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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。
Objective To evaluate the effects of selenium supplementation on the progression of heart failure in chronic Keshan disease (CKD) using a randomized trial. Methods A total of 139 patients with CKD were divided into experimental group and control group using randomized, controlled and double-blind experimental design, with 71 cases and 68 cases respectively. The test group oral administration of 200μg selenium yeast capsules per day, the control group oral equivalent of selenium-free yeast capsules. All the patients were followed up for 9 months. Blood samples were collected for determination of serum Se, serum BNP, MMP1, TIMP1, ), Plasma endothelin (ET) content. The end of the study was all-cause death. All analyzes use intention analysis. Results After 9 months of intervention, the serum Se of the experimental group was significantly higher than that of the control group (P <0.05). There was no significant difference between the two groups in BNP, MMP1, TIMP1, AngⅡ and ET. Survival analysis using Kaplan-Meier method, two-stage test results showed that there was no significant difference between groups (P> 0.05) and the patient’s survival rate decreased over time, but about 140 d after selenium, The survival of the experimental group started better than the control group. Conclusion Selenium supplementation at 9 months showed no significant improvement in heart failure and survival of CKD patients.