桑白皮汤治疗痰热壅肺型支气管扩张症稳定期伴铜绿假单胞菌定植随机对照研究OA

Objective To evaluate the efficacy and safety of Sangbaipi Decoction for stable bronchiectasis with phlegm-heat obstructing Fei syndrome(THOFS)and Pseudomonas aeruginosa colonization.Methods A randomized,double-blind,placebo-controlled trial was conducted.A total of 112 patients with stable bronchiectasis(THOFS)and Pseudomonas aeruginosa colonization were included and randomly assigned to the treatment group and the control group at a ratio of 1∶1.On the basis of conventional Western medicine symptomatic treatment,the treatment group was given Sangbaipi Decoction granules,while the control group was given placebo granules.The treatment course was 3 months,with a follow-up period of 3 months.The time to the first acute exacerbation,the rate of acute exacerbation,the number of acute exacerbations per year,the St.George's Respiratory Questionnaire(SGRQ)score,the Leicester Cough Questionnaire(LCQ)score,the clinical efficacy of Chinese medicine syndromes,and the incidence of adverse reactions were compared between the two groups.Results Compared with the control group,the time to the first acute exacerbation in the treatment group was later within 6 months(P＜0.001),the rate of acute exacerbation in the treatment group was lower within 6 months(x2=9.144,P＜0.01),and the usage rate of antibiotics was lower(x2=6.966,P＜0.01).The risk of acute exacerbation within 1 year reduced in the treatment group(P＜0.05).The treatment group showed better improvement values in symptom score,activity score and total score of SGRQ after 3 months of enrollment compared baseline,as well as better improvement value in LCQ score(P＜0.05),and the clinical effective rate of Chinese medicine syndromes in the treatment group was higher(x2=4.636,P＜0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups(x2=0.049,P＞0.05).Conclusion Sangbaipi Decoction can delay the time to the first acute exacerbation in patients with stable bronchiectasis and Pseudomonas aeruginosa colonization,reduce the rate of acute exacerbation and the number of acute exacerbations within 1 year,and improve clinical symptoms and quality of life,and with good safety.