叶酸与依那普利联合治疗对降低血压和血糖的疗效：一项多中心、随机、双盲、平行对照临床试验

Efficacy of folic acid and enalapril combined therapy on reduction of blood pressure and plasma glucose: a multicenter, randomized, double-blind, parallel-controlled, clinical trial.

作者信息

Mao Guangyun, Hong Xiumei, Xing Houxun, Liu Ping, Liu Haipeng, Yu Yunxian, Zhang Shanchun, Jiang Shanqun, Wang Xiaobin, Xu Xiping

机构信息

Anhui Biomedical Institute, Anhui Medical University, Hefei, China.

出版信息

Nutrition. 2008 Nov-Dec;24(11-12):1088-96. doi: 10.1016/j.nut.2008.05.009. Epub 2008 Jul 24.

DOI:10.1016/j.nut.2008.05.009

PMID:18656328

Abstract

OBJECTIVE

We compared the efficacy of folic acid (FA) plus enalapril with enalapril alone on the reduction of blood pressure (BP) and fasting plasma glucose (FPG) in adult Chinese hypertensive patients.

METHODS

Four hundred eighty subjects with mild to moderate BP were randomly assigned to one of three treatment groups: 1) 10 mg of enalapril (control group), 2) 10 mg of enalapril plus 0.4 mg of FA (low-FA group), or 3) 10 mg of enalapril plus 0.8 mg of FA (high-FA group) daily for 8 wk. Generalized linear mixed models were used to compare the reduction in BP and FPG level from baseline to week 8 of the treatment and the difference among the three treatment groups, adjusting for pertinent covariates.

RESULTS

Four hundred forty-three subjects (57.3% women, 27-75 y of age) successfully completed the trial. After the 8-wk treatment, compared with baseline, all treatment groups showed significant reduction of BP but not of FPG. There was no significant difference in BP or FPG reduction among the three treatment groups. In subgroup analysis, we found that in subjects with hyperglycemia (FPG >or=6.1 mmol/L) at baseline, FPG reduction was significantly greater in the high-FA group (-0.80 +/- 1.20 mmol/L) than in the low-FA group (-0.39 +/- 1.44 mmol/L) and the control group (-0.23 +/- 1.30 mmol/L). Regression analysis further confirmed that FPG reduction in the high-FA group was -0.68 +/- 0.28 mmol/L greater than in the control group (P = 0.015), even after adjustment for important covariates. A dose-response trend was evident (P for trend = 0.025) and the test for an interaction between treatment group and baseline FPG was significant (P < 0.001).

CONCLUSION

In this sample of adult Chinese hypertensive patients, FA combined with enalapril showed a greater beneficial effect on reduction of FPG in a dose-related fashion than did enalapril alone among subjects with hyperglycemia.

摘要

目的

我们比较了叶酸（FA）联合依那普利与单用依那普利对成年中国高血压患者降低血压（BP）和空腹血糖（FPG）的疗效。

方法

480例轻至中度血压患者被随机分配到三个治疗组之一：1）10毫克依那普利（对照组），2）10毫克依那普利加0.4毫克FA（低FA组），或3）10毫克依那普利加0.8毫克FA（高FA组），每日服用8周。使用广义线性混合模型比较治疗第8周时BP和FPG水平相对于基线的降低情况以及三个治疗组之间的差异，并对相关协变量进行校正。

结果

443名受试者（57.3%为女性，年龄27 - 75岁）成功完成试验。8周治疗后，与基线相比，所有治疗组的BP均显著降低，但FPG未降低。三个治疗组在BP或FPG降低方面无显著差异。在亚组分析中，我们发现基线时血糖升高（FPG≥6.1 mmol/L）的受试者中，高FA组（-0.80±1.20 mmol/L）的FPG降低幅度显著大于低FA组（-0.39±1.44 mmol/L）和对照组（-0.23±1.30 mmol/L）。回归分析进一步证实，即使在对重要协变量进行校正后，高FA组的FPG降低幅度仍比对照组大-0.68±0.28 mmol/L（P = 0.015）。剂量反应趋势明显（趋势P = 0.025），治疗组与基线FPG之间的交互作用检验具有显著性（P < 0.001）。