RESUMEN
BACKGROUND: Knowledge of drug safety in the pediatric population of China is limited. This study was designed to evaluate ADRs in children reported to the spontaneous reporting system (SRS) of Shanghai in 2009. METHODOLOGY AND PRINCIPAL FINDINGS: Crude ADR reports submitted to Shanghai SRS in 2009 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to age, gender, category of ADR (System Organ Class [SOC]), the severity of reports and type of reporter. RESULTS: A male overrepresentation was observed regarding the total number of reports. The most frequently reported group of drugs were vaccines (42.15%). Skin rash and fever were the commonest symptoms reported in the total pediatric dataset. The proportion of children that suffered from a serious ADR was 2.16% and that for drug related deaths was 0.34%. And we found that the multiple drug exposure experienced a high proportion of serious ADRs compared with the single drug use (χ²â=â15.99, P<0.0001). Sixty-five percent of ADRs were for children less than 6 years of age. And more than half of reports were from doctors. CONCLUSIONS: In our study, consumers were more likely to report new ADRs though they appear to contribute a relatively small percentage of total reports. We propose that patients would take an active role in reporting ADRs. More researches are needed in order to achieve better understanding the characteristics of ADRs in pediatric population of China.
Asunto(s)
Participación de la Comunidad/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Vacunas/efectos adversos , Adolescente , Factores de Edad , Niño , Preescolar , China/epidemiología , Femenino , Humanos , Lactante , Recién Nacido , Modelos Logísticos , Masculino , Factores SexualesRESUMEN
BACKGROUND: The detection of signals of adverse drug events (ADEs) has increased because of the use of data mining algorithms in spontaneous reporting systems (SRSs). However, different data mining algorithms have different traits and conditions for application. The objective of our study was to explore the application of association rule (AR) mining in ADE signal detection and to compare its performance with that of other algorithms. METHODOLOGY/PRINCIPAL FINDINGS: Monte Carlo simulation was applied to generate drug-ADE reports randomly according to the characteristics of SRS datasets. Thousand simulated datasets were mined by AR and other algorithms. On average, 108,337 reports were generated by the Monte Carlo simulation. Based on the predefined criterion that 10% of the drug-ADE combinations were true signals, with RR equaling to 10, 4.9, 1.5, and 1.2, AR detected, on average, 284 suspected associations with a minimum support of 3 and a minimum lift of 1.2. The area under the receiver operating characteristic (ROC) curve of the AR was 0.788, which was equivalent to that shown for other algorithms. Additionally, AR was applied to reports submitted to the Shanghai SRS in 2009. Five hundred seventy combinations were detected using AR from 24,297 SRS reports, and they were compared with recognized ADEs identified by clinical experts and various other sources. CONCLUSIONS/SIGNIFICANCE: AR appears to be an effective method for ADE signal detection, both in simulated and real SRS datasets. The limitations of this method exposed in our study, i.e., a non-uniform thresholds setting and redundant rules, require further research.
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Algoritmos , Minería de Datos/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Bases de Datos Farmacéuticas , Método de Montecarlo , Redes Neurales de la Computación , Curva ROCRESUMEN
Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.
