Jiang Xue-Liang, Cui Hui-Fei, Gao Jing, Fan Hua
*Department of Gastroenterology, Chinese PLA General Hospital of Jinan Military Command †College of Pharmaceutical Science, Shandong University, Jinan, Shandong Province, China.
J Clin Gastroenterol. 2015 Aug;49(7):582-8. doi: 10.1097/MCG.0000000000000319.
To evaluate the efficacy of low-dose (3.5 mg/kg) infliximab for induction and maintenance treatment in Chinese patients with ulcerative colitis.
Treatment with 4 to 5 mg/kg of infliximab also proved to be effective in treating moderate to severe ulcerative colitis. At present there is no relevant study on the effectiveness of infliximab doses lower than 4 mg/kg in patients with ulcerative colitis.
A prospective, randomized, double-blind, placebo-controlled, and single-centered study was designed. A total of 123 patients (from 17 provinces of China) with moderate to severe active ulcerative colitis despite treatment with concurrent drugs received placebo or low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab intravenously at weeks 0, 2, and 6 and then every 8 weeks through week 22. Patients were followed up for 30 weeks.
Overall, 73% and 78% of patients who received low-dose (3.5 mg/kg) and standard-dose (5 mg/kg) infliximab, respectively, had clinical responses at week 8, as compared with 37% of patients who received placebo (P<0.01 for both comparisons with placebo). The number of patients who received low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab with a clinical response at week 30 (63% and 66%, respectively) was more than the patients who received placebo (27%, P<0.01 for both comparisons).
Chinese patients with moderate to severe active ulcerative colitis treated with low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter were more likely to have a clinical response at weeks 8 and 30 than those who received placebo.
评估低剂量（3.5毫克/千克）英夫利昔单抗在中国溃疡性结肠炎患者诱导缓解及维持治疗中的疗效。
4至5毫克/千克英夫利昔单抗治疗中重度溃疡性结肠炎也被证明有效。目前尚无关于低于4毫克/千克剂量英夫利昔单抗治疗溃疡性结肠炎有效性的相关研究。
设计了一项前瞻性、随机、双盲、安慰剂对照、单中心研究。共123例（来自中国17个省份）尽管接受了联合药物治疗仍患有中重度活动性溃疡性结肠炎的患者，在第0、2和6周静脉注射安慰剂或低剂量（3.5毫克/千克）或标准剂量（5毫克/千克）英夫利昔单抗，此后每8周注射一次，直至第22周。对患者进行30周的随访。
总体而言，接受低剂量（3.5毫克/千克）和标准剂量（5毫克/千克）英夫利昔单抗治疗的患者在第8周时分别有73%和78%出现临床缓解，而接受安慰剂治疗的患者为37%（与安慰剂组相比，两组P均<0.01）。在第30周时出现临床缓解的接受低剂量（3.5毫克/千克）或标准剂量（5毫克/千克）英夫利昔单抗治疗的患者数量（分别为63%和66%）多于接受安慰剂治疗的患者（27%，与安慰剂组相比，两组P均<0.01）。
在第0、2和6周以及此后每8周接受低剂量（3.5毫克/千克）或标准剂量（5毫克/千克）英夫利昔单抗治疗的中国中重度活动性溃疡性结肠炎患者，在第8周和第30周时比接受安慰剂治疗的患者更有可能出现临床缓解。
