英夫利昔单抗对难治性溃疡性结肠炎的疗效“更佳”

圣迭戈(EGMN)——在医院医学会年会上，加州大学圣迭戈分校的胃肠病学家Derek R. Patel博士指出，英夫利昔单抗是重度急性激素难治性溃疡性结肠炎(UC)的最佳补救治疗。

在一项随机研究中，Laharie博士及其同事比较了56例接受英夫利昔单抗治疗的激素难治性UC患者和55例接受环孢菌素治疗的相似患者，结果显示各组1周内的有效率均约为85%。随访第3个月时，环孢菌素组和英夫利昔单抗组分别有10例(18%)和13例(23%)进行结肠切除术。环孢菌素组和英夫利昔单抗组分别有9例(16%)和16例(29%)患者发生严重不良事件。无1例患者死亡。

在另一项为期16周的随机双盲对照研究中，R. Panccione博士及其同事在239例激素难治性UC患者中对硫唑嘌呤单药治疗、英夫利昔单抗​​单药治疗和联合治疗进行了比较。在无激素临床缓解和黏膜愈合这两个最重要终点方面，含英夫利昔单抗治疗(即英夫利昔单抗单药治疗和联合治疗)的疗效均显著优于硫唑嘌呤单药治疗。

Patel博士表示，Travis或Lindgren指数涉及每天的大便次数、C反应蛋白水平和其他因素，根据这些指数通常可预测激素治疗3天后是否失败。因此，根据这些指数及其他指数的评价结果，可及早进行药物或手术补救治疗。但药物治疗并不适合所有患者，一些患者可能需进行结肠切除术，尽管可能出现并发症。可能需要手术治疗的患者包括持续大量出血、中毒性巨结肠、并存癌症或异型增生，慢性难治性UC和不依从的患者。

Patel博士声明无经济利益冲突。

SAN DIEGO (EGMN) – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

“If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring,” Dr. Patel said.

“I think infliximab would be the optimal medical rescue therapy for these patients” in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

“In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy,” Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes “allow you to move on to medical or surgical rescue therapy early on,” he said.

“But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy,” despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

“Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons,” Dr. Patel said.

Dr. Patel said he has no disclosures.