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目的系统评价睾酮补充治疗对中老年男性胰岛素抵抗的疗效及安全性。方法计算机检索PubMed(1966.1～2010.7)、EMbase(1984.1～2010.7)、Cochrane图书馆临床对照试验资料库(2010年第3期)和CBM(1978～2010.7)、CNKI(1994.1～2010.7)、万方数据库(1994～2010.7)、维普信息资源系统(1989～2010.7),收集国内外所有关于睾酮治疗中老年男性胰岛素抵抗的随机对照试验。按Cochrane系统评价方法选择试验和评价质量后,对同质研究采用RevMan 5.0软件进行Meta分析。对不能进行Meta分析的数据,则只进行描述性的定性分析。结果共纳入9个随机对照试验,合计573例患者,其中睾酮治疗308例,使用安慰剂治疗265例,各研究基线具有可比性。Meta分析结果显示:治疗后,睾酮治疗组在胰岛素抵抗指数(HOMA-IR)[WMD=–0.56,95%CI(–0.75,–0.37)]和空腹胰岛素(FINS)[WMD=–2.40,95%CI(–3.25,–1.56)]方面优于安慰剂组,而两组前列腺特异抗原(PSA)水平差异无统计学意义[WMD=–0.02,95%CI(–0.22,0.18)]。结论睾酮补充治疗在改善中老年男性糖尿病患者胰岛素抵抗方面优于安慰剂,而对PSA的影响与安慰剂相比差异无统计学意义。由于纳入研究质量有限,样本量又较少,上述结论尚需进一步开展大样本、多中心的随机双盲安慰剂对照试验加以验证。
Objective To evaluate the efficacy and safety of testosterone replacement therapy on insulin resistance in middle-aged and elderly men. Methods The clinical data of PubMed (1966.1 ~ 2010.7), EMbase (1984.1 ~ 2010.7), Cochrane Central Register of Controlled Trials (2010) and CBM (1978 ~ 2010.7), CNKI (1994.1 ~ 2010.7) (1994 ~ 2010.7) and VIP Information Resource System (1989 ~ 2010.7). All randomized controlled trials of testosterone in treating insulin resistance in middle-aged and elderly men were collected. After selection of tests and evaluation of quality based on the Cochrane review, a meta-analysis was performed using RevMan 5.0 software for homogeneous studies. For data that can not be Meta-analysis, only descriptive qualitative analysis. Results A total of 9 randomized controlled trials were enrolled in a total of 573 patients, of whom 308 were testosterone and 265 were placebo, with comparable baseline studies. Meta-analysis showed that after the treatment, the testosterone-treated group showed no significant difference in HOMA-IR [WMD = -0.56,95% CI -0.75 -0.37] and fasting insulin (WMD = -2.40,95 % CI (-3.25, -1.56)] was superior to placebo group. There was no significant difference in PSA level between the two groups [WMD = -0.02,95% CI (-0.22,0.18)]. Conclusion Testosterone supplementation is superior to placebo in improving insulin resistance in middle-aged and elderly men with diabetes, but there is no significant difference in the effect of PSA on placebo compared with placebo. Due to the limited quality of the included studies and the small sample size, the above conclusions need to be further examined in a large randomized double-blind placebo-controlled multicenter trial.