| Objective:To observe the self-characteristics of adverse drug reactions (ADR) in the elderly patients and investigate the characteristics and differences between ADR which occurred inside and outside the hospital in risk factors, induced drugs, clinical features, diagnosis and prevention.Methods:The self-designed questionnaire of ADR was used for the cross-sectional study, including basic information, brief history, ADR and medication records. 1364 elderly patients who discharged in the department of geriatrics of the second xiangya hospital of central south university during May 1, 2007 to Feb 29, 2008 were taken into the study. Do descriptive study on 406 cases of ADR occurred in 312 of them. According to the place where ADR occurred, the total cases of ADR were divided into two groups: outside hospital group (71 cases) and inside hospital group (335 cases) to investigate the characteristics and differences of ADR in risk factors, induced drugs, clinical features, diagnosis, and prevention between them.Results:1. The clinical analysis of 406 ADR cases in the elderly:(1) 312 of 1364 hospitalized old patients occurred 406 ADR cases, so the incidence of ADR was 22.87% in the elderly. The prevalence of ADR in the elderly with liver or renal dysfunction or ADR history or longer hospital stay days was significantly higher than that without those (p<0.05). The differences of incidence between sex, age and number of diseases division were not statistically significant.(2) The sequence of the four categories from high to low was antimicrobial agents(21.92%), circulatory system drugs(20.19%), hormone and related drugs(19.70%), central nervous system drugs(9.60 %). the incidence of oral administration was 50.2%, while the incidence of intravenous injection was 39.9%. It is common (53.9%) that patients with ADR took 6 to 10 kinds of drugs.(3) Most incubation period(72.4%) and the disease period (74.6 % ) of ADR was within one week. the mainly clinical manifestations were nutrition and metabolism disorders (22.9%), disorders of gastrointestinal system (14.0%),cardiovascular system (10.6%), and dual infection (10.1%). The incidence of hospital admission induced by ADR was 5.21%.(4) ADR considered definite was 208 cases (51.23%) while probable 155 cases (38.18%), possible 43 cases (10.59%). Type A was 348 cases (85.71%), type B was 58 cases (14.29%). Mild ADR was 134 cases (33.0%), moderate ADR was 173 cases (42.6%), severe ADR was 99 cases (24.4%). (5) Treatment without drug withdrawal accounted for 18.7%, while withdrawal was 68%, symptomatic treatment accounted for 70%. The incidence of heal was 77.34%, 21.67% of the cases was improved. The cases which had after-effects accounted for 0.49%, the mortality rate of ADR was 0.64%. The avoidable ADR was accounted for 76.11%, while 23.89% of those were inevitable.2. The contrast analysis between ADR cases occurred inside and outside of hospital in the elderly:(1) The prevalence of infectious disease in hospital group was obviously higher than that of outside group (p<0.05), but the prevalence of age, function of liver and kidney, ADR history, the number of basic diseases such as hypertension, coronary heart disease, diabetes, cerebrovascular disease and tumor were no statistical difference between the two groups (p>0.05).The number of drugs was (8.6±3.2) kinds in hospital group , which was significantly higher than that of persons who suffered from ADR outside hospital (4.2±2.1) kinds (t=-14.688, P<0.01). The compliance of patients who received administration in hospital was obviously better than that of people in outside hospital group(p<0.01).(2) Out of the hospital, ADR was mostly induced by circulatory system drugs (22.54%), which were followed by hormone and related drugs (18.31%), urinary system drugs (18.31%) and antimicrobial agents (8.45%). In hospital, the sequence from high to low were antimicrobial agents(24.78%), hormone and related drugs (20.00%),circulatory system drugs(19.70%), and central nervous system drugs(10.15%).The prevalence of ADR induced by intravenous injection in hospital group was significantly higher than that of outside group(P<0.01).(3) The incubation period of ADR which happened out of hospital was remarkably longer than that of in hospital (P<0.01), and the course of disease was significantly prolonged in outside group (P<0.01). Clinic manifestation of outside hospital group, such as damage of liver and gall system, endocrine disturbance and hypopotassaemia were remarkably higher than that of hospital group(P<0.01). Hypoglycemia and damage of nervous system was notably higher in hospital group than that of outside group (P<0.05). There were no statistical difference in the incidence of gastrointestinal system damage, cardiovascular system, dual infection, impairment of skin and its appendages, general immunity system, blood system damage system (p>0.05).(4) The percent of definite ADR in outside hospital group was significantly higher than that in hospital group (64.79% VS 48.36%, P< 0.05). In outside hospital group, the incidence of type A ADR was remarkably higher than that in hospital group(95.77% VS 83.58%, p< 0.01) and severe ADR was also higher (46.48% VS 19.70%,P<0.01>.(5) There were no statistical difference in treatment and prognosis between the two groups (P>0.05). The percent of avoidable ADR in outside hospital group was significantly higher than that in hospital group(90.14% VS 3.13%,P<0.01).Conclusions:1. The clinical analysis of 406 ADR cases in the elderly:(1) The high incidence of adverse drug reaction in the elderly was related to increasing age, liver and renal dysfunction, history of ADR, and longer hospitalization days.(2) The incubation and disease period of ADR were usually within a week and clinical characteristics such as metabolic and nutritional disturbance, gastrointestinal system damage, cardiovascular system damage, dual infection were common in the elderly.(3) The rate of hospital admission caused by ADR was high in the elderly.(4)Type A and mild and moderate degree of ADR in the elderly were seen frequently.(5)ADR in the elderly were mostly required drug withdrawal and symptomatic treatment. The prognosis of ADR was good and ADR can be prevented well.2. The contrast analysis between ADR cases occurred inside and outside of hospital in the elderly:(1)The risk factors of ADR such as liver and kidney function, ADR history and basic diseases in hospital group are similar to the outside group. Drugs which induced ADR (including circulatory system, hormone and related drugs, etc.) and major clinical manifestations (nutrition and metabolism disorders, gastrointestinal system damage, damage to the cardiovascular system, etc.) of the two groups were similar. Drug withdrawal was common and the prognosis was well in the two groups.(2)The outside hospital group had poorer compliance, taking more oral medicine and more traditional Chinese medicine, longer incubation period and duration of clinical, more hypokalemia, hepatobiliary system damage and endocrine disorders, diagnosis reliability was relatively better, more A-type and moderate or severe ADR and better prevention.(3)The hospital group had more combination drugs, more intravenous drugs, more antibiotics, more hypoglycemia and nervous system damage, mild or moderate ADR and relatively worse prevention.
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