煤工尘肺雾化吸入α-糜蛋白酶和可必特的临床疗效观察

Clinical observation of α-chymotrypsin and Combivent by aerosol inhalation in treatment of coal workers' pneumoconiosis

目的探讨煤工尘肺合并肺功能损伤,临床症状处于平稳期的患者吸入α-糜蛋白酶及可必特(M受体阻滞剂与β2受体激动剂联合制剂)的疗效。方法随机抽取肺功能损伤患者123人,随机分成3组,能顺利完成试验者115人,其中,可必特组(35例)、α-糜蛋白酶组(48例)和对照组(32例)。3组患者同期开始接受雾化吸入治疗,可必特组每次雾化吸入可必特2.5 ml加3.5 ml注射用水,α-糜蛋白酶组每次雾化吸入α-糜蛋白酶4 000 U加6 ml注射用水,对照组雾化吸入注射用水6 ml。连续5 d给药,每天2次,每次15 min。分别于试验前及试验后测定受试者肺功能(FEV1、FVC、EVC、FEF25%～75%、MEF75%、MEF50%),以及受试者临床症状积分、平地6 min走距离等指标,及时记录药物不良反应,评估治疗依从性。结果用药前各组临床症状积分、6 min走距离、肺功能各项指标的差别均无统计学意义。治疗后可必特组:临床症状积分下降、6 min走距离增加与治疗前比较,差异具有统计学意义(均P<0.01),肺功能指标FEV1、MEF75%、EVC较治疗前明显改善(均P<0.05);糜蛋白酶组:6 min走距离增加与治疗前比较,差异有统计学意义(P<0.05),临床症状积分与治疗前比较,差异无统计学意义,肺功能指标EVC较治疗前明显增加(P<0.01)。对照组:临床症状积分、6 min走距离与治疗前比较差异无统计学意义(均P>0.05),治疗后较治疗前FEF25%～75%(P<0.01)、MEF50%(P<0.05),2项肺功能指标差异有统计学意义。3组用药疗效比较:对于EVC指标,糜蛋白酶组疗效优于对照组,P<0.05;可必特组FEV1、FEF25%～75%、MEF50%(均P<0.05)、MEF75%、EVC(P<0.01),5项肺功能指标改善程度优于对照组;可必特组对于MEF75%(P<0.01)、EVC(P<0.05)改善程度优于糜蛋白酶组。结论可必特既对小气道功能障碍改善,又对阻塞性通气功能障碍、限制性通气功能障碍指标作用显著,且不良反应较小,依从性好,煤工尘肺患者所罹患的阻塞性通气功能障碍、限制性通气功能障碍或混合性通气功能障碍患者雾化吸入可必特是较为理想的治疗方法;糜蛋白酶针对限制性通气功能障碍指标有非常显著的疗效,不良反应小,较易被患者接受,是限制性通气功能障碍患者改善肺通气功能治疗方法之一;注射用水对小气道功能有损伤,不宜单纯应用。

[Objective]To study the therapeutic effect of α-chymotrypsin and Combivent（M-receptor blocker combined with β2 receptor agonist） by aerosol inhalation in treatment of coal workers＇ pneumoconiosis（CWP） patients who were complicated with pulmonary dysfunction and had stable clinical symptoms.[Methods]Among 123 patients with pulmonary dysfunction,115 patients had completed the trial,and they were randomly divided into the Combivent group（35 cases）,α-chymotrypsin group（48 cases） and the control group（32 cases）.Three groups were treated with aerosol inhalation,Combivent group was given Combivent 2.5 ml with injection water 3.5 ml,α-chymotrypsin group was given α-chymotrypsin 4 000 U with injection water 6 ml,and the control group was given injection water 6 ml,for 5 days,twice daily,15 min for every time.The pulmonary function（FEV-1,FVC,EVC,FEF25%-75%,MEF75% and MEF 50%）,clinical symptom scores and six minute walking distance of patients before and after treatment were observed,the adverse reactions were recorded,and the compliance was evaluated.[Results]Before treatment,there was no significant difference in clinical symptom scores,six minute walking distance and pulmonary function indexes among three groups.After treatment,the clinical symptom scores in Combivent group were lower than those before treatment,and six minute walking distance was higher than that before treatment（both P0.01）.FEV-1,MEF75% and EVC had improved significantly compared with before treatment（all P0.05）.In α-chymotrypsin group,six minute walking distance was higher than that before treatment（P0.05）,there was no significant difference in clinical symptom scores,and EVC had improved significantly compared with before treatment（P0.01）.In the control group,there was no significant difference in clinical symptom scores and six minute walking distance between before and after treatment（both P0.05）.FEF25%-75%（P0.01） and MEF50%（P0.05） had improved significantly compared with before treatment.The effect of EVC inα-chymotrypsin group was better than that in the control group（P0.05）.The improvement of FEV-1（P0.05）,FEF25%-75%（P0.05）,MEF 50%（P0.05）,MEF 75%（P0.01） and EVC（P0.01） in Combivent group were better than those in the control group.The improvement of MEF 75%（P0.01） and EVC（P0.05） in Combivent group was better than those in α-chymotrypsin group.[Conclusion]Combivent can improve the small airway dysfunction,obstructive ventilatory disorder and restrictive ventilation dysfunction,and has less adverse reactions and good compliance.Combivent by aerosol inhalation is an ideal treatment method for CWP patients with obstructive ventilatory disorder,restrictive ventilatory dysfunction and mixed ventilatory dysfunction.The α-chymotrypsin has significant effect on restrictive ventilatory dysfunction with less adverse reactions,and it is easy to be accepted by patients,which is one of treatment method for restrictive ventilatory dysfunction.The injection water may damage the small airway function,so it is inadvisable to application alone.