十一酸睾酮治疗LOH的疗效与安全性的Meta分析

Effect and safety of testosterone undecanoate in the treatment of late-onset hypogonadism: A meta-analysis

目的:应用Meta分析的方法评价十一酸睾酮治疗迟发性性腺功能减退(LOH)的疗效及安全性。方法:计算机检索Pubmed(至2014年4月1日)、Embase(至2014年3月28日)、Cochrane library(至2014年4月17日)、中国生物医学文献数据库(2001年1月1日至2014年2月2日)、中国期刊全文数据库(2001年1年1至2014年2月2日)、万方数据库(2000年1月1日到至2014年2月2日)、维普数据库(2000年1月1至2014年2月2日)。检索已经阅读的文献的参考文献。纳入十一酸睾酮(TU)治疗LOH的随机对照试验。采用Rveman5.2软件对纳入的文献进行质量评价及Meta分析。结果:筛选后纳入文献14篇,共1686例患者,Meta分析显示:与安慰剂或空白对照组相比,经十一酸睾酮治疗后的血清总睾酮升高[SMD=6.22,95%CI(3.99,8.45),P<0.01];血清游离睾酮升高[SMD=4.35,95%CI(1.86,6.85),P<0.01];黄体生成素下降[WMD=-2.23,95%CI(-4.03,-0.42),P<0.01];性激素结合球蛋白下降[WMD=2.00,95%CI(1.38,2.63),P<0.05];PADAM症状量表评分降低[WMD=-9.29,95%CI(-12.96,-6.03),P<0.01];AMS症状量表评分降低[WMD=-2.76,95%CI(-4.85,-0.66),P<0.05],血红蛋白升高[SMD=2.35,95%CI(0.29,4.41),P<0.05],血细胞压积升高[SMD=4.35,95%CI(1.36,7.33),P<0.01];谷草转氨酶、谷丙转氨酶、前列腺特异抗原、前列腺体积等无显著性差异(P均>0.05)。结论:十一酸睾酮能显著改善LOH患者的血清雄激素水平及临床症状,且未发现严重的不良反应;但由于纳入的研究数量较少,质量偏低,上述结论应用于临床需谨慎。

Objective： To evaluate the efficacy and safety of testosterone undecanoate（ TU） in the treatment of late-onset hypogonadism（ LOH） by meta-analysis. Methods： We searched Pubmed（ until April 1,2014）,Embase（ until March 28,2014）,Cochrane Library（ until April 17,2014）,CBM（ from January 1,2001 to February 2,2014）,CNKI（ from January 1,2001 to February 2,2014）,Wanfang Database（ from January 1,2000 to February 2,2014）,and VIP Database（ from January 1,2000 to February 2,2014） for randomized controlled trials of TU for the treatment of LOH. We evaluated the quality of the identified literature and performed meta-analysis on the included studies using the Rveman5. 2 software. Results： Totally,14 studies were included after screening,which involved 1 686 cases. Compared with the placebo and blank control groups,TU treatment significantly increased the levels of serum total testosterone（ SMD = 6. 22,95% CI 3. 99 to 8. 45,P 〈 0. 05） and serum free testosterone（ SMD = 4. 35,95% CI1. 86 to 6. 85,P 〈 0. 05） but decreased the contents of luteinizing hormone（ WMD =- 2. 23,95% CI- 4. 03 to- 0. 42,P 〈0. 05）,sex hormone binding globulin（ WMD = 2. 00,95% CI 1. 38 to 2. 63,P 〈 0. 05）. TU also remarkably reduced the scores of Partial Androgen Deficiency of the Aging Males（ WMD =- 9. 49,95% CI- 12. 96 to- 6. 03,P 〈 0. 05） and Aging Males’ Symptoms rating scale（ WMD =- 2. 76,95% CI- 4. 85 to- 0. 66,P 〈 0. 05） but increased the hemoglobin level（ SMD = 2. 35,95%CI 0. 29 to 4. 41,P 〈 0. 05） and packed-cell volume（ SMD = 4. 35,95% CI 1. 36 to 7. 33,P 〈 0. 05）. However,no significant changes were shown in aspertate aminotransferase,alanine transaminase,prostate-specific antigen,or prostate volume after TU treatment（ P 〉 0. 05）. Conclusion： TU could significantly increase the serum testosterone level and improve the clinical symptoms of LOH patients without inducing serious adverse reactions. However,due to the limited number and relatively low quality of the included studies,the above conclusion could be cautiously applied to clinical practice.