个体化方治疗稳定期支气管扩张症的单病例随机对照临床研究  

Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT

作　　者：王洁[1] 黄海茵[1] 杨佩兰[1] 汤杰[1] 王振伟[1] 张誉清[2] 马莹[3] 

机构地区：[1]上海中医药大学附属岳阳中西医结合医院呼吸科,上海200437 [2]加拿大麦克马斯特大学临床流行病与生物统计学系,加拿大汉密尔顿999040 [3]上海中医药大学附属岳阳中西医结合医院药剂科,上海200437

出　　处：《上海中医药杂志》2016年第3期39-43,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：上海市卫生局中医药科研基金项目(2012L019B)

摘　　要：目的运用单病例随机对照试验评价个体化治疗的特性,比较试验期(个体化方)与对照期(支扩稳定方)治疗一例稳定期支气管扩张症患者的疗效差异。方法受试者为一例处于稳定期的支气管扩张症患者。先通过预初试验,确定该患者的观察期与洗脱期;再进行3轮次随机双盲自身对照试验。观察临床症状视觉模拟评分(VAS)、24 h痰量及CAT量表评分变化情况。结果 1三轮次试验后,试验期临床症状总积分下降值明显多于对照期,差异有统计学意义(P<0.05)。同时,症状总积分差值的95%CI下限为1.53分(>0.5分),可认为试验方较对照方具有临床优效性。2三轮次试验后,试验期24 h痰量下降值明显高于对照期,差异有统计学意义(P<0.05)。3三轮次试验后,试验期与对照期相比,CAT量表评分明显降低,差异有统计学意义(P<0.05),说明试验方在提高生活质量方面优于对照方。结论单病例随机对照试验对本例稳定期支气管扩张症患者能体现出中医个体化治疗的优势,也为该患者提供了最高等级的循证医学依据。Objective To compare the efficacy of individualized herbal decoction with Bronchiectasis Stabilization Decoction within a patient with stable bronchiectasis through N-of-1 RCT（ Single case randomized controlled trial）. Methods The lengths of observation period and washout period of a patient with stable bronchiectasis were determined by preliminary test,and then We conducted N-of-1 RCT（ single-patient,double-blind,randomized,multiple crossover design） with 3cycles in 1 patient with stable bronchiectasis. The primary outcome was patient self-reported symptom scores on a visual analogue scale（ VAS）,24-hour sputum volume and CAT（ The COPD Assessment Test） scores were observed. Results 1After three rounds of trial,the symptom scores of the trial periods diminished significantly more than control periods（ P〈0.05）,and the lower limit of the 95% confidence interval of the mean change was 1. 53（〉 0. 5）,indicating that the individualized herbal decoction has clinical superiority over the controlled decoction. 2After three rounds of trial,24-hour sputum volume of the trial periods diminished significantly more than control periods（ P〈0.05）. 3After three rounds of trial,the scores of CAT scale of the trial periods diminished significantly more than control periods（ P〈0.05）,indicating better quality of life in the trial periods. Conclusion N-of-1 RCT reflected the advantage of TCM individualized treatment in this patient with stable bronchiectasis,it also provided with the highest rank of evidence of evidence-based medicine for this patient.

关 键 词：支气管扩张症 单病例随机对照试验 个体化治疗 中医药 

分 类 号：R259[医药卫生—中西医结合]