1.
Intravenous immunoglobulin for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis
Gaebel K, Blackhouse G, Campbell K, Robertson D, Xie F, Assasi N, Chalk C, Levine M, Goeree R
Open Medicine: a Peer-Reviewed, Independent, Open-Access Journal. 2010;4((3)):e154-66.
Abstract
BACKGROUND Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder that targets the myelin sheaths of the peripheral nervous system. Intravenous immunoglobulin (IVIg) is a blood product containing immunoglobulin G pooled from many human donors. In fall 2008, CIDP became an approved indication for IVIg in the United States and Canada. OBJECTIVE To evaluate the clinical effectiveness and safety of IVIg for the treatment of CIDP through a systematic review of published randomized controlled trials. METHODS We searched the MEDLINE (1996-2009, including in-process and other non-indexed citations), Embase (1996-2009) and other databases through the Ovid interface. We applied a methodological filter to limit retrieval to controlled clinical trials, meta-analyses and systematic reviews, and health technology assessments. Retrieval was limited to studies involving humans, and no language restrictions were employed. We pooled extracted data to estimate the effect size of IVIg treatment based on the random-effects model. RESULTS We identified 9 unique randomized controlled trials. Of these, 3 compared IVIg therapy with an active comparator (plasma exchange, plasma exchange using extracorporeal immunoadsorption, oral prednisolone, respectively); the other 6 trials had placebo controls. No incremental benefit was seen in terms of primary outcomes for comparisons of IVIg therapy and an active comparator. Data from 4 of the 6 placebo-controlled trials were included in a meta-analysis. A significant improvement in disability (i.e., reduction in disability score) was found, with a standardized mean difference of 0.65 (95% confidence interval [CI] 0.23 to 1.08) in favour of IVIg. A pooled analysis of the proportion of patients with a response to treatment, as defined by the investigators of each of the trials, resulted in a risk ratio of 2.74 (95% CI 1.80 to 4.15) favouring IVIg. INTERPRETATION IVIg therapy was statistically superior to placebo in reducing disability and impairment among patients with CIDP. The effectiveness of IVIg was similar to that of the alternative treatment strategies of plasma exchange and oral prednisolone.
2.
Randomized, double-blind, placebo-controlled trial of epoetin alfa in men with castration-resistant prostate cancer and anemia
Winquist E, Julian JA, Moore MJ, Nabid A, Sathya J, Wood L, Venner P, Levine M
Journal of Thrombosis and Haemostasis. 2009;27((4):):644-6.
3.
A randomized controlled trial comparing plasma removal with white cell reduction to prevent reactions to platelets
Heddle NM, Klama L, Meyer R, Walker I, Boshkov L, Roberts R, Chambers S, Podlosky L, O'Hoski P, Levine M
Transfusion. 1999;39((3):):231-8.
Abstract
BACKGROUND Recent data suggest that most reactions to platelets are caused by white cell (WBC)-derived cytokines that accumulate in the plasma portion of the component during storage. On the basis of this theory, the effectiveness of two interventions to prevent reactions, poststorage WBC reduction and plasma depletion, were compared. STUDY DESIGN A multiple crossover design was used, in which platelet components for transfusion to a patient randomly were WBC reduced after storage, or the plasma supernatant was removed. Adults >17 years of age, with a hematologic disease requiring platelet transfusion support, were eligible for the study. Patients were assessed for signs and symptoms characteristic of a reaction during, immediately after, and 1 hour after transfusion. Reactions were graded as mild, moderate, or severe. Interleukin 6 levels were also measured in the transfused platelet components. RESULTS There were 380 analyzable platelet transfusions to 30 patients. The frequency of reactions was 25.8 percent (48/186) in the transfusions of poststorage WBC-reduced platelets and 17.0 percent (33/194) in the transfusions of plasma-depleted platelets (p<0.008). The severity of the reaction was graded by the patient. Severe reactions occurred more frequently in connection with poststorage WBC-reduced platelets than with plasma-depleted platelets: 33.4 percent (16/48) versus 18.2 percent (6/33), respectively (p = 0.048). Regression analysis identified interleukin 6 as the most significant of the evaluated factors in its correlation with the risk of reaction. CONCLUSION Plasma removal is more effective than poststorage WBC reduction in preventing reactions, especially severe reactions to platelets.