Análise de impacto orçamentário de dispositivos contraceptivos na saúde suplementar brasileira / Budget impact analysis of contraceptive devices on Brazilian supplementary health

Objetivo: Analisar o impacto orçamentário da adoção de dispositivos contraceptivos reversíveis de longa duração em uma operadora de plano de saúde localizada no Sul do Brasil. Especificamente, analisamos a incorporação do implante subdérmico de etonogestrel (Implanon®) como alternativa ao sistema intrauterino de levonorgestrel (DIU Mirena® ou DIU Kyleena®), ao longo de um período de 15 anos. Métodos: Realizamos uma análise do impacto orçamentário incremental, considerando a inclusão gradual do implante subdérmico de etonogestrel. Foram considerados dados de uma operadora de planos de saúde com mais de 600.000 beneficiários. O horizonte temporal de 15 anos permitiu uma avaliação abrangente dos efeitos financeiros. Resultados: Identificamos 5.345 pacientes elegíveis para a utilização de contraceptivos reversíveis de longa duração. No cenário em que somente o sistema intrauterino de levonorgestrel era adotado, projetou-se um impacto orçamentário total de R$ 746.379.857,80 ao longo de 15 anos. No cenário alternativo, com a incorporação gradual do implante subdérmico, o impacto orçamentário total foi calculado em R$ 689.800.196,83. Isso resultou em um impacto orçamentário incremental negativo de -R$ 56.579.660,97 ao longo do período. Conclusão: A análise de impacto orçamentário realizada indica um potencial benefício financeiro ao adotar o implante subdérmico de etonogestrel como alternativa ao sistema intrauterino de levonorgestrel para contracepção. Esse achado sugere possíveis reduções de custos na área de saúde suplementar no Brasil, reforçando a importância de avaliar opções economicamente viáveis.

Objective: To analyze the budgetary impact of the adoption of long-acting reversible contraceptive devices in a health plan operator located in southern Brazil. Specifically, we analyzed the incorporation of the etonogestrel subdermal implant (Implanon®) as an alternative to the levonorgestrel intrauterine system (Mirena® IUD or Kyleena® IUD), over a period of 15 years. Methods: We performed an analysis of the incremental budgetary impact, considering the gradual inclusion of the etonogestrel subdermal implant. Data from a health plan operator with more than 600,000 beneficiaries were considered. The 15-year time horizon allowed for a comprehensive assessment of the financial effects. Results: We identified 5,345 patients eligible for the use of long-acting reversible contraceptives. In the scenario where only the levonorgestrel intrauterine system was adopted, a total budget impact of BRL 746,379,857.80 was projected over 15 years. In the alternative scenario, with the gradual incorporation of the subdermal implant, the total budgetary impact was calculated at BRL 689,800,196.83. This resulted in a negative incremental budgetary impact of -R$56,579,660.97 over the period. Conclusion: The budget impact analysis carried out indicates a potential financial benefit in adopting the etonogestrel subdermal implant as an alternative to the levonorgestrel intrauterine system for contraception. This finding suggests possible cost reductions in the supplementary healthcare area in Brazil, reinforcing the importance of evaluating economically viable options.

O uso de métodos contraceptivos hormonais em pacientes com asma: repercussões clínicas / The use of hormonal contraceptives methods in patients with asthma: clinical repercussions

Objetivo: Analisar o uso dos contraceptivos hormonais em mulheres com asma e a escolha desses métodos contraceptivos para essa população, com avaliação de eventuais repercussões sobre novos episódios de asma e sibilos. Métodos: Foram selecionados estudos longitudinais, ensaios clínicos, revisões sistemáticas e metanálises. As plataformas consultadas foram PubMed, Embase, Cochrane e SciELO, com a utilização dos descritores: "contracepção", "contracepção hormonal", "sistema intrauterino liberador de levonorgestrel" e "asma". Resultados: Dois grandes estudos demonstraram que o uso de contraceptivos hormonais esteve associado à redução do risco de novos episódios de asma. Uma revisão sistemática concluiu que os resultados para o uso de contraceptivos hormonais para mulheres com asma foram mistos, com aumento ou redução dos seguintes riscos: novo episódio de asma e aumento da frequência das crises e dos sibilos. O uso da contracepção hormonal em pacientes obesas portadoras de asma é controverso. Conclusão: Os resultados para o uso de contraceptivos hormonais em mulheres com asma são inconsistentes, com relatos de aumento ou de redução do risco de novos episódios. O uso do método contraceptivo deve ser discutido individualmente, levando-se em consideração outros fatores de risco associados e o desejo da mulher. A paciente deverá ser orientada se houver piora dos sintomas clínicos de asma na vigência do uso de qualquer método contraceptivo hormonal.

Objective: To analyze the use of hormonal contraceptives in women with asthma and the choice of this contraceptive method for this population, evaluating possible repercussions on new episodes of asthma and wheezing. Methods: Longitudinal studies, clinical trials, systematic reviews and meta-analyses were selected. Platforms consulted: PubMed, Embase, Cochrane, SciELO, using the descriptors: "contraception", "hormonal contraception", "levonorgestrel-releasing intrauterine system" and "asthma". Results: Two large studies demonstrated that the use of hormonal contraceptives was associated with a reduced risk of new episodes of asthma. A systematic review concluded that the results for the use of hormonal contraceptives for women with asthma were mixed, with increased or decrease in the following risks: new asthma episodes, increased frequency and wheezing. The use of hormonal contraception in obese patients with asthma is controversial. Conclusion: The results for the use of hormonal contraceptives in women with asthma are inconsistent, with reports of increased or reduced risk of new episodes. The use of the contraceptive method should be discussed individually, taking into account other associated risk factors and the woman's desire. The patient will be advised if there is a worsening of the clinical symptoms of asthma while using any hormonal contraceptive method.

