ABSTRACT
OBJECTIVE: Obstructive sleep apnea (OSA) can influence the appearance and proliferation of some tumors. The Sleep Apnea In Lung Cancer Screening (SAILS) study (NCT02764866) evaluated the prevalence of OSA and nocturnal hypoxemia in a high-risk population enrolled in a lung cancer screening program. METHODS: This was a prospective study of the prevalence of OSA in a lung cancer screening program. Subjects met the National Lung Screening Trial (NLST) age and smoking criteria (age 55-75 years; pack-years >30). Participants in the study were offered annual screening with low-dose computed tomography (LDCT) and pulmonary function testing, as well as home sleep apnea testing (HSAT) and a sleep-specific questionnaire. Sleep study-related variables, symptoms, and epidemiologic data were recorded. RESULTS: HSAT was offered to 279 subjects enrolled in our lung cancer screening program. HSAT results were available for 236 participants (mean age 63.6 years; mean tobacco exposure: 45 pack-years), of whom 59% were male and 53% were active smokers. Emphysema (74%) and chronic obstructive pulmonary disease (COPD) (62%) were common and in most cases mild in severity. OSA, including moderate to severe disease, was very common in this patient population. AHI distributions were as follows: AHI <5 (22.5%); 5-15 (36.4%); 15-30 (23.3%); and >30 (17.8%). Nocturnal hypoxemia (T90) (p = 0.003), diffusing capacity for carbon monoxide (DLCO) (p = 0.01), tobacco exposure (p = 0.024), and COPD (p = 0.023) were associated with OSA severity. Positive screening findings (nodules ≥6 mm) were associated with nocturnal hypoxemia on multivariate analysis adjusted for confounders (OR = 2.6, 95% CI = 1.12-6.09, p = 0.027). CONCLUSION: Moderate to severe OSA is very prevalent in patients enrolled in a lung cancer screening program. Nocturnal hypoxemia more than doubles the risk of positive screening findings.
Subject(s)
Early Detection of Cancer , Hypoxia/complications , Lung Neoplasms/diagnostic imaging , Sleep Apnea Syndromes/complications , Female , Humans , Male , Middle Aged , Polysomnography/methods , Prevalence , Prospective Studies , Severity of Illness Index , Surveys and QuestionnairesABSTRACT
The Publisher regrets that this article is an accidental duplication of an article that has already been published, DOI of original article: http://dx.doi.org/10.1016/j.ejogrb.2016.07.485. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.
ABSTRACT
OBJECTIVE: To compare 400 and 800 microg sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. DESIGN: Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 microg, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. SETTING: Fifteen obstetrics/gynaecology departments in ten countries. POPULATION: Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion. METHODS: Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. OUTCOME MEASURES: Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary). RESULTS: Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 microg misoprostol, 94.2% after 800 microg. Noninferiority of 400 microg misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-microg dose showed higher risk of incomplete abortion (P < 0.01) and continuing pregnancy (P < 0.01) than 800 microg. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-microg dose than the 800-microg dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. CONCLUSIONS: A 400-microg dose of misoprostol should not replace the 800-microg dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects.
Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Steroidal/administration & dosage , Abortion, Induced/methods , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Administration, Intravaginal , Administration, Sublingual , Adult , Drug Therapy, Combination , Female , Humans , Patient Satisfaction , Pregnancy , Pregnancy Trimester, First , Treatment OutcomeSubject(s)
Humans , Female , Pregnancy , Infant, Newborn , Maternal Mortality/trends , Social Class , Health Status , Pregnancy Complications/diagnosisABSTRACT
PURPOSE: To determine the effects of the orbital endoscopic technique in the dog (IOP, vascularization). METHODS: Eight dogs were used to examine the four quadrants of the posterior orbit that we have established as a theoretical division of the orbit. Thus, two examinations were performed for each region. In order to observe the effects of the current technique, a rigorous control on the visual parameters was established, paying special attention to the effects of the blood supply in the vessels of the eyeball, measuring the posterior ciliary arteries (in the dog, the central artery of the retina is very rudimentary) with the Doppler color and Power Doppler echography. RESULTS: The results compiled on the examination of the visual function, ocular mobility, the general examination of reflexes, examination of the ocular fundus and general condition did not show any significant alteration. Conjunctival chemosis occurred in one case, but spontaneously disappeared 76 hours after the operation. The IOP only showed a mild increase after the surgery in two cases. The PSV and EDV blood flow values increased in the immediate post-surgery, above all in the vessel belonging to the region operated in 6 out the 8 subjects, but had decreased at 7 days post-surgery. CONCLUSIONS: The results obtained did not show any significant alterations when the orbital endoscopic technique for the posterior orbit was used. A mild increase is observed in the blood velocity values of the posterior ciliary arteries after the surgery that seems to indicate a certain compression. However, these values are reduced significantly when the method is repeated within 7 days.
