百令胶囊联合复方异丙托溴铵治疗慢性阻塞性肺疾病急性加重期患者的临床研究OA北大核心CSTPCD
Clinical trial of Bailing capsules combined with ipratropium bromide in the treatment of patients with acute exacerabation of chronic obstructive pulmonary disease
目的 观察百令胶囊联合吸入用复方异丙托溴铵溶液治疗慢性阻塞性肺疾病急性加重期(AECOPD)患者的临床疗效和安全性.方法 将AECOPD患者随机分为对照组和试验组.对照组给予雾化吸入复方异丙托溴铵每次2.5 mL,每天3次;试验组在对照组治疗的基础上,给予百令胶囊每次2.5 g,每天3次,口服.2组患者均治疗2周.比较2组患者的临床疗效、用力肺活量(FVC)、动脉血氧分压(PO2)及血清肿瘤坏死因子-α(TNF-α)、可溶性细胞间黏附分子-1(sICAM-1)、可溶性髓系细胞触发受体-1(sTREM-1)水平,以及药物不良反应的发生情况.结果 试验组和对照组均入组49例,均无患者脱落.治疗后,试验组和对照组的总有效率分别为95.92％(47例/49例)和83.67％(41例/49例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组的 FVC 分别为(2.89±0.41)和(2.66±0.35)L,PO2分别为(83.39±8.02)和(76.78±7.55)mmHg,动脉二氧化碳分压分别为(48.47±5.11)和(56.02±6.42)mmHg,TNF-α分别为(41.14±6.03)和(69.64±8.29)ng·L-1,sICAM-1 分别为(327.52±31.19)和(420.20±38.88)μg·L-1,sTREM-1 分别为(31.14±3.22)和(38.85±5.29)ng·L-1,在统计学上差异均有统计学意义(均P＜0.05).试验组的药物不良反应主要有恶心、上腹部不适,对照组的药物不良反应主要有上腹部不适.试验组和对照组的总药物不良反应发生率分别为4.08％和2.04％,在统计学上差异无统计学意义(P＞0.05).结论 百令胶囊联合吸入用复方异丙托溴铵溶液治疗AECOPD患者的临床疗效优于单用复方异丙托溴铵,且不增加药物不良反应的发生率.
Objective To observe the clinical efficacy and safety of Bailing capsules combined with compound ipratropium bromide solution inhalation in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Methods AECOPD patients were randomly divided into control group and treatment group.The control group was given compound ipratropium bromide 2.5 mL each time,3 times a day.On the basis of control group,the treatment group was given Bailing capsules 2.5 g,3 times a day,orally.Two groups were treated for 2 weeks.The clinical efficacy,forced vital capacity(FVC),arterial partial pressure of oxygen(PO2),serum levels of tumor necrosis factor-α(TNF-α),soluble intercellular adhesion molecule-1(sIC AM-1),soluble triggering receptor expressed on myeloid cells-1(sTREM-1)and adverse drug reactions were compared between two groups.Results Forty-nine patients were enrolled in both the treatment group and the control group,and no patients dropped out.After treatment,the total effective rates of treatment and control groups were 95.92％(47 cases/49 cases)and 83.67％(41 cases/49 cases)with significant difference(P＜0.05).After treatment,FVC of the treatment and control groups were(2.89±0.41)and(2.66±0.35)L;PO2 were(83.39±8.02)and(76.78±7.55)mmHg;arterial partial carbon dioxide pressure were(48.47±5.11)and(56.02±6.42)mmHg;the levels of TNF-α were(41.14±6.03)and(69.64±8.29)ng·L-1;the levels of sICAM-1 were(327.52±31.19)and(420.20±38.88)μg·L-1;the levels of sTREM-1 were(31.14±3.22)and(38.85±5.29)ng·L-1;the differences were statistically significant(all P＜0.05).The adverse drug reactions in treatment group were nausea and upper abdominal discomfort,which in control group were upper abdominal discomfort.The total incidences of adverse drug reactions in the treatment and control groups were 4.08％and 2.04％,without significant difference(P＞0.05).Conclusion The clinical efficacy of Bailing Capsules combined with compound ipratropium bromide solution inhalation in the treatment of AECOPD patients is better than that of compound ipratropium bromide alone,without increasing the incidence of adverse drug reactions.
石琛;高瑜;刘红艳;姬文兰;胡萍
陕西省结核病防治院、陕西省第五人民医院内四科,陕西西安 710100陕西省结核病防治院、陕西省第五人民医院内五科,陕西西安 710100
中医学
百令胶囊吸入用复方异丙托溴铵溶液慢性阻塞性肺疾病急性加重期临床疗效安全性评价
Bailing capsulecompound ipratropium bromide solution inhalationacute exacerbation of chronic obstructive pulmonary diseaseclinical efficacysafety evaluation
《中国临床药理学杂志》 2024 (003)
317-320 / 4
陕西省科学技术厅-陕西省重点研发计划基金资助项目(S2020-YF-YBSF-0042)
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