期刊
BLOOD
卷 119, 期 6, 页码 1356-1362出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2011-08-374777
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- Roche
- Amgen
- GlaxoSmithKline
- sanofi-aventis
- Bayer Healthcare
- Boehringer-Ingelheim
- Amgen Canada
- Ariad Pharmaceuticals
- Astex Therapeutics
- Astra Zeneca
- Bristol-Myers Squibb
- Celgene
- Lilly
- Janssen-Ortho
- Merck Frosst Canada
- Novartis
- Oncothyreon
- Orthobiotech
- Pfizer
- S*Bio Ptd Ltd
- Schering Canada
- Zymogenetics
- Leo Pharma
- Octapharma
The benefit of adding rituximab to standard treatment in nonsplenectomized patients with primary immune thrombocytopenia (ITP) is uncertain. We performed a pilot randomized trial to determine the feasibility of recruitment, protocol adherence, and blinding of a larger trial of rituximab versus placebo; and to evaluate the potential efficacy of adjuvant rituximab in ITP. Nonsplenectomized adults with newly diagnosed or relapsed ITP who were receiving standard ITP therapy for a platelet count below 30 x 10(9)/L were randomly allocated to receive 4 weekly infusions of 375 mg/m(2) rituximab or saline placebo. Sixty patients were recruited over 46 months, which was slower than anticipated. Protocol adherence and follow-up targets were achieved, and blinding was successful for research staff but not for patients. After 6 months, there was no difference between rituximab and placebo groups for the composite outcome of any platelet count below 50 x 10(9)/L, significant bleeding or rescue treatment once standard treatment was stopped (21/32 [65.6%] vs 21/26 [80.8%]; relative risk = 0.81, 95% confidence intervals, 0.59%-1.11%). Timely accrual poses a challenge to the conduct of a large randomized trial of rituximab for presplenectomy ITP. No difference in the frequency of the composite outcome was observed in this pilot trial (registered at www.clinicaltrials.gov NCT00372892). (Blood. 2012; 119(6): 1356-1362)
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