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Predictive analysis on Shenmai injection-induced adverse reactions with Logistic model and ROC curve / 中国中药杂志
China Journal of Chinese Materia Medica ; (24): 1404-1409, 2015.
Artigo em Chinês | WPRIM | ID: wpr-246087
ABSTRACT
To study relevant risk factors of Shenmai injection induced adverse reactions by using Logistic model and ROC curve, and made the prediction for the occurrence of relevant adverse reactions/events. Case data of patients treated with Shenmai injection were collected by using the prospective, multi-center, large-sample, nested-case control method, in order to analyze the risk factors of Shenmai injection-induced adverse reactions/events, establish the logistic model and draw the receiver operating characteristic (ROC) curve for risk factors. During the study, 7632 patients (including 3 477 males and 4 155 females) were included, and eight of them suffered adverse reactions/events. Based on a multi-factor Logistic model analysis, the age (> or = 50 years) (OR = 5.061, 95% CI 2.197-7.924; P = 0.001), the total number of medication days (OR = -1.020, 95% CI -l.652 - 0.388; P = 0.002) and the single dose (OR = 0.245, 95% CI 0.127-0.364; P = 0.000) were significant independent risk factors for Shenmai injection-induced adverse reactions/events. According to the results, ROC curves were drawn with age (> or = 50 years), the total number of days of inedication and single dose; The area under ROC curves the joint predictor (0.9753, 95% CI 0.9443-1.000, P < 0.005) was larger than that of the other three single indexes, with a higher risk prediction value. The independent risk factors for Shenmai injection-induced adverse reactions/events included the age (> or = 50 years), the total number of days of medication and single dose. In clinical practice, the age (> or = 50 years), the total number of days of medication and the medication dose can be substituted in the joint predictor calculation formula (P = 1 / [1 + e(-(-21.58 + 5.061 x Xage - 1.020 x Xd + 0.245 x X(mL)] to predict the potential adverse reactions of patients and adjust the dosage regimen.
Assuntos
Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Assunto principal: Medicamentos de Ervas Chinesas / Modelos Logísticos / China / Epidemiologia / Estudos Prospectivos / Fatores de Risco / Curva ROC / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Ensaio Clínico Controlado / Estudo de etiologia / Estudo observacional / Estudo prognóstico Limite: Adolescente / Adulto / Idoso / Aged80 / Criança / Criança, pré-escolar / Feminino / Humanos / Lactente / Masculino País/Região como assunto: Ásia Idioma: Chinês Revista: China Journal of Chinese Materia Medica Ano de publicação: 2015 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Assunto principal: Medicamentos de Ervas Chinesas / Modelos Logísticos / China / Epidemiologia / Estudos Prospectivos / Fatores de Risco / Curva ROC / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Ensaio Clínico Controlado / Estudo de etiologia / Estudo observacional / Estudo prognóstico Limite: Adolescente / Adulto / Idoso / Aged80 / Criança / Criança, pré-escolar / Feminino / Humanos / Lactente / Masculino País/Região como assunto: Ásia Idioma: Chinês Revista: China Journal of Chinese Materia Medica Ano de publicação: 2015 Tipo de documento: Artigo