with bronchiectasis.Repeated acute exacerbations will not only cause a sharp decline in lung function and damage to lung tissues,which will have a serious impact on the prognosis of patients,but also increase the number of hospitalizations and bring a heavy medical burden to individuals and society.At present,the main drugs for PA colonization are inhaled antibiotics and oral macrolides antibiotics,but there are no inhaled antibiotics on the market in China.Macrolide drugs also have a certain risk of drug resistance and adverse effects such as cardiovascular and alimentary systems.Traditional Chinese medicine has accumulated rich clinical experience in the treatment of drug-resistant bacterial infections and has achieved fruitful scientific research results.Through rigorous scientific research,they have explained the mechanism of action of ancient prescriptions on drug-resistant infections,such as regulating the body’s immunity,directly killing or inhibiting bacteria,and delaying or inhibiting bacterial resistance.Based on clinical practice,preliminary syndrome investigation and clinical research,combined with Dongyuan’s "Yin-Fire Theory",we concluded that the agreed formula "Bupi Qingfei Decoction" can reduce the times of acute exacerbations in patients with bronchiectasis chronically infected by PA.So we have carried out a study on the treatment of bronchiectasis combined with PA colonization with Bupi Qingfei Decoction,and objectively evaluated its impact on the number of acute exacerbations and quality of life in patients.2.Clinical study2.1 PurposeObjectively evaluate the effects of Bupi Qingfei Decoction on the number of acute exacerbations and quality of life in patients with bronchiectasis chronically infected by Pseudomonas aeruginosa,and explore the advantages of traditional Chinese medicine in the long-term management of colonizing bacteria.2.2 MethodThis is a randomized,positive drug parallel control.A total of 72 patients with bronchiectasis chronically infected by PA that meet the inclusion criteria were collected,of which 36 were in the control group and the observation group.All cases are from outpatients who attended the Pulmonary Disease Department of Xiyuan Hospital,China Academy of Chinese Medical Sciences from November 2017 to June 2019.We use a random number table for randomization grouping.The subjects who met the inclusion criteria were divided into two groups according to a random table,the observation group(Bupi Qingfei Decoction Granules+health education+postural sputum)and the control group(azithromycin tablets+health education+postural sputum).Statistical method:use SPSS22.0 statistical software for statistical analysis.Measurement data conform to normal distribution using t-test and paired t-test;non-normal distribution using rank-sum test and other methods.The count data adopts corrected chi-square test and so on.The difference of P-value<0.05 was statistically significant.2.3 Result2.3.1 General data analysisA total of 72 patients with bronchiectasis chronically infected by PA who met the inclusion criteria were enrolled in this study,36 in the observation group and 36 in the control group.Among them,5 cases passed off in the observation group and 7 cases passed off in the control group.Among the patients in the observation group,there were 5 males,accounting for 16.13%,and 26 females,accounting for 83.87%;the youngest was 19 years old and the oldest was 69 years old,with an average age of 53.93 ± 10.68 years;the course of disease was 20.96±12.87 years;acute exacerbations in the past year The frequency was 1.74±0.89 times;the quality of life(SGRQ)was 29.87±19.53 points.In the control group,there were 7 males,accounting for 24.14%,and 22 females,accounting for 75.86%;the youngest was 34 years old and the oldest was 70 years old,with an average age of 52.90±13.28 years;the course of disease was 16.59±14.78 years;the number of acute exacerbations in the past year 2.14±1.57 times;quality of life(SGRQ)32.07±19.42 points.The age,gender,course of disease,number of exacerbations in the past year,severity index(BSI),quality of life(SGRQ),lung function(FEV1%pred,FEV1/FVC),TCM Syndrome scores and other aspects were not statistically significant(P>0.05).2.3.2 Comparison of exacerbations before and after treatmentWithin 12 weeks of treatment,the number of exacerbations was 0.32 times/person in the observation group and 0.55 times/person in the control group,but the comparison between the two groups was not statistically significant(P>0.05);within 24 weeks and 48 weeks of treatment in the observation group The number of exacerbations within a week was 0.74 times/person and 1.03 times/person,respectively,and the control group was 1.17 times/person and 1.45 times/person,respectively.The number of acute exacerbations in the observation group was significantly less than that of the control group,and the comparisons between groups were statistically significant(P<0.05).2.3.3 Comparison of changes in the quality of life of the two groups of patientsIn comparison between the two groups,the comprehensive assessment of the quality of life changes at 12 weeks of treatment and 24 weeks of treatment was not statistically significant(P>0.05).In