清补苇茎汤治疗稳定期支气管扩张症伴气道黏液高分泌患者的临床疗效

Clinical Effect of Qingbu Weijing Decoction on Patients Suffering from Stable Bronchiectasis Complicated with Airway Mucus Hypersecretion

目的:评价清补苇茎汤治疗稳定期支气管扩张症伴气道黏液高分泌(气阴两虚、痰热蕴肺型)患者的临床疗效。方法:将80例稳定期支气管扩张症伴气道黏液高分泌患者随机分为观察组和对照组各40例。观察组失访1例,退出1例,完成38例;对照组失访1例,退出4例,完成35例。观察组口服清补苇茎汤颗粒剂,每日1剂,分2次服用。对照组口服羧甲司坦口服液,每次500 mg,每日3次。两组患者均进行健康教育及体位排痰。疗程12周,随访12个月。评价治疗后两组患者急性加重次数、咳嗽-咳痰评估问卷(CASA-Q)、中医证候积分、肺功能[呼气峰值流量(PEF)占预计值百分比(PEF%pred)、第1秒用力呼气容积占预计值百分比(FEV1%pred)、FEV1/用力肺活量(FVC)]及血清炎症因子[C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、白细胞介素-8(IL-8)、白细胞介素-10(IL-10)、中性粒细胞弹性蛋白酶(NE)]水平的变化。结果:与对照组比较,观察组患者治疗12周及随访12月后急性加重次数显著降低(P<0.01)。CASA-Q中的咳嗽症状域(COUS)评分,与本组治疗前比较,观察组在治疗4、8、12周后及随访3、6、9、12个月后COUS评分均增高,对照组在治疗期间增高,但在随访期间降低;治疗后,观察组COUS评分优于对照组(P<0.05,P<0.01)。咳嗽影响域(COUI)评分,与本组治疗前比较,观察组在治疗4、8、12后及随访3、6、9、12个月后COUI评分均增高,对照组该领域评分均降低;治疗后,观察组COUI评分明显优于对照组(P<0.05,P<0.01)。咳痰症状域(SPUS)评分,与本组治疗前比较,两组患者在治疗4、8、12周后及随访3、6、9、12个月后SPUS评分均增高;治疗后,观察组SPUS评分明显优于对照组(P<0.05,P<0.01)。咳痰影响域(SPUI)评分,与本组治疗前比较,观察组在治疗4、8、12周后及随访3、6、9、12个月后SPUI评分均增高,对照组在治疗期间增高,但在随访期间降低;治疗后,观察组随访3、6、9个月SPUI评分优于对照组(P<0.05)。观察组中医证候疗效有效率优于对照组,但组间比较仅在治疗8周(χ^(2)=3.868,P<0.05)及随访3个月(χ^(2)=6.510,P<0.05)差异具有统计学意义。与本组治疗前比较,两组患者在治疗4、8、12周后及随访3、6、9、12个月后中医证候积分得分均显著降低(P<0.01);除治疗4周外,其余观察组均明显优于对照组(P<0.05)。与本组治疗前比较,观察组患者的肺功能改善,其中PEF%pred组间及组内比较差异均具有统计学意义(P<0.05)。观察组及对照组均可下调血清炎症因子水平,但与本组治疗前比较,仅观察组TNF-α、IL-8、IL-10、NE差异具有统计学意义(P<0.05),IL-8组间比较差异具有统计学意义(P<0.05)。结论:清补苇茎汤治疗稳定期支气管扩张症伴气道黏液高分泌气阴两虚、痰热蕴肺型患者,可显著改善咳嗽咳痰症状及减少患者的反复急性加重,并可以下调血清炎症因子水平,一定程度改善患者肺功能。

Objective:To evaluate the clinical efficacy of Qingbu Weijing decoction in the treatment of patients suffering from stable bronchiectasis complicated with airway mucus hypersecretion(Qi and Yin deficiency,phlegm heat accumulation in lung).Method:Eighty patients with stable bronchiectasis and airway mucus hypersecretion were randomly divided into an observation group and a control group,40 in each group.In the observation group,38 cases were finally included for 1 case was lost and 1 withdrew,while in the control group,35 cases were finally included for 1 case was lost and 4 withdrew.The observation group was po administered with Qingbu Weijing decoction granules,1 dose twice a day.The control group was treated with oral Carbocysteine Oral Solutioncarboxymethylstein,500 mg each time for three times a day.Both groups received health education and postural drainage.After 12 weeks of treatment and 12 months of follow-up,the changes in the number of acute exacerbations,Cough and Sputum Assessment Questionnaire(CASA-Q),traditional Chinese medicine(TCM)syndrome score,lung function[percentage of peak expiratory flow(PEF)to estimated value(PEF%pred),percentage of forced expiratory volume in one second to estimated value(FEV1%pred),FEV1/forced vital capacity(FVC)]and serum inflammatory factors[C-reactive protein(CRP),tumor necrosis factor-α(TNF-α),interleukin-8(IL-8),interleukin-10(IL-10),neutrophil elastase(NE)]levels in the two groups after treatment were evaluated.Result:The number of acute exacerbations in the observation group was lower than that in the control group after 12 weeks of treatment and 12 months of followup(P<0.01).Compared with the condition before treatment,the cough symptom domain(COUS)score of CASA-Q in the observation group was increased after 4,8,12 weeks of treatment and 3,6,9,12 months of follow-up,while the COUS score in the control group was increased during treatment but decreased during follow-up,with the observation group higher than the control group(P<0.05,P<0.01).The cough influence domain(COUI)score in the observation group was higher than that before treatment at 4,8,12 weeks after treatment and 3,6,9,12 months after follow-up,while the COUI score in the control group was lower than that before treatment,with the observation group superior to the control group(P<0.05,P<0.01).In terms of sputum symptom domain(SPUS),the two groups both had elevated SPUS score after 4,8,12 weeks of treatment and 3,6,9,12 months of follow-up,but the observation group was better than the control group(P<0.05,P<0.01).In terms of sputum influence domain(SPUI),the observation group had elevated SPUI score after 4,8,12 weeks of treatment and 3,6,9,12 months of follow-up,while the control group presented increased SPUI score during treatment but reduced score during follow-up,with the observation group higher than the control group at 3,6,9 months of follow-up(P<0.05).The observation group outweighed the control group in the effective rate,while difference was only observed between the two groups after 8 weeks of treatment(χ^(2)=3.868,P<0.05)and 3 months of follow-up(χ^(2)=6.510,P<0.05).Compared with the condition before treatment,the TCM symptom score was lowered in both groups after 4,8,and 12 weeks of treatment and3,6,9,12 months of follow-up(P<0.01),and except for 4 weeks of treatment,the observation group had more reduction than the control group(P<0.05).The pulmonary function of patients in the observation group was improved compared with the condition before treatment,and there was difference in PEF%pred in intergroup and intragroup comparisons(P<0.05).Both groups had reduced level of serum inflammatory factors,but difference was only observed in TNF-α,IL-8,IL-10 and NE in the observation group compared with those before treatment(P<0.05),and in IL-8 between the two groups(P<0.05).Conclusion:Qingbu Weijing decoction in the treatment of stable bronchiectasis patients with airway mucus hypersecretion(Qi and Yin deficiency,phlegm and heat accumulation in lung)can significantly alleviate their cough and expectoration and reduce the repeated acute exacerbation,and can down-regulate the level of serum inflammatory factors,thereby improving the lung function of patients to a certain extent.