甲泼尼龙注射剂联合氨溴索注射液治疗哮喘患者的临床研究

Clinical trial of methylprednisolone injection combined with ambroxol injection in the treatment of patients with asthma

目的探究甲泼尼龙联合氨溴索治疗哮喘患者的疗效及其对血清细胞因子的影响。方法将80例哮喘患者随机分为对照组(40例)和试验组(40例)。对照组给予静脉滴注注射用甲泼尼龙琥珀酸钠,每次80 mg,qd;试验组在对照组治疗的基础上,给予静脉滴注盐酸氨溴索注射液,每次100 mL,bid。2组均连续治疗7 d。治疗后,比较2组患者的最大呼气峰值流速(PEF)、第1秒用力呼气容积(FEV1)、用力肺活量(FVC),用酶联免疫吸附实验法检测血清白细胞介素-6(IL-6)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子-α(TNF-α)水平,记录2组咳嗽、气促、哮鸣音、湿啰音等各症状体征缓解时间及药物不良反应情况。结果治疗后,试验组和对照组的总有效率分别为92.50%(37例/40例)和75.00%(30例/40例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FEV1分别为(1.42±0.26)和(1.29±0.13)L,FVC分别为(1.88±0.32)和(1.68±0.28)L,PEF分别为(2.97±0.85)和(2.60±0.67)L·s^(-1),血清IL-6水平分别为(7.59±0.96)和(11.38±1.17)pg·mL^(-1),hs-CRP水平分别为(11.95±1.27)和(18.61±1.32)mg·L^(-1),TNF-α水平分别为(31.48±3.65)和(39.58±4.30)ng·L^(-1),咳嗽缓解时间分别为(3.94±0.97)和(4.44±1.04)d,气促缓解时间分别为(3.93±1.07)和(4.54±1.13)d,哮鸣音缓解时间分别为(4.69±1.04)和(5.19±1.13)d,湿啰音缓解时间分别为(4.84±1.09)和(5.63±1.11)d。试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为7.50%和5.50%,差异无统计学意义(P>0.05)。结论甲泼尼龙联合氨溴索治疗哮喘可改善肺通气功能,改善气道炎症,调节免疫平衡,缓解哮喘病情,安全性高。

Objective To investigate the efficacy of methylprednisolone combined with ambroxol in the treatment of asthma and its effect on serum cytokines.Methods Eighty patients with asthma were randomly divided into control group(40 cases)and treatment group(40 cases).The control group was given intravenous drip of methylprednisolone sodium succinate for injection 80 mg each time,qd;based on control group,treatment group was given intravenous drip of ambroxol hydrochloride injection,100 mL each time,bid.The treatment time of both groups was 7 days.After treatment,peak expiratory flow rate(PEF),forced expiratory volume in the first second(FEV1),and forced vital capacity(FVC)were compared between the two groups,and serum interleukin-6(IL-6),hypersensitive C-reactive protein(hs-CRP),and tumor necrosis factor-α(TNF-α)levels were measured by enzyme-linked immunosorbent assay.The remission time of various symptoms and signs such as cough,shortness of breath,wheezing,and wet rales,adverse drug reactions were recorded in the two groups.Results After treatment,the total effective rate of the control group and treatment group were 92.50%(37 cases/40 cases)and 75.00%(30 cases/40 cases),respectively,the difference was statistically significant(P<0.05).After treatment,FEV1 were(1.42±0.26)and(1.29±0.13)L,FVC were(1.88±0.32)and(1.68±0.28)L,PEF were(2.97±0.85)and(2.60±0.67)L·s^(-1),serum IL-6 level were(7.59±0.96)and(11.38±1.17)pg·mL^(-1),hs-CRP level were(11.95±1.27)and(18.61±1.32)mg·L^(-1),TNF-αlevel were(31.48±3.65)and(39.58±4.30)ng·L^(-1),cough remission time were(3.94±0.97)and(4.44±1.04)d,shortness of breath remission time were(3.93±1.07)and(4.54±1.13)d,wheezing remission time were(4.69±1.04)and(5.19±1.13)d,wet rales remission were(4.84±1.09)and(5.63±1.11)d.The differences in the above indicators between the two groups had statistical significance(all P<0.05).The incidence rate of total adverse drug reactions in the control group was 7.50%and 5.50%,respectively,and the difference had no statistical significance(P>0.05).Conclusion Methylprednisolone combined with ambroxol can improve pulmonary ventilation function,airway inflammation,regulate immune balance and relieve asthma in the treatment of asthma,with high safety.