RESUMO
BACKGROUND: Clinical trials have established the high effectiveness and safety of medication abortion in clinical settings. However, barriers to clinical abortion care have shifted most medication abortion use to out-of-clinic settings, especially in the context of the COVID-19 pandemic. Given this shift, we aimed to estimate the effectiveness of self-managed medication abortion (medication abortion without clinical support), and to compare it to effectiveness of clinician-managed medication abortion. METHODS: For this prospective, observational cohort study, we recruited callers from two safe abortion accompaniment groups in Argentina and Nigeria who requested information on self-managed medication abortion. Before using one of two medication regimens (misoprostol alone or in combination with mifepristone), participants completed a baseline survey, and then two follow-up phone surveys at 1 week and 3 weeks after taking pills. The primary outcome was the proportion of participants reporting a complete abortion without surgical intervention. Legal restrictions precluded enrolment of a concurrent clinical control group; thus, a non-inferiority analysis compared abortion completion among those in our self-managed medication abortion cohort with abortion completion reported in historical clinical trials using the same medication regimens, restricted to participants with pregnancies of less than 9 weeks' gestation. This study was registered with ISCRTN, ISRCTN95769543. FINDINGS: Between July 31, 2019, and April 27, 2020, we enrolled 1051 participants. We analysed abortion outcomes for 961 participants, with an additional 47 participants reached after the study period. Most pregnancies were less than 12 weeks' duration. Participants in follow-up self-managed their abortions using misoprostol alone (593 participants) or the combined regimen of misoprostol plus mifepristone (356 participants). At last follow-up, 586 (99%) misoprostol alone users and 334 (94%) combined regimen users had a complete abortion without surgical intervention. For those with pregnancies of less than 9 weeks' gestation, both regimens were non-inferior to medication abortion effectiveness in clinical settings. INTERPRETATION: Findings from this prospective cohort study show that self-managed medication abortion with accompaniment group support is highly effective and, for those with pregnancies of less than 9 weeks' gestation, non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting. These findings support the use of remote self-managed models of early abortion care, as well as telemedicine, as is being considered in several countries because of the COVID-19 pandemic. FUNDING: David and Lucile Packard Foundation. TRANSLATIONS: For the Arabic, French, Bahasa Indonesian, Spanish and Yoruba translations of the Article see Supplementary Materials section.
Assuntos
Aborto Induzido , Autoadministração , Autogestão/métodos , Abortivos/administração & dosagem , Argentina , COVID-19 , Estudos de Coortes , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Nigéria , Gravidez , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
La legalización de la interrupción voluntaria del embarazo ha transformado la práctica médica con respecto a la atención de las pacientes que desean interrumpir la gestación hasta la semana 14 en Argentina. En la primera entrega, el equipo PROFAM compartió su punto de vista a través de una adaptación de su material educativo destinado, sobre todo, a aclarar los aspectos legales que hacen a la práctica cotidiana. En esta entrega se desarrolla en detalle el procedimiento para realizar un aborto farmacológico con misoprostol y mifepristona, así como las generalidades del aspirado manual endouterino. (AU)
The legalization of voluntary termination of pregnancy has transformed medical practice regarding the care of patients who wish to terminate a pregnancy up to 14 weeks in Argentina. In the first issue, the PROFAM team shared its point of view through an adaptation of its educational material aimed, above all, at clarifying the legal aspects of daily practice. In this issue, the procedure to perform a pharmacological abortion with misoprostol and mifepristone is developed in detail, as well as the generalities of manual uterine aspiration technique. (AU)
Assuntos
Humanos , Feminino , Gravidez , Curetagem a Vácuo/instrumentação , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Aborto Induzido/métodos , Aborto Legal/métodos , Argentina , Transtornos da Coagulação Sanguínea/complicações , Aspirantes a Aborto/psicologia , Infecções Sexualmente Transmissíveis/diagnóstico , Mifepristona/farmacologia , Idade Gestacional , Misoprostol/efeitos adversos , Misoprostol/farmacologia , Aborto , Dispositivos IntrauterinosRESUMO
Abstract Background: Levonorgestrel (LNG) is a progesterone receptor agonist used in both regular and emergency hormonal contraception; however, its effects on the endometrium as a contraceptive remain widely unknown and under public debate. Objective: To analyze the effects of LNG or mifepristone (MFP), a progesterone receptor antagonist and also known as RU-486, administered at the time of follicle rupture (FR) on endometrial transcriptome during the receptive period of the menstrual cycle. Methods: Ten volunteers ovulatory women were studied during two menstrual cycles, a control cycle and a consecutively treated cycle; in this last case, women were randomly allocated to two groups of 5 women each, receiving one dose of LNG (1.5 mg) or MFP (50 mg) the day of the FR by ultrasound. Endometrial biopsies were taken 6 days after drug administration and prepared for microarray analysis. Results: Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited. Conclusions: The administration of LNG as a hormonal emergency contraceptive resulted in an endometrial gene expression profile associated with receptivity. These results agree on the concept that LNG does not affect endometrial receptivity and/or embryo implantation when used as an emergency contraceptive.
