中文摘要：

目的采用随机化试验评价补硒对慢型克山病（CKD）心力衰竭进展的影响。方法采用随机、对照、双盲的试验设计,将139例CKD患者分为试验组和对照组,分别为71例和68例。试验组每天口服200μg硒酵母胶囊,对照组口服等量不含硒的酵母胶囊。随访观察9个月,采血检测全血硒（Se）、血清脑钠肽（BNP）、基质金属蛋白酶-1（MMP1）、基质金属蛋白酶抑制剂-1（TIMP1）、血浆血管紧张素Ⅱ（AngⅡ）、血浆内皮素（ET）含量。研究终点是全因死亡。所有分析均采用意向性分析。结果干预9个月后,试验组全血Se显著高于对照组（P〈0.05）,BNP、MMP1、TIMP1、AngⅡ、ET两组之间差异无统计学意义。利用Kaplan-Meier法进行生存分析,Two-stage检验结果虽显示组间生存率无显著性差异（P〉0.05）且病人的生存率均随时间推移呈下降水平,但大约补硒140 d后,试验组的生存状态开始好于对照组。结论9个月补硒对CKD病人心力衰竭和生存期未见有统计学意义的改善。

英文摘要：

Objective To evaluate the effects of selenium supplement on the progress of heart failure of chronic Keshan disease（ CKD）. Method In a randomized controlled double-blind trial,139 CKD subjects were divided into the experimental group of71 subjects who took 2 yeast capsules, each enriched 100 microgram selenium, per day, and the control group of 68 subjects who took 2 yeast capsules without ennriched selenium. The effects of intervention were evaluated after 9 months. Blood selenium（ Se）and serum Brain Natriuretic Peptide（ BNP）,Matrix metalloproteinase-1（ MMP1）,Matrix metalloproteinase inhibitor-1（ TIMP1）,plasma Angiotensin Ⅱ（ Ang Ⅱ）,Endothelin（ ET） were measured. The primary endpoint was all-cause death. All analysis was done by intention to treat. Results After 9 months, blood selenium of the subjects of the experimental group was statistically significantly higher than that of the control group（ P〈0. 05）; the difference of BNP,MMP1,TIMP1,AngⅡ,ET between the two groups were not significant statistically. Kaplan- Meier analysis of survival showed no statistically significant difference between the two groups（ P〉0. 05） though the survival rates of the two groups showed downward trend. When the subjects had selenium supplementation for 140 days,the survival rate of the experimental group was much higher than that of the control group although the survival rates of the two groups were still not statistically significant different. Conclusion In the CKD patients, there were no significance effects on the progress of heart failure for a short time and did not extend the survival time of the subjects significantly in statistics.