【摘要】：類風(fēng)濕性關(guān)節(jié)炎是一種慢性疾病,類風(fēng)濕性關(guān)節(jié)炎患者在治療該疾病過程中往往需要長期用藥、聯(lián)合用藥。同時,因藥物劑量、劑型、用藥時間以及患者個體差異等因素的影響,會發(fā)生一些與藥物相關(guān)的不良反應(yīng)。因此,對此類藥物誘發(fā)的藥物不良反應(yīng)進(jìn)行監(jiān)測十分必要。本文應(yīng)用北京市藥品不良反應(yīng)監(jiān)測中心自發(fā)呈報系統(tǒng)數(shù)據(jù)庫數(shù)據(jù),經(jīng)過對數(shù)據(jù)的規(guī)范及整理,采用多種數(shù)據(jù)挖掘方法并輔助計算機技術(shù)對抗類風(fēng)濕性關(guān)節(jié)炎藥物發(fā)生不良反應(yīng)報告進(jìn)行深入分析,針對類風(fēng)濕性關(guān)節(jié)炎用藥后所產(chǎn)生不良反應(yīng)報告的人口學(xué)特點,以及對用藥安全性差異等方面進(jìn)行研究,以期更好的提供有效信息,促進(jìn)該類用藥風(fēng)險/收益的平衡,保障患者的用藥安全。本文分析了抗類風(fēng)濕性關(guān)節(jié)炎藥物的進(jìn)展情況及安全性監(jiān)測的現(xiàn)狀,指出在當(dāng)前狀況下對抗類風(fēng)濕性關(guān)節(jié)炎藥物進(jìn)行監(jiān)測的必要性與重要性;從年齡、性別、不良反應(yīng)所累及系統(tǒng)和器官及不同給藥途徑等角度對所引發(fā)的不良反應(yīng)進(jìn)行了分析,研究結(jié)果表明隨著患者年齡的不斷增加,藥品不良反應(yīng)發(fā)生頻率增高、嚴(yán)重程度也再加重;應(yīng)用抗類風(fēng)濕性關(guān)節(jié)炎藥物所誘發(fā)的不良反應(yīng)累及的器官和系統(tǒng)最多的是皮膚系統(tǒng)、消化系統(tǒng)、神經(jīng)系統(tǒng)和循環(huán)系統(tǒng);采用多種數(shù)據(jù)挖掘方法(包括ROR法和BCPNN法)對抗類風(fēng)濕性關(guān)節(jié)炎藥物不良反應(yīng)報告進(jìn)行深入剖析,找出異常風(fēng)險信號,為臨床用藥提供警示;采用Logistic模型分析來氟米特和甲氨蝶呤聯(lián)合用藥情況,發(fā)現(xiàn)對于特定人群面臨“肝功能異�！边@一不良反應(yīng)的風(fēng)險與兩種藥物各自單獨應(yīng)用比較會增加;輔助計算機技術(shù),在參照藥品說明書中所列的不良反應(yīng)信號的基礎(chǔ)上,共發(fā)現(xiàn)新的不良反應(yīng)信號共計97個,其中嚴(yán)重不良反應(yīng)信號12個,為藥品上市后再評價提供了有效數(shù)據(jù)。針對目前國內(nèi)藥物不良反應(yīng)安全性監(jiān)測的現(xiàn)狀和問題,提出了完善藥品不良反應(yīng)報告管理制度、開放藥品不良反應(yīng)信息查詢網(wǎng)絡(luò)、健全藥品不良反應(yīng)上報激勵機制及設(shè)立專項救助基金等可行的對策及建議。
[Abstract]:Rheumatoid arthritis is a chronic disease. Patients with rheumatoid arthritis often need long-term medication and combined medication in the treatment of rheumatoid arthritis. At the same time, some adverse reactions related to drugs will occur due to the influence of drug dose, dosage form, drug use time and individual differences of patients. Therefore, it is necessary to monitor the adverse drug reactions induced by these drugs. In this paper, the database data of spontaneous reporting system of Beijing adverse Drug reaction Monitoring Center are used to standardize and collate the data. A variety of data mining methods and computer technology were used to analyze the adverse reactions of rheumatoid arthritis drugs, and the demographic characteristics of adverse reactions after treatment of rheumatoid arthritis were analyzed. In order to provide effective information, promote the balance of risk / income of this kind of drug use, and ensure the safety of drug use, the safety of drug use was studied in order to provide effective information, promote the balance of risk / benefit of this kind of drug use, and study the difference of safety of drug use. In this paper, the progress of anti-rheumatoid arthritis drugs and the present situation of safety monitoring were analyzed, and the necessity and importance of monitoring anti-rheumatoid arthritis drugs under the current situation were pointed out. The adverse reactions caused by age, sex, system and organs involved in adverse reactions and different routes of administration were analyzed. the results showed that the frequency of adverse drug reactions increased with the increasing age of patients. The severity is also aggravated; The organs and systems involved in the adverse reactions induced by antirheumatoid arthritis drugs were the skin system, digestive system, nervous system and circulatory system. A variety of data mining methods (including Ror method and BCPNN method) were used to analyze the adverse drug reactions of rheumatoid arthritis in order to find out the abnormal risk signal and provide a warning for clinical drug use. Logistic model was used to analyze the combined use of leflunomide and methotrexate. It was found that the risk of "abnormal liver function" in specific population was higher than that of the two drugs alone. On the basis of referring to the adverse reaction signals listed in the drug specification, a total of 97 new adverse reaction signals were found by auxiliary computer technology, of which 12 were serious adverse reaction signals, which provided effective data for the re-evaluation of drugs after listing. In view of the present situation and problems of adverse drug reaction safety monitoring in China, this paper puts forward to perfect the management system of adverse drug reaction report and open up the adverse drug reaction information inquiry network. Feasible countermeasures and suggestions, such as perfecting the incentive mechanism for reporting adverse drug reactions and setting up special rescue funds.
【學(xué)位授予單位】：天津大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2015
【分類號】：R976

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