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阿达木单抗用于布地奈德和甲氨蝶呤难治性胶原性结肠炎。

Adalimumab in budesonide and methotrexate refractory collagenous colitis.

作者信息

Münch Andreas, Ignatova Simone, Ström Magnus

机构信息

Linköping University Hospital, Clinic of Endocrinology and Gastroenterology, Linköping, Sweden.

出版信息

Scand J Gastroenterol. 2012 Jan;47(1):59-63. doi: 10.3109/00365521.2011.639079. Epub 2011 Dec 8.

DOI:10.3109/00365521.2011.639079
PMID:22149977
Abstract

BACKGROUND

We described three patients with collagenous colitis (CC) who developed side effects or were refractory to both budesonide and methotrexate and were given adalimumab (ADA) as a third-line treatment.

METHOD/PATIENTS: Three patients (two women, mean age 45 years and one man, 74 years old) were included. Mean bowel movements per day per week were calculated and stool weight/24 h registered prior to and following ADA treatment. ADA was given in doses 160 mg s.c. (baseline), 80 mg (week 2) and 40 mg (week 4). Sigmoidoscopies with biopsies were performed at baseline and after 6 weeks to examine changes in histology. The Psychological General Well-Being Index (PGWBI) and Short Health Scale (SHS) were used at baseline and after 6 weeks.

RESULTS

The two female patients tolerated the treatment well. The male patient developed, despite clinical response, side effects (vomiting, abdominal pain) after 80 mg of ADA and the treatment was stopped as side effects reoccurred after rechallenge. The two women were in clinical remission at week 6 and the mean stool frequency per day decreased from mean 11 to 2. Mean stool weight/24 h changed from 600 to 185 g. The quality of life improved drastically in all patients. There were no consistent changes in histology.

CONCLUSION

ADA seems effective in budesonide and methotrexate refractory CC and can be administrated to selected patients to achieve clinical remission, improve quality of life and possibly avoid colectomy. Further studies for induction and maintenance treatment should be conducted to confirm efficacy and examine safety issues, even in long term.

摘要

背景

我们描述了三名胶原性结肠炎(CC)患者,他们出现了副作用,或对布地奈德和甲氨蝶呤均无效,因此接受阿达木单抗(ADA)作为三线治疗。

方法/患者:纳入三名患者(两名女性,平均年龄45岁,一名男性,74岁)。计算ADA治疗前后每周每天的平均排便次数,并记录24小时粪便重量。ADA的给药剂量为皮下注射160mg(基线)、80mg(第2周)和40mg(第4周)。在基线和6周后进行乙状结肠镜检查并取活检,以检查组织学变化。在基线和6周后使用心理总体幸福感指数(PGWBI)和简短健康量表(SHS)。

结果

两名女性患者对治疗耐受性良好。尽管有临床反应,但男性患者在使用80mg ADA后出现了副作用(呕吐、腹痛),再次给药后副作用复发,因此停止治疗。两名女性在第6周时临床缓解,每天的平均排便频率从平均11次降至2次。24小时平均粪便重量从600g变为185g。所有患者的生活质量均大幅改善。组织学上没有一致的变化。

结论

ADA似乎对布地奈德和甲氨蝶呤难治性CC有效,可用于选定患者以实现临床缓解、改善生活质量并可能避免结肠切除术。即使是长期,也应进行进一步的诱导和维持治疗研究,以确认疗效并检查安全性问题。

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