Análise da dispensação de pílula do dia seguinte em uma farmácia do município no oeste do estado do Paraná / Analysis of the dispension of the pill of the following day in a pharmacy in the municipality in the west of the state of Paraná / Análisis de la dispensación de la píldora del día siguiente en una farmacia del municipio del oeste del estado de Paraná

pílula contraceptiva de emergência (CE) é chamada pelos médicos de pílula anticoncepcional pós-coito. É um método anticoncepcional de emergência e deve ser tomada até 72 horas após a relação sexual. É adequado para casos de abuso sexual, preservativos rompidos ou falha de outros métodos anticoncepcionais. Sendo assim, o objetivo do presente estudo foi avaliar o perfil da dispensação do contraceptivo de emergência (CE) em uma farmácia comercial localizada em um distrito do município de Assis Chateaubriand no oeste do estado do Paraná. Para o desenvolvimento da pesquisa, foi avaliado a quantidade do medicamento dispensado com o princípio ativo levonorgestrel no período de três meses em uma farmácia de dispensação de medicamentos no distrito de Bragantina, assim como a faixa etária da paciente que utilizou, o seu estado civil e o motivo da compra da pílula. O projeto foi aprovado pelo Comitê de ética sob o número do CAAE: 60509322.3.0000.0109. Os resultados mostraram que no período do desenvolvimento da pesquisa, 10 pacientes fizeram uso da CE, sendo 5 solteiras e 5 casadas, sendo 50%. Quando relatado a idade das pacientes que fazem uso do CE, os resultados foram entre 19 até 41 anos. Quando perguntado para as pacientes se elas faziam uso de outro método contraceptivo e se presente, qual seria este método, os resultados encontrados foram: 40% das mulheres não utilizam outro método contraceptivo e 60% fazem o uso de outro contraceptivo, destes, o percentual foi de 66% que faziam o uso de preservativo e 34% faziam o uso de anticoncepcional. Em relação ao horário pós-coito, isto é, quantas horas após o coito elas procuraram a farmácia para comprar a CE, os resultados encontrados foram de 08 horas até 52 horas. Sendo assim, conclui-se que o estudo possui relevância frente à procura da PDS, no entanto, é de suma importância não esquecer de que a PDS deve ser utilizada somente em casos de emergências e não como uso rotineiro, para isso, existem outros métodos de contraceptivos que podem ser de recurso rotineiro. Neste sentido, mais estudos são necessários para avaliar se a população tem conhecimento sobre o tema, se o farmacêutico está preparado para atendê-los e o porquê da população não se programar melhor para evitar os possíveis "acidentes".

The morning after pill (PDS) is called the post-coital birth control pill by doctors. It is an emergency contraceptive method and must be taken within 72 hours of sexual intercourse. It is suitable for cases of sexual abuse, broken condoms or failure of other contraceptive methods. Therefore, the objective of the present study will be to evaluate the profile of the dispensation of emergency contraceptives (EC) in a pharmacy in the western municipality of the state of Paraná. For the development of the research, the amount of medication dispensed in a period of three months in a drug dispensing pharmacy was evaluated, as well as the age group of the patient who will use it, her marital status and the reason for purchasing the pill. The project was approved by the Ethics Committee under CAAE number: 60509322.3.0000.0109. The results showed that during the research development period, 10 patients used PDS, 5 of them single and 5 married, being 50%. When reporting the age of patients using the morning-after pill, the results ranged from 19 to 41 years. When asked to patients if they used another contraceptive method and, if present, which method this would be, the results found were: 40% of women do not use another contraceptive method and 60% use another contraceptive, of these, the percentage 66% used condoms and 34% used contraceptives. Regarding the post-coital time, that is, how many hours after coitus they looked for the pharmacy to buy the PDS, the results found were from 08 hours to 52 hours. Therefore, it is concluded that care with medication intake becomes more important when it comes to EC, due to its potential risks to the female body, which can have consequences, especially when used excessively and without prior knowledge. Thus, more guidance on the use and its adverse effects, as more studies on the subject are necessary, in order to minimize the damage that PDS can cause in the female organism.

La píldora del día después (PDS) es llamada por los médicos píldora anticonceptiva poscoital. Es un método anticonceptivo de emergencia y debe ser tomada dentro de las 72 horas siguientes a la relación sexual. Está indicada en casos de abuso sexual, rotura del preservativo o fracaso de otros métodos anticonceptivos. Por lo tanto, el objetivo del presente estudio será evaluar el perfil de la dispensación de anticonceptivos de emergencia (AE) en una farmacia del municipio oeste del estado de Paraná. Para el desarrollo de la investigación, se evaluó la cantidad de medicación dispensada en un período de tres meses en una farmacia dispensadora de medicamentos, así como el grupo etario de la paciente que la utilizará, su estado civil y el motivo de compra de la píldora. El proyecto fue aprobado por el Comité de Ética con el número CAAE: 60509322.3.0000.0109. Los resultados mostraron que durante el período de desarrollo de la investigación, 10 pacientes utilizaron la PDS, 5 de ellas solteras y 5 casadas, siendo el 50%. Al informar sobre la edad de las pacientes que utilizaban la píldora del día después, los resultados oscilaron entre 19 y 41 años. Cuando se preguntó a las pacientes si utilizaban otro método anticonceptivo y, en caso afirmativo, cuál sería, los resultados encontrados fueron: 40% de las mujeres no utilizan otro método anticonceptivo y 60% utilizan otro anticonceptivo, de estas, el porcentaje 66% utilizó preservativo y 34% anticonceptivos. En cuanto al tiempo post-coital, es decir, cuántas horas después del coito buscaron la farmacia para comprar la PDS, los resultados encontrados fueron de 08 horas a 52 horas. Por lo tanto, se concluye que el cuidado con la ingesta de medicamentos se vuelve más importante cuando se trata de la AE, debido a sus riesgos potenciales para el organismo femenino, que pueden tener consecuencias, especialmente cuando se usa en exceso y sin conocimiento previo. Por lo tanto, son necesarias más orientaciones sobre el uso y sus efectos adversos, así como más estudios sobre el tema, con el fin de minimizar los daños que la PDS puede causar en el organismo femenino.

