An analysis of adverse drug reactions of thalidomide in treatment of immune-related bowel diseases / 中华内科杂志

ABSTRACT

Objective To investigate the safety of thalidomide in the treatment of immune-related bowel diseases for providing clinical reference.Methods Thirty-five patients with immune-related bowel diseases (31 Crohn's disease,2 ulcerative colitis and 2 Behcet's disease) treated with thalidomide were enrolled in this study.The incidence,type,severity,duration of thalidomide related adverse drug reaction (ADR) and the dose-effect relationship of neurotoxicity were analyzed.Results All the patients were treated with a mean dose of thalidomide (109.29 ± 30.37) mg/d for (18.8 ± 12.4) months,and 33 occurred ADR.The three most frequent ADR were numbness [51.4％ (18/35)],somnolence [48.6％ (17/35)] and dermatitis [37.1％ (13/35)].The median time to development of these three ADR were 6.50,0.25,and 1.00 months,respectively.Severe ADR leading to withdrawal accounted for 20.0％ (7/35),including reasons of peripheral neuritis (3/7),dermatitis (2/7) and myelosuppression (2/7).The incidence of peripheral neuritis was not significantly related to the maximal and initial dose of thalidomide (P ＞ 0.05).Conclusions Although the incidence of ADR was relatively high during the treatment of thalidomide,most of them were mild and well tolerated.Thalidomide can be safely used in patients with immune-related bowel diseases under close monitoring.