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金属支架改善恶性食管狭窄患者的吞咽困难、营养状况及生存率:一项比较改良型Gianturco Z支架与塑料Atkinson管的随机对照试验。

Metal stents improve dysphagia, nutrition and survival in malignant oesophageal stenosis: a randomized controlled trial comparing modified Gianturco Z-stents with plastic Atkinson tubes.

作者信息

Roseveare C D, Patel P, Simmonds N, Goggin P M, Kimble J, Shepherd H A

机构信息

Dept of Gastroenterology, Royal Hampshire County Hospital, Winchester, UK.

出版信息

Eur J Gastroenterol Hepatol. 1998 Aug;10(8):653-7.

PMID:9744693
Abstract

OBJECTIVE

To compare modified Gianturco metal stents with plastic Atkinson tubes in the palliation of malignant dysphagia.

DESIGN

Patient single-blind, multi-centre prospective, randomized trial.

SETTING

Three district general hospitals in the Wessex region.

PARTICIPANTS

Thirty one consecutive patients with inoperable malignant oesophageal stenosis causing dysphagia and suitable for treatment with an endoprosthesis.

INTERVENTIONS

Patients were randomized to receive either a modified Gianturco metal stent or a plastic Atkinson tube. Sedation was similar and patients were given identical dietary advice. Data were collected after insertion until the patients' death.

MAIN OUTCOME MEASURES

Procedural mortality/morbidity; hospital stay; weight loss; quality of life (Nottingham Health Profile, Spitzer QL index and specific questions about dysphagia and enjoyment of food); duration of survival after insertion; cost effectiveness of each intervention.

RESULTS

Overall complication rates were similar in the two groups. Compared with Atkinson tubes, patients with Gianturco stents had better palliation of dysphagia (median dysphagia score 1 vs 2, P = 0.04), maintained their weight longer (median percent weight loss 0.66 vs 6.51, P = 0.007), enjoyed food more (enjoyment score 2 vs 1, P = 0.03) and survived longer (log rank P < 0.025). Patients with metal stents were discharged from hospital earlier (Gianturco 4 days, Atkinson 10 days, P = 0.001), and initial treatment cost was lower if the cost of hospital stay exceeded pound sterling 120 per day.

CONCLUSION

Gianturco stents are superior to Atkinson tubes in the palliation of malignant oesophageal stenosis.

摘要

目的

比较改良的Gianturco金属支架与塑料Atkinson管在缓解恶性吞咽困难方面的效果。

设计

患者单盲、多中心前瞻性随机试验。

地点

韦塞克斯地区的三家区综合医院。

参与者

31例因恶性食管狭窄导致吞咽困难且适合使用内置假体治疗的连续患者。

干预措施

患者被随机分为接受改良的Gianturco金属支架或塑料Atkinson管。镇静方式相似,且给予患者相同的饮食建议。收集植入后直至患者死亡的数据。

主要观察指标

手术死亡率/发病率;住院时间;体重减轻情况;生活质量(诺丁汉健康概况、斯皮策QL指数以及关于吞咽困难和食物享受的具体问题);植入后的生存时间;每种干预措施的成本效益。

结果

两组的总体并发症发生率相似。与Atkinson管相比,使用Gianturco支架的患者吞咽困难缓解情况更好(吞咽困难中位数评分1比2,P = 0.04),体重维持时间更长(体重减轻中位数百分比0.66比6.51,P = 0.007),对食物的享受程度更高(享受评分2比1,P = 0.03),且生存时间更长(对数秩检验P < 0.025)。使用金属支架的患者出院更早(Gianturco支架组4天,Atkinson管组10天,P = 0.001),如果住院费用超过每天120英镑,则初始治疗成本更低。

结论

在缓解恶性食管狭窄方面,Gianturco支架优于Atkinson管。

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