ABSTRACT
To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.
Subject(s)
Aged , Female , Humans , Middle Aged , Adverse Drug Reaction Reporting Systems , Bayes Theorem , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Pharmacovigilance , Risk ManagementABSTRACT
We present the final results of a study using the IRDI (Clinical Risk Indicators in child Development). Based on a psychoanalytic approach, 31 risk signs for child development were constructed and applied to 726 children between the ages of 0 and 18 months. One sub-sample was evaluated at the age of three. The results showed a predictive capacity of IRDIs to indicate developmental problems; 15 indicators for the IRDI were also highlighted that predict psychic risk for the constitution of the subject.
No presente artigo, apresentam-se os resultados finais da Pesquisa IRFI. A partir da psicanálise, 31 indicadores clínicos de risco para o desenvolvimento infantil (IRDI) foram construídos e aplicados em 726 crianças entre 0 e 18 meses. Uma sub-amostra foi avaliada com a idade de 3 anos. Os resultados apontaram a capacidade dos IRDI para predizer problemas de desenvolvimento e destacaram ainda 15 indicadores do IRDI com capacidade para predizer risco psíquico para a constituição subjetiva.
El presente artículo presenta los resultados finales de la pesquisa IRDI. Desde el psicoanálisis, 31 signos de riesgo para el desarrollo infantil (IRDI) se han construido y aplicado a 726 niños entre 0 y 18 meses. Se evaluó una sub nuestra a los 3 años de edad. Los resultados muestran que los IRDI poseen una capacidad de predecir problemas de desarrollo 15 signos muestran una capacidad de predicción de riesgo psíquico para la constitución subjetiva.
Cet article présente les résultats de la recherche IRDI. A partir de la psychanalyse, 31 signes cliniques de risque pour le développement de l´enfant (IRDI) ont été développés et appliqués à 726 enfants à l'âge entre 0 et 18 mois. Un sous-échantillon a été évalué à l´âge de trois ans. Les résultats ont montré que les IRDI ont la capacité de prédire des problèmes de développement. Un groupe de 15 signes prévoit d'ailleurs le risque psychique de la constitution subjective.