中华临床医师杂志（电子版）
中華臨床醫師雜誌（電子版）
중화림상의사잡지（전자판）
CHINESE JOURNAL OF CLINICIANS(ELECTRONIC VERSION)
2013年
20期
9081-9085
,共5页
李发贵%吴兆芳%迟庆霞%乔秀丽%王书军
李髮貴%吳兆芳%遲慶霞%喬秀麗%王書軍
리발귀%오조방%지경하%교수려%왕서군
糖尿病,2型%胰岛素抗体%重组人胰岛素%免疫原性
糖尿病,2型%胰島素抗體%重組人胰島素%免疫原性
당뇨병,2형%이도소항체%중조인이도소%면역원성
Diabetes mellitus,type 2%Insulin antibodies%Recombinant human insulin%Immunogenicity
目的：探讨重组人胰岛素治疗2型糖尿病的免疫原性及其临床意义。方法应用放射免疫法检测179例重组人胰岛素治疗的2型糖尿病患者及429例未用胰岛素治疗的2型糖尿病患者胰岛素抗体（INS-Ab）的阳性率，并分析INS-Ab阳性患者的临床特征及其危险因素。结果（1）重组人胰岛素治疗组中INS-Ab阳性率为36.31%，而未用重组人胰岛素组INS-Ab阳性率为0.23%，差异具有统计学意义（χ2＝166.19，P＝0.000）。（2）Logistic回归分析显示在应用重组人胰岛素的患者中INS-Ab阳性的危险因素分别为胰岛素治疗时间（OR＝1.201，P＝0.006）及糖尿病病程（OR＝1.07，P＝0.004）。应用重组人胰岛素半年以上、糖尿病病程5年以上并已接受重组人胰岛素治疗时，INS-Ab阳性率明显升高（P＜0.05）。重组人胰岛素治疗组中，INS-Ab阳性组HOMR-IR明显高于INS-Ab阴性组（18.48±21.58 vs.6.90±14.39， t＝3.68，P＝0.000），高胰岛素血症组INS-Ab阳性率也明显高于无高胰岛素血症组（59.26%vs.20.99%，χ2＝33.684，P＝0.000）。（3）INS-Ab阳性患者空腹胰岛素及餐后2 h胰岛素水平均明显高于INS-Ab阴性者（P＜0.05），低血糖发生次数明显高于阴性者（Z＝-6.109，P＝0.000）。（4）INS-Ab 阳性组糖化血红蛋白达标率明显低于阴性组（χ2＝4.422，P＝0.035）。（5）诺和灵30R、甘舒林30R及优泌林30R胰岛素抗体阳性率分别为37.25%、38.46%、28.13%，差异无统计学意义（χ2＝0.948，P＝0.623）。结论（1）重组人胰岛素治疗2型糖尿病仍具有免疫原性，在应用重组人胰岛素的患者中重组人胰岛素应用超过半年、低血糖频发、糖尿病病程5年以上的应及时检测 INS-Ab。（2）已经使用重组人胰岛素的糖尿病患者也应常规查血清胰岛素水平，及时发现高胰岛素血症及免疫性胰岛素抵抗。（3）INS-Ab 是胰岛素抵抗的危险因素，是影响糖尿病患者糖化血红蛋白达标率的因素之一。
目的：探討重組人胰島素治療2型糖尿病的免疫原性及其臨床意義。方法應用放射免疫法檢測179例重組人胰島素治療的2型糖尿病患者及429例未用胰島素治療的2型糖尿病患者胰島素抗體（INS-Ab）的暘性率，併分析INS-Ab暘性患者的臨床特徵及其危險因素。結果（1）重組人胰島素治療組中INS-Ab暘性率為36.31%，而未用重組人胰島素組INS-Ab暘性率為0.23%，差異具有統計學意義（χ2＝166.19，P＝0.000）。（2）Logistic迴歸分析顯示在應用重組人胰島素的患者中INS-Ab暘性的危險因素分彆為胰島素治療時間（OR＝1.201，P＝0.006）及糖尿病病程（OR＝1.07，P＝0.004）。應用重組人胰島素半年以上、糖尿病病程5年以上併已接受重組人胰島素治療時，INS-Ab暘性率明顯升高（P＜0.05）。重組人胰島素治療組中，INS-Ab暘性組HOMR-IR明顯高于INS-Ab陰性組（18.48±21.58 vs.6.90±14.39， t＝3.68，P＝0.000），高胰島素血癥組INS-Ab暘性率也明顯高于無高胰島素血癥組（59.26%vs.20.99%，χ2＝33.684，P＝0.000）。（3）INS-Ab暘性患者空腹胰島素及餐後2 h胰島素水平均明顯高于INS-Ab陰性者（P＜0.05），低血糖髮生次數明顯高于陰性者（Z＝-6.109，P＝0.000）。（4）INS-Ab 暘性組糖化血紅蛋白達標率明顯低于陰性組（χ2＝4.422，P＝0.035）。（5）諾和靈30R、甘舒林30R及優泌林30R胰島素抗體暘性率分彆為37.25%、38.46%、28.13%，差異無統計學意義（χ2＝0.948，P＝0.623）。結論（1）重組人胰島素治療2型糖尿病仍具有免疫原性，在應用重組人胰島素的患者中重組人胰島素應用超過半年、低血糖頻髮、糖尿病病程5年以上的應及時檢測 INS-Ab。（2）已經使用重組人胰島素的糖尿病患者也應常規查血清胰島素水平，及時髮現高胰島素血癥及免疫性胰島素牴抗。（3）INS-Ab 是胰島素牴抗的危險因素，是影響糖尿病患者糖化血紅蛋白達標率的因素之一。
목적：탐토중조인이도소치료2형당뇨병적면역원성급기림상의의。방법응용방사면역법검측179례중조인이도소치료적2형당뇨병환자급429례미용이도소치료적2형당뇨병환자이도소항체（INS-Ab）적양성솔，병분석INS-Ab양성환자적림상특정급기위험인소。결과（1）중조인이도소치료조중INS-Ab양성솔위36.31%，이미용중조인이도소조INS-Ab양성솔위0.23%，차이구유통계학의의（χ2＝166.19，P＝0.000）。（2）Logistic회귀분석현시재응용중조인이도소적환자중INS-Ab양성적위험인소분별위이도소치료시간（OR＝1.201，P＝0.006）급당뇨병병정（OR＝1.07，P＝0.004）。응용중조인이도소반년이상、당뇨병병정5년이상병이접수중조인이도소치료시，INS-Ab양성솔명현승고（P＜0.05）。중조인이도소치료조중，INS-Ab양성조HOMR-IR명현고우INS-Ab음성조（18.48±21.58 vs.6.90±14.39， t＝3.68，P＝0.000），고이도소혈증조INS-Ab양성솔야명현고우무고이도소혈증조（59.26%vs.20.99%，χ2＝33.684，P＝0.000）。（3）INS-Ab양성환자공복이도소급찬후2 h이도소수평균명현고우INS-Ab음성자（P＜0.05），저혈당발생차수명현고우음성자（Z＝-6.109，P＝0.000）。（4）INS-Ab 양성조당화혈홍단백체표솔명현저우음성조（χ2＝4.422，P＝0.035）。（5）낙화령30R、감서림30R급우비림30R이도소항체양성솔분별위37.25%、38.46%、28.13%，차이무통계학의의（χ2＝0.948，P＝0.623）。결론（1）중조인이도소치료2형당뇨병잉구유면역원성，재응용중조인이도소적환자중중조인이도소응용초과반년、저혈당빈발、당뇨병병정5년이상적응급시검측 INS-Ab。（2）이경사용중조인이도소적당뇨병환자야응상규사혈청이도소수평，급시발현고이도소혈증급면역성이도소저항。（3）INS-Ab 시이도소저항적위험인소，시영향당뇨병환자당화혈홍단백체표솔적인소지일。
