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一项关于可扩张金属支架缓解不可切除癌症所致食管梗阻的对照试验。

A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer.

作者信息

Knyrim K, Wagner H J, Bethge N, Keymling M, Vakil N

机构信息

Medizinische Klinik I, Städtische Kliniken, Kassel, Germany.

出版信息

N Engl J Med. 1993 Oct 28;329(18):1302-7. doi: 10.1056/NEJM199310283291803.

DOI:10.1056/NEJM199310283291803
PMID:7692297
Abstract

BACKGROUND

Esophageal obstruction due to cancer can produce debilitating dysphagia. Rapid palliation is usually possible with endoscopic placement of a plastic esophageal prosthesis, but this device has a high rate of complications. A new alternative is a metal-mesh stent that collapses to 3 mm in diameter at placement but can then expand up to 16 mm.

METHODS

Patients with esophageal carcinoma (39 patients) or malignant extrinsic obstruction (3 patients) were randomly assigned to treatment with either a plastic prosthesis (16 mm in diameter) or an expansile metal-mesh stent. The patients were evaluated every six weeks until death. The degree of palliation was expressed as a dysphagia score and a Karnofsky performance score.

RESULTS

Complications were significantly less frequent with the metal stents than with the plastic prostheses (no complications vs. nine; P < 0.001). The dysphagia and Karnofsky scores improved significantly and to a similar degree in both treatment groups. The most common causes of recurrent dysphagia were migration of the plastic prostheses (five patients) and ingrowth or overgrowth of the metal stents by tumor (five patients). The rates of reintervention were similar in both treatment groups, as were the 30-day mortality rates. The period of hospitalization after placement of a prosthesis was significantly longer in the group given plastic prostheses than in the group given metal stents (mean +/- SE, 12.5 +/- 2.1 vs. 5.4 +/- 1.0 days; P = 0.005). Despite their higher initial cost, the metal stents were cost effective because of the absence of fatal complications and the decrease in the hospital stay.

CONCLUSIONS

Expansile metal stents are a safe and cost-effective alternative to conventional plastic endoprostheses in the treatment of esophageal obstruction due to inoperable cancer.

摘要

背景

癌症导致的食管梗阻可引起使人虚弱的吞咽困难。通过内镜放置塑料食管假体通常可实现快速缓解,但该装置并发症发生率高。一种新的替代方法是金属网支架,其在放置时直径可缩至3毫米,但随后可扩张至16毫米。

方法

食管癌患者(39例)或恶性外部梗阻患者(3例)被随机分配接受塑料假体(直径16毫米)或可扩张金属网支架治疗。每六周对患者进行评估直至死亡。缓解程度用吞咽困难评分和卡诺夫斯基功能状态评分表示。

结果

金属支架的并发症明显少于塑料假体(无并发症与9例并发症;P<0.001)。两个治疗组的吞咽困难和卡诺夫斯基评分均显著改善且程度相似。吞咽困难复发的最常见原因是塑料假体移位(5例患者)和肿瘤向内生长或金属支架过度生长(5例患者)。两个治疗组的再次干预率相似,30天死亡率也相似。放置假体后,接受塑料假体治疗的组住院时间明显长于接受金属支架治疗的组(均值±标准误,12.5±2.1天对5.4±1.0天;P=0.005)。尽管金属支架初始成本较高,但由于无致命并发症且住院时间缩短,其具有成本效益。

结论

在治疗因无法手术的癌症导致的食管梗阻时,可扩张金属支架是传统塑料内置假体的一种安全且具有成本效益的替代方法。

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