Five-year Contraceptive Use of 52-mg Levonorgestrel Releasing Intrauterine System in Young Women, Menstrual Patterns, and New Contraceptive Choice / Cinco anos de uso contraceptivo do sistema intrauterino liberador de levonorgestrel 52 mg em mulheres jovens, padrões menstruais e nova escolha contraceptiva

Abstract Objective To evaluate the continuation rates of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) during the first 5 years of use, reasons for its discontinuation, bleeding patterns, and new contraceptive choice after the 5th year, in adolescents and young women. Methods The present study was a 5-year prospective cohort conducted in a Family Planning Service of a tertiary hospital in Brazil. We selected 100 healthy women between 15 and 24 years old who used 52-mg LNG-IUS for contraception. The clinical follow-up of these women took place from June 2017 to December 2022. The study evaluated the continuation rates of the method, reasons for its discontinuation, bleeding patterns, and new contraceptive choice after the 5th year. Continuous data were reported as mean ± standard deviation (SD) and range (minimum-maximum). Categorical variables were described as percentages. Results The continuation rates of LNG-IUS were 89.1% (82/92), 82.9% (72/87), 75.3% (64/85), 70.5% (60/85), and 64.2% (54/84) in the 1st, 2nd, 3rd, 4th, and 5th years of use, respectively. The main reason for discontinuation was acne (11/30). Amenorrhea rates were 50, 54.1, 39, 35.7, and 51.8% at 12, 24, 36, 48, and 60 months, respectively. All patients who completed the study and needed contraception after the 5th year opted for long-acting contraceptive methods (LARC). Conclusion The LNG-IUS showed high continuation rates in adolescents and young women in the first 5 years of use. Most patients who completed the study chose a LARC method after the 5th year.

Resumo Objetivo Avaliar as taxas de continuação do sistema intrauterino liberador de levonorgestrel (SIU-LNG) 52 mg durante os primeiros 5 anos de uso, razões de sua descontinuação, padrões de sangramento e nova escolha contraceptiva após o 5° ano, em adolescentes e mulheres jovens. Métodos O estudo foi uma coorte prospectiva de 5 anos realizada em um Serviço de Planejamento Familiar de um hospital terciário no Brasil. Selecionamos 100 mulheres saudáveis entre 15 e 24 anos que usaram o SIU-LNG 52 mg para contracepção. O acompanhamento clínico dessas mulheres ocorreu de junho de 2017 a dezembro de 2022. O estudo avaliou as taxas de continuação do método, razões de sua descontinuação, padrões de sangramento e nova escolha contraceptiva após o 5° ano. Os dados contínuos foram relatados como média ± DP e intervalo (mínimo-máximo). As variáveis categóricas foram descritas como porcentagens. Resultados As taxas de continuação do SIU-LNG foram 89,1% (82/92), 82,9% (72/87), 75,3% (64/85), 70,5% (60/85) e 64,2% (54/84) no 1°, 2°, 3°, 4° e 5° anos de uso, respectivamente. O principal motivo de descontinuação foi a acne (11/30). As taxas de amenorreia foram de 50, 54,1, 39, 35,7 e 51,8% aos 12, 24, 36, 48 e 60 meses, respectivamente. Todas as pacientes que completaram o estudo e necessitaram de contracepção após o 5° ano optaram por métodos contraceptivos de longa duração (LARC). Conclusão O SIU-LNG apresentou altas taxas de continuação em adolescentes e mulheres jovens nos primeiros 5 anos de uso. A maioria das pacientes que completou o estudo escolheu um método LARC após o 5° ano.

Hormonal intrauterine device in women with renal transplantation: a prospective observational study

SUMMARY OBJECTIVE: The main objective of this study is to evaluate the rate of continuity and satisfaction with hormonal intrauterine device in renal transplant recipients. METHODS: This was a prospective observational study. The sample consisted of patients treated at a Family Planning Outpatient Clinic, from August 2016 to September 2021. Information on each patient's age, parity, and associated diseases as well as satisfaction with the method were analyzed. Patients were invited to participate through electronic messages, and the questionnaire included questions about acceptance of the contraceptive method. RESULTS: A total of 40 patients were included in the study. The mean age of the renal transplant patients was 32.5 years. The mean duration of hormonal intrauterine device use was 37 months. Acceptance of the method was high, with 97.5% of patients remaining on the method for 1 year and 85% of patients using the hormonal intrauterine device at the time of the study. There were no pregnancies or renal transplant complications in the study. Regarding satisfaction with the method, the majority (77.5%) scored 10. CONCLUSION: Patients were satisfied or very satisfied with the hormonal intrauterine device. Therefore, the continuation rate was high. Furthermore, this contraceptive method proved to be safe and effective in kidney transplant recipients. No complications, graft rejection, or graft failure were observed after intrauterine hormonal device insertion and during follow-up.

Comparative study of the levonorgestrel intrauterine system and laparoscopic hysterectomy for the treatment of heavy menstrual bleeding in enlarged uteri

ABSTRACT Objective To evaluate the effectiveness of the levonorgestrel intrauterine system in the treatment of patients with heavy menstrual bleeding and an enlarged uterus and to compare satisfaction and its complications with hysterectomy. Methods This was a comparative cross-sectional observational study of women with heavy menstrual bleeding and an enlarged uterus. Sixty-two women were treated and followed up for four years. Insertion of the levonorgestrel intrauterine system was performed in Group 1, and laparoscopic hysterectomy was performed in Group 2. Results In Group 1 (n=31), 21 patients (67.7%) showed improvement in the bleeding pattern, and 11 patients (35.5%) had amenorrhea. Five patients (16.1%) remained with heavy bleeding and were considered to have experienced treatment failure. There were seven expulsions (22.6%); in five patients, bleeding remained heavy, but in two patients the bleeding returned to that of normal menstruation. No relationship was found between treatment failure and greater hysterometries (p=0.40) or greater uterine volumes (p=0.50), whereas expulsion was greater in uteri with smaller hysterometries (p=0.04). There were 13 (21%) complications, seven (53.8%) in the group that underwent insertion of the levonorgestrel intrauterine system (all were device expulsions), and six (46.2%) in the surgical group, which were the most severe ones (p=0.76). Regarding satisfaction, 12 patients (38.7%) were dissatisfied with the levonorgestrel intrauterine system and one (3.23%) was dissatisfied with the surgical treatment (p=0.00). Conclusion Treatment with the levonorgestrel intrauterine system in patients with heavy menstrual bleeding and an enlarged uterus was effective, and when compared with laparoscopic hysterectomy, it had a lower rate of satisfaction and the same rate of complications, although less severe.

