摘要
目的:该研究目的为评价补肺健脾益肾法对早期COPD稳定期(肺功能Ⅰ、Ⅱ级患者)的疗效,减少COPD患者的急性加重次数,减缓COPD患者肺功能的下降程度和减轻症状,提高患者的生存质量。方法:我们选择60例患者参加。研究采用随机、单盲、安慰剂对照的试验设计,以轻、中度的稳定期(肺功能Ⅰ、Ⅱ级)患者为对象,分为试验组(中药颗粒剂)和对照组(中药颗粒安慰剂),开展中医辨证治疗与安慰剂比较研究,治疗9个月,随访3个月。疗效评价指标选用COPD急性加重次数、肺功能、呼吸困难分级(MMRC)、临床症状、6 min步行距离(6MWT)、COPD病人报告的临床结局(PRO量表)等,通过比较上述疗效评价指标在治疗前和治疗后的差异,建立临床数据库进行统计分析和评价。结果:试验组COPD急性加重次数显著减少,肺功能相关指标下降,临床症状积分、呼吸困难评价积分和PRO量表积分降低,6 min步行距离增加,试验组显著优于对照组(P<0.05或(P<0.01),且未发现明显的不良反应。结论:试验组(中药颗粒组)的临床疗效优于对照组(中药颗粒安慰剂组)。补肺健脾益肾法辨证治疗早期COPD患者获得良好的临床效果,它不但可以减少COPD患者的急性发作次数,减缓肺功能下降程度,改善患者的临床症状和呼吸困难程度,提高患者的运动能力,还可以提高患者的生存质量。
Objective:To evaluate the efficacy of COPD in the early stage of COPD(pulmonary function,grade II),and reduce the number of acute exacerbation of patients with COPD,reduce the degree of pulmonary function and reduce the symptoms,improve the quality of life of patients. Methods:We chose 60 patients to take part in. The study was carried out with a randomized,single blind,placebo-controlled trial design with mild and moderate stable phase(pulmonary function,grade II)patients as the object,divided into experimental group(Chinese medicine granule)and control group(Chinese medicine granule placebo),to carry out treatment of traditional Chinese medicine treatment and placebo,9 months,3 months follow-up. The clinical outcomes of PRO(MMRC),clinical symptoms,clinical symptoms,six minutes walking distance(6MWT)and COPD were evaluated by comparing the clinical outcomes of the patients with COPD. Results:The number of acute exacerbation of COPD in experimental group was significantly decreased,and the lung function was associated with lower,clinical symptom score,respiratory difficulty score and PRO score,and six minutes walking distance were significantly higher than that in control group(P〈0.05 or P〈0.01),and no obvious adverse reactions were found. Conclusion:The clinical efficacy of the experimental group(TCM group)was better than that of the control group(placebo group). To obtain good clinical effect,it not only can reduce the number of acute exacerbation of COPD patients,reduce the degree of pulmonary function decline,improve the clinical symptoms and respiratory difficulty,improve the patient's ability to exercise,but also improve the quality of life of patients with COPD.
出处
《辽宁中医药大学学报》
CAS
2015年第12期78-81,共4页
Journal of Liaoning University of Traditional Chinese Medicine
基金
广东省普通高校重点实验室项目(AAF110111A14)
关键词
补肺健脾益肾法
COPD稳定期
疗效评价
tonify the lung fortify the spleen and kidney
COPD stability
evaluation of therapeutic effect