罗沙替丁在重症患者应激性溃疡预防中的应用

Administration of Roxatidine in prevention of stress ulcer in critically ill patients

目的 分析罗沙替丁预防应激性溃疡(SU)的有效性和安全性.方法 选择2017年10月至2018年3月首都医科大学附属复兴医院重症监护病房(ICU)收治的入住时间≥5 d、机械通气时间>48 h、具有发生SU危险因素的成年患者作为研究对象,将患者随机分为试验组(罗沙替丁组)和对照组(奥美拉唑组).记录患者人口学资料、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)及入组1、3、5 d序贯器官衰竭评分(SOFA)、肠内营养和消化道出血情况.比较两组入组5 d内的胃液pH均值和pH≥4.0的时间占比;首次用药前及用药5 d结束后的胃液细菌培养和病原菌检测结果;入组1、3、5 d检测便潜血.记录是否出现不良反应、ICU住院时间及总住院时间及28 d预后.采用Logistic逐步回归分析应激性溃疡出血(SUB)发生的危险因素,比较发生SUB与未发生SUB患者的疾病严重程度、器官功能状态和营养支持治疗喂养量.结果 共入选患者36例,试验组和对照组各18例,两组患者性别、年龄、体质量指数(BMI)、APACHEⅡ评分及入组1、3、5 d SOFA评分、每24 h内胃液pH均值及pH≥4.0的时间占比、肠内营养治疗及消化道出血病例数、ICU住院时间及总住院时间、28 d病死率比较差异均无统计学意义(均P>0.05),研究期间无药物不良反应发生.Logistic回归模型提示,高血压为ICU内患者发生SUB的危险因素〔优势比(OR)=4.52,95%可信区间(95%CI)为1.06~19.23,P=0.042〕;发生SUB的患者与未发生SUB的患者在疾病严重程度和营养支持治疗喂养量比较差异均无统计学意义(均P>0.05).结论 注射用罗沙替丁与奥美拉唑在抑制胃酸分泌、控制SU、消化道出血等方面具有相似的疗效和安全性.

Objective To analyze the efficacy and safety of roxatidine in the prevention of stress ulcer(SU).Methods The adult patients admitted into the intensive care unit(ICU)of Fu Xing Hospital,Capital Medical University from October 2017 to March 2018 who had stayed in hospital for≥5 days,required mechanical ventilation>48 hours and had risk factors for occurring SU were recruited as the study objects.The patients were randomly divided into an experimental group(rosatidine group)and a control group(omeprazole group).Demographic data,acute physiology and chronic health evaluation Il(APACHE II)score and sequential organ failure assessment(SOFA)score on day 1,3 and 5 after enrolment,the situations of enteral nutrition support and gastrointestinal bleeding were recorded.The pH of gastric juice and the time ratio of pH≥4.0 within 5 days were compared between the two groups.Before the first administration and after the 5th day of final administration,bacterial cultures of gastric juice were performed,the pathogenic bacteria were tested and the examination results were recorded.Fecal occult blood was detected on day 1,3 and 5 after enrolment.The incidence of adverse reactions,the times of ICU stay and total hospitalization and 28-day prognosis were recorded.Logistic regression was used to analyze the risk factors for the occurrence of stress ulcer bleeding(SUB),and the degree of disease severity,organ function status and feeding amount of nutritional support treatment between the patients with and without SUB were compared.Results A total of 36 patients were recruited,18 in experimental group and 18 in control group.There were no statistical significant differences between the two groups in gender,age,body mass index(BMI),APACHE II score and SOFA scores on the lst,3rd and 5th day afer recruitment,average pH value of gastric juice in every 24 hours and the time ratio of pH≥4.0,the numbers of cases treated with enteral nutrition and of cases of gastrointestinal bleeding,lengths of ICU stay and total hospitalization and 28-day mortality(all P>0.05).No adverse effects related to the drugs were found during the study.Logistic regression model showed that hypertension was a risk factor for the occurrence of SUB in ICU patients[odds rate(OR)=4.52,95%confidence interval(95%CI)was 1.06-19.23,P=0.042);there were no statistical significant differences in disease severity and nutritional support feeding amount between patients with and without SUB occurrence(both P>0.05).Conclusion The roxatidine and omeprazole injections have similar efficacy and safety in inhibiting gastric acid secretion,controlling SU and gastrointestinal hemorhage,etc.aspects.