Zentralblatt für Gynäkologie
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Randomized Controlled Trial Comparative Study Clinical Trial
[Does para-cervical block offer additional advantages in abortion induction with gemeprost in the 2nd trimester?].
Uterus-specific synthetic Prostaglandin analogues (gemeprost, sulproston etc.) have been widely employed for termination of pregnancy in the second trimester. Since paracervical anaesthesia may be useful during this procedure, we investigated in this prospective randomised study its impact on the clinical course of abortion and pain especially in the late first and second stage of labour. ⋯ Paracervical anaesthesia is a method for analgesia during second trimester abortion with a low rate of side effects. It can shorten the duration of last period of second trimester abortion in some cases but has no impact on the perception of pain nor requirement of analgesics and so with only limited benefit in second trimester abortion with vaginal gemeprost.
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With the identification and recombinant production of the hematopoietic growth factors, these cytokines have been evaluated in the treatment of primary bone marrow failure states and following myelosuppressive chemotherapy or radiotherapy. An increasing number of clinical trials with hematopoietic factors have been performed in patients with haematological and oncological diseases. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin and, in phase I/II trials, thrombopoietin (TPO) are available for the clinical use. ⋯ This results in a marked reduction of infectious risks and a shortening of drug- and radiation-induced myelosuppression. CSFs are most important in mobilizing peripheral blood progenitor cells (PBPC) and have allowed high-dose therapy combined with stem cell support in gynecological malignancies, e.g. ovarian carcinoma and breast cancer. However, evidence based, clinical practical guidelines for the use of hematopoietic growth factors in gynecological malignancies are not for all circumstances available.
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From 1973 through 1993, the University of Leipzig Women's Hospital treated 285 patients with primary vulvar malignancies. Of these, 269 cases (94.3%) were squamous cell carcinomas. The patients age averaged 69 years (25-95 years). 232 women (81.4%) were older than 60 years. ⋯ These findings, therefore, justify the individualized operative treatment of patients with vulvar carcinoma according to each patient's initial prognostic situation. The relatively seldom vulvar carcinoma should only be treated by experienced surgeons in an appropriate hospital environment. Moreover, assessment of histological sections must be standardized, reproducible and above all, include the very accurate evaluation of all resection edges.
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Review Randomized Controlled Trial Clinical Trial
[Recurrent and 2nd line therapy in ovarian carcinoma: an overview of conventional systemic therapy modalities].
Remarkable improvements in primary surgery and chemotherapy for advanced ovarian cancer have been achieved in the last decades. Nevertheless, the majority of patients still develop recurrent disease and ultimately die from ovarian cancer. Evaluation of efficient second-line treatment is of clinical relevance. ⋯ Therefore, recommendations remain inconclusive. Retrospective comparisons may help the clinician to chose the currently best available treatment for an individual patient, however, these treatments have to be evaluated in prospectively randomised trials. The protocols of the ongoing studies in refractory or recurrent ovarian cancer of the AGO Ovarian Cancer Study Group are outlined.
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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.