Objective:To explore clinical characteristics of adverse drug reactions of novel antineoplastic drugs in patients with human immunodeficiency virus infection/acquired immunodeficiency syndrome(HIV/AIDS).Methods:The study was a retrospective case-control design. The subjects were selected from patients who used novel antineoplastic drugs in Henan Provincial Infectious Disease Hospital from January 1 to December 31, 2023. Clinical data of patients were collected through the hospital electronic medical record system. Adverse reactions of novel antineoplastic drugs were screened and the incidence was calculated. According to results of HIV antibody testing, adverse reaction incidence was compared between HIV antibody-negative and-positive patients. Then the patients with HIV/AIDS were divided into 2 groups according to whether adverse reactions occurred and the differences in clinical data between them were compared; the clinical manifestations, intervention and outcomes of adverse reactions were analyzed descriptively.Results:A total of 182 patients were enrolled in this study, the overall incidence rate of adverse reactions of novel antineoplastic drugs was 56.6% (103/182), and the incidences in HIV antibody-positive and -negative patients were 55.9% (76/136) and 58.7% (27/46), respectively, with no statistically significant difference ( P>0.05). In patients with HIV/AIDS, the proportions of patients over 50 years old [80.3% (61/76) vs. 63.3% (38/60)], with a history of previous adverse reactions [43.4% (33/76) vs. 23.3% (14/60)], and with other comorbidities [57.9% (44/76) vs. 40.0% (24/60)] in the adverse reactions group were higher than those in the non-adverse reactions group, and the differences were all statistical significance (all P<0.05). No statistically significant differences were found in gender, CD4 + T lymphocyte levels, HIV viral load, antiretroviral treatment regimens, and tumor types between the 2 groups (all P>0.05). Adverse reactions occurred for 91 times in the 76 patients, 27 (29.7%) of which were grade 1, 45 (49.4%) were grade 2, and 19 (20.9%) were grade 3 or severer. According to clinical characteristics, there were 209 performances of adverse reactions in 76 patients, mainly including hand-foot syndrome, fatigue, hypertension, rash, etc., with the main affected system and organs being the skin and its appendages and the gastrointestinal system. The involved drugs mainly were anlotinib (44 cases, 21.0%), lenvatinib (29 cases, 13.9%), and bevacizumab (23 cases, 11.0%). After drug adjustments and symptomatic treatments, 80 times of adverse reactions were eventually improved, 4 were not, and 3 were with unknown information. Conclusions:The incidences of adverse reactions of novel antineoplastic drugs were similar between patients with and without HIV/AIDS. In HIV/AIDS patients with tumors, those over 50 years old, with other diseases, and with a history of adverse reactions might have higher risks of adverse reactions, which mainly involved the skin and its appendages and the gastrointestinal system, with a severity of mostly grade 1 to 2. With timely managements, the prognosis was favorable.

Objective:To explore clinical characteristics of adverse drug reactions of novel antineoplastic drugs in patients with human immunodeficiency virus infection/acquired immunodeficiency syndrome(HIV/AIDS).Methods:The study was a retrospective case-control design. The subjects were selected from patients who used novel antineoplastic drugs in Henan Provincial Infectious Disease Hospital from January 1 to December 31, 2023. Clinical data of patients were collected through the hospital electronic medical record system. Adverse reactions of novel antineoplastic drugs were screened and the incidence was calculated. According to results of HIV antibody testing, adverse reaction incidence was compared between HIV antibody-negative and-positive patients. Then the patients with HIV/AIDS were divided into 2 groups according to whether adverse reactions occurred and the differences in clinical data between them were compared; the clinical manifestations, intervention and outcomes of adverse reactions were analyzed descriptively.Results:A total of 182 patients were enrolled in this study, the overall incidence rate of adverse reactions of novel antineoplastic drugs was 56.6% (103/182), and the incidences in HIV antibody-positive and -negative patients were 55.9% (76/136) and 58.7% (27/46), respectively, with no statistically significant difference ( P>0.05). In patients with HIV/AIDS, the proportions of patients over 50 years old [80.3% (61/76) vs. 63.3% (38/60)], with a history of previous adverse reactions [43.4% (33/76) vs. 23.3% (14/60)], and with other comorbidities [57.9% (44/76) vs. 40.0% (24/60)] in the adverse reactions group were higher than those in the non-adverse reactions group, and the differences were all statistical significance (all P<0.05). No statistically significant differences were found in gender, CD4 + T lymphocyte levels, HIV viral load, antiretroviral treatment regimens, and tumor types between the 2 groups (all P>0.05). Adverse reactions occurred for 91 times in the 76 patients, 27 (29.7%) of which were grade 1, 45 (49.4%) were grade 2, and 19 (20.9%) were grade 3 or severer. According to clinical characteristics, there were 209 performances of adverse reactions in 76 patients, mainly including hand-foot syndrome, fatigue, hypertension, rash, etc., with the main affected system and organs being the skin and its appendages and the gastrointestinal system. The involved drugs mainly were anlotinib (44 cases, 21.0%), lenvatinib (29 cases, 13.9%), and bevacizumab (23 cases, 11.0%). After drug adjustments and symptomatic treatments, 80 times of adverse reactions were eventually improved, 4 were not, and 3 were with unknown information. Conclusions:The incidences of adverse reactions of novel antineoplastic drugs were similar between patients with and without HIV/AIDS. In HIV/AIDS patients with tumors, those over 50 years old, with other diseases, and with a history of adverse reactions might have higher risks of adverse reactions, which mainly involved the skin and its appendages and the gastrointestinal system, with a severity of mostly grade 1 to 2. With timely managements, the prognosis was favorable.