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粒细胞-单核细胞分离术治疗激素依赖、不耐受/抵抗硫唑嘌呤的中度溃疡性结肠炎:一项前瞻性多中心研究

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study.

作者信息

Imperiali Gianni, Amato Arnaldo, Terpin Maria Maddalena, Beverina Ivo, Bortoli Aurora, Devani Massimo, Viganò Chiara

机构信息

Gastroenterology Division, Valduce Hospital, Como, Italy.

Gastroenterology Division, Legnano Hospital, ASST Ovest Milanese, Legnano, Italy.

出版信息

Gastroenterol Res Pract. 2017;2017:9728324. doi: 10.1155/2017/9728324. Epub 2017 Dec 21.

Abstract

BACKGROUND

Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results.

AIM

To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis.

METHODS

Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery.

RESULTS

From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved.

CONCLUSIONS

Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.

摘要

背景

尽管粒细胞-单核细胞分离术受成本和结果变异性的限制,但已被提议用于治疗溃疡性结肠炎。

目的

评估粒细胞-单核细胞分离术对依赖类固醇、不耐受/抵抗硫唑嘌呤的中度溃疡性结肠炎患者的有效性。

方法

前瞻性纳入符合纳入标准的连续患者,采用分离术进行治疗,并随访12个月。该研究的主要终点是12个月时无需使用类固醇的临床缓解,且无需生物治疗或手术。

结果

2013年1月至12月,共纳入33例患者。随访一年后,12例(36%)患者实现临床缓解,无需使用类固醇,也无需生物治疗或手术;3例(9%)出现临床反应(但未实现临床缓解)。此外,12例(36%)患者需要生物治疗,4例(12%)接受了结肠切除术,另外2例(6%)实现了类固醇剂量的减少但未停用。

结论

我们的研究表明,对于依赖类固醇、不耐受或抵抗硫唑嘌呤的中度溃疡性结肠炎患者,标准疗程的粒细胞-单核细胞分离术可使36%的患者实现无需使用类固醇的临床缓解。在这一特定亚组患者中,分离术可能是生物治疗或手术的替代方案。该试验已在Clinicaltrial.gov上注册,注册号为NCT03189888。

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