阿法骨化醇软胶囊对慢性阻塞性肺疾病患者免疫功能的临床研究

Effect of alfacalcidol soft capsules on immune function in patients with chronic obstructive pulmonary disease

目的评价阿法骨化醇软胶囊对慢性阻塞性肺疾病(COPD)患者免疫功能的影响。方法入选172例COPD患者,随机分成试验组86例和对照组86例,2组常规治疗相同(包括戒烟、支气管扩张剂、祛痰剂等),试验组口服阿法骨化醇软胶囊0.25μg,1天1次,治疗时间为6个月,比较2组治疗前后免疫功能(CD3+、CD4+、CD8+和CD4+/CD8+)、肺功能[用力肺活量(FVC)、第l秒用力呼气容积(FEV1)、FEV1/FVC、肺一氧化碳弥散量/肺泡容积(DLC0/VA)]及随访半年COPD急性发作情况。结果治疗后,试验组CD3+、CD4+、CD8+和CD4+/CD8+均较治疗前和对照组显著升高;治疗后,试验组FEV1、FEV1/FVC、DLCO/VA均显著高于治疗前和对照组(P<0.05)。对照组治疗前后CD3+、CD4+、CD8+、CD4+/CD8+、FEV1、FEV1/FVC、DLCO/VA比较,差异无统计学意义(P>0.05)。试验组6个月内COPD急性加重的发生率(9.30%)显著低于对照组(25.58%)(P<0.05)。结论阿法骨化醇软胶囊可通过改善COPD患者免疫功能来改善肺功能,降低急性发作次数。

Objective To explore the effect of alfacalcidol soft capsules on immune function in patients with chronic obstructive pulmonary disease（ COPD）. Methods A total of 172 COPD patients were randomly divided into the trial group（ n = 86） and the control group（ n = 86）.They all accepted the conventional treatment,but the patients in the trial group were given the treatment of alfacalcidol soft capsules 0. 25 μg·d-1for 6 months. The difference of immune function（ CD3＋,CD4＋,CD8＋and CD4＋/ CD8＋）,pulmonary function [forced vital capacity（ FVC）,forced expiratory volume in one second（ FEV1）,FEV1 / FVC,diffusion capacity for carbon monoxide of lung / alveolar volume（ DLCO / VA） ]and acute exacerbations of COPD during 6 months follow-up were compared between the two groups. Results The contrations of CD3＋,CD4＋,CD8＋and CD4＋/ CD8＋after treatment in the trial group were significantly higher than that before treatment and control group（ P〈0. 05）. The FEV1,FEV1 /FVC,DLCO/VA after treatment in the trial group were significantly higher than that before treatment and control group（ P〈0. 05）. There were no significant difference of CD3＋,CD4＋,CD8＋,CD4＋/ CD8＋,FEV1,FEV1 /FVC,DLCO/VA before and aftertreatment in the control goup（ P〈0. 05）. The rate of acute exacerbations of COPD in the trial group（ 9. 30%） was significantly lower than that in the control group（ 25. 58%） during 6 months follow-up. Conclusion Alfacalcidol soft capsules could improve the pulmonary function and reduce acute exacerbations by improving immune function of patients with COPD.