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OBJECTIVE To investigate adverse event signals associated with ofatumumab and rituximab in the treatment of multiple sclerosis(MS), provide more evidences for the clinical safe medication based on the U.S. food and drug administration's adverse event reporting system(FAERS) data. METHODS Postmarking adverse event reports of ofatumumab and rituximab were extracted to form an analysis dataset. Disproportionality analysis combined with bayesian confidence propagation neural nework (BCPNN) was conducted for adverse event signal monitoring. Adverse events meeting threshold conditions were selected and summarized for analysis. RESULTS The ofatumumab group collected a total of 72 310 adverse event reports, of which 325 showed positive signals, covering 24 system organ classes (SOCs), involving “infections and infestations” “nervous system disorders” and “musculoskeletal and connective tissue disorders”. The rituximab group collected 23 203 adverse event reports, with 311 showing positive signals, covering 25 SOC, involving “injury, poisoning and procedural complications” “infections and infestations” and “nervous system disorders”. Except for “gastrointestinal disorders” and “eye disorders”, both drugs exhibited significant differences in each SOC. CONCLUSION There are substantial differences in the risk of adverse events between ofatumumab and rituximab in the treatment of MS. Therefore, medication monitoring is required during the treatment. Due to the limitations of real-world studies for quantitative analysis, the above conclusions need to be validated through large-scale cohort studies.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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