Subject(s)
Endoscopy/methods , Orbit , Animals , Dogs , Endoscopy/adverse effects , Orbit/anatomy & histology , Orbit/blood supplyABSTRACT
BAG-family proteins share a conserved protein interaction region, called the 'BAG domain', which binds and regulates Hsp70/Hsc70 molecular chaperones. This family of cochaperones functionally regulates signal transducing proteins and transcription factors important for cell stress responses, apoptosis, proliferation, cell migration and hormone action. Aberrant overexpression of the founding member of this family, BAG1, occurs in human cancers. In this study, a structure-based approach was used to identify interacting residues in a BAG1--Hsc70 complex. An Hsc70-binding fragment of BAG1 was shown by multidimensional NMR methods to consist of an antiparallel three-helix bundle. NMR chemical shift experiments marked surface residues on the second (alpha 2) and third (alpha 3) helices in the BAG domain that are involved in chaperone binding. Structural predictions were confirmed by site-directed mutagenesis of these residues, resulting in loss of binding of BAG1 to Hsc70 in vitro and in cells. Molecular docking of BAG1 to Hsc70 and mutagenesis of Hsc70 marked the molecular surface of the ATPase domain necessary for interaction with BAG1. The results provide a structural basis for understanding the mechanism by which BAG proteins link molecular chaperones and cell signaling pathways.
Subject(s)
HSP70 Heat-Shock Proteins/metabolism , Transcription Factors/chemistry , Transcription Factors/metabolism , Adenosine Triphosphatases/chemistry , Adenosine Triphosphatases/genetics , Adenosine Triphosphatases/metabolism , Amino Acid Sequence , Animals , Binding Sites , COS Cells , Computer Simulation , DNA-Binding Proteins , Genes, Reporter , HSC70 Heat-Shock Proteins , HSP70 Heat-Shock Proteins/chemistry , HSP70 Heat-Shock Proteins/genetics , Membrane Proteins/chemistry , Mice , Models, Molecular , Molecular Sequence Data , Mutation/genetics , Nuclear Magnetic Resonance, Biomolecular , Protein Binding , Protein Structure, Tertiary , Qa-SNARE Proteins , Receptors, Androgen/metabolism , Sequence Alignment , Transcription Factors/genetics , Transcriptional ActivationABSTRACT
Determinar las repercusiones que tiene la técnica de endoscopia orbitaria en el perro (PIO, vascularización), Sujetos, material y métodos: Se utilizan como sujetos de estudio ocho perros sobre los que se practica una exploración por cuadrantes de la órbita posterior, de los cuatro en los que establecemos una división teórica de la órbita, por lo que llevamos a cabo dos exploraciones por cada región. Para conocer las repercusiones de la técnica, a todos ellos se les practica un control riguroso sobre parámetros oculares, poniendo una especial atención a los efectos sobre el aporte sanguíneo del globo ocular mediante las medidas de las arterias ciliares posteriores (en el perro la arteria central de la retina es muy rudimentaria) con ecografía-doppler. Resultados: Los resultados recogidos sobre el examen de la función visual, movilidad ocular, examen general de reflejos, exploración del fondo de ojo y estado general no demostraron ninguna alteración significativa. En un caso se produjo quemosis conjuntival que desapareció espontáneamente a las 76 horas de la intervención. La PIO sólo demostró un muy ligero aumento tras la intervención en dos casos. Los valores de flujo sanguíneo PSV y EDV aumentaron en el postoperatorio inmediato sobre todo en el vaso perteneciente a la región operada en 6 de los 8 casos reduciéndose en el examen realizado a los 7 días de la intervención. Conclusiones: Los resultados obtenidos no nos muestran alteraciones importantes al realizar la técnica de endoscopia orbitaria de la órbita posterior. Se pone de manifiesto un ligero aumento en la velocidad de flujo sanguíneo de las arterias ciliares posteriores tras la intervención que parecen indicar una cierta compresión aunque los valores se reducen significativamente al repetir las medidas a los 7 días (AU)
Subject(s)
Animals , Dogs , Orbit , EndoscopyABSTRACT
