1.Signal mining of adverse drug reactions in the heart and nervous system during pregnancy based on adverse reaction reports in the hospital
Tingting CHEN ; Chaoxin CHEN ; Fanxiang ZENG ; Jinhua ZHANG
Adverse Drug Reactions Journal 2024;26(2):82-86
Objective:To analyze the spontaneous reports on adverse drug reaction (ADR) in a hospital and to mine the risk signals of drug that might be associated with cardiac and neurological ADRs in pregnant women.Methods:The ADR reports in the database of China Hospital Pharmacovigilance System reported by Fujian Maternal and Child Health Hospital from January 1st, 2000 to December 31st, 2022 was downloaded. ADR reports about pregnancy women were collected, and the proportions and clinical manifestations of ADRs classified as "cardiac disorders" and "nervous system disorders" according to systems and organs were analyzed by descriptive statistic method. Data mining was conducted on drugs that might be associated with cardiac disorders and nervous system disorders in ADR reports using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. The definition of risk signals in ROR method was the number of adverse reaction/event reports on the target drug (a) ≥3, and the lower limit of the 95% confidence interval ( CI) of ROR >1. The definition of risk signals in BCPNN method was the information component minus twice the standard deviation ( IC-2 SD) >0. When the calculation results of an adverse reaction/event was in accordance with above-mentioned conditions in both methods, a suspected drug risk signal was determined. Results:A total of 783 ADR reports about pregnancy women were included in the analysis. Ninety-four reports (12.0%) were about cardiac disorders, mainly manifested as palpitations; 121 reports (15.5%) were about nervous system disorders, mainly characterized by trembling and dizziness. These ADRs of cardiac disorders and nervous system disorders often occurred in the third trimester of pregnancy. Through the ROR and BCPNN methods, results showed that ritodrine hydrochloride injection (a=61, ROR=14.64, the lower limit of 95 %CI=9.08; IC-2 SD=1.36) and ritodrine hydrochloride tablets (a=24, ROR=8.34, the lower limit of 95 %CI=4.64; IC-2 SD=1.10) were risk signals of drug leading to cardiac disorders during pregnancy, while magnesium sulfate injection (a=37, ROR=6.66, the lower limit of 95 %CI=4.10; IC-2 SD=0.98) and ritodrine hydrochloride injection (a=45, ROR=3.72, the lower limit of 95 %CI=2.44; IC-2 SD=0.56) were risk signals of drug leading to nervous system disorders during pregnancy. Conclusion:Ritodrine and magnesium sulfate may be associated with cardiac and nervous system ADR in women during pregnancy, which should arouse clinical vigilance.
2.Signal mining of adverse drug reactions in the heart and nervous system during pregnancy based on adverse reaction reports in the hospital
Tingting CHEN ; Chaoxin CHEN ; Fanxiang ZENG ; Jinhua ZHANG
Adverse Drug Reactions Journal 2024;26(2):82-86
Objective:To analyze the spontaneous reports on adverse drug reaction (ADR) in a hospital and to mine the risk signals of drug that might be associated with cardiac and neurological ADRs in pregnant women.Methods:The ADR reports in the database of China Hospital Pharmacovigilance System reported by Fujian Maternal and Child Health Hospital from January 1st, 2000 to December 31st, 2022 was downloaded. ADR reports about pregnancy women were collected, and the proportions and clinical manifestations of ADRs classified as "cardiac disorders" and "nervous system disorders" according to systems and organs were analyzed by descriptive statistic method. Data mining was conducted on drugs that might be associated with cardiac disorders and nervous system disorders in ADR reports using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. The definition of risk signals in ROR method was the number of adverse reaction/event reports on the target drug (a) ≥3, and the lower limit of the 95% confidence interval ( CI) of ROR >1. The definition of risk signals in BCPNN method was the information component minus twice the standard deviation ( IC-2 SD) >0. When the calculation results of an adverse reaction/event was in accordance with above-mentioned conditions in both methods, a suspected drug risk signal was determined. Results:A total of 783 ADR reports about pregnancy women were included in the analysis. Ninety-four reports (12.0%) were about cardiac disorders, mainly manifested as palpitations; 121 reports (15.5%) were about nervous system disorders, mainly characterized by trembling and dizziness. These ADRs of cardiac disorders and nervous system disorders often occurred in the third trimester of pregnancy. Through the ROR and BCPNN methods, results showed that ritodrine hydrochloride injection (a=61, ROR=14.64, the lower limit of 95 %CI=9.08; IC-2 SD=1.36) and ritodrine hydrochloride tablets (a=24, ROR=8.34, the lower limit of 95 %CI=4.64; IC-2 SD=1.10) were risk signals of drug leading to cardiac disorders during pregnancy, while magnesium sulfate injection (a=37, ROR=6.66, the lower limit of 95 %CI=4.10; IC-2 SD=0.98) and ritodrine hydrochloride injection (a=45, ROR=3.72, the lower limit of 95 %CI=2.44; IC-2 SD=0.56) were risk signals of drug leading to nervous system disorders during pregnancy. Conclusion:Ritodrine and magnesium sulfate may be associated with cardiac and nervous system ADR in women during pregnancy, which should arouse clinical vigilance.
3.A study on the efficacy ofβ-lactam antibiotics combined with macrolides in treatment of severe community-acquired pneumonia in children
Jiafeng LI ; Shibiao WANG ; Guanghua LIU ; Guanyu RUAN ; Fanxiang ZENG
Journal of Clinical Pediatrics 2014;(5):453-455
Objective To investigate the clinical efficacy ofβ-lactam combined with macrolides antibiotics in treatment of severe community-acquired pneumonia (CAP) in children. Methods Children with severe CAP on admission between 2012 February and 2012 April were divided into treatment group and control group. With the same symptom specific supportive treat-ment, the patients in the treatment group were treated with both cefmetazole and azithromycin, while the patients in the control group were treated with cefmetazole alone. The total effective rate, number of days of symptoms and signs disappeared and num-ber of days of hospitalization were observed. Results The total effective rate was 87.8%in the trearment group and 61.3%in the control group with significant difference (P<0.05). Compared with control group, the recovery time of temperature, time of pulmonary rale disappearing and cough retraction were reduced (P<0.05). As well as the number of days of hospitalization was decreased (P<0.05). Conclusions The treatment of severe CAP in children with combination of azithromycin and cefmetazole results in better curative effect. A combined medication ofβ-lactam and macrolides antibiotics may be rational and effective.

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