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目的 采用随机化试验评价补硒提高抗氧化能力对慢型克山病预后的影响.方法 采用随机对照双盲的试验设计,按随机数字表法将139例慢型克山病患者分为试验组和对照组,分别为71和68例.试验组每天口服硒酵母胶囊,对照组口服等量不含硒的酵母胶囊.随访观察9个月,采血检测血硒含量,血清谷胱甘肽过氧化物酶(GSH-Px)活力、总超氧化物歧化酶(TSOD)、总抗氧化能力(TAOC)和丙二醛(MDA)含量.比较两组人群血硒和抗氧化指标的水平,采用Kaplan-Meier法进行生存分析,用Log-rank法检验结局发生率曲线之间的差异.结果 干预9个月后,试验组血硒[(141.2±71.0)μg/L]、GSH-Px活力[(109.7±22.0)U/ml]、TSOD[(76.6±31.8)U/ml]高于对照组[(67.9±29.4) μg/L、(93.8±12.9)U/ml、(62.7±20.9) U/ml,t=-6.93、-4.53、-2.66,P均＜0.05],两组TAOC、MDA比较差异无统计学意义[(14.1±4.0)比(14.2±4.2)U/ml、(8.8±2.7)比(9.0±2.6) nmoL/ml,t=0.12、0.35,P均＞0.05].Log-rank检验结果显示,两组人群生存率比较差异无统计学意义(x2=0.18,P＞0.05),且患者的生存率均随时间推移呈下降水平,但补硒140 d后,试验组的生存状态开始好于对照组.结论 慢型克山病患者在正常治疗条件下,每天补硒200 μg 9个月,抗氧化能力显著提高,但未见生存期具有统计学意义的延长.“,”Objective To evaluate the effects of increased antioxidant capacity through selenium supplement on the prognosis of chronic Keshan disease (CKD).Methods In a randomized controlled double-blind trial,139 CKD subjects were divided into the experimental group of 71 subjects who took capsules containing selenium by random number table per day,and the control group of 68 subjects who took 2 yeast capsules without selenium.The effects of intervention were evaluated after 9 months.Blood selenium and serum glutathione peroxidase (GSH-Px) activity,total superoxide dismutase (TSOD),total antioxidant capacity (TAOC) and malondialdehyde (MDA) were measured.Blood selenium level of the two groups and antioxidant lipid oxidation level indicators were examined,and survival analysis was done using the Kaplan-Meier method,the difference between the rate curve generating was analyzed using Log-rank test.Results After 9 months,blood selenium [(141.2 ± 71.0) μg/L],serum GSH-Px activity [(109.7 ± 22.0) U/ml],TSOD [(76.6 ± 31.8) U/ml] of the subjects of the experimental group were statistically significantly higher than those of the control group [(67.9 ± 29.4) μg/L,(93.8 ± 12.9),(62.7 ± 20.9)U/ml,t =-6.93,-4.53,-2.66,all P ＜ 0.05];the difference of serum TAOC and MDA between the two groups was not significant statistically [(14.1 ± 4.0) vs.(14.2 ± 4.2) U/ml,(8.8 ± 2.7) vs.(9.0 ± 2.6) nmol/ml,t =0.12,0.35,all P ＞ 0.05].Kaplan-Meier analysis of survival showed no statistical significant difference between the two groups (x2 =0.18,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 significantly different.Conclusion Supplementation of 200 μg selenium per day for 9 months has significantly increased the antioxidant capacity of the CKD subjects with routine treatment even though it has not extend the survival time of the subjects significantly in statistics.