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高剂量钡剂嵌顿治疗结肠憩室出血复发:一项随机对照试验。

High-dose barium impaction therapy for the recurrence of colonic diverticular bleeding: a randomized controlled trial.

机构信息

*Department of Gastroenterology and Hepatology †Clinical Research and Informatics, International Clinical Research Center Research Institute ‡Department of Radiology §Department of Nursing, National Center for Global Health and Medicine, Tokyo, Japan; and ‖Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Chiba, Japan.

出版信息

Ann Surg. 2015 Feb;261(2):269-75. doi: 10.1097/SLA.0000000000000658.

Abstract

OBJECTIVE

We compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding.

BACKGROUND

Previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding.

METHODS

After spontaneous cessation of bleeding, patients were randomly assigned to conservative treatment (n = 27) or high-dose barium impaction therapy (n = 27). Patients were followed up for 1 year after enrollment of the last patient. The main outcome measure was rebleeding.

RESULTS

Median follow-up period was 584.5 days. The probability of rebleeding at 30-day, 180-day, 1-year, and 2-year follow-up in all patients was 3.7%, 14.8%, 28.4%, and 32.7%, respectively. By group, probability at 1 year was 42.5% in the conservative group and 14.8% in the barium group (log-rank test, P = 0.04). After adjustment for a history of hypertension, the hazard ratio of rebleeding in the barium group was 0.34 (95% confidence interval, 0.12-0.98). No complications or laboratory abnormalities due to barium therapy were observed. Compared with the conservative group, the barium group had significantly (P < 0.05) fewer hospitalizations per patient (1.7 vs 1.2), units of blood transfused (1.9 vs 0.7), colonoscopies (1.4 times vs 1.1 times), and hospital stay days (15 days vs 11 days) during the follow-up period. No patients died and none required angiographic or surgical procedures in either group.

CONCLUSIONS

High-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding, and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination. ClinicalTrials.gov Identifier, UMIN 000002832.

摘要

目的

比较钡剂治疗和保守治疗预防憩室出血患者复发的临床疗效。

背景

既往病例报告表明,钡剂嵌顿疗法可对憩室出血提供初始止血并预防再出血。

方法

出血自行停止后,患者被随机分配至保守治疗组(n=27)或大剂量钡剂嵌顿治疗组(n=27)。所有患者在最后一名患者入组后随访 1 年。主要观察指标为再出血。

结果

中位随访期为 584.5 天。所有患者在 30 天、180 天、1 年和 2 年随访时的再出血概率分别为 3.7%、14.8%、28.4%和 32.7%。按组计算,1 年时保守组的概率为 42.5%,钡剂组为 14.8%(对数秩检验,P=0.04)。在校正高血压病史后,钡剂组再出血的风险比为 0.34(95%置信区间,0.12-0.98)。未观察到因钡剂治疗引起的并发症或实验室异常。与保守组相比,钡剂组患者的住院次数(1.7 次比 1.2 次)、输血量(1.9 单位比 0.7 单位)、结肠镜检查次数(1.4 次比 1.1 次)和住院天数(15 天比 11 天)均明显减少(均 P<0.05)。两组均无患者死亡,也无需进行血管造影或手术治疗。

结论

大剂量钡剂嵌顿疗法可有效预防复发性出血,减少再住院和输血以及结肠镜检查的需求。临床试验注册号:UMIN000002832。

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