慢支咳喘灵对慢性阻塞性肺疾病稳定期患者肺功能和生活质量的影响

Effect of Manzhi Kechuan Ling on Pulmonary Function and Quality of Life of Patients with Chronic Obstructive Pulmonary Disease at Stationary Stage

【目的】观察中药慢支咳喘灵对慢性阻塞性肺疾病(COPD)稳定期患者肺功能和生活质量的影响。【方法】将76例COPD稳定期患者随机分为治疗组40例和对照组36例,治疗组给予中药慢支咳喘灵(主要由人参、黄芪、白术、茯苓、山药、补骨脂、鹿角胶、紫河车、阿胶、核桃肉、蛤蚧、炒紫苏子、川贝母、法半夏、益母草、桃仁、甘草等组成)口服6个月,停药后观察6个月;对照组不予任何药物治疗,观察1年。主要观察两组治疗前和治疗后6个月、12个月患者肺功能[一秒钟用力呼气容积(FEV1)、FEV1占用力肺活量百分比(FEV1%),用力肺活量(FVC)、FVC占预计值百分比(FVC%),FEV1与FVC的比值(FEV1/FVC)以及FEV1、FVC治疗前后差值和变异率]、中医证候积分、生活质量评分和年急性发作次数等指标的变化,并测定治疗前、治疗后6个月肺功能Ⅲ级的COPD患者动脉血气分析的血氧分压(PaO2)、二氧化碳分压(PaCO2)等指标。【结果】在肺功能方面,治疗6个月后治疗组FEV1、FVC均有明显改善(与治疗前比较,P<0.05),而对照组FEV1、FVC经6个月、12个月观察呈下降趋势,其中12个月后下降与治疗前比较,差异有显著性意义(P<0.05或P<0.01);两组FEV1、FVC治疗后6个月、12个月与治疗前的差值及变异率比较,差异均有显著性意义(P<0.05或P<0.01)。在动脉血气分析方面,治疗6个月后治疗组PaO2上升而PaCO2下降(与治疗前比较,P<0.05),对照组PaO2、PaCO2则无明显变化(P>0.05);两组间比较,差异有显著性意义(P<0.01)。在中医证候积分方面,治疗组治疗后6个月、12个月中医证候积分较治疗前显著下降(P<0.01),对照组中医证候积分则显著增加(P<0.05或P<0.01);两组间比较,差异均有显著性意义(P<0.001)。在生活质量评分方面,治疗组治疗后6个月、12个月患者生活质量总平均分均显著下降(与治疗前比较,P<0.05或P<0.01),而对照组患者生活质量总平均分随时间推移呈上升趋势,其中12个月后较治疗前有显著性升高(P<0.05);两组间比较,差异均有显著性意义(P<0.01)。在年急性发作次数方面,治疗组的发作次数少于对照组(P<0.001)。【结论】中药慢支咳喘灵可以延缓COPD患者肺功能下降,减轻临床症状,改善生活质量,减少年急性发作次数。

Objective To observe the effect of Manzhi Kechuan Ling （MKL） on pulmonary function and quality of life （QOL） of patients with chronic obstructive pulmonary disease （COPD） at stationary stage. Methods Seventy-six COPD patients were randomized into two groups. The treatment group （N = 40） received oral use of MKL （mainly composed of Radix Ginseng, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Colla Comus Cervi, Placenta Hominis, Gecko, Semen Juglandis, Gecko, Fructus Perillae, Bulbus Fritillariae Cirrhosae, Rhizoma Pinelliae） for 6 months, and was followed up for another 6 months after suspension of medication. The control group （N = 36 ） did not receive any medication. The pulmonary function, TCM syndrome scores, QOL scores and annual acute attack times were examined before treatment, 6 and 12 months after treatment. Meanwhile, artery blood gas analysis was performed before treatment and 6 months after treatment. Results In the treatment group , the pulmonary function indexes of forced expiratory volume in one second （ FEV1 ） and forced vital capacity （FVC） were improved 6 months after treatment （P 〈 0. 05 compared with those before treatment）, and FEV1 and FVC after 6-month follow-up did not differ from those before treatment （P 〉 0.05 ）. In the control group, FEV1 and FVC presented a decreasing trend 6 and 12 months after treatment, and FEV1 and FCV 12 months after treatment differed from those before treatment （ P 〈 0.05 or P 〈 0. 01 ）. The differences of FEV1 and FVC before treatment and 6 or 12 months after treatment as well as the variability rate in the treatment group differed from those in the control group （ P 〈 0. 05 or P 〈 0.01 ）. The Results of artery blood gas analysis showed that oxygen partial pressure （ PaO2 ） increased and partial pressure of carbon dioxide （ PaCO2 ） decreased in arterial blood of treatment group 6 months after treatment （ P 〈 0.05 compared with those before treatment）, but there was no significant difference in the control group （ P 〉 0. 05）. There showed statistical differences of PaO2 and PaCO2 between the two groups 6 months after treatment （P 〈 0.01 ）. TCM syndrome scores were decreased in the treatment group 6 and 12 months after treatment （ P 〈 0. 01 compared with those before treatment）, while increased in the control group （ P 〈 0.05 or P 〈 0. 01 compared with those before treatment ）. There showed statistical differences of TCM syndrome scores between the two groups 6 and 12 months after treatment （P 〈 0. 001 ）. The QOL scores were decreased in the treatment group 6 and 12 months after treatment （P 〈0. 05 or P 〈 0.01 compared with those before treatment）, while showed an increasing trend in the control group （P 〈 0. 05, 12 months after treatment vs before treatment）. There showed statistical differences of QOL scores between the two groups 6 and 12 months after treatment （P 〈 0.01 ）. The annual acute attack times in the treatment group were less than those in the control group （P 〈 0. 001 ）. Conclusion MKL is effective in improving pulmonary function, relieving symptoms and signs, improving QOL and reducing annual acute attack times in COPD patients.