糜蛋白酶注射剂联合盐酸氨溴索注射液治疗慢性阻塞性肺疾病的临床研究

Clinical trial of chymotrypsin injection combined with ambroxol hydrochloride injection in the treatment of chronic obstructive pulmonary disease

目的探讨糜蛋白酶联合盐酸氨溴索治疗慢性阻塞性肺疾病的临床疗效和安全性。方法将85例慢性阻塞性肺疾病急性加重期患者通过随机数表法分为试验组45例和对照组40例,在常规治疗基础上,对照组给予盐酸氨溴索注射液雾化治疗,剂量15 mg,bid;试验组在对照组基础上,联合注射用糜蛋白酶雾化治疗,剂量4000 U,bid;2组均连续治疗7 d。比较2组临床疗效、血气指标、炎症因子、氧化应激产物的变化及药物不良反应。结果治疗后,试验组和对照组临床疗效总有效率分别为88.89%(40例/45例)和70.00%(28例/40例),差异有统计学意义(P<0.05);试验组和对照组动脉血氧分压(PaO2)分别为(85.18±7.33)和(73.95±9.97)mmHg,二氧化碳分压(PaCO2)分别为(39.89±5.62)和(46.90±6.90)mmHg,肿瘤坏死因子-α(TNF-α)分别为(15.99±2.23)和(24.96±2.75)ng·L^-1,白介素-6(IL-6)分别为(38.85±4.05)和(53.24±5.15)ng·L^-1,高敏C反应蛋白(hs-CRP)分别为(8.14±1.71)和(12.14±1.82)mg·L^-1,丙二醛(MDA)分别为(4.16±0.58)和(6.39±1.22)mmol·L^-1,超氧化物歧化酶(SOD)分别为(105.61±16.11)和(89.17±8.49)U·mL^-1,差异均有统计学意义(均P<0.05);试验组出现恶心呕吐3例,药物不良反应发生率为6.67%(3例/45例),对照组出现恶心呕吐2例,药物不良反应发生率为5.00%(2例/40例),2组药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论糜蛋白酶联合盐酸氨溴索治疗慢性阻塞性肺疾病的疗效显著,可有效改善炎症因子、氧化应激产物表达,提高临床疗效,且不增加药物不良反应。

Objective To observe the efficacy and safety of chymotrypsin combined with ambroxol hydrochloride in treatment of chronic obstructive pulmonary disease.Methods A total of 85 patients with acute exacerbation of chronic obstructive pulmonary disease were randomLy divided into treatment group group(45 cases)and control group(40 cases),on the basis of routine treatment,the control group was given ambroxol hydrochloride injection atomization treatment,the dose was 15 mg,bid;the treatment group was treated with chymotrypsin injection on the basis of the control group,the dose was 4000 U,bid;the 2 groups were treated continuously for 7 days.The clinical efficacy,the changes of blood gas index,inflammatory factors,oxidative stress products and adverse drug reactions were compared between the 2 groups.Results After treatment,the total effective rates in the treatment group and the control group were 88.89%(40 cases/45 cases)and 70.00%(28 cases/40 cases),respectively,with significant difference(P<0.05);the arterial partial pressure of oxygen(PaO2)in the treatment group and the control group were(85.18±7.33)and(73.95±9.97)mmH g,respectively.The arterial partial pressure of carbon dioxide(PaCO2)were(39.89±5.62)and(46.90±6.90)mmH g,respectively.The tumor necrosis factor-α(TNF-α)were(15.99±2.23)and(24.96±2.75)ng·L^-1,respectively.The interleukin-6(IL-6)were(38.85±4.05)and(53.24±5.15)ng·L^-1,respectively.The high-sensitivity C-reactive protein(hs-CRP)were(8.14±1.71)and(12.14±1.82)mg·L^-1,respectively.The malondialdehyde(MDA)(4.16±0.58)and(6.39±1.22)mmol·L^-1,respectively.The superoxide dismutase(SOD)were(105.61±16.11)and(89.17±8.49)U·mL^-1,respectively,with significant difference(all P<0.05);there were 3 cases of nausea and vomiting in the treatment group,the incidence of adverse drug reactions was 6.67%(3 cases/45 cases),there were 3 cases of nausea and vomiting in the control group,the incidence of adverse drug reactions was 5.00%(2 cases/40 cases),there was no significant difference in the incidence of adverse drug reactions between the two groups(P>0.05).Conclusion Chymotrypsin combined with ambroxol hydrochloride is well for chronic obstructive pulmonary disease,which can effectively improve the expression of inflammatory factors and oxidative stress products,improve clinical efficacy,and do not increase adverse drug reactions.