摘要
目的:探讨麻射安金丸对慢性阻塞性肺疾病(慢阻肺)气道黏液高分泌患者肺功能、炎症因子水平及急性发作风险的影响.方法:选取2021年6月至2022年2月我院就诊的慢阻肺气道黏液高分泌患者118例,按照随机数字表法分为对照组和观察组各59例,对照组雾化吸入乙酰半胱氨酸溶液,观察组在此基础上增加麻射安金丸;比较两组临床疗效、中医证候评分、肺功能、炎症因子水平,生活质量和活动能力,记录用药期间不良反应发生率.随访观察12个月,采用Kaplan-Meier曲线绘制慢阻肺急性发作风险曲线.结果:治疗14 d后,观察组总有效率(91.53％)明显高于对照组(77.97％)(P＜0.05);观察组中医证候[咳痰(2.21± 0.61)、喘息(2.22±0.48)、咳嗽(2.02+0.44)、胸闷(1.81±0.52)]积分明显低于对照组[咳痰(2.54±0.77)、喘息(2.53±0.46)、咳嗽(2.23±0.47)、胸闷(2.09±0.48)](P＜0.05);观察组肺功能[PEF(332.07±44.21)、FEV1/FVC(62.11±4.55)、FEV1(63.29±4.98)水平]明显高于对照组[PEF(309.21±42.87)、FEV1/FVC(60.01±5.22)、FEV1(60.25±5.37)](P＜0.05);观察组[TNF-α(10.26± 3.01)、IL-8(24.11±3.26)、CRP(4.63±1.23)]含量明显低于对照组[TNF-α(12.03±3.12)、IL-8(26.56+4.36)、CRP(5.24±1.33)](P＜0.05);观察组 SGRQ(18.23±4.01)评分明显低于对照组(20.21±3.21),6MWT(448.58±68.57)水平明显高于对照组(422.65± 60.21)(P＜0.05);观察组不良反应率(8.47％)和对照组(3.39％)对比差异无统计学意义(P＞0.05);随访观察12个月,每组各失访2例,最终两组例数均为57例,其中观察组急性发作风险明显低于对照组(P＜0.05).结论:麻射安金丸可降低慢阻肺气道黏液高分泌患者炎症水平,改善肺功能,提高生活质量和活动能力,疗效显著且急性发作风险低.
Abstract
Objective:To explore the effects of Mashe Anjin Pills(麻射安金丸)on lung function,levels of inflammatory factors,and acute attack risk in patients with chronic obstructive pulmonary disease(COPD)characterized by airway mucus hypersecretion.Methods:From June 2021 to February 2022,118 COPD patients with airway mucus hypersecretion treated in this hospital were enrolled and randomly divided into a control group(n=59)and an observation group(n=59)using a random number table.The control group received acetylcysteine nebuliza-tion,and the observation group received Mashe Anjin Pills in addition to acetylcysteine nebulization.Clinical efficacy,traditional Chinese medicine(TCM)syndrome scores,lung function,inflammatory factor levels,quality of life,activity capacity,and the incidence of adverse re-actions during the treatment period of the two groups were compared.Follow-up observation was conducted for 12 months,and Kaplan-Meier curves were used to illustrate the acute attack risk curve of COPD.Results:After 14 days of treatment,the total effective rate in the observa-tion group was 91.53％,significantly higher than 77.97％in the control group(P＜0.05).TCM syndrome scores in the observation group[expectoration(2.21+0.61),wheezing(2.22±0.48),cough(2.02±0.44),and chest tightness(1.81±0.52)]were significantly lower than those in the control group[expectoration(2.54±0.77),wheezing(2.53±0.46),cough(2.23±0.47),and chest tightness(2.09+0.48)](P＜0.05).Lung function indicators[PEF(332.07+44.21),FEV1/FVC(62.11+4.55),and FEV1(63.29±4.98)]in the ob-servation group were significantly higher than those in the control group[PEF(309.21±42.87),FEV1/FVC(60.01±5.22),and FEV1(60.25±5.37)](P＜0.05).Inflammatory factor levels[TNF-α(10.26±3.01),IL-8(24.11±3.26),and CRP(4.63±1.23)]in the ob-servation group were significantly lower than those in the control group[TNF-α(12.03±3.12),IL-8(26.56±4.36),and CRP(5.24± 1.33)](P＜0.05).The observation group had significantly lower SGRQ scores(18.23±4.01)and higher 6MWT levels(448.58+68.57)than the control group(20.21±3.21 and 422.65±60.21,respectively)(P＜0.05).The incidence of adverse reactions in the observation group was 8.47％,which was not significantly different from 3.39％in the control group(P＞0.05).During the 12-month follow-up,two ca-ses were lost to follow-up in each group,resulting in a final sample size of 57 in both groups.The observation group had a significantly lower risk of acute attack than the control group(Log-rank X2=4.844,P=0.028).Conclusion:Mashe Anjin Pills can reduce inflammatory lev-els,improve lung function,enhance the quality of life and activity capacity,and significantly lower the risk of acute attack in patients with COPD characterized by airway mucus hypersecretion.
基金项目
河北省中医药管理局中医药科研项计划课题(2022274)
国家科技期刊平台
NSTL
万方数据