Tratamiento a largo plazo del dolor pélvico con levonorgestrel en mujeres con endometriosis que desean posponer el embarazo y preservar su fertilidad. Serie de casos / Long-term management of pelvic pain with levonorgestrel in women with endometriosis who desire to postpone a future pregnancy and preserve their fertility. Case Series

Resumen OBJETIVO: Valorar el tratamiento a largo plazo del dolor pélvico con levonorgestrel en mujeres con endometriosis que desean posponer el embarazo y preservar su fertilidad. MATERIALES Y MÉTODOS: Estudio ambispectivo, con intervención medicamentosa, longitudinal y descriptivo de serie de casos. Parámetros de estudio: medición de la intensidad del dolor a los 12, 24 y 36 meses posteriores a la colocación de un implante único de goserelina (Zoladex de 10,6 mg, AstraZeneca AB, Gärtunavägen). Al retorno de la menstruación se colocó un dispositivo intrauterino con levonorgestrel (Mirena Bayer AG, Leverkusen). La intensidad del dolor pélvico se midió con la Escala Numérica del Dolor (Escala ENA). RESULTADOS: Se estudiaron 14 pacientes de las que 5 refirieron dolor: 4 con intensidad 1 y una con intensidad 3. El resto de las pacientes no refirió dolor. Todas las pacientes refirieron alivio general subjetivo a los 12 meses de seguimiento. CONCLUSIONES: El levonorgestrel administrado por vía intrauterina puede ser una alternativa para mantener, a largo plazo, sin dolor a pacientes con endometriosis que desean posponer el embarazo. Para confirmar lo aquí encontrado hacen falta estudios controlados, con asignación al azar y con un tamaño de muestra realmente representativo.

Abstract OBJECTIVE: To assess the long-term treatment of pelvic pain with levonorgestrel in women with endometriosis who wish to postpone pregnancy and preserve their fertility. MATERIALS AND METHODS: Ambispective study, with drug intervention, longitudinal and descriptive case series. Study parameters: measurement of pain intensity at 12, 24 and 36 months after placement of a single goserelin implant (Zoladex 10.6 mg, AstraZeneca AB, Gärtunavägen). At the return of menstruation, an intrauterine device containing levonorgestrel (Mirena Bayer AG, Leverkusen) was inserted. The intensity of pelvic pain was measured with the Numerical Pain Scale (NPS). RESULTS: Fourteen patients were studied of whom five reported pain: four with intensity 1 and one with intensity 3. The rest of the patients reported no pain. All patients reported subjective general relief at 12 months follow-up. CONCLUSIONS: Levonorgestrel administered intrauterine may be an alternative for the long-term pain-free treatment of patients with endometriosis who wish to postpone pregnancy. Controlled, randomized studies with a truly representative sample size are needed to confirm the findings.

Knowledge, Attitude, and Practices Related to the SARS-CoV-2 Pandemic among Women Seeking Contraceptive Methods / Conhecimento, atitude e práticas relacionadas à pandemia de SARS-CoV-2 entre mulheres que buscam métodos anticoncepcionais

Abstract Objective To determine knowledge, attitude, and preventive (KAP) practices towards the SARS-CoV-2 (COVID-19) pandemic among women in reproductive age seeking to use copper or hormonal intrauterine devices (IUD/LNG-IUS). Methods We conducted a cross-sectional study in which we applied a questionnaire on 400 women about KAP practices on COVID-19 at the University of Campinas, Campinas, SP, Brazil, from May to August 2020. Results The mean (±SD) age of the women was 30.8±7.9 years, and 72.8% of them reported being pregnant at least once. Most women (95%) had heard or read about COVID-19, and their main sources of information were television (91%) and government websites (53%). However, 53% of the women had doubts about the veracity of the information accessed. Conclusion Women without a partner and with>12 years of schooling had more information about COVID-19 and on its impact on new pregnancy, and those from high socioeconomic status had a higher chance of maintaining physical distance. Safety, effectiveness, comfort, and absence of hormone in the contraceptive method (in the case of TCu380A IUD) were the main reasons for the participants to seek the service during the pandemic, and the possibility to stop menstrual bleeding was the main reason to choose the LNG-IUS.

Resumo Objetivo Determinar o conhecimento, atitude e práticas preventivas (CAP) em relação à pandemia de SARS-CoV-2 (Covid-19) entre mulheres em idade reprodutiva que buscam usar dispositivo intrauterino com cobre (DIU TCu 380) ou sistema intrauterino liberador de levonorgestrel (SIU-LNG). Métodos Foi realizado um estudo transversal e um questionário foi aplicado a 400 mulheres para conhecer o CAP sobre o COVID-19 na Universidade Estadual de Campinas, Campinas, SP, Brasil, no período de maio a agosto de 2020. Resultados A média (±DP) de idade das mulheres foi de 30,8±7,9 anos, e 72,8% delas relataram ter engravidado pelo menos uma vez. A maioria das mulheres (95%) tinha ouvido ou lido sobre a a Covid-19, e suas principais fontes de informação foram a televisão (91%) e sites do governo (53%). Porém, 53% das mulheres tinham dúvidas a respeito da veracidade das informações acessadas. Conclusão Mulheres sem companheiro e com mais de 12 anos de escolaridade tiveram mais informações sobre a COVID-19 e sobre o seu impacto em uma nova gravidez, e aquelas de nível socioeconômico alto tiveram maior chance de manter distância física. Segurança, eficácia, conforto e ausência de hormônio no método anticoncepcional (no caso do DIU TCu380A) foram os principais motivos para as participantes procurarem o serviço durante a pandemia, e a possibilidade de controlar o sangramento menstrual abundante foi o principal motivo para a escolha do SIU-LNG.

Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study

Background: Heavy menstrual bleeding (HMB) poses threat to the quality of life among women. To prevent HMB, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative method. Objectives: The objective of this study was to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study. Materials and Methods: This study was performed among 60 patients who visited the gynecology and obstetrics outpatient department (OPD) at the Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKMH), Kolkata, West Bengal, India from May 2019 to April 2020 due to HMB. The mean demographic and clinical profiles were evaluated, and comparative analysis was performed for hemoglobin (Hb), spotting, pain, and endometrial thickness on day 0 and follow-up 3 months, 6 months, and 12 months. Results: The mean age of patients was 37.77 ± 4.58 years was obtained. The Hb level was significantly (P < .001) increased, whereas pictorial blood loss assessment chart (PBAC) score, endometrial thickness, spotting, and pain were significantly (P < .01 and P < .001) reduced. The majority of patients had pallor, but the rates of spontaneous expulsion and hysterectomy were observed lower after using LNG-IUS among studied patients. Conclusion: the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better quality of life. This can be the alternative to hysterectomy and oral pills for long-term use. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.

