Malling H J
Allergy Unit, National University Hospital, Copenhagen, Denmark.
Drug Saf. 2000 Oct;23(4):323-32. doi: 10.2165/00002018-200023040-00005.
The clinical advantages of allergen-specific immunotherapy are counterbalanced by the risk of inducing systemic adverse effects. Although the frequency of life-threatening systemic reactions is low, the treatment carries a risk of inducing anaphylactic reactions. A fundamental point in risk assessment is to use a clinically meaningful and internationally accepted grading system for reactions. Of importance in minimising the risk of systemic adverse effects is the identification of at-risk patients and factors, the institution of procedures for monitoring patients before injections, and the adjustment of dosages in accordance with defined rules. Asthma, especially uncontrolled asthma, is a significant risk factor for the induction of systemic reactions. Likewise, dose escalation during allergen exposure, i.e. during pollen seasons, increases the risk of adverse effects. It is recommended that standardised extracts with a documented potency and consistency between production batches are used in order to prevent overdose when changing to a new vial. The intensity of the induction regimen is a balance between the risk of inducing systemic reactions and the time required to administer the regimen. Single injections once a week are generally well tolerated, in contrast to rush immunotherapy which may carry an increased frequency of adverse effects. A clustered induction regimen (2 to 4 injections per visit) represents a compromise of a patient-friendly fast regimen without an unacceptably high frequency of systemic reactions. A major issue in improving the safety of allergen injections is minimising the human factor, e.g. mistakes of patient identification, allergen extracts and dosages. Meticulous care in monitoring every patient before the injection, which requires education and training of the staff in the dosage decision process, is the cornerstone in reducing adverse effects. Involving the patient actively in the safety monitoring process might be helpful and improves patient compliance by allowing the patient to be an active partner in the treatment. Finally, if anaphylactic reactions are induced, a successful outcome is related to the staff being able to identify the early signs and to institute immediate rescue treatment. A quality assurance programme is the optimal way to minimise the risk of immunotherapy-associated systemic reactions.
变应原特异性免疫疗法的临床优势被诱发全身不良反应的风险所抵消。尽管危及生命的全身反应发生率较低，但该治疗仍有诱发过敏反应的风险。风险评估的一个基本要点是使用具有临床意义且国际认可的反应分级系统。识别高危患者和风险因素、制定注射前患者监测程序以及根据既定规则调整剂量，对于将全身不良反应的风险降至最低至关重要。哮喘，尤其是未得到控制的哮喘，是诱发全身反应的一个重要风险因素。同样，在变应原暴露期间，即在花粉季节，剂量递增会增加不良反应的风险。建议使用生产批次间效力和一致性有记录的标准化提取物，以防止更换新瓶时出现过量用药。诱导方案的强度是诱发全身反应的风险与实施该方案所需时间之间的平衡。与可能会增加不良反应发生率的快速免疫疗法相比，每周一次的单次注射通常耐受性良好。集群诱导方案（每次就诊注射2至4次）代表了一种对患者友好的快速方案，且全身反应发生率不会高到不可接受。提高变应原注射安全性的一个主要问题是尽量减少人为因素，例如患者识别、变应原提取物和剂量方面的错误。在注射前对每位患者进行细致监测，这需要对工作人员进行剂量决策过程的教育和培训，是减少不良反应的基石。让患者积极参与安全监测过程可能会有所帮助，并通过让患者成为治疗中的积极参与者来提高患者的依从性。最后，如果诱发了过敏反应，成功的结果与工作人员能够识别早期症状并立即实施抢救治疗有关联。质量保证计划是将免疫疗法相关全身反应风险降至最低的最佳方法。