Assuntos
Humanos , Feminino , Adulto , Adulto Jovem , Implantação do Embrião/efeitos dos fármacos , Mifepristona/farmacologia , Levanogestrel/farmacologia , Anticoncepcionais Hormonais Pós-Coito/farmacologia , Endométrio , Transcriptoma/efeitos dos fármacos , Ovulação , Fatores de Tempo , Mifepristona/administração & dosagem , Levanogestrel/administração & dosagem , Anticoncepcionais Hormonais Pós-Coito/administração & dosagemRESUMO
BACKGROUND: Levonorgestrel (LNG) is a progesterone receptor agonist used in both regular and emergency hormonal contraception; however, its effects on the endometrium as a contraceptive remain widely unknown and under public debate. OBJECTIVE: To analyze the effects of LNG or mifepristone (MFP), a progesterone receptor antagonist and also known as RU-486, administered at the time of follicle rupture (FR) on endometrial transcriptome during the receptive period of the menstrual cycle. METHODS: Ten volunteers ovulatory women were studied during two menstrual cycles, a control cycle and a consecutively treated cycle; in this last case, women were randomly allocated to two groups of 5 women each, receiving one dose of LNG (1.5 mg) or MFP (50 mg) the day of the FR by ultrasound. Endometrial biopsies were taken 6 days after drug administration and prepared for microarray analysis. RESULTS: Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited. CONCLUSIONS: The administration of LNG as a hormonal emergency contraceptive resulted in an endometrial gene expression profile associated with receptivity. These results agree on the concept that LNG does not affect endometrial receptivity and/or embryo implantation when used as an emergency contraceptive.
Assuntos
Anticoncepcionais Hormonais Pós-Coito/farmacologia , Implantação do Embrião/efeitos dos fármacos , Endométrio , Levanogestrel/farmacologia , Mifepristona/farmacologia , Transcriptoma/efeitos dos fármacos , Adulto , Anticoncepcionais Hormonais Pós-Coito/administração & dosagem , Feminino , Humanos , Levanogestrel/administração & dosagem , Mifepristona/administração & dosagem , Ovulação , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: The objectives were to evaluate the safety and acceptability of outpatient medical abortion in selected women without a pretreatment ultrasound or pelvic examination. STUDY DESIGN: We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other medical problem that we judged to be significant), surgical completion of the abortion and satisfaction in women provided with medical abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting medical abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2months (in the United States and Mexico) or 3months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete abortion, defined as requiring no further treatment. RESULTS: Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam. CONCLUSIONS: In this study, medical abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable. IMPLICATIONS: Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.
Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido/métodos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Administração Oral , Administração Sublingual , Adolescente , Adulto , Feminino , Humanos , México , Moldávia , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Gravidez Ectópica/diagnóstico , Estudos Prospectivos , Ultrassonografia , Estados Unidos , Útero/diagnóstico por imagem , Adulto JovemRESUMO
OBJECTIVES: To investigate whether starting progestin-only contraception immediately after mifepristone reduced the efficacy of early medical abortion with a mifepristone-misoprostol regimen. METHODS: A review of patient records from October 1, 2012 to March 31, 2013 from four Marie Stopes Mexico clinics in Mexico City was conducted. Patients were eligible for inclusion if they had undergone a medical abortion with mifepristone-misoprostol at no later than 63days of pregnancy, had a recorded outcome, and had either started progestin-only contraception immediately after mifepristone administration or had not started contraception. The primary outcome-successful induced abortion-was defined as the complete evacuation of uterine contents without the need for further intervention. A secondary outcome was the number of induced abortions completed without the need for manual vacuum aspiration. RESULTS: Records from 2204 patients were included; 448 (20.3%) patients had started progestin-only contraception, and 1756 (79.7%) had not. Patients not taking progestin-only contraception were significantly more likely to be primigravidas and nulliparous. Medical abortion success did not vary between the two groups; 1890 (85.8%) were successful and 2085 (94.6%) were completed without the need for manual vacuum aspiration. Different methods of progestin-only contraception did not affect medical abortion outcomes. CONCLUSION: Beginning progestin-only contraception immediately following mifepristone for early medical abortion was not associated with reduced medical abortion effectiveness.
