摘要
目的观察胰激肽原酶肠溶片联合维生素B12和叶酸对降低高血压合并2型糖尿病患者尿微量白蛋白的有效性和安全性。方法采用随机、开放、平行对照设计。研究对象为原发性高血压合并2型糖尿病患者,随机分为试验组(胰激肽原酶肠溶片+叶酸+维生素B12)和对照组(胰激肽原酶肠溶片),总观察时间为12周。疗效评价指标为尿白蛋白/肌酐(A/C)比值、血浆总同型半胱氨酸(tHcy)水平。结果治疗前试验组与对照组尿A/C比值(150.08±161.33比158.13±195.43)比较差异无统计学意义,用药12周后,试验组尿A/C比值与对照组比较显著降低(186.37±83.87比106.06±100.39)(P>0.05);血浆tHcy水平在对照组上升0.51mmol/L,试验组下降2.27mmol/L,两组比较,差异具有统计学意义(17.85±11.27比13.21±10.31,P=0.0478);治疗12周后,两组空腹血糖和糖化血红蛋白改善差异无统计学意义(P>0.05);治疗期间,两组不良反应发生率差异无统计学意义(3.51%比4.35%,P>0.05)。结论胰激肽原酶联合维生素B12和叶酸治疗12周后,可明显降低原发性高血压合并糖尿病患者尿A/C比值和血浆tHcy水平,且有较好临床安全性。
Objective To observe the effects of pancreatic kininogenase in combination with folic acid and methylvitamin B12 on the urine albumin excretory rate （UAER） in type 2 diabetes mellitus （T2DM） patients with hypertension. Methods Protocol was designed in randomized, open label, active control and parallel assignment. Eligible subjects were allocated randomly into two groups, testing group, received pancreatic kininogenase in combination with folic acid and methyl-vitamin B12, and control group, received pancreatic kininogenase alone. All patients were followed up for 12 weeks. Urine albumin to urine creatinine ratio （A/C ratio） and plasma concentration of homocysteine were determined at baseline and 12 weeks after therapy. Statistic analysis of data were processed by version 9. 1 SAS. Results After 12 weeks therapy, the A/C ratio of testing group was lowered more than that of control group （ - 52. 34 ± 41.74 vs. - 63.85 ± 44.96, P = 0. 0082）. Plasma homocysteine concentration of control group increased by 0. 51 mmol/L and that of testing group decreased by 2. 27 mmol/L. There was significant difference between two groups （ 17.85 ± 11.27 vs. 13.21 ± 10. 31, P =0. 0478）. FPG and HbAlc levels did not show significant differences between 2 groups （P 〉0.05）. Incidence rate of adverse reaction between 2 groups had no significant difference （3.51% vs. 4. 35%, P 〉 0.05 ）. Main adverse reactions were epigastric discomfort, dermatorrhagia and erythrocyturia. Conclusions Pancreatic kininogenase in combination with methyl-vitamin B12 and folic acid can significantly lower A/C ratio and plasma homocysteine concentration in type 2 diabetes mellitus patients with hypertension.
出处
《中国心血管杂志》
2008年第6期416-419,共4页
Chinese Journal of Cardiovascular Medicine
关键词
高血压
糖尿病
2型
胰激肽酶原
Hypertension
Diabetes mellitus, type 2
Pancreatic kininogenas
