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

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.

• Authors: Han-qing Luo, Bei Tan, Hong Lü, Jia-ming Qian
• Journal: Zhonghua nei ke za zhi (Zhonghua Nei Ke Za Zhi) Vol. 52 Issue 9 Pg. 726-9 (Sep 2013) ISSN: 0578-1426 [Print] China
• PMID: 24314159 (Publication Type: Clinical Trial, English Abstract, Journal Article)

Chemical References

• Thalidomide

Topics

• Adult
• Behcet Syndrome (drug therapy)
• Colitis, Ulcerative (drug therapy)
• Crohn Disease (drug therapy)
• Dose-Response Relationship, Drug
• Drug-Related Side Effects and Adverse Reactions
• Female
• Humans
• Male
• Middle Aged
• Thalidomide (adverse effects, therapeutic use)
• Young Adult