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Termiination Ofpregnancy with Reduced Doses Ofmifepristone

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Termiination Ofpregnancy with Reduced Doses Ofmifepristone Prevenci6n de la neumonia nosocomial: descontaminaci6n digestiva 33 Kerver AJH, Rommes JH, Mevissen-Verhage EAE, Hulstaert PF, Vos A, selectiva y sulcralfato. Medicina Intiensva 1992;16:81-5. Verhoef J, et al. Prevention of colonization and infection in critically ill 26 Pugin J, Auckenthaler R, Lew DP, Suter PM. Oropharyngeal decontamina- patients: a prospective randomized study. Crit Care Med 1988;16:1087-93. tion decreases incidence of ventilator-associated pneumonia. J'AMA 1991; 34 Rodriguez-Roldin JM, Altuna-Cuesta A, Lopez A, Carrillo A, Garcia J, Leon 265:2704-10. J, et al. Prevention of nosocomial lung infection in ventilated patients: use of 27 Ulrich C, Harinck-deWeerd JE, Bakker NC, Jacz K, Doornbos L, de Ridder an antimicrobial pharyngeal nonabsorbable paste. Grit Care Med 1990;18: VA. Selective decontamination of the digestive tract with norfloxacin in the 1239-42. prevention of ICU-acquired infections: a prospective randomized study. 35 Ferrer M, Torres A, Gonzilez J, Puig de la Bellacasa J, Gatell JM, Jim6nez Intensive Care Med 1989;15:424-31. MT, et al. Utility of selective digestive decontamination in a general 28 Unerti K, Ruckdeschel G, Selbmann HK, Jensen U, Forst H, Lenhart FP, population of mechanically ventilated patients. Am Rev Respir Dis 1992;145: et al. Prevention of colonization and respiratory infections in long-term A112. ventilated patients by local antimicrobial prophylaxis. Intensive Care Med 36 Begg CB. A measure to aid in the interpretation ofpublished clinical trials. Stat 1987;13:106-13. Med 1985;4:1-9. 29 Winter R, Humphreys H, Pick A, MacGowan AP, Willatts SM, Speller DCE. 37 Webb CH. Antibiotic resistance associated with selective decontamination of A controlled trial of selective decontamination of the digestive tract in the digestive tract.JHosp Infect 1992;22:1-5. intensive care and its effect on nosocomial infection. JAntmicrob Chemother 38 Van Saene HKF, Unertl KE, Alcock SR, Stoutenbeek CP, Hart CA. 1992;30:73-87. Emergence of antibiotic resistance during selective digestive decontamina- 30 Sanchez M, Cambronero JA, Lopez G, Cerda E, Rodriguez JM, Rubio J, et al. tion?JYHosp Infect 1993;24:158-62. Selective decontamination of the digestive tract in intubated patients: a 39 Stewart LA, Parnar MKB. Meta-analysis of the literature or of individual multicentric, double-blind, placebo controlled study. In: Proceedings of the patient data: is there a difference? Lancet 1993;341:418-22. 32nd Interscience Conference on Antnicrobial Agents and Chemotherapy. 40 Boissel JP, Blanchard J, Panak E, Peyrieux JC, Sacks H. Considerations for Anaheim, Califomia: ICAAC, 1992. the meta-analysis of randomized clinical trials. Controaed ClGn Trials 31 Brun-Buisson C, Legrand P, Rauss A, Richard C, Montravers F, Besbes M, 1989;1O:254-81. et al. Intestinal decontamination for control of nosocomial multiresistant 41 McGlynn EA, Kosekoff J, Brook RH. Format and conduct of consensus Gram-negative bacilli. Ann Intern Med 1989;110:873-81. development conferences; multinational comparison. Int J Technol Assess 32 Hammond JMJ, Potgieter PD, Saunders GL, Forder AA. Double-blind study Health Care 1990;6:450-69. of selective decontamination of the digestive tract in intensive care. Lancet 1992;340:5-9. (Accepted 17June 1993) Termiination ofpregnancy with reduced doses ofmifepristone World Health Organisation Task Force on Post-ovulatory Methods ofFertility Regulation Abstract propynyl]estra-4,9-dien-3-one) has been registered for Objectives-To compare the abortifacient termination of early pregnancy in France and China efficacy and side effects of three doses of the since September 1988, in Great Britain since July 1991, antiprogestin mifepristone plus prostaglandin for and in Sweden since September 1992. In France and termination ofearly pregnancy. China mifepristone can be used for inducing abortion Design-Randomised, double blind multicentre in pregnancies of up to seven weeks of amenorrhoea, trial. while in Britain and Sweden it can be used in preg- Setting-lI departments of obstetrics and gynae- nancies ofup to nine weeks of amenorrhoea. In all four cology and of family planning, mostly in university countries the recommended treatment is a single dose hospitals, in seven countries. of 600 mg mifepristone (three tablets of 200 mg) Subjects-1182 women with an early pregnancy followed 36-48 hours later by a suitable prostaglandin (menstrual delay of7-28 days) requesting abortion. analogue with uterotonic activity (such as a vaginal Interventions-Single doses of200 mg, 400 mg, or suppository of gemeprost or oral tablets of miso- 600 mg mifepristone followed, 48 hours later, by prostol), and this combination gives complete abortion vaginal pessary of 1 mg of the prostaglandin El in 95-96% of cases.' In the largest series reported to analogue gemeprost. date efficacy was 95 3% among 15 709 women treated Main outcome measures-Outcome oftreatment; in France with vaginal gemeprost or intramuscular duration and subjective amount of menstrual