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亚硒酸钠治疗儿童大骨节病的系统评价:随机对照试验研究。

Sodium selenite for treatment of Kashin-Beck disease in children: a systematic review of randomised controlled trials.

机构信息

Department of Geriatrics, West China Hospital, Sichuan University, Guoxuexiang 37, Chengdu, Sichuan province, China.

出版信息

Osteoarthritis Cartilage. 2012 Jul;20(7):605-13. doi: 10.1016/j.joca.2012.02.012. Epub 2012 Feb 24.

DOI:10.1016/j.joca.2012.02.012
PMID:22370124
Abstract

OBJECTIVE

To assess the effectiveness and safety of sodium selenite in treatment of patients with Kashin-Beck disease (KBD).

METHODS

We searched for all publications between January 1966 and October 2011 using seven electronic databases. All randomized controlled trials (RCTs) assessing the effects of sodium selenite on KBD vs no treatment or placebo were included. For dichotomous data, odds ratios (OR) and 95% confidence intervals (CI) were estimated according to the intention-to-treat principles. For continuous data, mean difference (MD) was used for outcomes pooled on the same scale.

RESULTS

A total of 10 RCTs involving 2244 patients were included. The methodological quality of the included studies was low. When comparing the outcome of sodium selenite treatment group vs the control group, the OR of repairing rate of metaphyseal lesions was 5.63 (95% CI: 3.67-8.63) and repairing rate at the distal end of phalanges was 2.98 (95% CI: 1.32-6.70) based on X-ray assessment, which was statistically significant difference in favour of sodium selenite. In one RCT which reported data on clinical improvement, no statistically significant difference was observed in the treatment vs control group (OR 1.50, 95% CI: 0.43-5.30). Se content in hair was (MD 0.11, 95% CI: 0.09-0.13) which was statistically significant higher in selenium group.

CONCLUSIONS

Current evidence suggests that sodium selenite is more effective than placebo or no treatment in patients with KBD. However, the evidence was limited by potential biases; thus, further high quality large-scale RCTs are still needed to evaluate the short term and long term effects of selenium.

摘要

目的

评估亚硒酸钠治疗大骨节病(KBD)患者的有效性和安全性。

方法

我们检索了 1966 年 1 月至 2011 年 10 月期间的七个电子数据库,纳入所有评估亚硒酸钠治疗 KBD 与未治疗或安慰剂比较的随机对照试验(RCT)。对于二分类数据,根据意向治疗原则估计比值比(OR)和 95%置信区间(CI)。对于连续数据,在同一尺度上汇总结果使用均数差(MD)。

结果

共纳入 10 项 RCT,涉及 2244 例患者。纳入研究的方法学质量较低。当比较亚硒酸钠治疗组与对照组的结局时,基于 X 射线评估,干骺端病变修复率的 OR 为 5.63(95%CI:3.67-8.63),指骨末端修复率为 2.98(95%CI:1.32-6.70),差异有统计学意义。在一项报告临床改善数据的 RCT 中,治疗组与对照组之间无统计学差异(OR 1.50,95%CI:0.43-5.30)。头发中的硒含量(MD 0.11,95%CI:0.09-0.13)在硒组中显著更高。

结论

目前的证据表明,亚硒酸钠在 KBD 患者中比安慰剂或未治疗更有效。然而,由于潜在偏倚,证据有限;因此,仍需要进一步开展高质量、大规模的 RCT 来评估硒的短期和长期效果。

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