布地格福联合白葡奈氏菌片维持治疗中重度慢性阻塞性肺疾病稳定期患者的临床观察

Clinical observation of Budigafol combined with Staphylococcus and Neisseria tablets in the maintenance treatment of patients with stable moderate to severe chronic obstructive pulmonary disease

目的 考察布地格福联合白葡奈氏菌片维持治疗中重度慢性阻塞性肺疾病(COPD)稳定期患者的临床效果。方法 将2021年10月1日至2023年1月31日于我院呼吸与危重症医学科感染病区就诊的122例中重度COPD稳定期患者,按照随机数字表法分为对照组(n=61)和观察组(n=61)。对照组患者单用布地格福吸入气雾剂(每次2揿,每日2次),观察组患者在对照组用药的基础上加用白葡奈氏菌片(每次1.2 mg,每日3次),两组疗程均为3个月。比较两组患者治疗前后的生活质量、运动耐量、肺功能、炎症指标、免疫功能,以及COPD急性发作次数和不良反应发生情况。结果 对照组和观察组分别脱落12、9例患者。治疗后,两组患者的6分钟步行距离均较治疗前显著延长(P<0.05),COPD评估测试问卷评分、St George’s呼吸问卷评分、残气量与肺总量的比值、呼出气一氧化氮浓度、血清C反应蛋白及白细胞介素6水平均较治疗前显著降低(P<0.05),第1秒用力呼气容积(FEV_1)、FEV_1与用力肺活量的比值、肺一氧化碳弥散量实测值占预计值的百分比以及FEV_1实测值占预计值的百分比均较治疗前显著升高(P<0.05),且观察组上述指标的改善程度均显著优于对照组(P<0.05)。与治疗前比较,治疗后对照组患者的免疫功能指标及观察组患者的血清免疫球蛋白A(IgA)、IgM水平差异均无统计学意义(P>0.05);观察组患者的CD3~+、CD4~+、B淋巴细胞、自然杀伤细胞的百分比和CD4~+/CD8~+以及IgG水平均显著升高(P<0.05),CD8~+细胞百分比显著降低(P<0.05),且观察组的改善程度均显著优于对照组(P<0.05)。两组患者在随访期间的COPD急性发作次数和治疗期间的不良反应发生率比较,差异均无统计学意义(P>0.05)。结论 布地格福联合白葡奈氏菌片能有效改善中重度COPD稳定期患者的免疫功能,降低其炎症水平,提升其运动耐量和生活质量,且用药安全性较好。

OBJECTIVE To investigate the clinical effect of Budigafol combined with Staphylococcus and neisseria tablets in maintenance treatment of patients with stable moderate to severe chronic obstructive pulmonary disease(COPD).METHODS A total of 122 patients with stable moderate to severe COPD who were admitted to the infections diseases ward of the department of respiratory and critical care medicine in our hospital from October 1,2021 to January 31,2023 were divided into control group(n=61)and observation group(n=61)according to the random number table method.Patients in the control group were treated with Budigafol inhalation aerosol alone(2 presses each time,twice a day),and patients in the observation group were treated with Staphylococcus and neisseria tablets(1.2 mg each time,3 times a day)on the basis of the control group.The treatment course of both groups was 3 months.The quality of life,exercise tolerance,lung function,inflammatory indexes,immune function,as well as the number of acute attacks of COPD and the occurrence of adverse reactions were compared between the two groups before and after treatment.RESULTS Control group and observation group shed 12 and 9 patients,respectively.After treatment,the 6 minute walking distance of the two groups of patients was significantly prolonged compared with that before treatment(P<0.05).The COPD assessment test questionnaire score,St George’s respiratory questionnaire score,the ratio of residual volume to total lung capacity,the fractional exhaled nitric oxide,the serum levels of C-reactive protein and interleukin-6 were significantly decreased compared with those before treatment(P<0.05).The forced expiratory volume in one second(FEV1),the ratio of FEV1 to forced vital capacity,the percentage of the measured value of carbon monoxide diffusion capacity to the predicted value,and the percentage of the measured value of FEV1 to the predicted value were significantly increased compared with those before treatment(P<0.05).The improvement of the above indicators in the observation group was significantly better than that in the control group(P<0.05).Compared with before treatment,there was no statistical significance in the immune function indexes of the control group or the serum levels of immunoglobulin A(IgA)and IgM in the observation group after treatment(P>0.05).The percentages of CD3+,CD4+,B lymphocytes and natural killer cells,the levels of CD4+/CD8+and IgG were significantly increased in the observation group(P<0.05),the percentage of CD8+cells was significantly decreased(P<0.05),and the improvement degree of the observation group was significantly better than that of the control group(P<0.05).There was no significant difference in the number of acute exacerbations of COPD during the follow-up period and the incidence of adverse events during treatment between the two groups(P>0.05).CONCLUSIONS Budigafol combined with Staphylococcus and neisseria tablets can effectively improve the immune function of patients with stable moderate to severe COPD,further reduce the level of inflammation,and improve their exercise tolerance and their quality of life with good safety.