Clinical efficacy of GnRH-a combined with a levonorgestrel-releasing intrauterine system (Mirena) in patients with adenomyosis and its effects on ovarian function, CA125, CA153 and CEA expression / 中国基层医药

Objective:To investigate the efficacy of gonadotropin releasing hormone agonist (GnRH-a) combined with a levonorgestrel-releasing intrauterine system (Mirena) in patients with adenomyosis and its effects on ovarian function, carbohydrate antigen (CA) 125, CA153 and carcino-embryonic antigen (CEA) expression.Methods:Seventy-eight patients with adenomyosis who received treatment from September 2017 to September 2020 in Shaoxing People's Hospital were included in this study. They were randomly divided into treatment and control groups ( n = 39/group). Patients in the control group were treated with a levonorgestrel-releasing intrauterine system. Patients in the treatment group were treated with GnRH-a, once per month in the first 3 months based on treatment with a levonorgestrel-releasing intrauterine system. After 6 months of treatment, changes in dysmenorrheal relief, menstrual volume, uterine volume, endometrial thickness, ovarian function, CA125, CA153 and CEA levels relative to before treatment were compared. Results:Visual analog scale score and pictorial blood assessment chart score in the treatment group were (1.36 ± 0.28) points and (38.98 ± 5.42) points, which were significantly lower than those in the control group [(1.78 ± 0.31) points, (63.42 ± 6.75) points, t = 6.27, 17.63, both P < 0.05). Uterine volume and endometrial thickness in the treatment group were (209.74 ± 15.65) cm 3 and (7.37 ± 0.57) mm, respectively, which were significantly lower than those in the control group [(278.39 ± 20.90) cm 3, (8.63 ± 0.86) mm, t = 16.45, 7.62, P < 0.05]. There were no significant differences in serum levels of luteinizing hormone, follicle stimulating hormone and estradiol between the two groups (all P > 0.05). Serum CA125, CA153 and CEA levels in the treatment group were (26.87 ± 7.21) U/L, (23.12 ± 7.38) U/mL and (5.45 ± 0.96) μg/L, respectively, which were significantly lower than those in the control group [(49.93 ± 8.97) U/L, (38.94 ± 6.21) U/mL, (8.23 ± 1.35) μg/L, t = 12.51,10.24,10.48, P < 0.05]. Conclusion:GnRH-a combined with a levonorgestrel-releasing intrauterine system (Mirena) can markedly relieve dysmenorrhea, reduce menstrual volume, uterine volume, and endometrial thickness, has no obvious effects on ovarian function, and greatly reduce the levels of CA125, CA153 and CEA. Therefore, the combined method is a safe and effective non-surgical treatment method of adenomyosis.

Effect of levonorgestrel intrauterine system assisted progesterone capsule on menstruation and recurrence after hysteroscopic polypectomy in patients with endometrial polyps / 中国医师进修杂志

Objective:To explore the effect of Mirena assisted progesterone capsule in the treatment of endometrial polyps after hysteroscopic polypectomy (TCRP).Methods:One hundred and two patients with endometrial polyps treated with TCRP in Shapingba District People′s Hospital of Chongqing City from September 2018 to September 2019 were randomly divided into observation group and control group, with 51 cases in each group. In the control group, levonorgestrel intrauterine system was placed in the uterine cavity after operation, and the observation group was given progesterone capsule for 3 menstrual cycles on the basis of the control group. The curative effect, endometrial thickness, menstrual condition (menstrual period and menstrual volume) before and after treatment were compared between the two groups; and the endometrial tyrosine kinase growth factor receptor (C-kit), C-kit ligand stem cell factor (SCF) and aldehyde dehydrogenase 1(ALDH1) levels before and after treatment were compared between the two groups.Results:After treatment for 3 menstrual cycles, the total effective rate in the observation group was higher than that in the control group: 96.08% (49/51) vs. 82.35% (42/51), χ2 = 4.99, P<0.05. After treatment for 3 menstrual cycles, the endometrial thickness, menstrual period and menstrual volume in the observation group were shorter than those in the control group: (0.50 ± 0.09) cm vs. (0.63 ± 0.12) cm, (5.08 ± 0.64) d vs. (6.14 ± 0.79) d, (182.27 ± 15.04) ml vs. (236.17 ± 17.18) ml, the differences were statistically significant ( P<0.05). After treatment for 3 menstrual cycles, the levels of C-kit, SCF and ALDH1 in the observation group were shorter than those in the control group: 0.11 ± 0.02 vs. 0.18 ± 0.03, 0.20 ± 0.04 vs. 0.29 ± 0.05, 0.13 ± 0.03 vs. 0.20 ± 0.04, and the differences were statistically significant( P<0.05). The recurrence rate 12 months after treatment in the observation group was lower than that in the control group: 2.08% (1/48) vs. 17.07% (7/41), χ2 = 4.38, P<0.05. Conclusions:The treatment of levonorgestrel intrauterine system combined with progesterone capsule has a positive effect on the recovery of endometrium and menstruation after TCRP for endometrial polyps. It can regulate the expression of related factors in endometrial tissue and reduce recurrence.

Apresentação não usual de dois casos de uso de dispositivoIntrauterino hormonal - Mirena® / Two cases of unusual presentation of hormonal levonorgestrel intrauterine system - Mirena®

Os contraceptivos intrauterinos contendo levonorgestrel, Mirena®, amplamente utilizados na ginecologia contemporânea como método eficaz de contracepção e controle de distúrbios menstruais, mostrou reduzir as taxas de câncer de endométrio. Além disso, complicações como perfuração e migração são raras, exigindo intervenção rápida. Descrição: Dois casos atípicos acerca do uso de dispositivo intrauterino hormonal, o primeiro trata de migração do dispositivo para a cavidade abdominal, após 1 ano e 8 meses da inserção, sem perfuração, com retirada videolaparoscópica. O segundo é um caso de câncer primário de endométrio em paciente com 3 anos de uso de Mirena®. Discussão: A migração do dispositivo intrauterino é uma complicação rara, pouco relatada na literatura, a abordagem videolaparoscópica é a preferencial e foi realizada no caso em questão. O dispositivo intrauterino hormonal também está relacionado à diminuição das taxas de câncer de endométrio e, inclusive, é usado como método preventivo em mulheres de alto risco. Após revisão de literatura, apenas seis casos similares foram descritos. Conclusão: O dispositivo hormonal intrauterino, apesar de seguro, pode implicar apresentações raras, como migração e perfuração, que exigem conhecimento e agilidade da equipe profissional. O segundo caso apresentado é um evento raro, que faz atentar para mulheres com padrão hemorrágico incomum em uso do Mirena®. (AU)