The generation of neutralizing antibodies by peptide immunization is dependent on achieving conformational compatibility between antibodies and native protein. Consequently, approaches are needed for developing conformational mimics of protein neutralization sites. We replace putative main-chain hydrogen bonds (NH --> O=CRNH) with a hydrazone link (N-N=CH-CH(2)CH(2)) and scan constrained peptides for fit with neutralizing monoclonal antibodies (MAbs). To explore this approach, a V3 MAb 58.2 that potently neutralizes T-cell lab-adapted HIV-1(MN) was used to identify a cyclic peptide, [JHIGPGR(Aib)F(D-Ala)GZ]G-NH(2) (loop 5), that binds with >1000-fold higher affinity than the unconstrained peptide. NMR structural studies suggested that loop 5 stabilized beta-turns at GPGR and R(Aib)F(D-Ala) in aqueous solvent implying considerable conformational mimicry of a Fab 58.2 bound V3 peptide determined by X-ray crystallography [Stanfield, R. L. et al. (1999) Structure 142, 131-142]. Rabbit polyclonal antibodies (PAbs) generated to loop 5 but not to the corresponding uncyclized peptide bound the HIV-1(MN) envelope glycoprotein, gp120. When individual rabbit antisera were scanned with linear and cyclic peptides, further animal-to-animal differences in antibody populations were characterized. Loop 5 PAbs that most closely mimicked MAb 58.2 neutralized HIV-1(MN) with similar potency. These results demonstrate the remarkable effect that conformation can have on peptide affinity and immunogenicity and identify an approach that can be used to achieve these results. The implications for synthetic vaccine and HIV-1 vaccine research are discussed.
Subject(s)
AIDS Vaccines/chemistry , HIV-1/immunology , Vaccines, Synthetic/chemistry , AIDS Vaccines/chemical synthesis , AIDS Vaccines/immunology , Amino Acid Sequence , Animals , Antibodies, Monoclonal/biosynthesis , Antibodies, Monoclonal/chemistry , Antibodies, Monoclonal/metabolism , Binding Sites, Antibody , Binding, Competitive/immunology , Clone Cells , Enzyme-Linked Immunosorbent Assay , Female , HIV Envelope Protein gp120/administration & dosage , HIV Envelope Protein gp120/immunology , HIV Envelope Protein gp120/metabolism , Humans , Hybridomas , Mice , Molecular Mimicry , Molecular Sequence Data , Nuclear Magnetic Resonance, Biomolecular , Oligopeptides/administration & dosage , Oligopeptides/chemical synthesis , Oligopeptides/immunology , Oligopeptides/metabolism , Peptides, Cyclic/administration & dosage , Peptides, Cyclic/chemical synthesis , Peptides, Cyclic/immunology , Peptides, Cyclic/metabolism , Rabbits , Structure-Activity Relationship , Vaccines, Synthetic/immunologyABSTRACT
Objetivo: La endoscopia es una técnica útil que puede ser aplicada para el estudio de la patología orbitaria debido a su escasa iatrogenia. En este trabajo describimos la técnica quirúrgica para la extracción de cuerpos extraños orbitarios. Métodos: En un modelo experimental en el perro insertamos un cuerpo extraño esférico metálico en la porción intracónica de la órbita. Tras anestesia general practicamos una peritomía de 2 mm en la conjuntiva. Después introducimos el sistema óptico y un abbocath de 14G para introducir una pinza de cuerpos extraños de 1,7 mm. Resultados: Tras la exploración orbitaria identificamos el cuerpo extraño que fue extraído mediante la pinza en todos los casos. La extracción resultó sencilla y escasamente traumática para la órbita. Conclusiones: La cirugía endoscópica de la órbita es una técnica sencilla y escasamente traumática, que puede ser utilizada para la extracción de cuerpos extraños (AU)
No disponible
Subject(s)
Animals , Dogs , Orbit , Ophthalmologic Surgical Procedures , Endoscopes , Disease Models, Animal , Endoscopy , Equipment Design , Eye Foreign BodiesABSTRACT
Twenty-three thousand maternal deaths per year in Latin America and the Caribbean reflects clearly the critical situation in this part of the world. Although we don't know exactly how many women die every year from pregnancy and childbirth, it is clear that the majority of these women are from low socioeconomic backgrounds, live in remote places and have a low level of education. Hemorrhages, infections and hypertension induced by pregnancy are the most common causes of maternal mortality. These pathologies can in many cases be prevented if there is a will for a positive change that involves different sectors related with health. The role of the scientific societies, and the role of FIGO through the 'Save the Mothers' Project are of extreme importance, assuming a chief role and compromise that can help in the right way to be able to revert this situation.
