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随机对照临床试验:脾射频消融与脾切除术治疗重度脾功能亢进症的比较。

Randomized clinical trial of splenic radiofrequency ablation versus splenectomy for severe hypersplenism.

机构信息

Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.

出版信息

Br J Surg. 2011 Mar;98(3):354-61. doi: 10.1002/bjs.7367. Epub 2010 Dec 24.

Abstract

BACKGROUND

Radiofrequency ablation (RFA) is a relatively new treatment for hypersplenism. The results of a randomized clinical trial comparing RFA and splenectomy with 5 years of follow-up are reported.

METHODS

Fifty-seven patients with hypersplenism due to liver cirrhosis were assigned randomly (in a 1 : 2 ratio) to splenectomy (19 patients) or RFA (38). The RFA group was subdivided according to the percentage of the spleen ablated: less than 50 per cent (9 patients), 50-70 per cent (18) or over 70 per cent (11). Routine blood tests were performed before and after operation, and total spleen volume and ablated volume were measured by contrast-enhanced computed tomography. The primary endpoint of the trial was recurrence of hypersplenism, assessed as platelet and white cell counts, at 5 years after surgery.

RESULTS

White cell and platelet counts increased rapidly after intervention in both groups. By 36 months after operation peripheral platelet and white cell counts had decreased significantly in the RFA group compared with the splenectomy group, and declined to baseline levels by 48 months. Hypersplenism recurred after 6 months in patients with less than 50 per cent of the spleen ablated. Blood cell count in the splenectomy group and in patients with more than 50 per cent of the spleen ablated decreased with time after operation, but to levels that remained significantly higher than those before operation (P < 0·050). Splenic volume reached its nadir 12 months after RFA and then increased with time.

CONCLUSION

Splenic RFA represents an attractive alternative treatment for hypersplenism induced by liver cirrhosis, particularly when more than 50 per cent of the spleen is ablated.

摘要

背景

射频消融(RFA)是治疗脾功能亢进症的一种相对较新的治疗方法。报告了一项比较 RFA 和脾切除术的随机临床试验结果,随访时间为 5 年。

方法

57 例因肝硬化导致脾功能亢进的患者随机(1:2 比例)分为脾切除术(19 例)或 RFA(38 例)。RFA 组根据消融的脾脏百分比进一步分为:小于 50%(9 例)、50-70%(18 例)或大于 70%(11 例)。术前和术后均进行常规血液检查,并通过增强 CT 测量总脾脏体积和消融体积。该试验的主要终点是手术后 5 年脾功能亢进的复发,通过血小板和白细胞计数来评估。

结果

两组干预后白细胞和血小板计数均迅速增加。术后 36 个月时,RFA 组外周血小板和白细胞计数明显低于脾切除术组,48 个月时降至基线水平。脾脏消融小于 50%的患者在术后 6 个月时脾功能亢进复发。脾切除术组和脾脏消融大于 50%的患者的血细胞计数随术后时间的推移而下降,但仍显著高于术前水平(P < 0.050)。RFA 后 12 个月脾脏体积达到最低点,然后随时间增加。

结论

对于由肝硬化引起的脾功能亢进,RFA 代表一种有吸引力的替代治疗方法,特别是当消融超过 50%的脾脏时。

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