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The Pharmacoepidemiological Study Of Adverse Drug Reaction Caused By Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) In Shanghai Patients With Orthropathy

Posted on:2005-02-10Degree:DoctorType:Dissertation
Country:ChinaCandidate:W ShiFull Text:PDF
GTID:1104360125967367Subject:Pharmacology
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To explore the rules and characteristics of adverse drug reaction (ADR) of common used NSAIDs, we conducted metrological analysis on data of ADR of NSAIDs from medical journal reports during the period of year 1960 to 2002 following the guideline of ADR assessment by The Center of ADR Monitoring of State Food and Drug Administration of China. The results show that there is no difference among different age groups and different gender for the amount of ADR of common used NSAIDs. The ADR commonly appeared within 3months after drug intake. Gastrointestinal was the most frequent injured, accounted for 57.8%. Followed were skin injury, respiratory system injury, central nervous system injury and hepototoxicity. The outcome of ADR of common used NSAIDs was good as 98.3% (2048/2083) patients can get fully recovered or improved and a few left sequela or death. Due to the limitation of the information of available literature, the metrological analysis can only depict the general profile of the ADR caused by NSAIDs. In order to get more useful information including incidence of ADR, severity, risk factors, impact on patient's quality of life (QOL) and the data on pharmacoeconomics, we applied in turn meta analysis, retrospective and prospective study.Using meta analysis to evaluate the data of efficacy and safety profile of NSAIDs from 19 articles of random clinical trial published from 1990 to 2001 in Chinese journal. The total number of the enrolled patients for evaluation of efficacy and safety are 1732 and 2925 respectively. The results show that the efficacy and safety data are comparatively heterogeneous among different kinds of NSAIDs. The effective rate are: nabumetone 66.7% (61.9%~71.4%), meloxicam 68.4% (59.2%~77.6%), naproxen 64.5% (59.8%~69.1%), nimesulide 79.8% (75.7%~84%), ibuprofen 77.2% (70.7%~83.8%), diclofenac 77.1% (69.2%~85%) and oxaprozin 65.8% (59.5%~72%). The ADR rate are:nabumetone 16.3%(12.5%~20%), meloxicam 10.2%(4.2%~16.2%), naproxen 29.2%(24.8%~33.6%), nimesulide 20.2%(16%~24.3%), ibuprofen 16.7%(14.7%~18.8%), diclofenac 19.3%(11.9%~26.7%)and oxaprozin 6.4%(8.9%~16.7%).To investigate the ADR and related risk factors of NSAIDs in NSAIDs long-term used patients in Shanghai, a cross-sectional survey was carried out and 1002 patients were recruited. A retrospective questionnaire was designed to get the information on personal general information, disease, family history of disease, quality of life assessment before NSAIDs intake, dietary habit, life style, usage of NSAIDs, concomitant therapy drug, ADR, treatment and prognosis, etc. The results show that the ADR rate was about 30.8~48.1% for the patients on NSAIDs for more than 1 year. The ADR mainly are gastrointestinal symptoms, skin rash and central nerve system symptoms. Severe ADR was about 7%. The outcome of ADR treatment was satisfactory.In general, the candidate risk factors of ADR were different for each NSAID. Each of the candidate risk factors were defined and studied to evaluate its role in the determination of ADR from NSAIDs. "The family history of ADR caused by NSAIDs" was found a significant risk factor for the four commonly used NSAIDs: meloxicam, diclofenac, nimesulide and nabumetone.145 patients had taken nabumetone and among them 49 (33.8%) suffered ADR. The multivariate analysis shows that only "family history of ADR caused by NSAIDs", "adverse effect of emotional problem on daily work and life", "family income", "degree of personal care" and "being interested in every challenge" were significantly related to the occurrence of ADR induced by nabumetone . 447 patients were involved in the investigation of ibuprofen and among them 144 patients(32.2%)suffered ADR. 7 risk factors were identified. They were "concomitant drug therapy", "smoking", "acceptance to unchangeable things", "in general, how would you describe your health?", "when do you take cola every day", "compared to six months ago, how would you rate your health in general now?", "impact...
Keywords/Search Tags:Pharmacoepidemiological
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