Assuntos
Abortivos Esteroides/administração & dosagem , Aborto Induzido/métodos , Anticoncepção/métodos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Progestinas/administração & dosagem , Adolescente , Adulto , Anticoncepção/efeitos adversos , Feminino , Número de Gestações , Humanos , México , Gravidez , Primeiro Trimestre da Gravidez , Autoadministração , Ultrassonografia , Curetagem a Vácuo/estatística & dados numéricos , Adulto JovemRESUMO
Stress is an important condition of modern life. The successful wound healing requires the execution of three major overlapping phases: inflammation, proliferation, and remodeling, and stress can disturb this process. Chronic stress impairs wound healing through the activation of the hypothalamic-pituitary-adrenal axis, and the glucocorticoids (GCs) hormones have been shown to delay wound closure. Therefore, the aim of this study was to investigate the effects of a GC receptor antagonist (RU486) treatment on cutaneous healing in chronically stressed mice. Male mice were submitted to rotational stress, whereas control animals were not subjected to stress. Stressed and control animals were treated with RU486. A full-thickness excisional lesion was generated, and seven days later, lesions were recovered. The RU486 treatment improves wound healing since contraction takes place earlier in RU486-treated in comparison to non-treated mice, and the RU486 treatment also improves the angiogenesis in Stress+RU486 mice when compared to stressed animals. The Stress+RU486 group showed a decrease in inflammatory cell infiltration and in hypoxia-inducible factor-1α and inducible nitric oxide synthase expression; meanwhile, there was an increase in myofibroblasts quantity. In conclusion, blockade of GC receptors with RU486 partially ameliorates stress-impaired wound healing, suggesting that stress inhibits healing through more than one functional pathway.
Assuntos
Antagonistas de Hormônios/administração & dosagem , Mifepristona/administração & dosagem , Receptores de Glucocorticoides/antagonistas & inibidores , Pele/lesões , Estresse Fisiológico , Cicatrização , Animais , Masculino , Camundongos , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the experience of women receiving mifepristone-misoprostol for early induced abortion in public sector facilities in the Federal District of Mexico City. METHODS: An open-label prospective study was conducted with 1000 pregnant women who sought induced abortion with a pregnancy of up to 63days of gestation, as measured from the date of their last menstrual period. The study was conducted in three public sector healthcare facilities: two secondary level hospitals and one primary care clinic. Women ingested 200mg mifepristone on day 1, followed by 800µg buccal misoprostol 24hours later, and they returned for follow-up on day 8. The primary outcome was complete abortion without recourse to surgical intervention. RESULTS: A total of 971 women received mifepristone-misoprostol and were included in the analysis for efficacy of treatment. The overall efficacy of the combined medical abortion regimen studied was 97.3% (n=945); the success rate did not vary significantly by gestational age (95.9%-100%; P=0.449). Most women (n=922, 95.0%) had a successful induced abortion with only one dose of misoprostol. CONCLUSION: The combined mifepristone and buccal misoprostol regimen was found to be highly effective and acceptable among Mexican women. www.ClinicalTrials.gov: NCT00386282.
Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido/métodos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Abortivos Esteroides/efeitos adversos , Aborto Induzido/efeitos adversos , Aborto Induzido/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , México , Pessoa de Meia-Idade , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Aceitação pelo Paciente de Cuidados de Saúde , Estudos Prospectivos , Resultado do Tratamento , População Urbana , Adulto JovemRESUMO
There is clinical and experimental evidence suggesting that antiprogestins might be used for the treatment of selected breast cancer patients. Our aim was to evaluate the effect of albumin-bound paclitaxel (Nab-paclitaxel) and pegylated doxorubicin liposomes (PEG-LD) in combination with mifepristone (MFP) in experimental breast cancer models expressing different ratios of progesterone receptor (PR) isoforms A and B. We used two antiprogestin-responsive (PRA>PRB) and two resistant (PRAAssuntos
Antineoplásicos/administração & dosagem
, Neoplasias da Mama/metabolismo
, Mifepristona/administração & dosagem
, Receptores de Progesterona/metabolismo
, Albuminas/administração & dosagem
, Animais
, Doxorrubicina/administração & dosagem
, Feminino
, Imunofluorescência
, Humanos
, Imuno-Histoquímica
, Lipossomos
, Camundongos
, Camundongos Endogâmicos BALB C
, Camundongos Nus
, Nanopartículas
, Paclitaxel/administração & dosagem
, Isoformas de Proteínas
, Ensaios Antitumorais Modelo de Xenoenxerto
RESUMO
OBJECTIVE: To characterize the legal and clinical knowledge of Guatemalan obstetrician-gynecologists (OB/GYNs) regarding medical abortion and to determine factors associated with approval of its use for specific indications. METHODS: A trained interviewer administered a multiple-choice survey to 172 private-practice OB/GYNs across Guatemala. Univariate, bivariate, and multivariate analyses characterized medical abortion opinion and knowledge, and logistic regression identified influential factors. RESULTS: 73% of OB/GYNs knew that abortion is legally permitted when the woman's life is at risk. Although 92% knew that misoprostol can be used to induce abortion, only 35% knew the WHO-recommended dosage. Only 25% knew of mifepristone. Compared with older OB/GYNs, those under 40 years of age were 7 times more likely, and 40-49 year olds were twice as likely to approve of medical abortion for fetal death and severe eclampsia with fetal death, respectively. CONCLUSION: Current indications for abortion under Guatemalan law, as well as OB/GYN practices and beliefs regarding medical abortion, are hindering women's access to safe medical abortion and, therefore, potential reductions in maternal morbidity and mortality. Future research should aim to identify whether and why Guatemalan OB/GYNs are unfamiliar with these drugs, prefer to use other methods, or are completely against abortion.
Assuntos
Aborto Induzido/psicologia , Atitude do Pessoal de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Médicos/estatística & dados numéricos , Abortivos/administração & dosagem , Abortivos/uso terapêutico , Aborto Induzido/legislação & jurisprudência , Aborto Induzido/métodos , Adulto , Coleta de Dados , Relação Dose-Resposta a Droga , Feminino , Guatemala , Ginecologia/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Mifepristona/administração & dosagem , Mifepristona/uso terapêutico , Misoprostol/administração & dosagem , Misoprostol/uso terapêutico , Análise Multivariada , Obstetrícia/estatística & dados numéricos , GravidezRESUMO
The lateral septum (LS) is a limbic brain region that receives serotonergic projections from raphe neurons and participates in the modulation of stress responses and affective states. The present study determined whether mineralocorticoid receptors (MRs) and/or glucocorticoid receptors (GRs) located in the LS interact with the serotonergic system in the regulation of depressive-like behavior of rats subjected to the forced swimming test (FST). We also studied the effect of corticosterone release induced by the FST on MR- and GR-mRNA expression in the LS. Specifically, we studied the antidepressant-like effects of spironolactone (a MR antagonist), mifepristone (a GR antagonist), and the antidepressant clomipramine (CMI) administered directly into the LS. In addition, spironolactone and CMI actions were studied in animals with serotonergic depletion induced by dl-p-chlorophenylalanine (pCPA). Finally, adrenalectomized and Sham-operated rats were subjected to the FST to determine MR- and GR-mRNA expression in the LS at different post-FST intervals. The results showed that intraseptal injection of spironolactone, but not mifepristone induced antidepressant-like actions in the FST; this effect was blocked by pCPA treatment. CMI and spironolactone increased 5-HT concentrations in the LS of rats subjected to the FST. Increases in corticosterone release, induced by the FST, correlated with a decrease in MR-mRNA expression in the LS; no correlation was found with GR-mRNA expression. In conclusion, MRs in the lateral septum, but not GRs, participate in the regulation of depressive-like behavior of animals subjected to the FST. Both serotonin and corticosterone play an important role in MR actions in the LS.
