Predictive analysis on Shenmai injection-induced adverse reactions with Logistic model and ROC curve.
- Author:
Feng DING
;
Qing-ping SHI
;
Xiao-dong JIANG
;
Yan LIU
;
Ran SANG
;
Jin-xiu ZHU
;
Sheng-tong WEI
;
Zhi-ming XIN
;
Ru SONG
- Publication Type:Clinical Trial
- MeSH:
Adolescent;
Adult;
Aged;
Aged, 80 and over;
Child;
Child, Preschool;
China;
epidemiology;
Drug-Related Side Effects and Adverse Reactions;
epidemiology;
etiology;
Drugs, Chinese Herbal;
administration & dosage;
adverse effects;
Female;
Humans;
Infant;
Logistic Models;
Male;
Middle Aged;
Prospective Studies;
ROC Curve;
Risk Factors;
Young Adult
- From:
China Journal of Chinese Materia Medica
2015;40(7):1404-1409
- CountryChina
- Language:Chinese
-
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.
