發(fā)布時(shí)間：2018-03-28 14:21

  本文選題：藥物不良事件　切入點(diǎn)：主動(dòng)監(jiān)測(cè)　出處：《中國(guó)人民解放軍醫(yī)學(xué)院》2017年碩士論文

【摘要】：研究背景:藥品不良反應(yīng)(Adverse Drug Reaction,ADR )監(jiān)測(cè)是藥品安全性監(jiān)測(cè)的主要手段,是藥品上市后評(píng)價(jià)的重要組成部分。自動(dòng)監(jiān)測(cè)作為藥品上市后安全性研究的新方法,具有良好的發(fā)展前景。解放軍總醫(yī)院團(tuán)隊(duì)研發(fā)的“醫(yī)療機(jī)構(gòu)ADE主動(dòng)監(jiān)測(cè)與智能評(píng)估警示系統(tǒng)”在量化指標(biāo)的自動(dòng)監(jiān)測(cè)方面取得了較好的成績(jī),但由于無(wú)法利用醫(yī)療電子檔案中的非結(jié)構(gòu)文本數(shù)據(jù),監(jiān)測(cè)項(xiàng)目受到局限,系統(tǒng)功能有待擴(kuò)展。研究目的:本研究旨在開(kāi)展基于文本信息的變態(tài)反應(yīng)ADE主動(dòng)監(jiān)測(cè)關(guān)鍵技術(shù)研究及模塊開(kāi)發(fā),并制訂自動(dòng)監(jiān)測(cè)系統(tǒng)的規(guī)范化操作流程,擴(kuò)展系統(tǒng)的應(yīng)用范圍,強(qiáng)化優(yōu)質(zhì)電子醫(yī)療病歷資源的利用與藥品安全性再評(píng)價(jià)研究。研究方法:(1)探索基于醫(yī)療文本信息的ADE自動(dòng)監(jiān)測(cè)技術(shù),將變態(tài)反應(yīng)模塊分為皮膚類變態(tài)反應(yīng)及過(guò)敏性休克兩部分,通過(guò)建立特征詞集、生成自然語(yǔ)言分析器、完成文本分類器的輸出、模塊測(cè)試等步驟,完成變態(tài)反應(yīng)自動(dòng)監(jiān)測(cè)模塊的開(kāi)發(fā)。(2)結(jié)合前期工作基礎(chǔ),總結(jié)經(jīng)驗(yàn),梳理、制定自動(dòng)監(jiān)測(cè)系統(tǒng)規(guī)范化操作流程,繪制流程圖,為多中心藥物評(píng)價(jià)研究提供應(yīng)用指導(dǎo)。(3)在上述研究的基礎(chǔ)上,開(kāi)展注射用鹽酸羅沙替丁醋酸酯的安全性再評(píng)價(jià)自動(dòng)監(jiān)測(cè)實(shí)踐,包括血小板減少、血紅蛋白減少、白細(xì)胞減少、肝功能損害、腎功能損害、胰酶異常、皮膚類變態(tài)反應(yīng)、過(guò)敏性休克、心律失常等9個(gè)方面ADR事件。研究結(jié)果:(1)開(kāi)發(fā)完成變態(tài)反應(yīng)監(jiān)測(cè)模塊符合“醫(yī)療機(jī)構(gòu)ADE主動(dòng)監(jiān)測(cè)及智能評(píng)估警示系統(tǒng)”框架原則,基本實(shí)現(xiàn)了設(shè)計(jì)需求。并在隨后變態(tài)反應(yīng)模塊測(cè)試過(guò)程中獲得了 14042例注射用頭孢曲松鈉、13818例注射用尖吻蝮蛇血凝酶在真實(shí)世界的皮膚類變態(tài)反應(yīng)發(fā)生率,分別為0.33%、0.065%,和11969丹參酮ⅡA磺酸鈉注射液、11281例馬來(lái)酸桂哌齊特注射液、25280例注射用頭孢曲松鈉的過(guò)敏性休克及過(guò)敏樣反應(yīng)的發(fā)生率,分別是 0.025%、0.018%、0.0079%。(2)制訂了自動(dòng)監(jiān)測(cè)系統(tǒng)的規(guī)范化操作流程,并貫以詳細(xì)的監(jiān)測(cè)路線流程圖。(3)完成9284例注射用鹽酸羅沙替丁醋酸酯用藥人群9種ADR主動(dòng)監(jiān)測(cè)與評(píng)價(jià)研究,發(fā)生率分別是:肝功能損害0.93%-1.04%,血紅蛋白減少0.20%-0.23%,白細(xì)胞減少0.13%-0.15%,血小板減少0.11%-0.12%,腎功能損害0.28%,胰酶異常0.01%,皮膚類變態(tài)反應(yīng)0.05%,心律失常0.08%;總體發(fā)生率1.79%( 95%CI: 1.62%-2.06%);過(guò)敏性休克病例0;表明該藥在臨床規(guī)范用藥情況下的整體風(fēng)險(xiǎn)性較小,但用藥時(shí)長(zhǎng)、患者年齡等為ADR發(fā)生的危險(xiǎn)因素,應(yīng)予以關(guān)注。結(jié)論:開(kāi)發(fā)完成變態(tài)反應(yīng)監(jiān)測(cè)模塊采用的貝葉斯網(wǎng)絡(luò)和決策樹(shù)分類算法成熟,文本分類性能良好,能夠滿足藥品安全性主動(dòng)監(jiān)測(cè)的的需要,特別是皮膚類變態(tài)反應(yīng)模塊的敏感度、準(zhǔn)確度均達(dá)到了較高水平。自動(dòng)監(jiān)測(cè)流程的梳理為降低系統(tǒng)使用難度,保障研究成果質(zhì)量的穩(wěn)定性方面做出了貢獻(xiàn),并得到籍此開(kāi)展的大樣本真實(shí)世界藥物安全評(píng)價(jià)研究的結(jié)果支持。
[Abstract]:Research background: adverse drug reactions (Adverse Drug, Reaction, ADR) is the main means of monitoring drug safety monitoring, is an important part of the postmarketing evaluation. As a new method for automatic monitoring of the safety of marketed medicines, with good prospects for development. The Liberation Army General Hospital Research Team "medical ADE active surveillance has achieved good results in the automatic monitoring of quantitative indicators and warning system of intelligent evaluation, but unable to use unstructured text data in electronic medical archives, monitoring project is limited, the system function to be extended. The purpose of this study was to carry out research on the key technology and the development of active monitoring module allergy ADE text based on the information, and to develop standardized automatic monitoring system operation process, expand the application range, strengthen