主页 > 医学新闻 >
【medical-news】对胆道支架标示外使用的研究
对胆道支架标示外使用的研究
Newswise — Although approved by the U.S. Food and Drug Administration as a palliative treatment for cancer patients who have developed bile-duct obstructions, biliary stents are sometimes used “off-label” for the treatment of peripheral vascular disease (PVD). A study in today’s issue of the American Journal of Therapeutics finds that off-label use of biliary stents is increasing, and that the majority of adverse events and device malfunctions associated with the use of these stents occurs during off-label usage.
Newswise——胆道支架虽然被美国FDA批准作为一种姑息治疗措施用于胆道梗阻的癌症患者，但是却时常被超出应用范围使用于周围血管疾病（PVD）。今天在《美国治疗杂志》（American Journal of Therapeutics）上的研究发现标示外使用胆道支架的情况在增加，随之而来的是严重不良作用及器械故障。
“Our study found that more than 1 million patients received biliary stents for ‘off-label’ treatments between 2003 and 2006,” explains cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and senior author of the study. “We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during ‘off-label’ use.”
文章通讯作者William Maisel医学博士、公共卫生硕士说：“我们研究发现在2003至2006期间总共有1百万例以上的患者接受了超出标示应用范围以外的胆道支架治疗，其中80%有不良反应和器械故障的报道。”
The most common off-label use for biliary stents is treatment of peripheral arterial disease (PAD), which develops when leg arteries become narrowed by cholesterol plaques. Patients who suffer from PAD can develop pain, skin ulcers, reduced exercise tolerance and even loss of limb. The condition affects millions of patients throughout the U.S. and is a significant cause of morbidity and mortality.
胆道支架最常见的标示外使用是用于PAD的治疗。PAD为胆固醇斑块导致动脉狭窄所致，常见于腿部动脉，临床表现为疼痛、皮肤溃疡及运动耐力下降，最终能致残。PAD在美国的发病人数达数百万之多，不管在发病率还是死亡率中都是一个重要因素。
“Clinical management of peripheral artery disease can be challenging,” explains Maisel. Although noninvasive treatment strategies such as exercise training can help some patients, for many others, pain and discomfort persist. In an effort to unblock the vessels, many physicians have turned to stents, flexible tubular devices which can keep the vessels propped open.
“临床处理周围动脉疾病极具挑战性，”Maisel说。虽然诸如运动训练等无创疗法能帮组一些患者，但是多数都是病通不断。为了解除梗阻，许多医生求助于支架、弹性管具等能把血管撑开的器械。
Because there is little data supporting the clinical utility and safety of biliary stents for treatment of vascular disorders, Maisel and colleague Jonathan Bridges, MD, of BIDMC’s Cardiovascular Institute decided to take a closer look.
由于缺乏支持胆管支架用于治疗血管疾病的资料，Maisel和他的同事Jonathan Bridges医学博士决定一探究竟。
The authors determined that biliary stent implants among PVD patients increased 21.4 percent, from 227,145 in 2003 to 275,795 in 2006; approximately 1 million biliary stents were implanted off-label in the peripheral vasculature in total. Additionally, using the publicly available MAUDE (Manufacturer and User Facility Device Experience) database -- a compilation of serious adverse events and malfunctions associated with medical devices that have been reported to the FDA -- the authors reviewed all reports involving biliary stents between 2003 and 2006. During this time period, 1,036 confirmed biliary-stent malfunctions were reported, 81.2 percent of which occurred during off-label use. Malfunctions were most often due to premature stent dislodgement, premature deployment or failure of the catheter/delivery system.
他们发现胆道支架在PVD中的植入数量从2003年的227125枚到2006年的275795枚，上升了21.4%，大约有总数达1百万枚的胆道支架被标示外是用于外周血管。利用公开的制造商和使用者设备器械记录（MAUDE）库的资料——其中编录了报告给FDA的医疗器械的严重不良反应和故障——作者统计了在2003年至2006年内有关胆道支架的报告。在期间，有1036例为明确的胆道支架故障，其中81.2%发生在标示外使用的情况。故障常为支架过早变位，管道/传递系统过早展开或无法展开。
In addition, notes Maisel, 87.9 percent of the 561 adverse events associated with biliary stent use during the study period occurred during off-label use, with retained product, additional catheter procedures or surgery being the most common adverse events. Thirteen patient deaths were reported during off-label use. “Like the malfunctions, we found that many more adverse events occurring during the use of biliary stents in peripheral blood vessels than when they were used in a biliary or gastrointestinal location,” he adds.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-04-26 17:14
医学,生命科学网