Intrauterine contraceptives containing levonorgestrel, Mirena®, widely used in contemporary gynecology as an effective method of contraception and control of menstrual disorders, have shown to reduce rates of endometrial cancer. In addition, complications such as perforation and migration are rare, requiring rapid intervention. Description: Two atypical cases about the use of intrauterine hormonal device, the first deals with migration of the device to the abdominal cavity, after 1 year and 8 months of insertion, without perforation, with videolaparoscopic withdrawal. The second is a case of primary endometrial cancer in a patient with 3 years of use of Mirena®. Discussion: Migration of the intrauterine device is a rare complication, little reported in the literature, the videolaparoscopic approach is the preferred one and was performed in the case in question. The hormonal intrauterine device is also related to the decreased rates of endometrial cancer and is also used as a preventive method in high-risk women. After reviewing the literature, only six similar cases were described. Conclusion: The intrauterine hormonal device, although safe, may imply rare presentations, such as migration and perforation, which require knowledge and agility of the professional team. The second case presented is a rare event, which makes it aware for women with an unusual hemorrhagic pattern to use Mirena®. (AU)

Análisis y consideraciones técnicas acerca de dispositivos intrauterinos de levonorgestrel para la evaluación de productos similares y genéricos / Analysis and technical considerations about levonorgestrel intrauterine devices for the evaluation of generic and similar products

Los dispositivos intrauterinos hormonales de levonorgestrel son métodos anticonceptivos seguros y eficaces. Al igual que los medicamentos convencionales, una vez expirada la patente, las autoridades regulatorias de salud pueden aprobar el registro de productos similares. El objetivo de ello es disminuir los costos, considerando el elevado precio del producto original. Este tipo de productos están regulados y se aplican requisitos generales similares a los medicamentos tradicionales para demostración de seguridad y eficacia. Las propiedades mecánicas únicas del producto de referencia plantean un gran desafío a los productos similares. El presente artículo analiza de manera comparativa las características de los diversos sistemas intrauterinos hormonales de levonorgestrel, disponibles en el mercado. La autoridad sanitaria y los diversos centros clínicos deben considerar que en este tipo de productos no hay, hasta la fecha en el mundo, genéricos intercambiables y que por lo tanto, se debe decidir la intercambiabilidad de éstos sobre la base de estudios de bioequivalencia in vivo, luego de la demostración de equivalencia farmacéutica in vitro, tal y como sugiere la FDA, o en su defecto deberían ser registrados como productos nuevos, con estudios clínicos apropiados que demuestren seguridad y eficacia.

Levonorgestrel hormonal intrauterine systems are safe and effective contraceptive methods. Like conventional drugs, once the patent expires, health regulatory authorities can approve the registration of similar products. The objective of this is to reduce costs, considering the high price of the original product. These types of products are regulated as drugs and similar general requirements apply to traditional drugs for demonstration of safety and efficacy. The unique mechanical properties of the reference product pose a great challenge to similar products. This article comparatively analyzes the characteristics of the various levonorgestrel hormonal intrauterine systems available on the market. Therefore, the health authority and clinical centers must consider that up to date, there are no interchangeable generics in this type of products worldwide. Thus, their interchangeability must be decided on the basis of in vivo bioequivalence studies after the demonstration of in vitro pharmaceutical equivalence, as suggested by the FDA. Without that, they should be registered as new products, with appropriate clinical studies that demonstrate safety and efficacy.

Continuation rates of the 52-mg levonorgestrel-releasing intrauterine system according to the primary reason for its use / Taxas de continuação com o sistema intrauterino de liberação de levonorgestrel de 52mg de acordo com o motivo principal de seu uso

Abstract Objective To evaluate whether continuation rates with the 52-mg levonorgestrelreleasing intrauterine system (LNG-IUS) up to 5 years after placement differed between women using the method exclusively for contraception and those using the device for medical reasons alone. Methods A retrospective cohort study was conducted in a family planning clinic with 5,034 LNG-IUS users: 4,287 using the method exclusively for contraception and 747 for medical reasons alone. The continuation rate at 1 to 5 years of use was calculated by life table analysis. Results Initially, the continuation rate was significantly higher in the contraception group: 85.8 versus 83.4 and 77.4 versus 76.0 per 100 women-years in the 1st and 2nd years of use, respectively. There were more discontinuations due to bleeding/spotting in the medical reasons group in the first two years. The discontinuation rate according to reason for use was not significantly different from the third to the fifth year of use. No women discontinued due to amenorrhea in either group. Conclusion The continuation rate was significantly higher in the contraception group in the first two years of use. Amenorrhea was not a reason for discontinuation in either group, suggesting that counselling in this respect was adequate. Nevertheless, counselling could perhaps have been better with regards to the expected long period of bleeding and spotting in the first two years after placement.

Resumo Objetivo Avaliar a taxa de continuação até 5 anos de uso do sistema intrauterino liberador de 52-mg levonorgestrel por dia (SIU LNG) -IUS) é diferente entre mulheres que o usam exclusivamente como anticoncepcional que entre as que usam exclusivamente por razões médicas. Métodos Estudo retrospectivo realizado em uma clínica de Planejamento Familiar 5.034 usuárias de SIU LNG, 4.287 que optaram pelo método apenas como anticoncepcional e 747 que o usavamsomente por razoesmédicas. A taxa de continuação de um até cinco ano foi calculada por meio de análise de tabela de vida Resultados No início a taxa de continuação foi significativamente maior no grupo da anticoncepção: 85,8 versus 83,4 e 77,4 versus 76,0 por 100 anos-mulher no 1° e 2° ano de uso, respectivamente. Houve mais descontinuações por sangrado-manchado no grupo de razões médicas nos dos primeiros anos. A taxa de continuação não foi significativamente diferente desde o terceiro até o quinto ano de uso. Nenhuma mulher de ambos os grupos descontinuou por amenorreia. Conclusão A taxa de continuação foi significativamente maior no grupo de anticoncepção durante os dos primeiros anos de uso. Amenorreia não foi motivo de descontinuação em ambos os grupos, sugerindo que a orientação a esse respeito foi adequada. Entretanto, a orientação referente ao longo período de sangramentos irregulares nos dois primeiros anos após a inserção, precisaria ser melhorado.