the quality of electronic medical records and resources With the drug safety evaluation research. Research methods: (1) to explore the medical text information automatic monitoring technology based on ADE, the module is divided into two parts of allergic skin allergy and allergic shock, characterized by the establishment of a set of words that generate natural language parser, complete output text classifier, step test module so, complete allergy automatic monitoring module development. (2) based on previous work, sum up experience, combing, making the automatic monitoring system of standardized operation flow, flow chart, provide guidance for the evaluation of application of multi center drugs. (3) on the basis of the above research, and practice to carry out safety evaluation of automatic monitoring Roxatidine Acetate Hydrochloride For Injection, including thrombocytopenia, decreased hemoglobin, leukopenia, liver damage, kidney damage, abnormal skin allergy pancreatin, and anaphylactic shock, Arrhythmia in 9 aspects of ADR events. Results: (1) developed allergic reaction monitoring module in accordance with the "medical institutions ADE assessment of active monitoring and intelligent warning system" framework of principles, the basic realization of the design requirements. And obtained 14042 cases of Ceftriaxone Sodium for Injection in the subsequent testing of allergic reaction module, the incidence of 13818 cases in Haemocoagulase Agkistrodon for Injection the real world of skin allergy, were 0.33%, 0.065%, and 11969 of sodium tanshinone A sulfonate injection, 11281 cases of Cinepazide Maleate Injection, the incidence of anaphylaxis and anaphylactoid reaction in 25280 cases of Ceftriaxone Sodium for Injection, respectively is 0.025%, 0.018%, 0.0079%. (2) developed a standardized automatic monitoring system operation process and through a detailed flow chart of monitoring line. (3) 9284 cases completed with hydrochloric acid injection of roxatidine acetate medication group 9 ADR Active monitoring and evaluation, the incidence of liver damage were: 0.93%-1.04%, decreased hemoglobin 0.20%-0.23%, leukopenia 0.13%-0.15% thrombocytopenic 0.11%-0.12%, 0.28% renal dysfunction, abnormal trypsin 0.01%, skin allergy 0.05%, arrhythmia in 0.08%; the overall incidence rate of 1.79% (95%CI: 1.62%-2.06%); 0 cases showed allergic shock; the drug in the clinical standard medication case of overall risk is small, but the medication duration, patient age and other risk factors of ADR, which should be paid more attention. Conclusion: the completion of the development of Bayesian networks and decision tree classification of variable state reaction monitoring module adopts the mature algorithm, text classification performance is good, can satisfy the needs of the drug active safety monitoring, especially the skin allergy module sensitivity and accuracy have reached a high level. The automatic monitoring processes in order to reduce system We have made contributions to the difficulty of using, ensuring the stability of the quality of the research results, and supported the results of the large sample real world drug safety evaluation carried out.

【學(xué)位授予單位】：中國(guó)人民解放軍醫(yī)學(xué)院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R95

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