Assuntos
Clomipramina/farmacologia , Mifepristona/farmacologia , Antagonistas de Receptores de Mineralocorticoides , Receptores de Glucocorticoides/antagonistas & inibidores , Septo do Cérebro/efeitos dos fármacos , Serotonina/metabolismo , Espironolactona/farmacologia , Animais , Antidepressivos/farmacologia , Clomipramina/administração & dosagem , Corticosterona/metabolismo , Interações Medicamentosas , Fenclonina/farmacologia , Ácido Hidroxi-Indolacético/metabolismo , Resposta de Imobilidade Tônica/efeitos dos fármacos , Masculino , Microinjeções , Mifepristona/administração & dosagem , Mifepristona/antagonistas & inibidores , Ratos , Ratos Wistar , Receptores de Glucocorticoides/metabolismo , Receptores de Mineralocorticoides/metabolismo , Septo do Cérebro/metabolismo , Espironolactona/administração & dosagem , Espironolactona/antagonistas & inibidoresRESUMO
OBJECTIVE: To evaluate the efficacy and safety of home administration of buccal misoprostol after mifepristone for medical abortion up to 70 days' gestation in a general practice in Curaçao, where induced abortion is severely restricted by law. METHODS: In a prospective study 330 women received 200 mg mifepristone and were instructed to take four tablets (800 µg) of misoprostol via the buccal route 24-36 h later, at home. One week later, follow-up took place. RESULTS: The outcome could be evaluated in 307 of the 330 women. The efficacy of the mifepristone-buccal misoprostol procedure was 97.7% (300/307). In seven women vacuum aspirations for continuing pregnancy or incomplete abortion following treatment were required. Success rates at 64-70 days' gestation were the same as for gestations of less than 64 days duration. The main adverse effects were nausea and diarrhoea. CONCLUSION: Home administration of buccal misoprostol 24-36 h after mifepristone is a safe and effective method of medical abortion up to 70 days. It could be applied in a general practice in Curaçao, where induced abortion is legally restricted.
Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido/métodos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Administração Bucal , Adulto , Instituições de Assistência Ambulatorial , Amenorreia/induzido quimicamente , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Antilhas Holandesas , Gravidez , Estudos Prospectivos , Autoadministração/métodos , Resultado do Tratamento , Adulto JovemRESUMO
Sepsis and septic shock can be caused by Gram-positive and -negative bacteria and other microorganisms. In the case of Gram-negative bacteria, endotoxin, a normal constituent of the bacterial wall, also known as lipopolysaccharide (LPS), has been considered as one of the principal agents causing the undesirable effects in this critical illness. The response to LPS involves a rapid secretion of proinflammatory cytokines such as tumour necrosis factor (TNF)-α, interleukin (IL)-1, IL-6, interferon (IFN)-γ and the concomitant induction of anti-inflammatory mediators such as IL-10, transforming growth factor (TGF)-ß or glucocorticoids, which render the host temporarily refractory to subsequent lethal doses of LPS challenge in a process known as LPS or endotoxin tolerance. Although protective from the development of sepsis or systemic inflammation, endotoxin tolerance has also been pointed out as the main cause of the non-specific humoral and cellular immunosuppression described in these patients. In this report we demonstrate, using a mouse model, that mifepristone (RU486), a known glucocorticoid receptor antagonist, could play an important role in the restoration of both adaptive humoral and cellular immune response in LPS immunosuppressed mice, suggesting the involvement of endogenous glucocorticoids in this phenomenon. On the other hand, using cyclophosphamide and gemcitabine, we demonstrated that regulatory/suppressor CD4(+) CD25(+) forkhead boxP3(+) and GR-1(+) CD11b(+) cells do not play a major role in the establishment or the maintenance of endotoxin tolerance, a central mechanism for inducing an immunosuppression state.