Incidencia a un año de deseo sexual hipoactivo en mujeres que planifican con implante subdérmico de levonorgestrel. Estudio de cohorte. Armenia, Colombia, 2014-2019 / One-year incidence of low libido in women using levonorgestrel subdermal implant as contraception. Cohort study. Armenia, Colombia, 2014-2019

RESUMEN Objetivo: definir la incidencia de deseo sexual hipoactivo (DSH) en mujeres que planifican con el implante subdérmico de levonorgestrel (LNG) después de 12 meses, y conocer otros efectos adversos. Materiales y métodos: estudio de cohorte, cuyas participantes fueron mujeres mayores de 18 años sin hijos ni embarazos previos y con pareja estable, a quienes se les había insertado el implante de LNG al menos tres meses previos en una clínica privada de carácter universitario en Armenia (Quindío), Colombia, entre 2014 y 2019. Se excluyeron mujeres con antecedentes de disfunción sexual, infecciones de transmisión sexual en los últimos 6 meses, peso mayor a 89 Kg y dificultades para el seguimiento. El muestreo fue consecutivo. Se describieron las características de la población estudiada, se estimó la incidencia acumulada de DSH y efectos adversos relacionados con el implante subdérmico de LNG Resultados: participaron 238 mujeres cuya edad media fue de 24,69 (DE ± 5,82) años. Se determinó una incidencia de deseo sexual hipoactivo del 18,82%. El 60,25% de las mujeres fueron diagnosticadas con DHS en los primeros 6 meses de seguimiento. Los efectos adversos se hicieron presentes desde los primeros 3 meses de la inserción del implante, el sangrado irregular (62,34%) fue el más frecuente, seguido de la amenorrea (38,91%) y el aumento de peso (33,89%). Conclusiones: es importante que los médicos y las usuarias se informen sobre la presencia del trastorno de deseo sexual hipoactivo y los efectos adversos que pueden surgir con el uso del implante subdérmico de levonorgestrel. Las futuras investigaciones deben confirmar estos hallazgos, así como su eventual base fisiológica.

ABSTRACT Objective: To determine the incidence of low libido in women using the levonorgestrel (LNG) sub-dermal implant for contraception after 12 months and to identify other adverse effects. Materials and methods: Cohort study that included women over the age of 18, with no children or prior gestations and in a stable relationship, with an LNG implant inserted at least three months before in a private teaching hospital in Armenia (Quindío), Colombia, between 2014 and 2019. Women with a history of sexual dysfunction, sexually transmitted infections in the past six months, weighing more than 89 kg and difficult to follow were excluded. Consecutive sampling was used. The characteristics of the study population were described, the cumulative incidence of low libido and the adverse effects related to the LNG sub-dermal implant after 12 months of follow-up were estimated. The tool used was the Female Sexual Dysfunction Index (FSFI). Descriptive statistics were applied. Results: The participants were 238 women with a mean age of 24.69 (SD ± 5.82) years. An 18.82% incidence of low libido was found. In 60.25% of the women were diagnosed with low libido in the first 6 months of follow-up. Adverse effects manifested as early as 3 months after the insertion of the implant, the most frequent being irregular bleeding (62.34%), followed by amenorrhea (38.91%) and weight gain (33.89%). Conclusions: It is important for practitioners and users to become aware of the presence of low libido disorder and the adverse events that may occur with the use of the levonorgestrel subdermal implant. Future research is required to confirm these findings and the underlying physiological cause.

Meta analysis of levonorgestrel releasing intrauterine system and mifepristone in the treatment of adenomyosis / 中国医师杂志

Objective:To evaluate the efficacy of levonorgestrel-releasing intrauterine system (LNG-IUS) (mirena) versus mifepristone therapy for adenomyosis.Methods:We retrived the Cochrane library, the Pubmed, EMbase, China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, China Biomedical Literatue Database (CBM) and other databases to identify randomized controlled trials (RCTs) involving the comparison of levonorgestrel-releasing intrauterine system and mifepristone up to October 2018. The quality assessment and data extraction for RCTs were conducted by two reviewers independently. Then data were analyzed with Stata 11.0 software.Results:A total of 17 RCTs involving 1 772 patients were included. The results indicated that mirena was more effective than mifepristone [RR=1.25, 95% CI(1.19, 1.32), P<0.01]. The decrease in endometrial thickness [MD=-1.94, 95% CI(-2.19, -1.70), P<0.01], uterine volume [MD=-18.99, 95% CI(-19.90, -18.07), P<0.01] and the incidence of adverse reactions [RR=0.67, 95% CI(0.47, 0.95), P=0.026] in mirena group were significantly different compared with the mifepristone group. Also the dysmenorrhea score and menstrual blood volume of mirena group were lower than mifepristone group ( P<0.05). Conclusions:Current evidence shows that the efficacy and safety of mirena was better than mifepristone in the treatment for adenomyosis patients. Since the limitation of quantity and quality of included studies, large-scale high-quality RCTs are needed to verify the above conclusion.

Effects of medroxyprogesterone acetate combined with a levonorgestrel-releasing intrauterine contraceptive system on sex hormone and vascular endothelial growth factor levels after laparoscopic surgery for moderate and severe endometriosis / 中国基层医药

