桉柠蒎治疗老年人稳定期慢性阻塞性肺疾病的疗效

Efficacy of eucalyptol-limonene-pinene enteric capsule on stable chronic obstructive pulmonary disease in the elderly

目的评估长期口服桉柠蒎治疗稳定期慢性阻塞性肺疾病（COPD）的疗效。方法共纳人稳定期COPD患者120例，随机分为桉柠蒎组63例和对照组57例，桉柠蒎组采用常规治疗联合桉柠蒎治疗，对照组则仅采用常规治疗，主要临床终点为年急性加重次数，次要临床终点为肺功能指标及圣乔治呼吸问卷（SGRQ）评分。结果经1年治疗后急性加重发生次数分别为桉柠蒎组0．70次／年、对照组为1．21次／年，桉柠蒎组明显低于对照组（Z=-3．887，P=0．000）；1年内桉柠蒎组与对照组患者未发生急性加重的比例分别为25．4％（16／63）和5．3%（3／57）（x^2=9．103，P=0．003）。两组用力肺活量（FVC）、第1秒用力呼气容积（FEV，）、第1秒用力呼气容积占预计值百分比（FEVl00）5次不同时间测量差异有统计学意义（桉柠蒎组：F=15．429、36．389、33．278，均P=0．000；对照组：F=54．238、94．213、83．774，均P=0．000），桉柠蒎组FEV1／FVC5次不同时间测量差异无统计学意义（F=0．861，P=0．451），对照组FEV1／FVC5次不同时间测量差异有统计学意义（F=2．766，P=0．043）；两组患者治疗后SGRQ评分中各项评分均较治疗前有所下降，且治疗后两组患者症状评分差异有统计学意义（t=2．109，P=0．037）。桉柠蒎组共有3例（4．8％）出现不良反应，对照组有2例（3．5％），桉柠蒎组与对照组不良反应发生率差异无统计学意义（x^2=0．013，P：0．732）。结论长期口服桉柠蒎可以减少稳定期COPD患者急性加重的次数、改善生活质量、延缓肺功能下降趋势，且安全性较好。

Objective To evaluate the efficacy of eucalyptol-limonene-pinene enteric capsule on stable chronic obstructive pulmonary disease （COPD） in the elderly. Methods A total of 120 patients with stable COPD were randomized into ELP group （n = 63） with conventional treatment combined ELP and control group （n= 57） with conventional treatment without ELP. Primary outcome was the number of exacerbations per year, and secondly outcomes were lung function parameters and St. George＇s Respiratory Questionnaire （SGRQ）. Results After 1 year of treatment, numbers of exacerbations per patient per year were lower in ELP group than in control group （0.70 times/y vs. 1.21 times/y, Z=- 3. 887, P=0. 000）. The proportion of exacerbation-free patients were 25.4% （16/63） in ELP group and 5.3% （3/57） in control group （x^2 =9. 103, P=0. 003）. The differences in the forced vital capacity （FVC）, forced expiratory volume in one second （FEV1）, and FEV1/ FVC ratio （FEV1%） between 5 different time points measurements were statistically significant in both groups （ELP group：F=15.429, 36. 389, 33. 278, respectively, all P=0.000;control group：F= 54. 238, 94. 213 and 83. 774, respectively, all P=0. 000）. Difference in FEV1/FVC ratio between 5 different time point was statistically significant in control group（F=2.766,P=0.043）, but not in ELPgroup（F=0.861,P=0.451）. After treatment, SGRQ score was decreased in both group, and difference in symptom score was statistically significant between the two groups （ t = 2. 109, P= 0. 037）. The adverse reactions were found in 3 cases in ELP group, and in 2 cases in control group with no statistically significant difference between the two groups （3 （4.8%） vs. 2 （3.5%）, x^2 = 0. 013, P= 0. 7321. Conclusions Long-term oral administration of eucalyptol-limonene-pinene enteric capsule can significantly decrease exacerbation frequency, improve quality of life, delay the deterioration in lung function, and have good safety in elderly patients with stable COPD.