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To analyze the characteristics of adverse drug reactions (adverse drug reaction, ADRs) of oral riluzole in patients with amyotrophic lateral sclerosis (amyotrophic lateral sclerosis, ALS), and to provide references for clinical safe medication.
Data of ALS patients treated with riluzole at Peking Union Medical College Hospital from May 2018 to August 2023 were collected. Patients with ADRs were retrospectively analyzed regarding demographic information, medication details, clinical manifestations, time of onset, management, and outcomes. Causality assessment was performed according to China’s Measures for Reporting and Monitoring of Adverse Drug Reactions, severity was evaluated using CTCAE V5.0, and ADRs were coded using MedDRA terms.
A total of 67 ALS patients were included, among whom 22 experienced ADRs (32.8%). The incidence of ADRs was higher in females (44.0%) than in males (26.2%). A total of 54 ADR episodes were recorded. The most common ADRs involved the nervous system (20 cases/54 cases, 37.0%), followed by gastrointestinal system disorders (13 cases/54 cases, 24.1%), general disorders and administration site conditions (7 cases/54 cases, 13.0%), and various laboratory investigations (6 cases/54 cases, 11.1%). One patient (1.5%) experienced a grade 3 serious ADR (interstitial lung disease). Seventeen patients (77.3%) developed ADRs within the first three months of treatment. Sixteen patients (72.7%) tolerated the ADRs without specific intervention, while six (27.3%) improved after drug discontinuation, dose reduction, or symptomatic treatment.
The most common ADRs of riluzole in ALS patients involve the nervous system, gastrointestinal tract, and elevated liver enzymes (all not higher than twice the normal value), mostly occurring early in the treatment course. Clinicians should remain vigilant for respiratory ADRs and potential heightened inflammatory responses, with close monitoring recommended during the first six months of treatment.
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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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