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雷公藤与硫唑嘌呤预防克罗恩病患者术后复发的随机临床试验

Tripterygium wilfordii Hook. f. versus azathioprine for prevention of postoperative recurrence in patients with Crohn's disease: a randomized clinical trial.

作者信息

Zhu Weiming, Li Yi, Gong Jianfeng, Zuo Lugen, Zhang Wei, Cao Lei, Gu Lili, Guo Zhen, Li Ning, Li Jieshou

机构信息

Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, PR China.

Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, PR China.

出版信息

Dig Liver Dis. 2015 Jan;47(1):14-9. doi: 10.1016/j.dld.2014.09.008. Epub 2014 Oct 30.

DOI:10.1016/j.dld.2014.09.008
PMID:25445405
Abstract

BACKGROUND

Tripterygium wilfordii Hook. f. (TwHF) has been used for many years to induce the remission of Crohn's disease in China.

AIMS

To compare TwHF versus azathioprine for the prevention of postoperative recurrence in Crohn's disease.

METHODS

90 Crohn's disease patients who had undergone resection were treated with TwHF 1.5mg/kg/day or azathioprine 2.0 mg/kg/day. The primary endpoint was clinical recurrence, and the secondary endpoint was endoscopic recurrence.

RESULTS

47 patients completed the trial. Clinical recurrence was observed in 6/45 patients in the TwHF group and 4/45 patients in the azathioprine group at week 26 (P=0.74). At week 52, 8/45 azathioprine patients and 12/45 TwHF patients had clinical recurrence (P = 0.45). During the first 26 weeks, 56.8% of the patients in the TwHF group versus 47.7% in the azathioprine group experienced endoscopic recurrence (P = 0.52). However, at week 52, 74.4% of patients in the TwHF group and 50% in the azathioprine group had endoscopic recurrence (P = 0.03).

CONCLUSIONS

TwHF was less effective in maintaining endoscopic remission at week 52, even though TwHF was comparable to azathioprine for preventing postoperative clinical recurrence.

摘要

背景

在中国,多年来一直使用雷公藤多苷(TwHF)诱导克罗恩病缓解。

目的

比较TwHF与硫唑嘌呤预防克罗恩病术后复发的效果。

方法

90例接受切除术的克罗恩病患者接受TwHF 1.5mg/kg/天或硫唑嘌呤2.0mg/kg/天治疗。主要终点为临床复发,次要终点为内镜复发。

结果

47例患者完成试验。在第26周时,TwHF组45例患者中有6例出现临床复发,硫唑嘌呤组45例患者中有4例出现临床复发(P = 0.74)。在第52周时,硫唑嘌呤组45例患者中有8例出现临床复发,TwHF组45例患者中有12例出现临床复发(P = 0.45)。在最初的26周内,TwHF组56.8%的患者出现内镜复发,硫唑嘌呤组为47.7%(P = 0.52)。然而,在第52周时,TwHF组74.4%的患者出现内镜复发,硫唑嘌呤组为50%(P = 0.03)。

结论

尽管TwHF在预防术后临床复发方面与硫唑嘌呤相当,但在第52周时维持内镜缓解方面效果较差。

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