A Real-World Disproportionality Analysis of Drug-Induced Immune Hemolytic Anemia in the FDA Adverse Event Reporting System.

BACKGROUND: Drug-induced immune hemolytic anemia (DIIHA) is a rare but potentially life-threatening pharmacogenic hematological adverse effect. Updating the risk of DIIHA among the currently available drugs based on spontaneously reported adverse event data is of great significance. OBJECTIVE: This study aimed to identify the top 50 drugs associated with immune hemolytic anemia in adults as well as common drugs that could cause immune hemolytic anemia in children based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: We extracted adverse events (AE) in the FAERS database from Q1 2004 to Q3 2022 using Open vigil2.1. We use the high-level term "anaemias haemolytic immune" according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary (version 24.0). The reported correlation between drugs and DIIHA risk was identified by reported odds ratio (ROR) and proportional reporting ratio (PRR). RESULTS: There were 10500309 AEs in FAERS from 2004Q1 to 2022Q3, of which 2326 (0.02%) were DIIHA cases. The incidence of DIIHA is comparable between males and females. The most common drugs associated with DIIHA in adults and children are summarized according to the number of AE reports. The top 3 categories in terms of quantity of drugs are antineoplastic agents, immunosuppressants, and antibiotics for systemic use. The top 5 drugs in terms of ROR and PRR are alemtuzumab, daclizumab, fludarabine, busulfan, and bendamustine in adults, with entecavir, treosulfan, vinorelbine, pegademase, and alemtuzumab for children. CONCLUSIONS: Our study identified the most common drugs that could induce DIIHA in adults and children, as well as the respective ROR and PRR value to discover new drug signals. This study provides references to clinicians for the management of rare DIIHA.

Icotinib and pemetrexed in treatment of lung adenocarcinoma and the effects on prognostic survival rate of patients.

Efficacy comparison of icotinib and pemetrexed in the treatment of lung adenocarcinoma and the effects on the prognostic survival rate of patients were investigated. A retrospective analysis was performed in 132 lung adenocarcinoma patients who were treated in the Affiliated Hospital of Weifang Medical University from July 2010 to July 2015. Among them, 69 patients were treated with icotinib (icotinib group), and 63 patients were treated with pemetrexed (pemetrexed group). In the icotinib group, 125 mg icotinib was orally administered continuously, 3 times a day, until progressive disease or intolerable adverse reactions occurred. In the pemetrexed group, 500 mg/m2 pemetrexed was intravenously dripped for a total of 4 cycles, 21 days for 1 cycle, until progressive disease or intolerable adverse reactions occurred. The efficacy, toxic and side effects, and survival rate of the two groups were evaluated. There was a statistically significant difference in toxic and side effects between the two groups of drugs after the treatment of lung adenocarcinoma (P<0.05). The median survival time of patients was 16 months in the icotinib group and 10 months in the pemetrexed group, with a statistically significant difference (P<0.05). The 1-year survival rate was higher in the icotinib group than that in the pemetrexed group (P<0.05). There was no difference in 2- and 3-year survival rates between the two groups (P>0.05). In conclusion, the clinical efficacy of icotinib is similar to that of pemetrexed in the treatment of lung adenocarcinoma, but icotinib has less adverse reactions, with better improvement in disease control.