[An analysis of adverse drug reactions of thalidomide in treatment of immune-related bowel diseases].

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.