Laxenaire M C, Charpentier C, Feldman L
Service d'Anesthésie-Réanimation Chirurgicale, CHU de Nancy.
Ann Fr Anesth Reanim. 1994;13(3):301-10. doi: 10.1016/s0750-7658(94)80038-3.
Changes in transfusion behaviour induce a widespread use of colloid plasma substitutes, the range of which has recently been enlarged by the marketing of starch derivatives. The product chosen depends, at least in part, on its adverse effects, anaphylactoid reactions being a part of these. This study aimed to discover the frequency and severity of these reactions according to the type of substitute available in France, to look for possible risk factors, and determine the mechanisms involved. A prospective inquiry was carried out in 49 public and private hospitals spread throughout France. It lasted for 15 months, between June 1991 and October 1992. A data sheet was filled in for each patient who was given a plasma substitute, whether or not there was an incident. When a reaction did occur, an assessment was carried out in two stages: straightaway, with the measurement of the concentrations of serum tryptase, antigelatin antibodies, urinary methylhistamine; and four to six weeks later, with skin tests. A series of 19.593 patients was thus collected: 48.1% were given gelatins, 26.7% starches, 15.7% albumin, and 9.5% dextrans. 43 anaphylactoid reactions were recorded, giving an overall frequency of 0.219%, or 1 reaction for 456 patients. The frequency differed according to the substitute considered: 0.345% for gelatins, 0.273% for dextrans, 0.099% for albumin, and 0.058% for starches. These reactions (grades III and IV) were serious in 20% of cases. Multivariate analysis revealed four independent risk factors: giving gelatins (odds ratio: 4.81), giving dextrans (odds ratio: 3.83), a history of drug allergy (odds ratio: 3.16), and being male (odds ratio: 1.98). The relative risks of anaphylactoid reactions due to one type of substitute with respect to another were estimated to be 6 times less for starches with respect to gelatins, and 4.7 times less than with dextrans. The relative risk of albumin is 3.4 times less than that of gelatins, and almost identical to that of the starches. An immuno-allergological assessment was only carried out in 15 patients who had been given a gelatin (Plasmion). IgE-dependent anaphylaxis was proven in 7 of these. To conclude, it was shown that gelatins and dextrans should be avoided in patients with a known history of drug allergy. When a reaction does occur, an allergological assessment must be carried out, as this may be due to specific antibodies. Should this prove to be the case, that particular substitute would be contraindicated for the rest of the patient's life.
输血行为的改变促使胶体血浆代用品得到广泛应用，最近淀粉衍生物上市后，其种类范围有所扩大。所选用的产品至少部分取决于其不良反应，类过敏反应就是其中一部分。本研究旨在根据法国现有的代用品类型，找出这些反应的发生频率和严重程度，寻找可能的风险因素，并确定其中涉及的机制。在法国各地的49家公立和私立医院进行了一项前瞻性调查。调查持续了15个月，从1991年6月至1992年10月。为每位接受血浆代用品的患者填写一份数据表，无论是否发生意外情况。当确实发生反应时，分两个阶段进行评估：立即测量血清类胰蛋白酶、抗明胶抗体、尿甲基组胺的浓度；四至六周后进行皮肤试验。这样共收集了19593例患者：48.１%接受明胶，26.7%接受淀粉，15.7%接受白蛋白，9.5%接受右旋糖酐。记录到43例类过敏反应，总发生率为0.219%，即每４56例患者中有1例发生反应。根据所考虑的代用品不同，发生率也有所差异：明胶为0.345%，右旋糖酐为0.273%，白蛋白为0.099%，淀粉为0.058%。这些反应（Ⅲ级和Ⅳ级）在20%的病例中较为严重。多因素分析揭示了四个独立的风险因素：给予明胶（优势比：4.81）、给予右旋糖酐（优势比：3.83）、有药物过敏史（优势比：3.16）以及男性（优势比：1.98）。相对于另一种代用品，某一种代用品引起类过敏反应 的相对风险估计为：淀粉相对于明胶低6倍，相对于右旋糖酐低4.7倍。白蛋白的相对风险比明胶低3.4倍，与淀粉几乎相同。仅对15例接受明胶（血浆素）的患者进行了免疫过敏评估。其中7例证实为IgE依赖型过敏反应。总之，研究表明，有药物过敏史的患者应避免使用明胶和右旋糖酐。当确实发生反应时，必须进行过敏评估，因为这可能是由特异性抗体引起的。如果情况确实如此，该特定代用品在患者余生中应禁用。