Objective To study the immunogenicity and its clinical significance of recombinant human insulin during in treatment of type 2 diabetes mellitus (T2DM) patients. Methods Using radioimmunoassay to detect insulin antibody of 179 T2DM patients treated with recombinant human insulin and 429 patients without insulin treatment, to compare the antibody positive rate, and to analyze the clinical features of antibody-positive patients and the risk factors for insulin antibodies. Results (1) The INS-Ab positive rate of insulin-treatment group was 36.31%, while 0.23%in without-using insulin group. The difference was statistically significant (χ2=166.19, P=0.000). (2) Logistic regression analysis showed that insulin-treated duration (OR=1.201, P=0.006), DM course (OR=1.07, P=0.004) were the risk factors for insulin antibodies in insulin-treated patients. While the application of recombinant human insulin was more than half year and the DM course was more than five years, the positive rate was significantly higher (P<0.05). HOMR-IR in INS-Ab positive patients was significantly higher than in INS-Ab negative ones(18.48±21.58 vs. 6.90±14.39, t=3.68, P=0.000). The INS-Ab positive rate of patients with hyperinsulinemia was 78.43%, while 19.53%of patients without hyperinsulinemia, the difference was significantly(χ2=33.684, P=0.000). (3) Fasting insulin and 2-hour postprandial insulin levels in INS-Ab positive patients were significantly higher than in INS-Ab negative ones(P<0.05). The occurrence of hypoglycemia in INS-Ab positive patients was significantly higher than in INS-Ab negative ones(Z=-6.109, P=0.000). (4) The compliance rate of glycated hemoglobin in INS-Ab positive group was significantly lower than in INS-Ab negative group(χ2=4.422, P=0.035). (5) The INS-Ab positive rate of Novolin 30R, Gan Shulin 30R and Humulin 30R were 37.25%, 38.46%, 28.13%, respectively. The difference was not statistically significant (χ2=0.948, P=0.623). Conclusions Recombinant human insulin to treat T2DM has immunogenicity, when the application of recombinant human insulin is more than half year in insulin-treated patients, hypoglycemia happened frequently, and the DM course is more than five years, it is time to detect insulin antibody. Diabetic patients who have used recombinant human insulin should be routinely check serum insulin levels to discover hyperinsulinemia and immune insulin resistance. INS-Ab is a risk factor for insulin resistance, and it is one of the impactions on the compliance rate of glycated hemoglobin in type 2 diabetes.
