Zentralblatt für Gynäkologie
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Treatment of a retained placenta with intraumbilical oxytocin injection.
The aim of the study was to assess the effect of intraumbilical administration of oxytocin in the management of retained placenta. This prospective double-blinded clinical study included 31 mothers with retained placenta. The women were divided into three groups: group 1 (n = 19) was given 20 IU syntocinon in 20 ml 0.9% NaCl saline intraumbilically into the vein (IUV); group 2 (n = 8) received 20 ml 0.9% NaCl saline; and group 3 (n = 4) received 0.2 mg ergometrine IUV in 20 ml 0.9% NaCl saline. ⋯ Febrility developed in one woman, and abdominal pain in two women from each group. Manual lysis of the placenta was performed in seven group 1, seven group 2, and all four group 3 women. IUV oxytocin injection provides a useful and inexpensive non-surgical, non-aggressive, cheap and pharmacological method which should be included in the treatment protocol for retained placenta before turning to the procedure of manual lysis of the placenta.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Conservative treatment vs. mastectomy without radiotherapy in aged women with breast cancer--a prospective and randomized trial.
To determine whether tumorectomy with tamoxifen in women over 70 years achieves the same treatment results as mastectomy plus tamoxifen. ⋯ Tumorectomy plus tamoxifen demonstrated to be as effective as Madden Op. plus tamoxifen in women over 70 years with T1-T2-N0 disease.
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Multicenter Study Clinical Trial
[Primary endocrine therapy as pre- and perimenopausal metastatic breast carcinoma with leuprorelin acetate depot. German Leuprorelin Study Group].
In an open, prospective, multicentre phase III clinical trial 73 patients with newly diagnosed, metastatic breast cancer were enrolled. Most of them were hormone-receptor-positive. All patients were pre- or perimenopausal and treated with monthly sc. injections of 3.75 mg leuprorelinacetate-depot as monotherapy until disease progression. 50/73 patients (68.5%) had low-risk metastatic disease. ⋯ Treatment was well tolerated leading in only one case to a premature withdrawal due to side effects. Leuprorelinacetate-depot is a safe and effective palliative drug for pre- and perimenopausal metastatic breast cancer patients. Like other GnRH-agonists which have been evaluated for this indication, leuprorelinacetate-depot can be used as first-line endocrine treatment in these patients.
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Multicenter Study Clinical Trial
[Treatment of uterine leiomyoma with depot leuprorelin acetate (Enantone-Gyn monthly depot). Effect on leiomyoma volume and operability. German Leuprorelin Study Group].
In an open, non-comparative clinical phase IV multicentre study the efficacy and safety of the GnRH agonist leuprorelin acetate depot (LAD) for patients with at least one symptomatic uterine leiomyoma was assessed. 144 premenopausal patients were enrolled and treated with up to six injections of 3.75 mg LAD/month subcutaneously prior to surgical intervention, e.g. either hysterectomy or myoma enucleation. Due to a profound suppression of serum-estradiol levels to castration range (< or = 30 pg/ml) an average volume reduction of all myomas from 86.6 +/- 101.3 ml to 38.5 +/- 63.5 ml became obvious for 90% of all patients. In parallel a significant shrinkage of uterine volume was observed. ⋯ Treatment was generally well tolerated. Most of the observed side effects were related to hypoestrogenism. The results of this study have shown that medical pretreatment for patients with uterine fibroids with LAD prior to surgical intervention is an effective measure to improve operability and could lead for several patients to minimal invasive surgery.