Department of Pediatrics, Kansai Medical University, Osaka, 573-1191, Japan.
Department of Pediatrics, Takatsuki General Hospital, Osaka, 569-1192, Japan.
Sci Rep. 2017 Dec 12;7(1):17453. doi: 10.1038/s41598-017-16730-6.
We evaluated the efficacy and safety of oral immunotherapy (OIT) combined with 24 weeks of omalizumab (OMB) at inducing desensitization in children with cow's milk allergy (CM) compared with an untreated group. The present study was a prospective randomized controlled trial. Sixteen patients (age, 6-14 years) with high IgE levels to CM were enrolled in the present study. Patients were randomized 1:1 to receive OMB-OIT group or untreated group. The primary outcome was the induction of desensitization at 8 weeks after OMB was discontinued in OMB-OIT treated group and at 32 weeks after study entry. None of the 6 children in the untreated group developed desensitization to CM while all of the 10 children in the OIT-OMB treated group achieved desensitization (P < 0.001). A significantly decreased wheal diameter in response to a skin prick test using CM was found in the OMB-OIT treated group (P < 0.05). These data suggest that OIT combined with OMB using microwave heated CM may help to induce desensitization for children with high-risk CM allergy. This prospective randomized controlled trial was intended for 50 participants but was prematurely discontinued due to overwhelming superiority of OMB combined with microwave heated OIT over CM avoidance.
我们评估了口服免疫治疗（OIT）联合奥马珠单抗（OMB）治疗 24 周与未治疗组相比，在诱导牛奶过敏（CM）儿童脱敏方面的疗效和安全性。本研究为前瞻性随机对照试验。本研究纳入了 16 名（年龄 6-14 岁）对 CM 高 IgE 水平的患者。患者被随机分为 1:1 接受 OMB-OIT 组或未治疗组。主要结局是在停用 OMB 后 8 周 OMB-OIT 治疗组和研究入组后 32 周时诱导脱敏。未治疗组 6 名儿童均未对 CM 产生脱敏，而 OIT-OMB 治疗组 10 名儿童均实现脱敏（P<0.001）。在 OMB-OIT 治疗组中，使用 CM 进行皮肤点刺试验时，发现风团直径显著减小（P<0.05）。这些数据表明，使用微波加热 CM 的 OIT 联合 OMB 可能有助于诱导高风险 CM 过敏儿童脱敏。这项前瞻性随机对照试验计划纳入 50 名参与者，但由于 OMB 联合微波加热 OIT 优于 CM 回避的压倒性优势，该试验提前停止。