the observation group,the total score of SGRQ was 24.71 ± 15.29 points at 12 weeks of treatment,which was 6.14±8.98 points lower than before treatment;at 24 weeks,it was 21.60 ± 15.65 points,which was 9.25±15.62 points lower than before treatment.In the control group,the total score of SGRQ was 27.16±18.68 points at 12 weeks of treatment,which was 4.91±8.09 points lower than before treatment;at 24 weeks,it was 24.63 ± 17.76 points,which was 7.45 ± 9.24 points lower than before treatment.Comparing the total scores of the SGRQ before and after treatment in the two groups,the observation group was lower than before treatment at 24 weeks of treatment(P<0.05);there was no statistical difference between the control group after treatment and before treatment(P>0.05));There was no statistically significant difference between the total scores of the SGRQ before and after treatment between the two groups of patients(P>0.05).2.3.4 Comparison of TCM Syndrome PointsIn the observation group,the TCM syndrome score was 13.10± 3.89 points at 12 weeks of treatment,which was a decrease of 13.29 ± 3.63 points compared with before treatment;at 24 weeks,it was 9.16±4.25 points,which was a decrease of 17.23±4.12 points compared with before treatment.The TCM syndrome score of the control group was 19.31 ± 5.93 points at 12 weeks of treatment,which was a decrease of 9.52±5.55 points compared with before treatment;at 24 weeks,it was 14.62 ±5.05 points,which was a decrease of 14.21±5.51 points compared with before treatment.After 12 weeks and 24 weeks of treatment,the scores of TCM syndromes in the observation group and the treatment group were lower than before treatment(P<0.05);the difference before and after treatment in the observation group was greater than that of the treatment group(P<0.05).2.3.5 Comparison of lung function changesPulmonary function indexes include FEV1%pred and FEV1/FVC.The FEV1%pred of the observation group was 51.35 ± 22.61%at 12 weeks of treatment,which was an increase of 1.79 ±9.50%compared to before treatment;at 24 weeks,it was 51.99±23.10%,which was an increase of 2.44±10.34%compared to before treatment.The FEV1%pred of the control group was 55.80±24.52%at 12 weeks of treatment,which was an increase of 3.80±11.39%compared to before treatment;at 24 weeks,it was 56.06±26.48%,which was an increase of 4.06±12.26%compared to before treatment.In the observation group,FEV1/FVC was 65.58±14.18%at 12 weeks of treatment,which was an increase of 1.30±9.39%compared to before treatment;at 24 weeks,it was 65.83 ± 17.76%,which was an increase of 1.55±11.38%compared to before treatment.In the control group,FEV1/FVC was 68.15±14.49%at 12 weeks of treatment,which was an increase of 4.62±11.14%compared to before treatment;at 24 weeks,it was 67.64±12.07%,which was an increase of 4.12±9.76%compared to before treatment.There was no statistical difference between the pulmonary function indexes of the two groups after treatment and the pulmonary function indexes before treatment(P>0.05);comparison between the two groups,the difference before and after treatment was not statistically different(P>0.05).2.3.6 Comparison of Bronchiectasis Severity IndexIn the observation group,the BSI score was 7.52±3.60 points at 12 weeks of treatment,which was a decrease of 1.77±2.36 points compared with before treatment;at 24 weeks,it was 6.48±3.80 points,which was a decrease of 2.81 ± 2.94 points compared with before treatment.The BSI score of the control group was 7.07±4.46 points at 12 weeks of treatment,which was 1.90±1.74 points lower than before treatment;at 24 weeks,it was 6.00±4.21 points,which was 2.97±1.38 points lower than before treatment.After 24 weeks of treatment,the BSI scores of the two groups of patients after treatment were lower than those before treatment(P<0.05).When the two groups were compared,the difference before and after treatment was not statistically significant(P>0.05).2.3.7 Comparison of sputum culture resultsStatistical analysis could not be performed due to some patient’s lack of sputum,little sputum,and unqualified specimens.2.3.8 Serum immunoglobulin comparisonIn these two groups of patients,the comparison of their serum immunoglobulin levels before and after treatment was not statistically significant(P>0.05).The comparison of serum immunoglobulin between the two groups after treatment was not statistically significant(P>0.05).3.Conclusion(1)Both Bupi Qingfei Decoction and Azithromycin can reduce exacerbations in patients with bronchiectasis colonized by PA,and the effect of Bupi Qingfei Decoction in reducing exacerbations is better than that of azithromycin.(2)Bupi Qingfei Decoction can improve respiratory symptoms(such as cough,sputum,wheezing,etc.)and TCM syndrome scores in patients with bronchiectasis colonized by PA(3)Through the research and exploration of the therapeutic effect of Bupi Qingfei Decoction on patients with bronchiectasis colonized by PA,it is preliminarily proved that traditional Chinese medicine can play an active role in improving clinical symptoms,improving quality of life,and reducing acute exacerbations,providing new ideas for the long-term management of colonizing bacteria. |
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