补脾清肺汤治疗铜绿假单胞菌定植支气管扩张症患者的临床疗效

Clinical Observation of Bupi Qingfei Decoction in Treatment of Bronchiectasis Colonized by Pseudomonas aeruginosa

目的:评价补脾清肺汤治疗铜绿假单胞菌(PA)定植支气管扩张症(肺脾气虚、痰热蕴肺证)患者的临床疗效。方法:将72例PA定植支气管扩张症(肺脾气虚、痰热蕴肺证)患者随机分为观察组和对照组各36例(观察组失访2例,退出3例,完成31例;对照组失访3例,退出4例,完成29例)。观察组口服补脾清肺汤颗粒剂,隔日1剂,早晚2次冲服;联合服用阿奇霉素片模拟片,0.5 g,隔日1次。对照组口服阿奇霉素片0.5 g,隔日1次;联合口服补脾清肺汤颗粒剂模拟剂,隔日1剂,早晚2次冲服。两组患者均进行健康教育及体位排痰。疗程24周,随访24周。评价治疗后两组患者急性加重次数、生活质量(圣·乔治呼吸问卷)评分、中医证候积分、肺功能[第1秒用力呼气容积占预计值的百分比(FEV1%pred),第1秒用力呼气容积与用力肺活量的比值(FEV1/FVC)]及血清免疫球蛋白(Ig)A,IgE,IgG,IgM水平变化。结果:观察组治疗24周及随访24周后急性加重次数低于对照组患者(P<0.05)。与本组治疗前比较,观察组治疗24周后生活质量(圣·乔治呼吸问卷)总分及症状评分明显下降(P<0.05);对照组治疗12周及24周后生活质量改善差异无统计学意义。观察组治疗12周后中医证候疗效有效率为64.52%(20/31),对照组为31.03%(9/29),观察组明显高于对照组(χ2=6.726,P<0.05),治疗24周后观察组有效率为83.87%(26/31),对照组为68.97%(20/29),观察组高于对照组,但差异无统计学意义。观察组治疗12周及24周后咳嗽、咳痰、乏力、纳呆、自汗、腹胀、便溏等症状得分改善明显优于对照组(P<0.05)。观察组及对照组在肺功能及血清免疫球蛋白方面差异无统计学意义。结论:补脾清肺汤治疗PA定植支气管扩张症(肺脾气虚、痰热蕴肺证)患者,可减少患者的急性加重次数,改善症状及生活质量。

Objective:To evaluate the clinical efficacy of Bupi Qingfei decoction in the treatment of bronchiectasis colonized by Pseudomonas aeruginosa(PA)(lung-spleen Qi deficiency syndrome and phlegm heat accumulating in lung syndrome).Method:A total of 72 bronchiectasis patients colonized with PA( lungspleen Qi deficiency syndrome and phlegm heat accumulating in lung syndrome)were randomly divided into the observation group(36 cases,two cases were lost to follow-up and three dropped out)and control group(36 cases,three cases were lost to follow-up and four dropped out).There were 31 cases in the observation group and 29 cases in the control group completing the trial.Patients in the observation group were treated with Bupi Qingfei decoction orally,once in the morning and again in the evening,one bag every other day,and simulated azithromycin tablet at the dose of 0.5 g,once every other day,while those in the control group with azithromycin tablet at 0.5 g,once every other day,and simulated Bupi Qingfei decoction,once in the morning and again in the evening,one bag every other day.Patients in both groups received health education and postural expectoration.The treatment lasted for 24 weeks,followed by a 24-week follow-up.The frequency of acute exacerbation,quality of life(St.George’s Respiratory Questionnaire)score,traditional Chinese medicine(TCM)syndrome score,lung function[forced expiratory volume in one second percentage of predicted(FEV1%pred)and FEV1/forced vital capacity(FVC)],and serum immunoglobulin(Ig)A,IgE,IgG,and IgM levels of the two groups were evaluated after treatment.Result:The frequencies of acute exacerbation after 24 weeks of treatment and during the 24-week follow-up in the observation group were lower than those in the control group(P<0.05).The total quality of life(St.George’s Respiratory Questionnaire)score and symptom scores in the observation group after 24 weeks of treatment were significantly decreased as compared with those before treatment(P<0.05).There was no significant improvement in the quality of life in the control group either after24 weeks of treatment or during the 24-week follow-up.The effective rate against TCM syndrome in the observation group was 64.52%(20/31)after 12 weeks of treatment,which was obviously higher than 31.03%(9/29)in the control group(χ2=6.726,P<0.05).After 24 weeks of treatment,the effective rate in the observation group was 83.87%,slightly higher than 68.97% in the control group.After 12 and 24 weeks of treatment,the scores of cough,expectoration,fatigue,anorexia,spontaneous sweating,abdominal distension,and loose stool in the observation group were better than those in the control group(P<0.05).There were no significant changes in lung function and serum immunoglobulin classes in the two groups.Conclusion:Bupi Qingfei decoction is effective in reducing the frequency of acute exacerbation,alleviating the symptoms,and improving the quality of life of bronchiectasis patients colonized by PA(lung-spleen Qi deficiency syndrome and phlegm heat accumulating in lung syndrome).