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The Analysis Of The Overall Adverse Drug Reactions And Anti-tumor Drug Related Adverse Reaction In Shanghai

Posted on:2008-12-16Degree:MasterType:Thesis
Country:ChinaCandidate:J P ShaFull Text:PDF
GTID:2144360218458993Subject:Clinical Pharmacy
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Drug Epidemiology of adverse drug reaction reporting and monitoring drug safety evaluation as the basis, medicine regulatory authorities and the pharmaceutical industry early access to the drug safety issues signal channels. Adverse Drug Reaction Monitoring national drug supervision departments in charge of the important duties is to evaluate the listing of drugs, to ensure drug safety. protect public health major means.Tumor is a kind of serious but common and frequently-occurring diseases that severely threatened human beings. For the nearly forty years, medication has turned to a new therapeutic management in tumor internal medicine clinical, which now has become one of the most popular research fields. The utilization of anti-tumor drugs in Shanghai is in an upward trend year by year. ADRs monitoring seems to be more and more significant accompanied with the multiplication of medicines.This research has been divided into two parts. In this research, I do systematically aggregate analyze the 4491 cases of reports, which were provided by the ADR monitoring center of shanghai, and analyze the dependability between the ADRs and ages,gender,administration route,and the identity of the reportors. Shanghai to further anticancer drug-related ADRs in the general law and the relevant characteristics ADRs particularly high incidence of cytotoxic drugs in clinical types, and the impact of drug-related factors of the statistical analysis, Discussion of adverse drug reactions occur and to the promotion of rational use of drugs, medication for clinical information.Primary part a aggregate analysis on the 4491 cases of ADRsObjective:To make a aggregate analysis on the 4491 cases of ADRs from age and ADRs,gender and ADRs,administration route and ADRs,and reporters and ADRs. To summary the clinical manifestation of ADRs, which were induced by drugs, and provide safety and reasonable administration reference for clinical.Methods:To carry on the study of the 4491 cases of ADRs reports through a retrospective way, and screening them by Access 2003 and Excel 2003.Results:After an entirety analysis, we can find that there are so many prolems in the ADRs reports, the quality of all the reports are in a low position. Drugs that induced the ADRs are concentrated in anti-infective drugs,psuch-drugs,antitumor drugs. The main reflection of ADRs is skin and its'accessories damaging. In this research, I also found 3 cases of new and serious ADRs, that may cause the doctors'attention. Meanwhile, I found that female is easier to suffer ADRs as to male, and the injection administration cause the most ADRs.Conclusions:The ADRs reports should be improved step by step, in order to support more and more sufficient and concrete data. When the doctors use some drugs that induce ADRs, they should pay attention to them and diagnosis as soon as possible.Second part Analysis of Antitumor Related adverse Drugs reaction ReportingObjective: To explore the general rule and the features of the adverse drug reaction of antitumor drugs in Shanghai, especially the ones with high incidence of cytotoxic drugs of comparison, As well as the original illness related to the logistic statistical analysis, and to provide information for clinical medication, we conducted the research as follows.Methods:To rethospective analysis combined with descriptive epidemiology. Will be 578 copies, According to the patients'age,gender,medication information,the manifestation and the date of ADRs, we built up the Excel table and carried out the statistical analysis. The results suggest the use of such drugs to the attention of observation. Screening the data by Access 2003 and Excel 2003,using SPSS 13.0 statistically.Results: These 578 cases ADRs involved in 126 anti-tumor relating drugs for 8 groups. From the anti-tumor relating drugs, cell-toxic drugs were about 41.3%, containing 43.5% drugs influencing nucleinic acid composition. The percentage of male was 56.9% and 43.1% for female. From the age structure, 50.2% patients were 45~64. Younger than 45a, there were 17.5% female and 12.5% male. From the resource, the ADRs that reported by the first rate hospital was 59.9%. The ADRs involved 478 tumor diseases (82.3%), containing cell-toxic ADRs 181 (37.9%). While to different tumor, the incidence rate of ADRs is 31.2% (149 cases) in digestive system and 21.8% (104 cases) in respiratory system tumor. And other anti-tumor drugs ADRs in different tumor Distribution (2=27.04 0.05) different mechanisms of cytotoxic drugs ADRs, in different parts of the tumor distribution (p <0.05) both existed overall difference. The harm of ADRs mainly skin and appendages disorders (22.5%); whole-general body disorder (20.8%) and gastro-intestinal system disorders (20.4%), which occupy 63.7% of the whole ADRs. The whole ADRs cases recovered well generally but 30 (5.2%) remained sequel or even died. In 239 cell-toxic drugs, The ADRs incidence of Gemcitabine and other 6 kinds of drugs is 125(52.3%). The ADRs distribution forms of paclitaxel and docetaxel with different dosages were similar. While the patients'gender, age, dosage, frequency of drug use, treatment days, the original disease, and other significantly related.Conclusion: The ADRs of anti-tumor involved an extensive organ-system, especially those cell-toxic drugs. We should take effective measures on monitoring and prevention to ensure the safety of medication. We should also pay more attention to those medications which has rare but serious ADRs.
Keywords/Search Tags:Adverse drug reactions, Anti-tumor drugs, Retrospective study, Systematic Review
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