老年患者万古霉素临床应用分析及安全性相关因素探讨

发布时间：2018-05-26 23:23

本文选题：万古霉素 + 老年患者　；参考：《中国人民解放军医学院》2014年硕士论文

【摘要】：目的：通过针对老年患者的万古霉素用药安全性监测及相关高风险点研究，，分析万古霉素相关性肾功能损害的危险因素，形成老年患者万古霉素用药评估样本数据，为建立万古霉素的合理用药核心评价指标提供数据支持；为老年患者高危药品目录品种筛选提供参考依据，降低临床用药风险。方法：采用多中心研究方法，分阶段观察应用万古霉素的老年住院患者个体概况、基础疾病、治疗方案、不良反应等药物应用情况及安全性相关因素。第一阶段采用回顾性研究方法，收集三家医院各40例病例进行预实验，并完善数据质量控制方案；第二阶段采用真实世界研究方法，收集13家医院各30例病例。重点分析用药行为合理性，根据用药前后肾功能指标变化及血药浓度监测的数据，分析血药谷浓度分布及血药浓度与患者年龄、肾功、疗效之间的关系。结果：纳入本研究的13所综合医院472例老年住院患者的用药情况显示，药品不良反应发生率为8.05%（38/472），万古霉素的药物利用指数（DUI）为0.77，临床选药符合用药适应症标准，针对致病菌用药占比为49.58%（234／472）；肾功能正常患者给药方案主要为1g， q12h，占40.71%，肾功能不全患者给药方案多为0.5g， q12h，占34.85%。用药前后血肌酐值、尿素氮值差异无统计学意义。472例老年患者中实施血药浓度监测166例、362次，其中342例次为血药谷浓度监测，20例次峰浓度监测。谷浓度值＜10mg.l-1所占比例最大（30.12%）。结论：1、临床应用中凭经验用药的比例过半，明显较高，给药浓度也偏高，说明临床按指证用药、按说明书规定溶媒配比的意识尚有待提高。2、虽然个体用药量整体偏低，但进一步分析可知其中肾功能不全组的用量明显低于肾功能正常组用量；患者的尿素氮、血清肌酐等肾功能监测值在万古霉素治疗前后无显著变化，说明临床医师较注意考虑用药与患者肾功能的内在联系。万古霉素导致肾功能损害的不良反应，提示临床医师应用万古霉素期间重视患者肾功能变化并个体调整治疗方案。3、血药浓度监测结果表明，肾功不全与肾功正常患者血药浓度监测比例未发现存在显著差异，但是多次监测后的监测值趋于正常浓度范围比例提高，提示借助血药浓度监测实施更精准的个体化用药调整、维持有效血药浓度范围、减少用药风险与耐药菌的产生很有必要。而对于复杂感染的患者，应根据患者病情和药疗目标，制定个体化有效目标浓度，在加强监测的同时适度突破有效浓度范围上限。与此同时应注意强调规范标本留取与采血时间。
[Abstract]:Objective: to analyze the risk factors of vancomycin-associated renal function damage in elderly patients by monitoring the safety of vancomycin use and to study the high risk points of vancomycin use in elderly patients, so as to form the sample data for evaluation of vancomycin use in elderly patients. To provide data support for establishing the core evaluation index of vancomycin, to provide reference for the selection of high risk drugs for elderly patients, and to reduce the risk of clinical use of vancomycin. Methods: Multi-center study was used to observe the application of vancomycin in aged inpatients in stages, such as individual profile, basic disease, treatment plan, adverse reaction and related factors of safety. In the first stage, 40 cases in three hospitals were collected for pre-experiment, and the data quality control scheme was improved. In the second stage, 30 cases in 13 hospitals were collected by real world method. According to the changes of renal function indexes and monitoring data of blood drug concentration before and after treatment, the relationship between serum drug concentration and age, renal function and curative effect was analyzed. Results: the drug use of 472 elderly inpatients in 13 general hospitals included in this study showed that the incidence of adverse drug reactions was 8.05 / 472%, the drug utilization index of vancomycin was 0.77, and the clinical drug selection was in accordance with the indication of drug use. The proportion of drug administration to pathogenic bacteria was 49.58% / 474%, and that of patients with normal renal function was 1g, q12h (40.71%), while that of patients with renal insufficiency was 0.5g, q12h (34.85g). There was no significant difference in serum creatinine and urea nitrogen before and after treatment. Among the 472 elderly patients, 166 patients were monitored for blood drug concentration for 362 times, 342 of which were monitored for 20 times of peak concentration. The maximum proportion of valley concentration < 10mg.l-1 was 30.12%. Conclusion: in clinical application, the proportion of drug used by experience is more than half, which is obviously higher, and the concentration of drug administration is also higher. It shows that the consciousness of prescribing the proportion of solute according to the instructions is still to be improved. 2, although the amount of individual drug is on the low side, the drug dosage of individual is on the low side. But further analysis showed that the dosage of renal insufficiency group was significantly lower than that of normal renal function group, and the renal function monitoring values such as urea nitrogen and serum creatinine had no significant change before and after vancomycin treatment. It shows that clinicians pay more attention to considering the internal relationship between drug use and renal function of patients. The adverse effects of vancomycin on renal function damage suggest that the clinicians pay attention to the changes of renal function and adjust the treatment regimen during the application of vancomycin. The results of monitoring the blood concentration of vancomycin indicate that, There was no significant difference in the blood drug concentration monitoring ratio between the patients with renal insufficiency and normal renal function, but the monitoring value tended to increase after repeated monitoring, suggesting that more accurate individualized drug use adjustment could be carried out with the help of blood drug concentration monitoring. It is necessary to maintain the effective range of blood drug concentration and reduce the risk of drug use and the production of drug resistant bacteria. For the patients with complicated infection, the individualized effective target concentration should be determined according to the patient's condition and the target of pharmacotherapy, and the upper limit of effective concentration should be appropriately broken through while the monitoring was strengthened. At the same time, attention should be paid to the standard specimen retention and blood collection time.
【学位授予单位】：中国人民解放军医学院
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R969.3

【参考文献】