金属支架置入术与塑料支架置入术治疗恶性肝外胆管梗阻的生活质量比较：一项随机对照试验
Higher quality of life after metal stent placement compared with plastic stent placement for malignant extrahepatic bile duct obstruction: a randomized controlled trial.
作者信息
Walter Daisy, van Boeckel Petra G A, Groenen Marcel J M, Weusten Bas L A M, Witteman Ben J, Tan Gi, Brink Menno A, Nicolai Jan, Tan Adriaan C, Alderliesten Joyce, Venneman Niels G, Laleman Wim, Jansen Jeroen M, Bodelier Alexander, Wolters Frank L, van der Waaij Laurens A, Breumelhof Ronald, Peters Frans T M, Scheffer Robbert C H, Steyerberg Ewout W, May Anne M, Leenders Max, Hirdes Meike M C, Vleggaar Frank P, Siersema Peter D
机构信息
aDepartment of Gastroenterology and Hepatology bJulius Center for Health Sciences and Primary Care, University Medical Center cDepartment of Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht dDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem eDepartment of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein fDepartment of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede gDepartment of Gastroenterology and Hepatology, Zorg Groep Twente, Hengelo hDepartment of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort iDepartment of Gastroenterology and Hepatology, Haga Hospital, Den Haag jDepartment of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen kDepartment of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht lDepartment of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede mDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam nDepartment of Gastroenterology and Hepatology, Amphia Hospital, Breda oDepartment of Gastroenterology and Hepatology, VieCuri Hospital, Venlods pDepartment of Gastroenterology and Hepatology, Martini Hospital qDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen rDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch sDepartment of Decision Analysis, Erasmus University Medical Center, Rotterdam, The Netherlands tDepartment of Gastroenterology and Hepatology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.
出版信息
Eur J Gastroenterol Hepatol. 2017 Feb;29(2):231-237. doi: 10.1097/MEG.0000000000000762.
OBJECTIVE
For palliation of extrahepatic bile duct obstruction, self-expandable metal stents (SEMS) are superior to plastic stents in terms of stent patency and occurrence of stent dysfunction. We assessed health-related quality of life (HRQoL) after stent placement to investigate whether this also results in a difference in HRQoL between patients treated with a plastic stent or SEMS.
PATIENTS AND METHODS
This randomized multicenter trial included 219 patients who were randomized to receive plastic stent (n=73) or SEMS [uncovered (n=75) and covered (n=71); n=146] placement. HRQoL was assessed with two general questionnaires (EQ-5D-3L and QLQ-C30) and one disease-specific questionnaire (PAN-26). Scores were analyzed using linear mixed model regression and included all patients with baseline and at least one follow-up measurement.
RESULTS
HRQoL data were available in 140 of 219 patients (64%); 71 patients (32%) declined participation and in eight patients (4%) only baseline questionnaires were available. On the QLQ-C30, the interaction between follow-up time and type of stent was significantly different on two of five functional scales [physical functioning (P=0.004) and emotional functioning (P=0.01)] in favor of patients with a SEMS. In addition, patients with SEMS reported significantly less frequent symptoms of fatigue (P=0.01), loss of appetite (P=0.02), and nausea and vomiting (0.04) over time. The EQ-VAS score decreased with time in both treatment groups, indicating a statistically significant decrease in HRQoL over time.
CONCLUSION
In patients with inoperable malignant extrahepatic bile duct obstruction, SEMS placement results in better scores for general and disease-specific HRQoL over time compared with plastic stent placement.
目的
对于缓解肝外胆管梗阻，自膨式金属支架（SEMS）在支架通畅性和支架功能障碍发生率方面优于塑料支架。我们评估了支架置入后的健康相关生活质量（HRQoL），以研究这是否也会导致接受塑料支架或SEMS治疗的患者在HRQoL上存在差异。
患者与方法
这项随机多中心试验纳入了219例患者，这些患者被随机分配接受塑料支架置入（n = 73）或SEMS置入[裸支架（n = 75）和覆膜支架（n = 71）；n = 146]。使用两份通用问卷（EQ-5D-3L和QLQ-C30）和一份疾病特异性问卷（PAN-26）评估HRQoL。使用线性混合模型回归分析得分，纳入所有有基线和至少一次随访测量的患者。
结果
219例患者中有140例（64%）可获得HRQoL数据；71例患者（32%）拒绝参与，8例患者（4%）仅可获得基线问卷。在QLQ-C30上，随访时间与支架类型之间的相互作用在五个功能量表中的两个量表上有显著差异[身体功能（P = 0.004）和情绪功能（P = 0.01）]，有利于接受SEMS的患者。此外，随着时间的推移，接受SEMS的患者报告的疲劳症状（P = 0.01）、食欲不振（P = 0.02）以及恶心和呕吐（0.04）的频率明显更低。两个治疗组的EQ-VAS评分均随时间下降，表明HRQoL随时间有统计学显著下降。
结论
对于无法手术的恶性肝外胆管梗阻患者，与塑料支架置入相比，随着时间的推移，SEMS置入导致总体和疾病特异性HRQoL得分更高。
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