用于克罗恩病的自体结肠提取蛋白口服混合物：一项双盲试验。
Oral mixture of autologous colon-extracted proteins for the Crohn's disease: A double-blind trial.
作者信息
Israeli Eran, Zigmond Ehud, Lalazar Gadi, Klein Athalia, Hemed Nilla, Goldin Eran, Ilan Yaron
机构信息
Eran Israeli, Ehud Zigmond, Gadi Lalazar, Athalia Klein, Nilla Hemed, Eran Goldin, Yaron Ilan, Gastroenterology and Liver Units, Department of Medicine, Hebrew University-Hadassah Medical Center, IL-91120 Jerusalem, Israel.
出版信息
World J Gastroenterol. 2015 May 14;21(18):5685-94. doi: 10.3748/wjg.v21.i18.5685.
AIM
To evaluate the safety and efficacy of oral administration of Alequel™, an autologous protein-containing colon extract.
METHODS
A total of 43 patients were enrolled in a randomized, placebo-controlled, double-blind trial. Patients were orally administered with autologous protein-containing colon extract three doses of autologous study drug per week for 15 wk, for a total of 45 doses. Patients were followed for safety parameters. Remission was defined as a Crohn's disease activity index (CDAI) score of less than or equal to 150. All patients were followed for changes in subsets of T cells by fluorescence-activated cell sorting analysis.
RESULTS
Analysis was performed on a total number of evaluable patients of 14 in the study drug group and 15 in the placebo group. Treatment was well tolerated by all patients. No major treatment-related adverse events were reported or observed in any of the treated patients during the feeding or follow-up periods. Between weeks 6 and 9 of the study, six of the 14 (43%) evaluable subjects who received the study drug achieved a CDAI of 150 or lower. In contrast, five of the 15 (33%) evaluable subjects in the placebo group achieved remission. Between weeks 9 and 12, the remission rates were 50% and 33% for the drug group and placebo group, respectively. Among the drug-treated subjects who achieved remission, the effect of the drug was judged as stable in eight of the 14 subjects as measured by at least two CDAI scores indicating remission in the 15-wk treatment period. A decreased percentage of peripheral natural killer T regulatory cells (a decrease of 28% vs an increase of 16%) and an increased ratio of CD4(+)/CD8(+) T lymphocytes (an increase of 11% vs a decrease of 9%) were noted in subjects with a significant clinical response.
CONCLUSION
Oral administration of the autologous colonic extract could be a safe and effective for the treatment of patients with moderate to severe Crohn's disease.
目的
评估口服Alequel™（一种含自体蛋白质的结肠提取物）的安全性和有效性。
方法
共有43例患者参加了一项随机、安慰剂对照、双盲试验。患者每周口服含自体蛋白质的结肠提取物三剂自体研究药物，共15周，总计45剂。对患者进行安全性参数随访。缓解定义为克罗恩病活动指数（CDAI）评分小于或等于150。通过荧光激活细胞分选分析对所有患者的T细胞亚群变化进行随访。
结果
对研究药物组14例和安慰剂组15例可评估患者进行了分析。所有患者对治疗耐受性良好。在喂养或随访期间，任何治疗患者均未报告或观察到重大治疗相关不良事件。在研究的第6至9周，接受研究药物的14例（43%）可评估受试者中有6例CDAI达到150或更低。相比之下，安慰剂组15例（33%）可评估受试者中有5例达到缓解。在第9至12周，药物组和安慰剂组的缓解率分别为50%和33%。在达到缓解的药物治疗受试者中，通过至少两个CDAI评分判断，在15周治疗期内有8例受试者的药物效果被判定为稳定，这些评分表明达到缓解。在有显著临床反应的受试者中，外周自然杀伤性T调节细胞百分比下降（下降28% vs上升16%），CD4(+)/CD8(+) T淋巴细胞比值上升（上升11% vs下降9%）。
结论
口服自体结肠提取物对中重度克罗恩病患者的治疗可能是安全有效的。
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