Assuntos
Mifepristona/administração & dosagem , Linfócitos T Reguladores/efeitos dos fármacos , Linfócitos T/efeitos dos fármacos , Animais , Antígenos CD/biossíntese , Ciclofosfamida/administração & dosagem , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Fatores de Transcrição Forkhead/biossíntese , Imunidade Celular/efeitos dos fármacos , Imunidade Humoral/efeitos dos fármacos , Terapia de Imunossupressão , Imunossupressores/administração & dosagem , Lipopolissacarídeos/administração & dosagem , Camundongos , Camundongos Endogâmicos BALB C , Mifepristona/farmacologia , Receptores de Glucocorticoides/antagonistas & inibidores , Linfócitos T/imunologia , Linfócitos T/metabolismo , Linfócitos T/patologia , Linfócitos T Reguladores/imunologia , Linfócitos T Reguladores/metabolismo , Linfócitos T Reguladores/patologia , GencitabinaRESUMO
AIM OF THE STUDY: This study assessed the involvement of endogenous glucocorticoids (GCs) in the anti-arthritic properties of bee venom (BV) on antigen-induced arthritis (AIA) in rabbits. MATERIALS AND METHODS: BV (1.5-6 microg/kg/day) was injected for 7 days before AIA induction, whereas the control group received sterile saline. The total and differential leukocyte count, PGE(2) levels in synovial fluid and synovial membrane cell infiltrate were evaluated. The contribution of GCs to BV action was assessed in rabbits treated with BV plus metyrapone, an inhibitor of GC synthesis, or RU-38 486, a steroid antagonist. RESULTS: Treatment with BV (1.5 microg/kg/day) reduced the leukocyte count and PGE(2) level (18571+/-1909 cells/mm(3) and 0.49+/-0.05 ng/mL, respectively) as well as the cellular infiltrate compared with the control group (40968+/-5248 cells/mm(3) and 2.92+/-0.68 ng/mL, p<0.05). The addition of metyrapone to BV treatment completely reversed the inhibition of AIA, whereas RU-38 486 was ineffective. CONCLUSION: Our data show that bee venom treatment prevents the development of antigen-induced arthritis in rabbits through the action of GCs.
Assuntos
Anti-Inflamatórios/farmacologia , Antígenos/administração & dosagem , Artrite Experimental/tratamento farmacológico , Venenos de Abelha/farmacologia , Glucocorticoides/fisiologia , Animais , Anti-Inflamatórios/uso terapêutico , Venenos de Abelha/uso terapêutico , Dinoprostona/metabolismo , Contagem de Leucócitos , Metirapona/administração & dosagem , Mifepristona/administração & dosagem , CoelhosRESUMO
BACKGROUND: Mifepristone in a dose of 10 mg is an effective emergency contraceptive when administered up to 120 hours after unprotected coitus. METHODS: Between May 2003 and February 2005, we conducted in Cuba a single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception up to 6 days after unprotected coitus. A total of 635 women who requested emergency contraception after a single act of unprotected intercourse were included in the study. RESULTS: After treatment there were 7/635 (1.1%) pregnancies (95% CI 0.4-2.3%). Pregnancy that might have occurred was prevented in 88.0% of the cases (95% CI 77.1-95.1%). The most common side effects reported by participants were fatigue (10.7%), dizziness (6.1%) and nausea (4.9%); vomiting was only reported by 0.6%. In 38/635 (6.0%) women menstruation was delayed more than 7 days. CONCLUSIONS: Mifepristone 10 mg administered is an effective emergency contraceptive with an acceptable profile of side effects up to five days, but greater studies are necessary to verify its efficacy up to 6 days after unprotected intercourse.
Assuntos
Anticoncepção Pós-Coito/métodos , Anticoncepcionais Orais Sintéticos/administração & dosagem , Anticoncepcionais Pós-Coito/administração & dosagem , Mifepristona/administração & dosagem , Adulto , Anticoncepcionais Orais Sintéticos/efeitos adversos , Anticoncepcionais Pós-Coito/efeitos adversos , Cuba , Feminino , Humanos , Menstruação/efeitos dos fármacos , Mifepristona/efeitos adversos , Gravidez/efeitos dos fármacos , Gravidez/estatística & dados numéricos , Fatores de Tempo , Resultado do TratamentoRESUMO
A double-blind, placebo-controlled, randomized trial, was carried out in 120 Norplant users to evaluate the effect of mifepristone, 100 mg/day administered for 2 consecutive days every 30 days, on the vaginal bleeding pattern. Treatment was given from months 2-7 of implant use. Volunteers recorded bleeding and spotting days, during treatment and for the ensuing 6-month period. During treatment, women on mifepristone recorded the same frequency of bleeding/spotting episodes but significantly less prolonged bleeding episodes than placebo controls (mean +/- SD: 11 +/- 3 vs. 22 +/- 23 days) and their total number of bleeding days was 35% lower than in the placebo group. After the end of mifepristone use, bleeding patterns were similar in both groups. One pregnancy occurred in the mifepristone-treated group, in month 6 of treatment, the outcome was a healthy male baby. We conclude that intermittent administration of mifepristone can offer a clinically significant improvement of the vaginal bleeding pattern in Norplant users.
