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To excavate and analyze signals of immune checkpoint inhibitors (ICIS) related adverse events of acute kidney injury through data mining methods based on the big data of FAERS, and to provide a reference for the safe clinical use of ICIS drugs.
Case reports were collected from April 2011 to March 2021 with immune checkpoint inhibitors (ICIS) as the first suspected drug and acute kidney injury (AKI) as the preferred term. Reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS) were used to study the relationship between ICIS and acute kidney injury. The incidence time, mortality and hospitalization rate of acute kidney injury were further studied.
1 528 cases of acute kidney injury were included. The proportion of people aged over 65 was the highest, reaching 65.38%. Males were about twice as large as females (64.66% vs 31.87%). Patients with chest cancer reported the most acute kidney injury (32.98%), followed by skin cancer (26.11%) and urogenital cancer (18.72%). Acute kidney injury was most reported in nivolumab monotherapy (54.78%). Cimepritimab had the strongest signal in immune checkpoint inhibitor monotherapy, which may be related to the patient population. The median onset time of acute kidney injury was 49 days in immune checkpoint inhibitor monotherapy regimens (interquartile range [IQR] 1~1 720).
The mechanism of action of immune checkpoint inhibitors differs from traditional cytotoxic and targeted drugs. The proper balance between activation and inhibition of immune molecule function is the key to a strong immune response, and sufficient attention should be given to its efficacy and safety.
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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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