盐酸氨溴索联合泼尼松治疗特发性肺间质纤维化急性加重期临床研究

Ambroxol Hydrochloride Combined with Prednisone in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

目的探讨盐酸氨溴索联合泼尼松治疗特发性肺间质纤维化(IPF)急性加重期的临床疗效。方法选取医院2015年10月至2018年9月收治的IPF急性加重期患者76例,按随机数字表法分为联合组与对照组,各38例。两组患者均给予常规疗法及醋酸泼尼松片,联合组患者在此基础上加用盐酸氨溴索片,均治疗3个月。结果治疗3个月后,两组患者最大通气量(MVV)、第1秒用力呼气容积/用力肺活量比值(FEV1/FVC)、一氧化碳弥散量(DLCO)、血氧分压(PaO2)、血酸碱度(p H)、6 min步行距离(6MWD)水平均较治疗前显著升高,且联合组明显高于对照组同期(P<0.05);两组患者血二氧化碳分压(PaCO2)水平及IPF患者报告临床结局(IPF-PRO)评分均较治疗前显著下降,且联合组明显低于对照组同期(P<0.05);治疗期间两组不良反应发生率相当(P>0.05)。结论盐酸氨溴索联合泼尼松治疗IPF急性加重期疗效显著,可显著改善患者肺功能、动脉血气运动耐量及生活质量,且安全性良好。

Objective To explore the clinical efficacy of ambroxol hydrochloride combined with prednisone in the treatment of acute exacerbation of idiopathic pulmonary fibrosis(IPF).Methods A total of 76 patients with acute exacerbation of IPF in the hospital from October 2015 to September 2018 were selected and divided into the combined group and control group according to the random number table method,38 cases in each group.The control group was given conventional therapy and prednisone acetate tablets,and the combined group was combined with ambroxol hydrochloride tablets on this basis.Both groups were treated for 3 months.Results After 3 months of treatment,the maximal voluntary ventilation(MVV),forced expiratory volume in 1 s/forced vital capacity(FEV1/FVC),diffusing capacity of carbon monoxide(DLCO),arterial blood gas indexes[partial pressure of blood oxygen(PaO2),partial pressure of blood carbon dioxide(PaCO2),blood pH(p H)],and 6 min walking distance(6 MWD)in the two groups were significantly increased compared with those before treatment,and the indexes in the combined group were significantly higher than those in control group(P<0.05).The PaCO2 levels and IPF patient reported outcome(IPF-PRO)scores in the two groups were significantly decreased compared with those before treatment,and the indexes in the combined group were significantly higher than those in control group(P<0.05).There were no significant differences in the adverse drug reactions rates between the two groups during the treatment(P>0.05).Conclusion Ambroxol hydrochloride combined with prednisone has prominent efficacy for acute exacerbation of IPF,which can significantly improve lung function,arterial blood gas exercise tolerance and quality of life,and has good safety.