[Use of a new steroid (Org OD 14) in the climacteric syndrome].

Reproduccion Pub Date : 1982-04-01
J Cittadini, J Ben, A R Badano, H J Denari, S Quiroga, A E Marcus, I Schlaen, P R Figueroa Casas
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Abstract

A double-blind study was carried out in 60 women with climacteric symptoms: 30 women were given Org OD 14 (2.5 mg) and 30 were given a placebo to be taken daily for six weeks. The effects of the medication on the climacteric symptoms, the subjective sensations, the plasma FSH levels and endometrial histology were studied. In the treated group compared with the control group the relief or improvement of the following climacteric symptoms were recorded: perspiration, palpitations, irritability and backache. A favourable effect on the subjective sensations was noted in both groups, although no significant difference for the group which received Org OD 14 was found. At the end of the treatment with Org OD 14, the FSH levels were found to be greatly reduced in comparison with the basal values; this, however, was not the case with the placebo group. With regard to endometrial histology, no sign of hyperplasia was found in any of the patients. No relevant side effects or symptoms of estrogenic or androgenic stimulation were recorded. For the climacteric patient needing estrogen therapy, it can be concluded that Org OD 14 is an effective and innocuous medication in the doses used.

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[在更年期综合征中使用一种新的类固醇(Org OD 14)]。
对60名有更年期症状的妇女进行了一项双盲研究:30名妇女服用Org OD 14(2.5毫克),30名妇女服用安慰剂,每天服用6周。观察药物对绝经期症状、主观感觉、血浆促卵泡刺激素水平及子宫内膜组织学的影响。治疗组与对照组比较,记录了下列更年期症状的缓解或改善:出汗、心悸、烦躁和背痛。两组对主观感觉都有良好的影响,尽管服用Org OD 14的组没有发现显著差异。在Org OD 14治疗结束时,与基础值相比,FSH水平显著降低;然而,安慰剂组的情况并非如此。在子宫内膜组织学方面,没有发现任何患者有增生的迹象。未记录雌激素或雄激素刺激的相关副作用或症状。对于需要雌激素治疗的更年期患者,可以得出结论,在使用剂量下,Org OD 14是一种有效且无害的药物。
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