Exploring the Individualized Treatment of Bronchiectasis by Traditional Chinese Medicine through N-of-1 Trials
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摘要: 目的比较个体化治疗（辨证论治方）和固定方（支气管扩张稳定方作为对照）在治疗稳定期支气管扩张症患者的疗效差异。方法先通过预初试验,确定单个病例支气管扩张患者的观察期与洗脱期。再根据单病例随机对照试验的常规方法,同一个体进行三轮随机双盲对照试验。以症状的视觉模拟评分为主要指标,次要指标为24小时痰量,还将症状积分与患者在盲态下的方剂偏好相结合制定了临床疗效标准。结果3例单病例试验在症状视觉模拟评分上均有不同程度的改善,其中1例患者（病例3）的24小时痰量从70 mL下降至30 mL,但辨证论治方与固定方之间在症状评分和24小时痰量上差异均无统计学意义。1例患者（病例2）表示了对一种方剂的偏好,在揭盲后证实是辨证论治方,该例试验被判定具有临床意义。结论单病例随机对照试验符合中医个体化治疗的理念,且具有良好的依从性,有必要建立临床疗效标准,并考虑疾病急性加重的影响。为进一步的研究提供了经验并开拓了思路。Abstract: ObjectiveTo compare the efficacy of individualized herbal decoction with controlled decoction for individual patients with stable bronchiectasis. MethodsWe conducted N-of-1 RCTs （single-patient, double-blind, randomized, multiple crossover design） in 3 patients with stable bronchiectasis. The primary outcome was patient self-rated symptom scores on visual analogue scales. Secondary outcome was 24-hour sputum volume. A clinical efficacy criterion which combined symptoms score and medication preference was also formulated. ResultsAll three patients showed various degrees of improvement on their symptoms and one patient’s （case 3） 24 h sputum volume decreased from 70 mL to 30 mL. However, no significant differences were found between individualized herbal decoction and control decoction on symptoms score, or on 24-hour sputum volume. One patient （case 2） had clear preference for the individualized herbal decoction over the standard one with the confirmation after unblinding. We therefore considered this case clinically important. Conclusion N-of-1 trials comply with individualized philosophy of TCM clinical practice and had good compliance. It is necessary to set up clinical efficacy criteria and to consider the interference of acute exacerbation.
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