Subject(s)
Health Services Accessibility , Maternal Mortality , Birth Rate , Female , Forecasting , Health Education , Humans , Latin America/epidemiology , Maternal Health Services/trends , Maternal Mortality/trends , Pregnancy , Quality of Health Care , Socioeconomic FactorsABSTRACT
PURPOSE: Endoscopy is a useful technique that may be applied to study orbital pathology because it is safe. In this paper we describe the surgical technique using endoscopy for orbital foreign body extraction. METHODS: In an experimental model in the dog we inserted a spheric metallic foreign body into the intraconal portion of the orbit. After general anesthesia we performed a 2 mm. peritomy in the conjuntiva. Then we introduced the optic system connected to a TV monitor. Associated to the optic system we fixed a 14-G Abbocath to introduce a 1.7 mm foreign body forceps. RESULTS: After a complete endoscopic exam of the orbit we identified the metallic foreign body. With the 1.7 mm forceps we could take out the foreign body. The extractions were very simple and the technique was not traumatic for the orbit. CONCLUSIONS: Endoscopic surgery of the orbit is a useful and safe technique to extract orbital foreign bodies in this experimental model.
Subject(s)
Eye Foreign Bodies/surgery , Orbit , Animals , Disease Models, Animal , Dogs , Endoscopes , Endoscopy , Equipment Design , Ophthalmologic Surgical Procedures/instrumentation , Ophthalmologic Surgical Procedures/methodsABSTRACT
The objective of this study was to confirm the effectiveness and safety of self-administration of misoprostol every 24 h, for abortion up to 9 weeks of gestation. A group of 720 volunteer subjects with gestations from 35 to 63 days received 800 micrograms of vaginal misoprostol every 24 h up to a maximum of three main doses for abortion. Outcome measures assessed included successful abortion (complete abortion without requiring surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, and mean time of return of menses. Complete abortion occurred in 644 of 720 (89.4%, 95% CI 87, 92) subjects. The mean decrease in hemoglobin was statistically significant (p = 0.0001). There were 14 subjects with clinically significant decreases in hemoglobin, but only two required transfusions. Vaginal bleeding lasted 6.7 +/- 3.9 days, spotting 8.1 +/- 4 days, and total bleeding 14 +/- 5.3 days. Mean expulsion time was 8.0 +/- 3.4 h. Although mifepristone remains unavailable, given the low price and availability of misoprostol in > 72 countries of the world, this latter drug constitutes an abortion alternative, provided that a minimum clinical network is nearby or accessible.
Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortion, Induced , Misoprostol/administration & dosage , Administration, Intravaginal , Adolescent , Adult , Female , Gestational Age , Humans , Kinetics , Middle Aged , Misoprostol/adverse effects , Pain , Pregnancy , Treatment Outcome , Uterine HemorrhageABSTRACT
BACKGROUND: The third hypervariable (V3) loop of HIV-1 gp120 has been termed the principal neutralizing determinant (PND) of the virus and is involved in many aspects of virus infectivity. The V3 loop is required for viral entry into the cell via membrane fusion and is believed to interact with cell surface chemokine receptors on T cells and macrophages. Sequence changes in V3 can affect chemokine receptor usage, and can, therefore, modulate which types of cells are infected. Antibodies raised against peptides with V3 sequences can neutralize laboratory-adapted strains of the virus and inhibit syncytia formation. Fab fragments of these neutralizing antibodies in complex with V3 loop peptides have been studied by X-ray crystallography to determine the conformation of the V3 loop. RESULTS: We have determined three crystal structures of Fab 58.2, a broadly neutralizing antibody, in complex with one linear and two cyclic peptides the amino acid sequence of which comes from the MN isolate of the gp120 V3 loop. Although the peptide conformations are very similar for the linear and cyclic forms, they differ from that seen for the identical peptide bound to a different broadly neutralizing antibody, Fab 59.1, and for a similar peptide bound to the MN-specific Fab 50.1. The conformational difference in the peptide is localized around residues Gly-Pro-Gly-Arg, which are highly conserved in different HIV-1 isolates and are predicted to adopt a type II beta turn. CONCLUSIONS: The V3 loop can adopt at least two different conformations for the highly conserved Gly-Pro-Gly-Arg sequence at the tip of the loop. Thus, the HIV-1 V3 loop has some inherent conformational flexibility that may relate to its biological function.
