江西多乐彩11选5

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RA患者接受生物制劑治療與腫瘤發生風險的薈萃分析

發布時間:2012-12-28 13:39:39

背景:關注類風濕關節炎(RA)患者接受生物制劑(BRMs)潛在的發生惡性腫瘤的風險。

研究目的:評價隨機對照試驗(RCTs)的RA患者使用BRMs后惡性腫瘤風險。

數據來源:通過電子數據庫、會議文獻資料和管理機構的網站搜索至2012年7月9日接受BRMs治療的RCTs,BRMs包括:阿巴西普、阿達木單抗、阿那白滯素、賽妥珠單抗、依那西普、戈利木單抗、英夫利昔、利妥昔單抗和托珠單抗。

研究篩選:獨立選擇那些至少隨訪了24周,任何一種BRMs與安慰劑或傳統的緩解病情的抗風濕藥物相比較安全性的研究,包括RCTs。

數據提取:由獨立的評審員選擇研究并提取有關質量和結果的數據,計算每種BRM的綜合估計和95%可信區間。

結果:總共分析了63項RCTs包含29423例患者,沒有觀察到惡性腫瘤發病風險在統計學上明顯的增加。29423例患者中,211例患者試驗期間發現一種惡性腫瘤(118例實體瘤,48例皮膚癌,14例淋巴瘤,5例血液系統非淋巴瘤和26例未明確的腫瘤),治療第一年發生任意惡性腫瘤的風險在BRMs聯合甲氨蝶呤組(0.77%; 95% CI, 0.65%-0.92%)、BRM單藥治療組(0.64%; 95% CI, 0.42%-0.95%)及對照組(0.66%; 95% CI, 0.52%-0.84%)都非常低。阿那白滯素聯合甲氨蝶呤較單用甲氨蝶呤風險更低(Peto比值比為0.11;95% CI,0.03-0.45)。盡管接受腫瘤壞死因子抑制劑治療者較對照組發生淋巴瘤的Peto比值比是2.1(95% CI,0.55-8.4),但特殊癌癥位點的風險并未顯示出明顯統計學意義。

結論:在已有的RCTs中,與其他緩解病情的抗風濕藥物或安慰劑相比,RA患者接受BRMs治療至少6個月并未顯著增加惡性腫瘤的發生風險。

【原文】

JAMA.2012 Sep 5;308(9):898-908.
Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis.
Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, Pollono EN, Cueto JP, Gonzales-Crespo MR, Fulton S, Suarez-Almazor ME.

Source:University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.

Abstract

CONTEXT:
Concerns exist regarding the potential development of malignancies in patients with rheumatoid arthritis (RA) who are receiving biologic response modifiers (BRMs).

OBJECTIVE: To assess the risk of malignancy in patients with RA enrolled in randomized controlled trials (RCTs) of BRMs.

DATA SOURCES: Electronic databases, conference proceedings, and websites of regulatory agencies were searched for RCTs evaluating abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab in RA from inception through July 9, 2012.

STUDY SELECTION: Independent selection of studies included RCTs that compared the safety of any BRMs used in RA patients with placebo and/or any traditional disease-modifying antirheumatic drugs with a minimum of 24 weeks of follow-up.

DATA EXTRACTION: Independent reviewers selected studies and extracted data on quality and outcomes. Pooled estimates and 95% confidence intervals were calculated for each BRM.

RESULTS: Sixty-three RCTs with 29,423 patients were analyzed. No statistically significant increased risk of developing malignancy was observed. Of the 29,423 patients, 211 developed a malignancy during the trial (118 solid tumors, 48 skin cancers, 14 lymphomas, 5 hematologic nonlymphomas, and 26 not specified). The incidence rate for any malignancy during the first year of therapy was very low in the BRM plus methotrexate group (0.77%; 95% CI, 0.65%-0.92%), the BRM monotherapy group (0.64%; 95% CI, 0.42%-0.95%), and the controls (0.66%; 95% CI, 0.52%-0.84%). Anakinra plus methotrexate showed lower odds compared with methotrexate alone (Peto odds ratio, 0.11; 95% CI, 0.03-0.45). No statistically significant risk was observed for specific cancer sites, although the Peto odds ratio for lymphoma was 2.1 (95% CI, 0.55-8.4) in patients receiving tumor necrosis factor inhibitors compared with controls.

CONCLUSION: The use of BRMs among patients with RA included in RCTs of at least 6 months| duration was not significantly associated with an increased risk of malignancy compared with other disease-modifying antirheumatic drugs or with placebo.

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江西多乐彩11选5