CN114504644B - 抗IgE抗体在用于治疗腺样体肥大中的应用 - Google Patents
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Abstract
本发明涉及抗IgE抗体在用于治疗腺样体肥大中的应用，属于抗体药领域。本发明首次发现抗IgE抗体可以用于治疗腺样体肥大。
Description
技术领域
本发明涉及抗IgE抗体在用于治疗腺样体肥大中的应用。
背景技术
腺样体肥大(adenoid hypertrophy，AH)是儿童的常见病、多发病，是一种与腺样体增生肥大有关的阻塞性疾病，腺样体的体积在儿童期有逐渐增大的趋势，通常在6岁或7岁时达到最大，但此时的腺样体肥大一般不堵塞后鼻孔，增大的腺样体正常情况下会在青春期自然消退。
目前，手术治疗仍是儿童腺样体肥大最常见的治疗方式。特别对于3级及以上患儿而言，在内镜或影像学综合评估上气道情况(包括鼻、鼻咽部、口咽、喉咽和喉部)后，临床检查符合扁桃体和(或)腺样体肥大且无手术禁忌时，手术是其首选治疗方式，同时患儿临床症状和患儿家长为患儿解决症状的诉求也应当同样被重视。据报道，行腺样体切除术的患儿最小年龄为3月龄，行腺样体和扁桃体切除术的最小年龄为6月龄。儿童正处于各器官、组织成长阶段，全身免疫系统尚未发育完善，局部免疫组织起主导作用，腺样体作为具有特定解剖结构的黏膜淋巴组织，参与呼吸道重要的局部免疫作用，腺样体切除可能影响儿童的免疫功能。虽然儿童腺样体切除术已被儿科医生熟练掌握，但其仍存在如麻醉并发症、术后呼吸衰竭、出血、腭咽关闭不全、鼻咽狭窄，术后语音改变、术后脱水等相关风险。
发明内容
本发明提供了抗IgE抗体(例如奥马珠单抗)在用于制备治疗腺样体肥大药物中的应用。
在一个具体实施方式中，所述抗IgE抗体为奥马珠单抗。
在一个具体实施方式中，所述抗IgE抗体用于治疗儿童腺样体肥大。
在一个具体实施方式中，所述腺样体肥大伴有过敏性疾病。
在一个具体实施方式中，所述过敏性疾病为过敏性鼻炎、过敏性哮喘、特应性皮炎、过敏性角膜结膜炎、慢性自发性荨麻疹、变应性支气管肺曲霉菌病、食物过敏、尘螨过敏和花粉过敏中的至少一种。
在一个具体实施方式中，所述过敏性鼻炎为轻度、中度或重度过敏性鼻炎。
在一个具体实施方式中，所述过敏性哮喘为中度或重度过敏性哮喘。
在一个具体实施方式中，在使用所述抗IgE抗体治疗前，患有所述腺样体肥大的个体的血清总IgE、皮肤点刺试验和特异性IgE中的至少一种为阳性。
在一个具体实施方式中，在使用所述抗IgE抗体治疗前，患有所述腺样体肥大的个体的总IgE水平高在30IU/ml以上。
在一个具体实施方式中，在使用所述抗IgE抗体治疗前，患有所述腺样体肥大的个体的总IgE水平高在100IU/ml以上。
本发明的有益效果：
在应用抗IgE抗体(例如奥马珠单抗)治疗中重度哮喘过程中，发明人首次发现抗IgE抗体对腺样体肥大有较好的疗效，通过使用抗IgE抗体的代替治疗可以有效避免手术治疗的相关风险和不良反应。
附图说明
图1显示了在使用奥马珠单抗治疗前腺样体体积为4级。其中，白色箭头处为鼻中隔；黑色箭头处为腺样体组织。
图2显示了在使用奥马珠单抗治疗4周后腺样体体积缩小为2级。其中，白色箭头处为鼻中隔；黑色箭头处为腺样体组织。
图3显示了在使用奥马珠单抗治疗12周后腺样体体积缩小为1级。其中，白色箭头处为鼻中隔；黑色箭头处为腺样体组织。
图4显示了在使用奥马珠单抗治疗16周后腺样体体积保持为1级。其中，白色箭头处为鼻中隔；黑色箭头处为腺样体组织；格子箭头处为咽鼓管开口。
图5显示了在使用奥马珠单抗治疗结束6月后腺样体体积保持为1级。其中，白色箭头处为鼻中隔；黑色箭头处为腺样体组织；格子箭头处为咽鼓管开口。
具体实施方式
以下通过优选的实施案例的形式对本发明的上述内容作进一步的详细说明，但其不构成对本发明的限制。
如无特别说明，本发明的实施例中的试剂均可通过商业途径购买。
注射用奥马珠单抗是一种重组的人源化单克隆抗体，为抗IgE靶向生物制剂。