Assuntos
Anticoncepcionais Femininos/efeitos adversos , Levanogestrel/efeitos adversos , Mifepristona/uso terapêutico , Hemorragia Uterina/tratamento farmacológico , Administração Oral , Adulto , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Humanos , Mifepristona/administração & dosagem , Gravidez , Estudos Prospectivos , Resultado do Tratamento , Hemorragia Uterina/induzido quimicamenteRESUMO
OBJECTIVES: To demonstrate the effectiveness and safety of mifepristone 600mg with misoprostol 800 mg, for termination of pregnancy at 9-14 weeks gestation. PATIENTS AND METHODS: This prospective study included 105 women at 9 to 14 weeks gestation given 800 mg of vaginal misoprostol, 2 or 3 days after a single dose of 600 mg of mifepristone for pregnancy termination. Outcomes measures included mean expulsion time, the interval between fotal and placental expulsion, adverse effects, vaginal bleeding, requirement for analgesia, and hospital stay, analyzed by parity and gestational age. RESULTS: Pregnancy termination was successful in 92.4% of the patients without requirement for surgery. The mean time to expulsion was 6 hours. The fetus and placenta were expelled together in 79% of the cases. In 15% the conception products were retained in the cervical canal, and removed with a ring forceps. Additional misoprostol doses were necessary in 33% and analgesia (nalbuphine sublingually, mean dose was 10mg) in 56%. Significant bleeding was observed in 7.5%, leading to curettage in 2 patients. No statistically significant differences were found between the rate of success and term (9-12 versus 12-14) or parity. CONCLUSION: Combining oral mifepristone and vaginal misoprostol is a successful alternative to surgical termination of pregnancy, even after 9 weeks' gestation. The use of nalbuphine for analgesia improves acceptability; sublingual administration helps avoid invasive procedures. Before 14 weeks gestation, the legal limit for termination of pregnancy in France, the choice between the surgical and medical alternatives should be left to the patient.
Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Abortivos Esteroides/efeitos adversos , Aborto Legal/métodos , Administração Intravaginal , Administração Oral , Administração Sublingual , Adolescente , Adulto , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Tempo de Internação , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Nalbufina/administração & dosagem , Nalbufina/efeitos adversos , Gravidez , Primeiro Trimestre da Gravidez , Estudos Prospectivos , Segurança , Fatores de Tempo , Resultado do TratamentoRESUMO
Emergency contraception is used to prevent pregnancy after unprotected sex but before pregnancy begins. Currently, women can use emergency contraception by taking higher doses of the active ingredients found in ordinary oral contraceptive pills [either combined estrogen-progestogen (progestin) or progestogen-only formulations], or by having providers insert copper-bearing intrauterine devices (IUDs). The antiprogestogen mifepristone also has an excellent efficacy and safety profile as emergency contraception, but it is currently available for this indication only in China. Many studies have documented providers' and women's fears about the individual and public health safety risks of emergency contraception. Some of these concerns include potentially increased risks of cardiovascular events (including arterial and venous disease), worries about possible effects on future fertility, feared teratogenic consequences following method failure or inadvertent use during pregnancy, exaggerated or extreme fears of adverse tolerability, and concerns about drug interactions with other medications. Wider public health questions include feared reductions in the use of ongoing, more effective contraception, possible 'abuse' of emergency contraception through overly frequent use, and potential increases in risky sexual encounters (owing to the existence of a back-up, postcoital method) and therefore in rates of sexually transmitted infections, including HIV/AIDS. These fears can each be generally allayed. Direct and indirect investigations of emergency contraception in the biomedical and social science literature, the extensively documented safety profile of ordinary oral contraceptives, and more than 30 years of clinical experience since hormonal emergency contraception was first described, give strong evidence for its safety. This review confirms declarations by the World Health Organization and the US Food and Drug Administration, and shows that emergency contraception has an excellent safety profile in nearly all women. Finally, emergency contraception allows women a second chance to avoid unwanted pregnancies. Whether pregnancy is carried to term or terminated, the condition has inherent risks that are greater than any posed by emergency contraception.