sulprostone as the prostaglandin.2 The failures bleeding; side effects and complications; and con- consisted of persisting pregnancies (1 20/6), incomplete centrations ofhaemoglobin. expulsion (2 8%), and women requiring a haemostatic Results-Outcome was similar with the three surgical procedure (0 7%). doses of mifepristone. Of the 1151 women with Several studies conducted on the pharmacokinetics known outcome, 95*5% had a complete abortion (364 of orally administered mifepristone indicate that con- (93.80/.) of those given 200 mg mifepristone, 368 centrations of the antiprogestin in the blood do not (94*10/6) of those given 400 mg, and 367 (94 30/) increase proportionally with increasing oral doses.3 of those given 600 mg), 3*7% had an incomplete This is probably because in humans mifepristone is abortion (14 (3*60I.), 15 (3*80/), and 14 (366%)), 0.3% bound to a, acid glycoprotein, which acts as a low had a missed abortion (three (0.8%), one (0 30/), and affinity carrier protein. The carrying capacity of al none), and 0 4% had a continuing live pregnancy acid glycoprotein is limited so that plasma levels of (two (050/), two (0 5%), and one (033%)). Of the 43 mifepristone correlate with the concentration of this women who had incomplete abortion, 23 underwent protein rather than the administered dose.4 From these emergency uterine curettage (usually for haemo- studies it seemed likely that the percentage ofsuccessful static purposes) and three of these women were abortions achieved by a single dose of 600 mg mife- given a blood transfusion. The numbers ofreported pristone could be obtained with smaller doses of complaints, bleeding patterns, and changes in the antiprogestin. Support for this assumption is blood pressure and haemoglobin concentrations provided by studies conducted under the auspices of Correspondence to: were similar with the three treatments. the World Health Organisation,'6 including a recent Dr P F AVan Look, Conclusions-For termination of early pregnancy randomised multicentre trial in which five 25 mg doses Special Programme of a single dose of200 mg mifepristone is as effective as of mifepristone given at 12 hour intervals were shown Research, Development and the currently recommended dose of 600 mg when to be as effective as the recommended single dose of Research Training in 600 and Baird administered doses Human Reproduction, used in combination with a vaginal pessary of 1 mg mg.7 Rodger single World Health Organisation, gemeprost. of 600 mg, 500 mg, and 400 mg of mifepristone and Avenue Appia, reported rates of complete abortion of 100%, 97%, and 1211 Geneva 27, 90% respectively.8 The number of women in each Switzerland. Introduction group was too small, however, to assess if the apparent The antiprogestin mifepristone (RU 486; 1 11-[p- downward trend was statistically significant. BMJ 1993;307:532-7 (dimethylamino)-phenyl] -17 -hydroxy- 17- [1- The purpose of the present randomised, double 532 BMJ VOLUME 307 28 AUGUST 1993 blind, multicentre trial was to compare the aborti- time of the six week visit. At each visit the women facient efficiency and side effects of three single doses were asked about possible side effects and about ofmifepristone (200 mg, 400 mg, and 600 mg) followed the presence and amount of vaginal bleeding. Blood 48 hours later by a vaginal pessary of 1 mg gemeprost in pressure, pulse, and a blood sample for measuring women with an early pregnancy. haemoglobin concentration were taken, and vaginal and ultrasound examinations were done ifindicated. As in our previous studies679 the outcome of treat- Subjects and methods ment was classified as complete abortion, incomplete Permission for the study was obtained from the abortion, missed abortion, or continuing live preg- WHO's Secretariat Committee on Research Involving nancy on the basis of the subject's history, and clinical Human Subjects and from the corresponding ethics findings on pelvic examination, and if indicated, ultra- committees of the 11 participating centres (Aberdeen, sonography. All data were recorded on standardised Edinburgh, Havana, Hong Kong, Ljubljana, Milan, forms and analysed at WHO headquarters, Geneva. Shanghai, Stockholm, Szeged, Tianjin, and Wuhan). Values given in the text and tables are arithmetic means Informed consent was obtained from all women taking and standard deviation unless stated otherwise. Com- part in the trial. The criteria used for selection of parisons between treatment groups and between subjects were similar to those of our earlier studies.67 outcome categories were made by the X2 test, X2 test for Women requesting termination of pregnancy were trend, Student's t test, or analysis of variance as recruited if they were in good general health and had a appropriate. Repeated measures analysis of variance history of regular menstrual cycles (25-35 days) for at was used to assess the significance of differences in least three months before conception, a menstrual blood pressure and haemoglobin concentration and of delay of 7-28 days, a positive urinary pregnancy test, changes in these parameters from pretreatment values and a normal intrauterine pregnancy as judged from within treatment group.
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