Gitlin N, Korner P, Yang H M
Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
Menopause. 1999 Fall;6(3):216-24. doi: 10.1097/00042192-199906030-00007.
To compare hepatic biochemical changes of a combined estrogen-androgen preparation with that of estrogen alone in postmenopausal women.
Hepatic biochemical values from 511 surgical and 130 nonsurgically menopausal women being treated with hormone replacement therapy were pooled from eight similarly designed studies performed between March 1988 and January 1996 comparing esterified estrogen-methyl-testosterone preparations with esterified estrogen, conjugated equine estrogens, and placebo controls. The eight studies in this meta-analysis were controlled, randomized, multicenter, double-blind with identical or similar treatment arms. For hepatic biochemistry parameters, raw data summaries and mean changes from baseline values with standard error (SE) were evaluated for the dosages and treatment groups at various time periods throughout the studies.
Eight controlled trials involving 641 surgically and nonsurgically menopausal women were included. Changes from the pretreatment baseline values of liver function were compared at 1, 3, 6, 12, 18, and 24 months of therapy. No patients demonstrated hepatotoxicity or clinically significant elevation of liver biochemistry values. None of the liver biochemistry changes measured in these studies were of clinical significance, nor were there biochemical differences between estrogen therapy alone compared with combined esterified estrogen-methyltestosterone preparation when administered to postmenopausal women during a period of up to 24 months.
Combined esterified estrogen-methyltestosterone therapy (in doses of 0.625 mg esterified estrogen + 1.25 mg methyltestosterone or 1.25 mg esterified estrogen + 2.5 mg methyltestosterone) was found to be safe regarding hepatic function in postmenopausal women during the course of 24 months in eight controlled clinical trials.
比较绝经后女性联合使用雌激素 - 雄激素制剂与单独使用雌激素时肝脏生化指标的变化。
对1988年3月至1996年1月期间进行的八项设计相似的研究中接受激素替代疗法的511名手术绝经女性和130名非手术绝经女性的肝脏生化值进行汇总分析。这些研究比较了酯化雌激素 - 甲基睾酮制剂与酯化雌激素、结合马雌激素及安慰剂对照。本荟萃分析中的八项研究均为对照、随机、多中心、双盲试验，治疗组相同或相似。对于肝脏生化参数，在研究的各个时间段，对不同剂量和治疗组的原始数据汇总以及相对于基线值的平均变化及其标准误差（SE）进行了评估。
纳入了八项涉及641名手术和非手术绝经女性的对照试验。在治疗的1、3、6、12、18和24个月时，比较了肝功能的治疗前基线值变化。没有患者表现出肝毒性或肝脏生化值的临床显著升高。这些研究中测量的肝脏生化变化均无临床意义，在长达24个月的时间内，单独使用雌激素治疗与联合使用酯化雌激素 - 甲基睾酮制剂治疗绝经后女性时，也没有生化差异。
在八项对照临床试验中发现，联合使用酯化雌激素 - 甲基睾酮疗法（剂量为0.625 mg酯化雌激素 + 1.25 mg甲基睾酮或1.25 mg酯化雌激素 + 2.5 mg甲基睾酮）在24个月的疗程中对绝经后女性的肝功能是安全的。
