Termination of early gestation with the anti-progestin steroid RU 486: medium versus low dose |
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| Authors: | D R Mishell D Shoupe P F Brenner M Lacarra J Horenstein P Lahteenmaki I M Spitz |
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| Affiliation: | 1. Steroid Research Laboratory University of Helsinki Helsinki, Finland;7. Center for Biomedical Research The Population Council New York, New York, U.S.A.;1. Department of Food Materials and Process Design Engineering, University of Agricultural Sciences and Natural Resources, Gorgan, Iran;2. Research Institute of Food Science and Technology, Mashhad, Iran;1. Department of Gynaecological Oncology, GRACE Centre, Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton TA1 5DA, UK;2. Dept of Gynaecology Oncology, Pan Birmingham Gynaecological Cancer Centre, City Hospital School of Cancer Sciences, University of Birmingham, Birmingham, UK;3. CNS Office, Main Admin Building, Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Castle Road, Cottingham HU16 5JQ, UK;4. The Christie NHS Foundation Trust and University of Manchester, UK;5. Institute of Cancer Sciences, Division of Molecular and Clinical Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK;6. Northern Centre for Cancer Care, Newcastle Hospitals NHS Foundation Trust, Newcastle NE7 7DN, UK;7. Beacon Centre, Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton TA1 5DA, UK;8. Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter EX2 5DW, UK;9. Dept of Surgery and Cancer, Gynaecologic Oncology, Imperial College London, UK;10. Nottingham University Hospitals NHS Trust, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UK;11. Department of Cellular Pathology, Birmingham Women''s Hospital, Birmingham B15 2TG, UK;12. Centre for Women''s and Newborn Health, Institute of Metabolism and Systems Research (IMSR), University of Birmingham, Birmingham Women''s and Children''s NHS Foundation Trust, Birmingham B15 2TG, UK;13. Department of Radiology, Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton TA1 5DA, UK;14. Royal United Hospitals Bath NHS Foundation Trust, Bath, UK;15. Leicester Cancer Research Centre, Room 4.27, 4th Floor, Robert Kilpatrick Building University of Leicester, Leicester LE2 7LX, UK;p. Birmingham Women''s and Children''s Hospital, Birmingham B15 2TG, UK;q. Gynaecology Oncology Department, St Michael’s Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol BS1 3NU, UK;r. The Academic Women’s Health Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK;s. Bristol Cancer Institute, University Hospitals Bristol and Weston NHS Trust, Bristol, UK;t. Royal Marsden NHS Foundation Trust, London, UK |
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| Abstract: | RU 486 is a synthetic steroid which has antiprogesterone and antiglucocorticoid activity. In order to determine the optimal dosage of this drug to terminate early pregnancy, we treated 106 healthy women with normal pregnancies by real time ultrasound examination whose gestational duration was less than 49 days from onset of last menses with either a medium or low dose treatment regimen. A total of 66 patients received the medium dose regimen (100 mg/day X 7 days). Another 10 patients received ergonovine (0.2 mg/day X 6 doses) on Day 4 of the same RU 486 treatment regimen. In the first group, 48 (73%) aborted successfully and, of the second group, 6 (60%) aborted. Eighty percent of the subjects in this group of 76 patients reported side effects of nausea and vomiting, heavy bleeding, severe menstrual cramps or headache. All these side effects were successfully treated with analgesic and antiemetic medication. The remaining 30 subjects were treated with a low dose regimen (50 mg/day X 7 days). Of these 30, 15 (50%) aborted; this incidence was significantly less (p less than 0.05). Following the medium dose treatment regimen, the AM cortisol levels were significantly elevated on treatment Days 4 and 8, as compared to baseline (p less than 0.001), although the mean levels were still within the normal range. With the low dose, there was a non-significant rise in AM cortisol values. Thus the rise in cortisol was significantly greater in the former group than the latter (p less than 0.05). With the medium dose regimen, the women who aborted had significantly lower (p less than 0.05) pretreatment mean B-HCG and progesterone levels than the group that failed to abort. Mean serum levels of RU 486 were not significantly different between the group who aborted and those who did not. RU 486 is a promising agent for termination of early pregnancy. |
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