加味苇茎汤治疗支气管扩张症稳定期(痰热蕴肺证)的系列单病例随机对照研究

A Series of N-of-1 Trials on the Treatment of Stable Stage of Bronchiectasis(Phlegm Heat Accumulating in the Lung Pattern)with Modified Weijing Decoction

目的评价加味苇茎汤治疗支气管扩张症稳定期(痰热蕴肺证)的临床疗效和安全性。方法运用系列单病例随机对照试验(N-of-1试验)的方法,选取诊断为支气管扩张症稳定期,辨证属于痰热蕴肺证的患者,在一个治疗周期内先后接受两种不同的治疗方案,试验期治疗用加味苇茎汤,对照期治疗用西药氨溴索片,期间设置洗脱期,试验期和对照期的用药先后顺序按随机化方式决定,以目测模拟尺测量法(visual analogue scales,VAS法)评价治疗前后的症状改变,记录24 h痰量和自我评估测试(COPD Assessment Test,CAT)评分,并观察研究期间的不良反应。采用SPSS 25.0、GraphPad Prism 8软件进行统计分析和绘图,入组前的组间差异比较采用独立样本t检验分析;试验期和对照期治疗前后的症状得分、24 h痰量和CAT评分对比,以及两组治疗前后的差值对比采用配对t检验,比较临床差异和统计学差异。结果共有9例患者入组,最终纳入分析的治疗轮次为16次。试验期治疗后中医证候总积分,咳嗽、咳痰、痰液颜色、胸闷胸痛、口苦口干、乏力疲倦等症状,24 h痰量和CAT评分较治疗前改善,差异均具有统计学意义(P<0.05)。试验期和对照期中医证候总积分、痰液颜色评分、胸闷胸痛评分和24 h痰量治疗前后差值比较,试验组较对照组改善明显,差异有统计学意义(P<0.05)。观察期间未出现与试验方法或药物有关的不良事件。结论加味苇茎汤能综合改善支气管扩张症稳定期患者的临床症状,总体疗效优于西药氨溴索,且安全性良好。

Objective To evaluate the clinical efficacy and safety of modified Weijing Decoction in the treatment of stable stage of bronchiectasis(phlegm heat accumulating in the lung pattern).Methods A series of N-of-1 trials using bronchiectasis patients in stable stage with phlegm heat accumulation in the lung pattern were performed.Participants meeting inclusion criteria underwent two distinct treatment protocols during a therapy period.Modified Weijing Decoction was used in the experimental period and ambroxol tablets were used in the control period,washout periods were set.The medication-use order in the control period and experimental period is random.The visual analog scale(VAS)was used to assess symptom changes before and after treatment.24-hour sputum volume and COPD self-assessment test(CAT)scores were recorded,while adverse reactions were monitored during the study period.Statistical analysis and drawing were performed on SPSS 25.0 and GraphPad Prism 8.Comparison of inter-group differences before grouping was assessed by independent samples t-test.Analysis of symptom score,24-hour sputum volume and CAT scores in the experimental and control periods,as well as comparison of differences between the above two groups before and after treatment were performed using paired t-test,which enabled comprehensive exploration of clinical and statistical distinctions.Results A total of 9 patients participated in 16 rounds of analysis.Statistically significant differences(P<0.05)before and after the treatment in the experimental period were noted in total Traditional Chinese Medicine(TCM)symptom scores,cough,sputum,sputum color,chest tightness and chest pain,bitter and dry mouth,fatigue and tiredness,24-hour sputum volume,and CAT score.Paired t-tests revealed significant variations(P<0.05)in the total TCM symptom scores,sputum color scores,scores of chest tightness and pain,and 24-hour sputum volume between experimental and control periods.No adverse events related to the test methods or drugs occurred during the observation period.Conclusion Modified Weijing Decoction could comprehensively improve clinical symptoms of bronchiectasis patients in stable stage.It exhibits superior efficacy compared to ambroxol and maintains a favorable safety profile.