奥司他韦治疗病毒性肺炎患者的疗效及肺泡表面活性蛋白基因多态性的临床研究OA
Clinical trial on the efficacy of oseltamivir in treating viral pneumonia patients and the polymorphism of pulmonary surfactant protein genes
目的 探究奥司他韦颗粒治疗病毒性肺炎肺损伤患者的临床疗效与安全性.方法 将本院成人急性重症病毒性肺炎患者按随机数表法分为对照组和试验组,所有入组患者均接受基础对症治疗,对照组给予利巴韦林注射液静脉滴注,每次0.5g,bid,治疗7 d;试验组给予磷酸奥司他韦颗粒口服,每次75 mg,bid,治疗5 d.比较2组肺泡表面活性蛋白B(SP-B)基因多态性、临床疗效、肺损伤标志物、炎症因子水平,并进行安全性评价.结果 共入组128例,对照组和试验组各64例,对照组脱落4例,对照组最终纳入60例.治疗后,对照组和试验组临床总有效率分别为75.00%(45例/60例)和92.19%(59例/64例),在统计学上差异有统计学意义(P<0.05).治疗后,对照组和试验组住院时长分别为(13.25±2.46)和(10.18±2.12)d,机械通气时间分别为(7.52±1.86)和(5.36±1.54)d,白细胞介素-1β 水平(IL-1β)分别为(36.59±3.32)和(34.68±3.29)pg·mL-1,IL-6 水平分别为(55.40±3.05)和(52.68±2.89)ng·L-1,肿瘤坏死因子-α(TNF-α)水平分别为(59.60±4.29)和(57.30±3.78)ng·L-1,肺泡细胞表面抗原(KL-6)水平分别为(499.12±70.22)和(470.28±67.14)U·mL-1,SP-D 分别为(256.44±34.66)和(239.38±32.31)ng·mL-1,野生型基因型分别占80.00%(48例/60例)和62.50%(40例/64例),野生型等位基因分别占91.67%(110例/120例)和78.13%(100例/128例),试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).经Pearson相关分析,在病毒性肺炎肺损伤患者中基因多态性与IL-1 β、IL-6、TNF-α、高敏C反应蛋白(hs-CRP)、KL-6、SP-D均呈显著正相关(均P<0.05).试验组的药物不良反应有恶心呕吐、腹泻腹痛、头晕头痛、失眠、贫血、肝功能异常、肾功能异常等.试验组和对照组的药物不良反应总发生率分别为31.25%(20例/64例)和26.67%(16例/60例),在统计学上差异无统计学意义(P>0.05).结论 SP-B基因多态性可能是影响奥司他韦颗粒治疗流感病毒性肺炎疗效的潜在生物标志物之一,需进一步验证.
Objective To explore the clinical efficacy and safety of oseltamivir granules in the treatment of patients with lung injury induced by viral pneumonia.Methods Adult patients with severe acute viral pneumonia admitted to our hospital were divided into control group and treatment group by the random number table method.All enrolled patients received basic symptomatic treatment.The control group was given ribavirin by intravenous infusion at a dose of 0.5 g twice daily for 7 days;the treatment group was administered oral oseltamivir phosphate granules at 75 mg twice daily for 5 days.The two groups were compared in terms of surfactant protein B(SP-B)gene polymorphism,lung injury markers and inflammatory factor levels,and safety evaluation was performed.Results A total of 128 patients were enrolled,with 64 cases in each group.Four patients dropped out from the control group,leaving 60 cases for final analysis in this group.After treatment,the total clinical effective rates of the control group and treatment group were 75.00%(45 cases/60 cases)and 92.19%(59 cases/64 cases),respectively,with statistically significant difference(P<0.05).After treatment,the length of hospital stay was(13.25±2.46)days in the control group and(10.18±2.12)days in the treatment group;the duration of mechanical ventilation was(7.52±1.86)and(5.36±1.54)days,respectively;the levels of interleukin-1 β(IL-1 β)were(36.59±3.32)and(34.68±3.29)pg·mL-1;IL-6 were(55.40±3.05)and(52.68±2.89)ng·L-1;tumor necrosis factor-α(TNF-α)were(59.60±4.29)and(57.30±3.78)ng·L-1;Krebs von den Lungen-6(KL-6)were(499.12±70.22)and(470.28±67.14)U·mL-1;SP-D were(256.44±34.66)and(239.38±32.31)ng·mL-1;the proportion of wild-type genotype was 80.00%(48 cases/60 cases)and 62.50%(40 cases/64 cases),the frequency of wild-type allele was 91.67%(110 cases/120 cases)and 78.13%(100 cases/128 cases).All above indicators showed statistically significant differences between the treatment group and the control group(all P<0.05).Pearson correlation analysis confirmed that SP-B gene polymorphism was positively correlated with IL-1 β,IL-6,TNF-α,high-sensitivity c-reactive protein(hs-CRP),KL-6 and SP-D in patients with viral pneumonia complicated with lung injury(all P<0.05).Adverse drug reactions in the treatment group included nausea and vomiting,diarrhea and abdominal pain,dizziness and headache,insomnia,anemia,abnormal liver function and abnormal renal function.The total incidence of adverse drug reactions was 31.25%(20 cases/64 cases)in the treatment group and 26.67%(16 cases/60 cases)in the control group,without statistically significant difference(P>0.05)
赵兴敏;张国庆;段伟静;刘艳萍;杨逢永
济南市人民医院 药剂科,山东济南 271100济南市人民医院 药剂科,山东济南 271100济南市人民医院 药剂科,山东济南 271100济南市人民医院 药剂科,山东济南 271100济南市人民医院 急诊重症监护室,山东济南 271100
医药卫生
奥司他韦颗粒病毒性肺炎肺损伤肺泡表面活性蛋白基因多态性
oseltamivir granuleviral pneumonialung injurypulmonary surfactant-associated proteingene polymorphism
《中国临床药理学杂志》 2026 (13)
1814-1819,6
济南市科技局临床医学创新计划基金资助项目(202225068)
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