摘要
目的分析天麦消渴片治疗新诊断2型糖尿病患者的疗效及影响因素。方法纳入符合条件的2型糖尿病患者84例，采用区组随机化分为2组：试验组42例，口服天麦消渴片240ms／次，每132次；对照组42例，口服西格列汀（捷诺维）100mg／d。治疗24周后以糖化血红蛋白（HbAlc）、空腹血糖（FPG）及餐后2h血糖（PG2h）、血清铬水平等评价服用天麦消渴片的有效性，同时通过测定胰岛素抵抗和13细胞功能的指标，探讨补铬改善血糖的作用机制。应用多因素线性回归分析各因素与HbAlc变化之间的关系。结果入组84例，76例完成了试验。治疗前糖尿病组血清铬水平显著低于正常对照组[（56±28）μg/L 比（112±21）μg/L，P=0．00]。治疗24周后，两组HbAle，FPG和PG2h较前均显著降低，血清铬水平显著增加。天麦消渴片组治疗后HbAlc下降≥1％者11例（占28．2％），基线血清铬水平较低，用药24周后升高[（36．2±18．0）μg／L比（71．4±36．1）μg/L，P=0．01]，同时HbAlc降低（8．38％±0．72％比6．77％±0．62％），降幅达1．61％。两组按基线血清铬水平分3个亚组，分别为〈40μg／L，40-65μg／L和〉65μg/L。当血清铬〈40μg/L时，天麦消渴片组HbAlc显著降低，下降幅度为1．09％；当血清铬〉65μg／L时，HbAlc无显著变化。西格列汀组HbAlc变化值（AHbAlc）与基线血清铬水平无关。治疗24周后，两组胰岛素抵抗指数（HOMA-IR）均有所降低，母细胞功能指数（HOMA-B）和早相分泌指数（IGI）有所增加。各指数组间比较差异无统计学意义。多因素线性回归分析显示基线血铬、基线HbAlc与AHbAlc显著相关。结论新诊断2型糖尿病患者体内普遍缺铬。补铬可使糖尿病患者HbAlc改善，当糖尿病患者血清铬低于40μg/L时，给予天麦消渴片补充铬至正常或略低于正常水平可使HbAlc显著降低。
Objective To explore the efficacy and influencing factors of chromium picolinate （ tianmaixiaoke tablet） in the treatment of newly diagnosed type 2 diabetes mellitus in China. Methods A total of 84 outpatients with newly diagnosed type 2 diabetes mellitus visiting 4 hospitals in Beijing were randomly divided into two equal groups ： study group receiving tianmaixiaoke tablet 240 mg bid for 24 weeks （n =42） and control group sitagliptin 100 mg qd for 24 weeks （n =42）. The levels of fasting plasma glucose （FPG）, plasma glucose 2 h after meal （PG2 h） and glycated hemoglobin （HbAlc） were detected before and 24 weeks after treatment. The serum levels of chromium and insulin were detected. Results Study was completed in 76 patients. The serum level of chromium was significantly lower in the diabetes group than in the normal group at baseline （ （56 ±28） μg/L vs （ 112 ±21 ） μg/L,P =0. 00）. At 24 weeks after treatment, the levels of HbAle, FPG and PG2 h decreased while the serum level of chromium increased significantly in both groups. There were 11 patients with changed HbA1 c from baseline （ AHbA1 c）≥1% in the study group. At 24 weeks after treatment, HbAle decreased by 1.61% （ from 8.38% ± 0. 72% to6. 77%± 0. 62% ） and serum level of chromium increased by 35. 14 μg/L in the AHbAlc≥1% group with a low baseline serum level of chromium （ （36. 2± 18.0）μg,/L）. Both study group and control group were divided into three subgroups according to baseline serum level of chromium. AHbAlc reduced with the increase in baseline serum level of chromium in study group, while in control group, AHbAlc was unrelated with baseline serum level of chromium. At 24 weeks after treatment, insulin resistance index （HOMA-IR） reduced, 13 cell function index （HOMA-β） and insulinogenic index （IGI） increased in both groups. Multiple linear regression showed that the variables significantly associated with AHbAlc were baseline HbAlc and the baseline serum level of chromium.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2012年第22期1522-1526,共5页
National Medical Journal of China
关键词
糖尿病
2型
天麦消渴片
吡考啉酸铬
Diabetes mellitus,type 2
Tianmaixiaoke Tablets
Chromium picolinate
