人参健脾丸辅助治疗脾肺气虚型稳定期慢性阻塞性肺疾病患者的临床研究

Clinical study of Renshen Jianpi pill as adjuvant therapy in stable chronic obstructive pulmonary disease patients with syndrome of spleen and lung qi-deficiency

目的:研究人参健脾丸辅助治疗脾肺气虚型稳定期慢性阻塞性肺疾病(COPD)患者的疗效。方法:采用随机对照方法将86例脾肺气虚型COPD稳定期患者分为中药治疗组和常规治疗组各43例。所有患者均给予COPD常规治疗,中药组在此基础上予人参健脾丸治疗。比较2组患者治疗前后的营养指标、免疫功能、生存质量评分[圣乔治呼吸问卷(SGRQ)]、肺功能、BODE指数。结果:中药组治疗后各项营养指标均明显高于治疗前(P<0.05)。中药组治疗后清蛋白、前清蛋白及胆固醇较常规组明显增高(P<0.05)。中药组治疗后6 min步行距离(6MWD)较治疗前明显增加(P<0.05);常规组治疗前后无明显差异(P>0.05);治疗后组间比较有统计学意义(P<0.05)。2组患者治疗后SGRQ总分均较治疗前明显降低,组间比较具有统计学差异(P<0.05)。2组体液免疫指标免疫球蛋白(Ig)A、IgM、IgG治疗前后及组间比较均无明显差异(P>0.05)。中药组治疗后CD3、CD4及CD4/CD8均较治疗前明显增高(P<0.05),治疗后组间比较具有统计学差异(P<0.05)。中药组治疗后改良呼吸困难量表(mMRC)、6MWD 2个维度和BODE指数均低于治疗前(P<0.05)。且BODE指数与常规组治疗后相比,具有统计学差异(P<0.05)。结论:人参健脾丸辅助治疗脾肺气虚型COPD稳定期患者具有较好的疗效。

Objective To study the effect of Renshen Jianpi pill as adjuvant therapy in stable chronic obstructive pulmonary disease （COPD） patients with syndrome of spleen and lung qi-defieiency. Methods Eighty-six stable COPD patients with syndrome of spleen and lung qi-deficiency were randomly divided into Renshen Jianpi pill therapy group and routine therapy group, with 43 cases in each group. All patients were given routine treatment. Besides routine therapy, patients in Renshen Jianpi pill group were administered with Renshen Jianpi pill. Nutrition indices, immune function, quality of life [the St George＇s respiratory questionnaire（SGRQ）] score, lung function, BODE index were determined before and after treatment. Results Nutrition indices in Renshen Jianpi pill group were significantly higher after treatment than before treatment （P〈0.05）. Compared to routine therapy group, albumin, prealbumin and cholesterol levels in Renshen Jianpi pill group were significantly higher （P〈0.05）. Six minutes walk distance （6MWD） in Renshen Jianpi pill group increased significantly （P〈0.05） when compared with pre-treatment value, but in routine therapy group there was no significant difference before and after treatment （P〉0.05）. The difference between the two groups was statistically significant （P〈0.05）. After treatment, SGRQ scores were significantly lower than pre-treatment in both two groups, and the difference between the two groups was significant （P〈0.05）. Immunoglobulin （Ig）A, IgM and IgG levels were not significantly different before and after treatment and between the two groups （P〉0.05）. CD3, CD4 and CD4/CD8 in Renshen Jianpi pill group were significantly higher after treatment than pre-treatment （P〈0.05）, and the difference between the two groups was statistically significant （P〈0.05）. The modified medical research council （mMRC）, 6MWD 2 dimension and BODE index in Renshen Jianpi pill group were significantly lower after treatment than before treatment （P〈0.05）, and the difference between the two groups was statistically significant （P〈0.05）. Conclusions Renshen Jianpi pill as adjuvant therapy had beneficial effect in treatment for stable COPD patients.