本文選題：萬古霉素 + 老年患者��； 參考：《中國人民解放軍醫(yī)學院》2014年碩士論文

【摘要】：目的：通過針對老年患者的萬古霉素用藥安全性監(jiān)測及相關(guān)高風險點研究，，分析萬古霉素相關(guān)性腎功能損害的危險因素，形成老年患者萬古霉素用藥評估樣本數(shù)據(jù)，為建立萬古霉素的合理用藥核心評價指標提供數(shù)據(jù)支持；為老年患者高危藥品目錄品種篩選提供參考依據(jù)，降低臨床用藥風險。 方法：采用多中心研究方法，分階段觀察應(yīng)用萬古霉素的老年住院患者個體概況、基礎(chǔ)疾病、治療方案、不良反應(yīng)等藥物應(yīng)用情況及安全性相關(guān)因素。第一階段采用回顧性研究方法，收集三家醫(yī)院各40例病例進行預(yù)實驗，并完善數(shù)據(jù)質(zhì)量控制方案；第二階段采用真實世界研究方法，收集13家醫(yī)院各30例病例。重點分析用藥行為合理性，根據(jù)用藥前后腎功能指標變化及血藥濃度監(jiān)測的數(shù)據(jù)，分析血藥谷濃度分布及血藥濃度與患者年齡、腎功、療效之間的關(guān)系。 結(jié)果：納入本研究的13所綜合醫(yī)院472例老年住院患者的用藥情況顯示，藥品不良反應(yīng)發(fā)生率為8.05%（38/472），萬古霉素的藥物利用指數(shù)（DUI）為0.77，臨床選藥符合用藥適應(yīng)癥標準，針對致病菌用藥占比為49.58%（234／472）；腎功能正�；颊呓o藥方案主要為1g， q12h，占40.71%，腎功能不全患者給藥方案多為0.5g， q12h，占34.85%。用藥前后血肌酐值、尿素氮值差異無統(tǒng)計學意義。472例老年患者中實施血藥濃度監(jiān)測166例、362次，其中342例次為血藥谷濃度監(jiān)測，20例次峰濃度監(jiān)測。谷濃度值＜10mg.l-1所占比例最大（30.12%）。 結(jié)論：1、臨床應(yīng)用中憑經(jīng)驗用藥的比例過半，明顯較高，給藥濃度也偏高，說明臨床按指證用藥、按說明書規(guī)定溶媒配比的意識尚有待提高。2、雖然個體用藥量整體偏低，但進一步分析可知其中腎功能不全組的用量明顯低于腎功能正常組用量；患者的尿素氮、血清肌酐等腎功能監(jiān)測值在萬古霉素治療前后無顯著變化，說明臨床醫(yī)師較注意考慮用藥與患者腎功能的內(nèi)在聯(lián)系。萬古霉素導(dǎo)致腎功能損害的不良反應(yīng)，提示臨床醫(yī)師應(yīng)用萬古霉素期間重視患者腎功能變化并個體調(diào)整治療方案。3、血藥濃度監(jiān)測結(jié)果表明，腎功不全與腎功正常患者血藥濃度監(jiān)測比例未發(fā)現(xiàn)存在顯著差異，但是多次監(jiān)測后的監(jiān)測值趨于正常濃度范圍比例提高，提示借助血藥濃度監(jiān)測實施更精準的個體化用藥調(diào)整、維持有效血藥濃度范圍、減少用藥風險與耐藥菌的產(chǎn)生很有必要。而對于復(fù)雜感染的患者，應(yīng)根據(jù)患者病情和藥療目標，制定個體化有效目標濃度，在加強監(jiān)測的同時適度突破有效濃度范圍上限。與此同時應(yīng)注意強調(diào)規(guī)范標本留取與采血時間。
[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.
【學位授予單位】：中國人民解放軍醫(yī)學院
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R969.3

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