过敏性鼻炎程度根据变应性鼻炎视觉模拟(VAS：0至10代表患者不同程度鼻塞的状态：0＝无鼻塞，10＝完全鼻塞)量表分为3个等级。0至3分为轻度过敏性鼻炎，4至6分为中度过敏性鼻炎，7至10分为重度过敏性鼻炎。
腺样体肥大分为4个等级：1级：阻塞程度0％至25％；2级：阻塞程度25％至50％；3级：阻塞程度50％至75％；4级：阻塞程度75％至100％，后鼻孔完全阻塞。
鉴于国内对使用奥马珠单抗的患者有一定标准要求，因此，患儿需同时满足如下标准方可纳入：(1)过敏原检测阳性：血清总IgE、皮肤点刺试验或特异性IgE(即过敏患者的血清中存在着具有变应原特异性的IgE，sIgE)阳性。(2)软式纤维光学内窥镜检查显示腺样体体积大小的肥大等级为2至4级。(3)年龄≥6岁且<18岁，过敏性哮喘的诊断符合中国儿童支气管哮喘诊断与防治指南(2016年版)，经第3级规范哮喘药物治疗能够达到完全控制的中度哮喘；经第4或第5级规范哮喘药物治疗能够达到完全控制，或即使经过上述治疗仍不能够完全控制的重度哮喘。(4)所有患者均经过吸入性糖皮质激素+长效支气管舒张剂常规治疗，控制不佳≥3个月。(5)患儿或其监护人能配合医务人员完成调查问卷。
排除标准：(1)对奥马珠单抗活性成分或者其他辅料有过敏反应的患者；(2)哮喘急性加重或急性发作的患儿；(3)总IgE<30kU/L的患儿；(4)有全身疾病史、腺样体切除术史、中耳炎病史、颅面畸形史。
具体根据表1、患儿总IgE水平和患儿体重(kg)确定奥马珠单抗合适的给药剂量和给药频率，见表2，用药持续到第16周。其中，奥马珠单抗给药的最大推荐剂量为600mg，每2周1次，因此，总IgE＞1500IU/mL的患者推荐奥马珠单抗按最大给药剂量(600mg，每2周1次)用药，以达到用药后降低患者血清游离IgE的目的。若每次给药剂量≤150mg，则于1个部位皮下注射；若剂量＞150mg，则按需分1-4个部位分别皮下注射。
表1
基于以上标准共获得22名患儿，男女比例为15:7，开始治疗的年龄为6岁-15岁。
根据中国儿童标准体重指数(BMI)生长曲线，22人中BMI异常9人，其中超重2人，肥胖7人，体重正常13人。
22例患儿中诊断为中度过敏性哮喘14例，重度过敏性哮喘8例，所有患儿均合并有过敏性鼻炎，其中轻度过敏性鼻炎8例(36.4％)，中度鼻炎3例(13.6％)，重度鼻炎11例(50％)。
将22名患儿依次标记为患儿1至患儿22。
患儿的年龄见表2。
对患儿的体重进行称重，结果见表2。
患儿的过敏性哮喘、过敏性鼻炎和腺样体肥大的程度见表2。
在开始使用奥马珠单抗治疗之前采用化学发光免疫测定法测定患儿的基线总IgE水平，结果见表2。
表2
根据表2的结果可知，22例患儿在使用奥马珠单抗治疗前腺样体肥大程度等级平均为2.409±0.170级，经奥马珠治疗后各患儿腺样体肥大程度均明显缩小，经奥马珠治疗16周后的腺样体肥大程度等级平均为0.955±0.080级。
对各患儿在使用奥马珠单抗治疗前、使用奥马珠单抗治疗后的第4周、第12周、第16周，及使用奥马珠单抗治疗结束6月后，通过软式纤维光学内窥镜检查腺样体体积大小，拍照，其中一名11岁男性患儿的跟踪照片结果为图1至图5。根据图1至图5可知，随着奥马珠治疗时间的延长，患儿的腺样体体积逐渐缩小，甚至在停止奥马珠治疗半年后，腺样体体积仍能保持1级，未再复发。
Claims (3)
1.抗IgE抗体在用于制备治疗儿童腺样体肥大药物中的应用，其中所述腺样体肥大等级为2至4级，且所述腺样体肥大伴有过敏性疾病；
所述抗IgE抗体为奥马珠单抗；
所述过敏性疾病为过敏性哮喘；
所述过敏性哮喘为中度或重度过敏性哮喘。
2.根据权利要求1所述的应用，其特征在于，在使用所述抗IgE抗体治疗前，患有所述腺样体肥大的个体的血清总IgE、皮肤点刺试验和特异性IgE中的至少一种为阳性。
3.根据权利要求1所述的应用，其特征在于，在使用所述抗IgE抗体治疗前，患有所述腺样体肥大的个体的总IgE水平高在100IU/ml以上。
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