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嗜碱性粒细胞活化试验在注射用生长激素制剂速发型药物反应诊断和管理中的作用:一例报告

Role of the basophil activation test in the diagnosis and management of immediate drug reaction to injectable growth hormone preparation: a case report.

作者信息

Barrale Maria, Romano Sara, Termini Donatella, Vinci Dario, Brusca Ignazio

机构信息

U.O.C Patologia di Clinica, Ospedale Buccheri La Ferla Palermo, Palermo, Italy.

U.O.C di Neonatologia e Pediatria, Ospedale Buccheri La Ferla Palermo, Palermo, Italy.

出版信息

Immunol Res. 2025 Jun 4;73(1):89. doi: 10.1007/s12026-025-09644-3.

Abstract

Hypersensitivity reactions to synthetic hormones are rare but can represent serious complications. Allergic responses to synthetic human growth hormone (rhGH) pharmaceutical preparations are uncommon. Despite their rarity, such reactions pose a significant clinical dilemma due to the associated risks and implications for ongoing treatment. Diagnosis is further complicated by the absence of standardized and commercially available in vitro tests, while in vivo testing carries the risk of systemic reactions, even at high dilutions. We report the case of a 6-year-old patient who experienced a severe reaction following rhGH administration. The diagnosis was investigated using the basophil activation test (BAT) prior to any in vivo testing. Given the potential risks of in vivo diagnostics, as previously reported in the literature, the BAT was employed to confirm the diagnosis and to identify a safe alternative rhGH formulation, which yielded negative results both in BAT and subsequent in vivo testing.

摘要

对合成激素的超敏反应虽罕见,但可能代表严重并发症。对合成人生长激素(rhGH)药物制剂的过敏反应并不常见。尽管此类反应罕见,但由于相关风险及对持续治疗的影响,它们构成了重大的临床困境。由于缺乏标准化且可商购的体外检测方法,诊断进一步复杂化,而体内检测即使在高稀释度下也存在全身反应的风险。我们报告了一例6岁患者在注射rhGH后发生严重反应的病例。在进行任何体内检测之前,使用嗜碱性粒细胞活化试验(BAT)对诊断进行了调查。鉴于体内诊断的潜在风险,如先前文献报道,采用BAT来确诊并确定一种安全的替代rhGH制剂,该制剂在BAT及随后的体内检测中均产生阴性结果。

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