Safety of an injection with a mixture of extracts from Herba Artemisiae annuae, Fructus Gardeniae and Flos Lonicerae |
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Authors: | Hou Ming Xu Yue Wang and Nai Feng Liu |
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Institution: | (1) China Pharmaceutical University, Nanjing, 210009, People’s Republic of China;(2) ADR Monitoring Center of Jiangsu Province, Nanjing, 210002, People’s Republic of China;(3) Zhongda Hospital Affiliated to Southeast University, Nanjing, 210009, People’s Republic of China |
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Abstract: | Objective This study aimed to evaluate the safety for an injection with a mixture of extracts from Herba Artemisiae annuae, Fructus Gardeniae and Flos Lonicerae and to determine the risk factors that may affect its adverse drug reactions. Methods A drug-oriented prospective observational study was performed. Physicians filled in clinical observation forms with detailed
information of the patients including general information, drug information, therapeutic effects and adverse drug events.
The adverse drug reaction factors were analyzed by both mono-factor and multiple-factor logistic regression methods. Results From April to July 2007, we collected 12,427 observation forms from 46 hospitals in Jiangsu Province of China. Among the
11,707 observation forms we analyzed, 8,074 patients were children younger than 14 years old (69%). Among 51 reported adverse
drug events, 45 cases were adverse drug reactions. The total adverse drug reaction incidence of the injection was 0.38%. While
most adverse drug reactions were previously known (e.g., rash, pruritus, vomiting and diarrhea), we observed three new ADR
symptoms: shiver, phlebitis and anhelation. All the adverse drug reactions were controlled very well through the follow-up
therapy, and none of them was life threatening. The mono-factor analysis showed that adverse drug reactions of the injection
were significantly correlated with total medication dose (P = 0.0049) and combination medication (P = 0.0143), especially with antimicrobial drugs (P = 0.0079) and macrolides (P = 0.0017). The multiple factor analysis confirmed these results: medication dosage and combination medication had a crucial
impact on adverse drug reactions of the injection; the risk was increased by 24.8% (the estimated value of relative risk was
1.248, 95% confidence interval: 1.054–1.479) and 89% (1.890, 1.001–3.566), respectively. Conclusion The total adverse drug reaction incidence of the injection was 0.38% and lower than we expected. Moreover, we observed three
new adverse drug reactions, none of which was severe.
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Keywords: | Adverse drug reactions China Combination medication Dosage Flos Lonicerae Fructus Gardeniae Herba Artemisiae annuae Intensive monitoring Pharmacovigilance |
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