Subject(s)
HIV Envelope Protein gp120/chemistry , Immunoglobulin Fab Fragments/chemistry , Protein Conformation , Amino Acid Sequence , Binding Sites/immunology , HIV Envelope Protein gp120/immunology , Humans , Hydrogen Bonding , Immunoglobulin Fab Fragments/immunology , Models, Molecular , Molecular Conformation , Molecular Sequence Data , Structure-Activity Relationship , Viral Proteins/chemistryABSTRACT
A group of 120 women with gestations from 64 to 84 days received 800 micrograms of vaginal misoprostol every 24 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects, and mean time of expulsion and vaginal bleeding. Complete abortion occurred in 104 of 120 (87%, 95% CI 79, 92) subjects. The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.2 mg/dL (SD 1.1) before treatment and 11.6 mg/dL (SD 1.0) after treatment. Statistically significant differences were found only between the success rates for white women in comparison with nonwhite women, in which case the success rates were higher for white than for nonwhite women. Vaginal bleeding lasted 8 +/- 5 days, spotting 4 +/- 3, and total bleeding 12 +/- 4 days. The acceptable expulsion time, the fact that postabortion systematic curettage was not needed, the clinically insignificant hemoglobin loss, and the success rate obtained show that misoprostol administered vaginally may be a valid method for interrupting gestations of 10-12 weeks.
PIP: The effectiveness and safety of vaginal misoprostol, without the need for postexpulsion systematic curettage, were investigated in 120 Cuban women seeking late first-trimester abortion (10-12 weeks). Women received 800 mcg of misoprostol vaginally every 24 hours, for a maximum of three doses. Complete abortion occurred in 104 women (87%); 87 women (73%) aborted after a single dose, 11 (9%) required two doses, and 6 (5%) received a third dose. The remaining 16 women (13%) underwent surgical abortion. Mean hemoglobin decreased from 12.2 mg/dl before treatment to 11.6 mg/dl after abortion--a difference that was statistically but not clinically significant. Side effects--which disappeared within 2 hours--included nausea (22%), vomiting (17%), diarrhea (54%), dizziness (25%), headache (19%), and chills (72%). Although 99% of subjects reported pelvic pain (99%), only 10% requested an analgesic for pain relief. Vaginal bleeding persisted for a mean of 8 days. According to logistic regression analysis, the only variable significantly associated with treatment success was race. The success rate was 94% among White women compared with 73% among Black and Black Cuban women. The acceptable expulsion period, the fact that a postabortion systematic curettage was not required, the clinically insignificant hemoglobin loss, and the high success rate all demonstrate that misoprostol administered vaginally may be a valid method for interrupting late first-trimester pregnancies.
Subject(s)
Abortifacient Agents, Nonsteroidal , Abortion, Induced , Misoprostol/administration & dosage , Administration, Intravaginal , Adolescent , Adult , Black People , Female , Gestational Age , Hemoglobins/analysis , Humans , Misoprostol/adverse effects , Pregnancy , Regression Analysis , Time Factors , Treatment Outcome , Uterine Hemorrhage , White PeopleABSTRACT
A prospective trial including 300 pregnant women seeking elective abortion was conducted to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 63 days' gestation. Subjects received methotrexate 50 mg orally and were randomly allocated to receive 800 micrograms of misoprostol vaginally 3, 4, or 5 days after administration of the methotrexate. The misoprostol dose was repeated 48 and 96 h later if abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. Complete abortion occurred in 273 of 300 patients (91%, 95%, CI 87, 94%) patients. No significant statistical differences were found in the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.69). Vaginal bleeding lasted 7.1 +/- 3.8 days, spotting 4.1 +/- 2.5 days, and total bleeding 11.2 +/- 4.1 days. Side effects for methotrexate were minimal, whereas, for misoprostol they were mild and transient except for pain. The use of methotrexate and misoprostol together could be an alternative to the intramuscular use of methotrexate or the use of antiprogestins and prostaglandin for medical abortion.