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Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Inyecciones/efectos adversos , Inyecciones/métodos , Medicina Tradicional China/efectos adversos , Medicina Tradicional China/métodos , Sistemas de Registro de Reacción Adversa a MedicamentosRESUMEN
PURPOSE: The study was to reflect and forecast the evolutive tendency and influence factors of secondary failure of sulphonylurea (SFS) changing with time by using a Markov (MKV) model in the elderly diabetic population in Shanghai. METHODS: A total of 549 patients with elderly diabetes mellitus (DM) were enrolled and grouped in the study. A door-to-door retrospective epidemiological survey was used to collect data. The MKV model was used to assess the process and influence factors of SFS and the MKV process decision support system was adopted to calculate state probability of the MKV process. RESULTS: The rate of SFS in the group of all cases, FPG < or = 10 mmol . L(-1) before treatment and FPG > 10 mmol . L(-1) before treatment, taking single type of sulphonylurea (SU) and taking two types of SU and over respectively was 9.11%, 3.55%, 11.03%, 8.54% and 11.21%. The years of changing into the state of secondary failure in half patients was 5 years, 11-12 years, 4 years, 5 years, 4 years, respectively in the following groups: all cases, FPG < or = 10 mmol . L(-1) before treatment and FPG > 10 mmol . L(-1) before treatment, taking single type of SU and taking two types of SU and over. CONCLUSIONS: A MKV model could predict the long-term evolutive process of SFS by a short-term observation; the speed of SFS was related to the degree of DM patients' condition, patients with higher glucose levels prior to treatment would develop SFS faster; but we cannot postpone the development of secondary failure by exchanging SU types.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Resistencia a Medicamentos , Cadenas de Markov , Compuestos de Sulfonilurea/farmacología , Anciano , Anciano de 80 o más Años , Glucemia/metabolismo , China/epidemiología , Técnicas de Apoyo para la Decisión , Quimioterapia Combinada , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de TiempoRESUMEN
PURPOSE: The study was to assess the quality of life (QOL) of the elderly diabetes mellitus (DM) in Shanghai community and to screen the possible risk factors. METHODS: A total of 951 patients with elderly DM and 1007 elderly subjects with normal glucose tolerance from the same community as control group were enrolled in the study. A door-to-door retrospectively epidemiological survey was used to collect data of QOL, demographic, and diabetic information. The SF-36 instrument (Chinese edition) was used to assess QOL. Multiple stepwise linear regression analysis was also used to identify possible risk factors of QOL in elder DM. RESULTS: In subjects with elderly DM, the general assessment of perceived health was worse, compared with the normal elderly people; the mean score of multi-item dimensions assessment had been decreased, the lowest and highest scores of which on SF-36, respectively, were general health and body pain (ranged from 42.08 to 77.00). Based on the multiple stepwise regression analysis, 23 risk factors entered 9 multiple regressive models (9 dependent variables of which stand for the scores of 8 dimensions and the total score on SF-36) with different amount ultimately. Within the 13 risk factors that affect QOL of the elderly diabetic patients, the negative correlated factors were gender, age, payment ability of medical treatment, tumor, level of fasting plasma glucose (FPG), medicines purchasing channels, diabetic microvascular complications, diabetic macrovascular complications, acute complications, while the positive correlated factors were occupation, income, exercises, knowledge of DM. The multiple correlation coefficient square (R2) represented the above 13 risk factors had a totally 30.5% impact on the entire QOL. CONCLUSIONS: QOL of elderly DM population had significantly been decreased; QOL of the elderly patients in Shanghai community had many risk factors, which on one hand stated the complexity of elderly DM, and on the other hand gave us many useful and practical methods to improve QOL of elderly DM.
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Diabetes Mellitus/epidemiología , Calidad de Vida , Salud Urbana , Anciano , Glucemia , China/epidemiología , Comorbilidad , Diabetes Mellitus/sangre , Femenino , Evaluación Geriátrica , Humanos , Masculino , Neoplasias/epidemiología , Análisis de Regresión , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
It has been proposed that instability of blood pressure may produce organ damage. Ketanserin is an anti-hypertensive drug with an ability to reduce blood pressure variability (BPV) in acute experiments in spontaneously hypertensive rats (SHRs). The present work was designed to observe the effects of long-term treatment with ketanserin on BPV and end-organ damage in SHRs. Ketanserin was mixed in rat chow at an estimated dose of 10 mg/kg/d. After 5 months of drug administration, BP was continuously recorded in conscious, freely moving rats for 24 h. The heart, kidneys, and abdominal aorta were then isolated and examined by using histologic methods and computer image analysis. In another work, the effects of hydralazine (40 mg/kg/d, for 5 months) on BP, BPV, and organ damage were observed in SHRs. Ketanserin significantly decreased BP and BPV, ameliorated impaired arterial baroreflex function, and significantly prevented the target organs of SHRs from being damaged. This preventive effect was characterized by decrease in left ventricular hypertrophy, diminution of glomerulus damage, and amelioration in vascular lesion. Hydralazine decreased BP but did not lower BPV. No organ protection was found in hydralazine-treated rats. In conclusion, long-term treatment with ketanserin reduced hypertensive organ damage. Lowering BP, decreasing BPV, and ameliorating arterial baroreflex function may contribute together to this effect.