抗类风湿性关节炎药物不良反应的监测研究

发布时间：2019-06-04 02:48

【摘要】：类风湿性关节炎是一种慢性疾病,类风湿性关节炎患者在治疗该疾病过程中往往需要长期用药、联合用药。同时,因药物剂量、剂型、用药时间以及患者个体差异等因素的影响,会发生一些与药物相关的不良反应。因此,对此类药物诱发的药物不良反应进行监测十分必要。本文应用北京市药品不良反应监测中心自发呈报系统数据库数据,经过对数据的规范及整理,采用多种数据挖掘方法并辅助计算机技术对抗类风湿性关节炎药物发生不良反应报告进行深入分析,针对类风湿性关节炎用药后所产生不良反应报告的人口学特点,以及对用药安全性差异等方面进行研究,以期更好的提供有效信息,促进该类用药风险/收益的平衡,保障患者的用药安全。本文分析了抗类风湿性关节炎药物的进展情况及安全性监测的现状,指出在当前状况下对抗类风湿性关节炎药物进行监测的必要性与重要性;从年龄、性别、不良反应所累及系统和器官及不同给药途径等角度对所引发的不良反应进行了分析,研究结果表明随着患者年龄的不断增加,药品不良反应发生频率增高、严重程度也再加重;应用抗类风湿性关节炎药物所诱发的不良反应累及的器官和系统最多的是皮肤系统、消化系统、神经系统和循环系统;采用多种数据挖掘方法(包括ROR法和BCPNN法)对抗类风湿性关节炎药物不良反应报告进行深入剖析,找出异常风险信号,为临床用药提供警示;采用Logistic模型分析来氟米特和甲氨蝶呤联合用药情况,发现对于特定人群面临“肝功能异常”这一不良反应的风险与两种药物各自单独应用比较会增加;辅助计算机技术,在参照药品说明书中所列的不良反应信号的基础上,共发现新的不良反应信号共计97个,其中严重不良反应信号12个,为药品上市后再评价提供了有效数据。针对目前国内药物不良反应安全性监测的现状和问题,提出了完善药品不良反应报告管理制度、开放药品不良反应信息查询网络、健全药品不良反应上报激励机制及设立专项救助基金等可行的对策及建议。
[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.
【学位授予单位】：天津大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R976

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