PIP: The safety and effectiveness of oral methotrexate and vaginal misoprostol for early abortion were evaluated in a prospective study of 300 women who presented to the Cuidad de la Habana (Havana, Cuba) for termination of a pregnancy of a gestational age of 63 days or less. All women were given 50 mg of methotrexate at study entry and then were randomly allocated to receive 800 mcg of misoprostol either 3, 4, or 5 days later. If abortion did not occur, misoprostol was readministered 48 and 96 hours later. Complete abortion occurred in 273 women (91%); the success rate was 72% (216 cases) after just one dose of misoprostol. There were no significant differences in abortion rates based on the day on which misoprostol was administered. Vaginal bleeding lasted an average of 7.1 +or- 3.8 days, spotting continued for 4.1 +or- 2.5 days, and total bleeding persisted for 11.2 +or- 4.1 days. Side effects for methotrexate included nausea (9.7%), vomiting (6.7%), dizziness (10.3%), fatigue (6.3%), headache (5.3%), and chills (5.3%). For misoprostol, side effects included nausea (23.0%), vomiting (25.3%), diarrhea (51.7%), dizziness (18.3%), headache (18.0%), chills (60.0%), and pelvic pain (97.3%). All signs and symptoms were of low intensity and short duration, however. These results suggest that combined use of methotrexate and misoprostol represents a feasible alternative to the intramuscular use of methotrexate or of antiprogestins and prostaglandin for medical abortion. The efficacy and safety of this new regimen are very close to those of RU-486, but the cost is considerably less.
Subject(s)
Abortifacient Agents, Nonsteroidal , Abortion, Induced , Methotrexate/administration & dosage , Misoprostol/administration & dosage , Administration, Intravaginal , Administration, Oral , Female , Gestational Age , Humans , Methotrexate/adverse effects , Misoprostol/adverse effects , Pregnancy , Prospective Studies , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the safety, efficacy, and acceptability of an oral drug regimen of medical abortion compared with surgical abortion. MATERIALS AND METHODS: 500 women with amenorrhea < 56 days chose either surgical abortion or 600 mg of mifepristone (RU-486) followed by 400 microg of misoprostol after 48 h. RESULTS: Medical regimen had more side effects than surgical abortion, including bleeding, cramping, nausea and vomiting. Only fever was more frequent in the surgical method. The failure rates for medical abortion exceeded those for surgical abortion, 16.0% vs. 4.0%. The adolescents' failure rate in the medical regimen group was only 1.7%. Several failures on medical abortion were not true drug failures, but surgical interventions not medically necessary (misdiagnosis). Women were satisfied with either method, but more preferred medical abortion. CONCLUSION: Medical methods are safe, effective, simpler and potentially allow greater privacy than surgical abortion methods. Therefore, medical methods could be the method of choice for abortion, particularly for adolescents.
Subject(s)
Abortifacient Agents, Steroidal , Abortion, Induced/methods , Abortion, Induced/statistics & numerical data , Mifepristone , Misoprostol , Vacuum Curettage , Abortion, Induced/adverse effects , Adolescent , Adult , Chi-Square Distribution , Cuba , Female , Humans , Patient Satisfaction , Pregnancy , Software , Treatment OutcomeABSTRACT
A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at < or = 63 days' gestation. Subjects received 50 mg/m2 methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 micrograms of misoprostol 3, 4, or 5 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), and side effects. Eighty-six cases (93%; 95% confidence interval [CI] 85%-97%) aborted in Group I; 90 cases (92%; 95% CI 84%-96%) aborted in Group II (relative risk [RR] = 1.09; RR 95% CI 0.38-3.14); and 89 (93%; 95% CI 86%-97%) cases aborted in Group III (RR = 0.97; RR 95% CI 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 (92%; 95% CI 89%-95%) patients. Twenty-two cases (8%; 95% CI 5%-11%) resulted in failure. Side effects for methotrexate were minimal while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.
PIP: A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at 63 days or less gestation. Subjects received 50 mg/sq. m methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 mcg of misoprostol 3, 4, or 5 days after methotrexate administration. The misoprostol dose was repeated 48 and 96 hours later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. 86 cases [93%; 95% confidence interval (CI), 85-97%] aborted in Group I; 90 cases (92%; 95% CI, 84-96%) aborted in Group II [relative risk (RR) = 1.09; RR 95% CI, 0.38-3.14]; and 89 cases (93%; 95% CI, 86-97%) aborted in Group III (RR = 0.97; RR 95% CI, 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after methotrexate administration (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 patients (92%; 95% CI, 89-95%). 22 cases (8%; 95% CI, 5-11%) resulted in failure. Side effects for methotrexate were minimal, while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.