Comparison of antigenicity of Hoechst 21 PH insulin using either implantable intraperitoneal pump or subcutaneous external pump infusion in type 1 diabetic patients
Comparison of antigenicity of Hoechst 21 PH insulin using either implantable intraperitoneal pump or subcutaneous external pump infusion in type 1 diabetic patients
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DOI：
10.2337/diacare.25.1.84
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发表时间：
2002-01-01
期刊：
影响因子：
16.2
通讯作者：
Pinget, M
中科院分区：
文献类型：
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作者：
Jeandidier, N;Boullu, S;Pinget, M
目的 - 使用连续皮下胰岛素输注 (CSII) 评估胰岛素 Hoechst 21PH (Hoe21PH) 的抗原性，并比较腹膜内或皮下给药时该胰岛素的抗原性。 研究设计和方法 - 使用可植入装置（连续腹膜胰岛素输注）腹膜给药 Hoe21PH (Hoe21PH，萨默维尔，新泽西州) 胰岛素[CPII]) 增加 2 型糖尿病患者的抗胰岛素抗体 (AIA) 水平。腹膜内给药、添加稳定剂（聚乙二醇）或由于储存在泵中而对胰岛素进行修饰可能与这种抗原性有关。在这项非随机研究中，24 名 1 型糖尿病患者接受了 CSII（n = 11，第 1 组）或 CPII（n = 13，第 2 组）治疗。在患者开始接受 Hoe21PH 治疗之前以及 3 个月和 6 个月后再次测量 AIA 水平，通过放射免疫分析 (RIA) 或酶联免疫吸附分析 (ELISA) 进行测量。 结果：两组患者的情况相当。第 1 组的 AIA 水平 (RIA) 保持稳定（24.3 +/- 8.5% [第 0 个月] 至 24.9 +/- 8.5.5% [第 6 个月]），第 2 组则增加（21.8 +/- 6.7% [第 0 个月] 至 41.8 +/- 6.9% [第 6 个月]）（P = 0.005，Wilcoxon 秩和检验）。使用 ELISA，第 I 组患者的 AIA 保持稳定（n = 9；3.8 +/- 0.8 单位/ml [第 0 个月]和 4.1 +/- 1.0 单位/ml [第 6 个月]），而第 2 组患者的 AIA 呈增加趋势（n = 12；4.1 +/- 0.7 单位/ml [第 0 个月]至 17.5 +/- 4.6 单位/ml [第 6 个月]）（P = 0.07），在第 0、3 和 6 个月使用 RIA 比较两组之间 AIA 形成的演变，显示出显着差异（方差分析，P = 0.009）。结论 - 通过两种不同的测定评估，皮下注射 Hoe21PH 胰岛素时，AIA 水平没有增加。 CPII被证明比CSII更具抗原性，这与Hoe21PH胰岛素的特异性抗原性无关。腹膜内给药途径或由于胰岛素储存在可植入装置中而导致的胰岛素修饰可能解释了这种抗原性。
OBJECTIVE- To assess the antigenicity of the insulin Hoechst 21PH (Hoe21PH) using continuous subcutaneous insulin infusion (CSII) and to compare the antigenicity of this insulin when administered intraperitoneally or subcutaneously.RESEARCH DESIGN AND METHODS- Peritoneal administration of Hoe21PH (Hoechst-Roussel, Somerville, NJ) insulin using implantable devices (continuous peritoneal insulin infusion [CPII]) increases anti-insulin antibody (AIA) levels in type diabetic patients. Intraperitoneal administration, addition of a stabilizer (polyethylene polypropylene glycol), or insulin modifications due to storage in the pump may be involved in this antigenicity. In this nonrandomized study, 24 type 1 diabetic patients were treated with either CSII (n = 11, group 1) or CPII (n = 13, group 2). AIA levels were measured by radioimmunossay (RIA) or enzyme-linked immunosorbent assay (ELISA) before starting patients on Hoe21PH and again after 3 and 6 months.RESULTS- Patients were comparable in the two groups. AIA levels (RIA) remained stable (24.3 +/- 8.5% [month 0] to 24.9 +/- 8.5.5% [month 6]) in group 1 and increased (21.8 +/- 6.7% [month 0] to 41.8 +/- 6.9% [month 6]) in group 2 (P = 0.005, Wilcoxon's rank-sum test). Using ELISA, AIA remained stable in the patients in group I (n = 9;3.8 +/- 0.8 units/ml [month 0] and 4.1 +/- 1.0 units/ml [month 6]) and tended to increase in the patients in group 2 (n = 12; 4.1 +/- 0.7 units/ml [month 0] to 17.5 +/- 4.6 units/ml [month 6]) (P = 0.07), Comparison of the evolution of AIA formation between the two groups, using RIA at, months 0, 3, and 6 showed a significant difference (analysis of variance, P = 0.009).CONCLUSIONS- No increase in AIA levels was demonstrated when Hoe21PH insulin was administered subcutaneously as assessed by two different assays. CPII is proven to be more antigenic than CSII, and this is not related to a specific antigenicity of Hoe21PH insulin. The intraperitoneal route of administration or insulin modifications due to insulin storage in implantable devices might explain this antigenicity.