目的：通过一系列单病例随机对照试验,研究清热中药在支气管扩张症稳定期的作用价值与特点。方法：同一个体进行三轮次随机双盲对照试验,每一轮包括试验期和对照期两个观察期,每期服药3周,停药1周,顺序随机确定。试验期服用个体化辨证方(以下简称个体化方),对照期服用个体化方减清热方(个体化方去除清热中药,包括清热解毒药、清热燥湿药及部分清热凉血药与清热泻火药)。主要观察指标为患者自我评价症状的likert量表(7分制),其他指标有24小时痰量等。单病例个体统计采用配对t检验,群体统计采用混合效应模型。结果：21例患者中,15例完成了包含3轮随机双盲对照试验的单病例试验(占71.43%)。1.各项观察指标均有不同程度的改善。从个体水平看,个体化方和个体化方减清热方的差别均无统计学意义(P＞0.05),从临床上分析,中医辨证痰热偏重的患者更倾向于个体化方,而正虚为主的患者倾向于个体化方减清热方。2．21位患者作为一个群体的统计结果,两种方剂的总体症状的likert量表评分分别为(2.08±0.68 VS 1.94±0.69), 其差值的均值(mean difference)及其95%可信区间为 0.19(0.01,0.37), P=0.040,具有统计学差异,提示个体化方减清热方较优,但不具备临床意义(MCID<0.5)。两种方剂的CAT量表评分亦有统计学差异(P=0.040),但不具备临床意义(MCID<0.5),其他三项指标(呼吸系统症状的likert量表评分、24小时痰量及中医证候评分)均无统计学差异。结论：就参加本项研究的支扩患者而言,在支扩稳定期似无必要在全程应用清热中药,可根据每个患者的痰热轻重,间断使用或减量使用清热中药,在改善症状与生活质量同时,可能降低中药费用并减少清热中药的潜在副作用。具有一定的临床上的参考价值。
Purpose：A series of single-case randomized controlled trials were used to study the value and characteristics of traditional Chinese medicine for heat clearing in the stable period of bronchiectasis.
Methods：Three rounds of randomized double-blind control trials were conducted on the same individual, and each round included two observation periods of the experimental period and the control period, 3 weeks for each dose and 1 week for discontinuation, and the order was determined randomly. During the test period, individualized prescription for syndrome differentiation (hereinafter referred to as individualized prescription) was taken, while in the control period, individualized prescription for heat reduction and heat clearing was taken (individualized prescription for heat removal of traditional Chinese medicine, including heat-clearing and antipyretic, heat-clearing and damp-dryness medicine, partial heat-clearing and blood-cooling medicine and heat-clearing and gunpowder). The main observation indicators were likert scale (7-point scale) of patients'' self-evaluation symptoms, and other indicators were 24h sputum volume, etc.. Paired t test was used for individual statistics and mixed effect model was used for population statistics.
Results：Of the 21 patients, 15 completed a single-case trial involving 3 rounds of randomized, double-blind, controlled trials (71.43%). 1. All the observation indicators were improved to varying degrees. At the individual level, there was no statistically significant difference between the individualized prescription and the individualized prescription for reducing heat (P > 0.05). According to clinical analysis, patients with excessive phlegm-heat differentiation in traditional Chinese medicine preferred the individualized prescription, while patients with mainly positive asthenia preferred the individualized prescription for reducing heat. 2. According to the statistical results of 21 patients as a group, likert scale scores of the overall symptoms of the two formulations were respectively (2.08 + 0.68 vs. 1.94 + 0.69), mean difference and 95% confidence interval were 0.19 (0.01,0.37), P=0.040, showing statistical differences, suggesting that individualized prescription for heat reduction and clearing was superior, but did not have clinical significance (MCID<0.5). The CAT scale scores of the two formulations were also statistically different (P=0.040), but had no clinical significance (MCID<0.5), while the other three indicators (likert scale score of respiratory symptoms, 24-hour sputum volume and TCM syndrome score) showed no statistical difference.
Conclusion：As for the patients with bronchial hypertrophy who participated in this study, it seems unnecessary to apply heat-clearing traditional Chinese medicine in the whole process at the stable stage of bronchial hypertrophy. According to the severity of phlegm heat in each patient, intermittent use or reduction of use of heat-clearing traditional Chinese medicine may reduce the cost of traditional Chinese medicine and reduce the potential side effects of heat-clearing traditional Chinese medicine while improving symptoms and quality of life. It has certain clinical reference value.