| ABSTRACT Objective:To analyze the influence factors in 7 aggressive cases of adverse reaction of monosialotetrahexosylganglioside sodium injection. Methods:7 cases of patients treated with monosialotetrahexosylganglioside sodium injection and occurred adverse reaction were investigated in the ADR/ADE monitoring system in our hospital and the population treated with the drug, clinical using process, the symptoms of adverse reaction were comparatively analyzed in order to find the inductive factors of the aggressive adverse reaction. Results:By the state quality inspection, the monosialotetrahexosylganglioside sodium injection was qualified. The aggregation of adverse reactions leading by the monosialotetrahexosylganglioside sodium injection showed convulsions, chills, fever and other symptoms of allergy. The occurrence time, solvent selection, dosage, dropping speed and other factors of 7 cases aggregation adverse reaction were basically the same, only in the amount of solvent and combined use of drugs were difference. Conclusion:There were many factors that could cause the aggressive adverse reaction, and it was difficult to determine the specific factors. Therefore, once the aggressive adverse reaction were found, the drug should be stopped immediately, timely reporting and finding the reasons, to improve the drug quality and promote clinical drug regulation. |
