苗药紫金牛、铁扫帚对COPD稳定期痰瘀互阻兼气阴两虚证患者的临床疗效观察

Observation of the Clinical Effect of Miao Medicine Ardisia japonica and Lespedeza cuneata on COPD Patients with Stable Phlegm and Blood Stasis and Qi and Yin Deficiency Syndrome

摘要: 目的：观察苗药紫金牛、铁扫帚对COPD稳定期痰瘀互阻兼气阴两虚证的临床疗效，为探明苗药紫金牛、铁扫帚防治COPD的作用机制提供一定的理论依据。方法：选取符合纳入标准的COPD稳定期痰瘀互阻兼气阴两虚证病例68例，按数字随机表分为西药对照组(34例)和苗药治疗组(34例)。西药对照组予沙美特罗替卡松(50 ug沙美特罗和250 ug丙酸氟替卡松)吸入治疗，每次1吸，每日早晚各1次。苗药治疗组予苗药紫金牛、铁扫帚煎剂口服，每次100 ml，每日3次，饭后1小时服用，同时予沙美特罗替卡松吸入治疗，每次1吸，每日1次。两组患者均以12周为1个疗程。观察治疗前后两组患者单个临床证候的中医证候积分、肺功能、CAT评分、6分钟步行距离(6MWD)、血氧饱和度(SPO2)下降值等指标。结果：两组治疗前后FEV1/FVC%、FEV1%perd组内比较均有显著差异(P < 0.01)；治疗后组间比较均有差异(P < 0.05)。两组治疗前后组内比较均有显著差异(P < 0.01)；治疗后组间比较亦有明显差异(P < 0.01)。两组治疗前后6MWD及SPO2下降值组内比较均有明显差异(P < 0.01)；治疗后二者组间比较均有差异(P < 0.05)。两组治疗前后咳嗽、喘息气促、易感冒、乏力、汗出、胸痛、口唇紫组内比较均有明显差异(P < 0.01)；治疗后组间对比除易感冒外，其余证候均有差异(P < 0.05)。两组治疗前后中医证候疗效比较有差异(P < 0.05)。两组治疗过程中均无明显不良事件发生。结论：苗药紫金牛、铁扫帚能在一定程度上改善COPD稳定期患者的肺功能、生活质量和运动耐量及中医临床症状和体征，有良好的临床疗效。

Abstract: Objective: To observe the clinical effect of miao medicine, Ardisia japonica and Lespedeza cuneata were used to treat phlegm and blood stasis, qi and yin deficiency syndrome belonging to stable stage of COPD, to provide some theoretical basis for studying the mechanism of action of Ardisia japonica, Lespedeza cuneata on the prevention and treatment of COPD. Methods: 68 patients that met the inclusive criteria were randomly divided into western medicine control group (34 cases) and miao medicine treatment group (34 cases). Patients belonging to COPD stable stage of both groups were treated and managed according to COPD guide and GOLD standards. Two groups had been asked for quitting smoking, getting away from smog and occupational exposure and strengthening physical exercise, etc. The control group was treated with Salmeterol-fluticasone (50 ug Salmeterol and 250 ug fluticasone) for two times a day and the treatment group was treated with miao medicine (Ardisia japonica, Lespedeza cuneata) for three times a day after meal and Salmeterol-fluticasone (50 ug Salmeterol and 250 ug fluticasone) for one time a day. The treatment lasted for twelve weeks. Changes of clinical symptoms, Lung function, COPD assessment test (CAT) questionnaire score, six-minute walking distance (6MWD) and descending SPO2 of two groups before and after treatment were observed. Results: The FEV1/FVC% and predicted values of FEV1% for both groups before and after treatment had obvious difference (P < 0.01); between the two groups had difference after treatment (P < 0.05). There was obvious difference (P < 0.01) for both groups before and after treatment and there was obvious difference (P < 0.01) between the two groups after treatment. There was obvious difference (P < 0.01) for both groups before and after treatment and there was difference (P < 0.05) between the two groups. After intra-group comparison of cough, wheeze and pant, easy cold, weakness, sweating, chest pain and purple lips, obvious difference (P < 0.01) was found. Except for easy cold, other symptoms were different after treatment (P < 0.05). In comparison of two groups’ patients' clinical symptoms of TCM, difference (P < 0.05) was found. Both groups had no adverse event. Conclusions: Miao medicine Ardisia japonica and Lespedeza cuneata can improve pulmonary function, quality of life, exercise tolerance and clinical symptoms and signs of traditional Chinese medicine in patients with COPD at stable stage to a certain extent.