Objective:To investigate the effects of medroxyprogesterone acetate combined with a levonorgestrel-releasing intrauterine contraceptive system (Mirena) on the levels of sex hormone and vascular endothelial growth factor in patients with moderate and severe endometriosis after laparoscopic surgery.Methods:A total of 102 patients with endometriosis who received laparoscopic conservative surgery in Hangzhou Ninth People's Hospital from October 2015 to May 2018 were retrospectively analyzed. They were randomly assigned to undergo either medroxyprogesterone acetate treatment alone (control group, n = 51) or medroxyprogesterone acetate treatment + levonorgestrel-releasing intrauterine contraceptive system application (observation group, n = 51) for 6 successive months. Clinical efficacy, serum luteinizing hormone, follicle-stimulating hormone, estradiol and vascular endothelial growth factor levels, Visual Analogue Scale score, endometriosis recurrence rate, and adverse reactions were compared between the control and observation groups. Results:Total effective rate in the observation group was significantly higher than that in the control group [94.12% (48/51) vs. 80.93% (41/51), χ2 = 4.320, P < 0.05]. At 6 months after surgery, serum luteinizing hormone, follicle-stimulating hormone, estradiol and vascular endothelial growth factor levels in the observation group were (5.72 ± 0.53) U/L, (5.05 ± 0.91) U/L, (156.02 ± 21.80) pmol/L and (155.39 ± 24.72) ng/L respectively, which were significantly lower than those in the control group [(6.51 ± 0.67) U/L, (5.73 ± 0.68) U/L, (177.20 ± 23.20) pmol/L and (186.22 ± 28.14) ng/L, t = 6.604, 4.275, 4.747 and 5.878, all P < 0.05). At 3 and 6 months after surgery, Visual Analogue Scale score in the observation group were (2.39 ± 0.33) points and (1.27 ± 0.20) points respectively, which were significantly lower than those in the control group [(2.72 ± 0.40) points, (1.52 ± 0.25) points, t = 4.545 and 5.577, both P < 0.05]. Two-year follow-up results revealed that endometriosis recurrence in the observation group was significantly lower than that in the control group [1.96% (1/51) vs. 13.73% (7/51), χ2 = 4.883, P < 0.05]. There was no significant difference in total incidence of adverse reactions between the two groups [15.69% (8/51) vs. 13.73% (7/51), χ2 = 0.078, P > 0.05]. Conclusion:Application of medroxyprogesterone acetate combined with a levonorgestrel-releasing intrauterine contraceptive system after laparoscopic surgery for moderate and severe endometriosis can effectively regulate serum levels of sex hormone and vascular endothelial growth factor, decrease endometriosis recurrence rate and is highly safe. This method is worthy of clinical promotion.

Custo-efetividade e limiar de custo para o uso do sistema intrauterino liberador de levonorgestrel para o tratamento do sangramento uterino anormal sob a perspectiva do Sistema de Saúde Suplementar no Brasil / Cost-effectiveness and cost threshold for the use of levonorgestrel-releasing intrauterine system for treatment of heavy menstrual bleeding from the Supplementary Health System perspective in Brazil

Objetivo: Definir um limiar de custo para o sistema intrauterino liberador de levonorgestrel 52 mg (SIU-LNG 52 mg) para o tratamento do sangramento uterino anormal (SUA) sob a perspectiva do Sistema de Saúde Suplementar brasileiro. Métodos: Foi elaborado um modelo de custo-efetividade para definir o limiar de custo de inserção de SIU-LNG 52 mg em mulheres com SUA em comparação à histerectomia. Um modelo de Markov foi estruturado com ciclos anuais para reproduzir o tratamento do SUA em um e cinco anos, considerando custos médicos diretos e o percentual de histerectomias evitadas como desfecho. O custo da histerectomia foi variado até o valor de 10.000 reais brasileiros (BRL) com incrementos de 500 BRL a cada nova simulação para avaliar o limiar de custo do SIU-LNG 52 mg para igualar o custo total de tratamento de ambas as estratégias analisadas. Resultados: O SIU-LNG 52 mg demonstrou ser uma opção de tratamento dominante quando comparada à histerectomia, levando à redução da frequência de realização do procedimento cirúrgico em 59,62% das mulheres e redução de 2.557,91 BRL no custo total de tratamento em cinco anos. Ao considerar a histerectomia a 6.000 BRL, o custo do procedimento com SIU-LNG 52 mg poderia ser de até 6.150,35 BRL e 3.994,60 BRL para igualar o custo total de tratamento, em horizontes temporais de um e cinco anos, respectivamente. Conclusão: SIU-LNG 52 mg demonstrou ser uma opção dominante para o manejo do SUA, sendo capaz de atrelar economia para o sistema de saúde a benefícios para a mulher perante a cirurgia.

Objective: To define a cost threshold for the use of levonorgestrel-releasing intrauterine system 52 mg (LNG-IUS 52 mg) for the treatment of heavy menstrual bleeding (HMB) in the Brazilian Supplementary Health System perspective. Methods: A cost-effectiveness model was built to define the cost threshold for insertion of LNG-IUS 52 mg considering women with diagnosis of HMB as the target population and hysterectomy as the comparator. A Markov model was structured with annual cycles to reproduce HMB treatment in 1 and 5 years, considering direct medical costs and the percentage of avoided hysterectomies as the outcome. Hysterectomy cost was varied up to 10,000 Brazilian real (BRL) with increments of 500 BRL at each new simulation to define LNG-IUS 52 mg cost threshold, to provide equal total treatment costs for both strategies. Results: LNG-IUS 52 mg proved to be a cost-saving option when compared to hysterectomy, leading to a reduction in the frequency of the surgical procedure by 59.62% and a total treatment cost reduction of 2,557.91 BRL in 5 years. When considering hysterectomy at 6,000 BRL, the cost of the procedure with LNG-IUS 52 mg could be up to 6,150.35 BRL and 3,994.60 BRL to provide equal total treatment cost in 1 and 5 years time horizon, respectively. Conclusion: LNG-IUS 52 mg has proven to be a cost-saving option for the health system in the management of HMB, in addition to the known benefits for women against surgery.

Analysis of the endometrial transcriptome at the time of implantation in women receiving a single post-ovulatory dose of levonorgestrel or mifepristone

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.

A influência do sobrepeso/ obesidade sobre o uso do levonorgestrel como método contraceptivo de emergência / The influence of overweight/obesity over the use of levonorgestrel as an emergency contraceptive method

A contracepção de emergência tem como objetivo prevenir uma gravidez indesejada após uma relação sexual desprotegida, falha do método contraceptivo regular ou agressão sexual. Dentre os métodos disponíveis atualmente, destaca-se a pílula hormonal de levonorgestrel (LNG) como uma das principais estratégias utilizadas, tendo em vista o perfil de segurança desse fármaco e a facilidade de acesso e utilização dele. No entanto, embora o efeito de tal molécula seja satisfatório, pesquisas sugerem que altos índices de massa corporal implicam uma redução da eficácia contraceptiva da pílula de LNG. Nesse sentido, esse estudo visa evidenciar, mediante revisão de literatura, a relação entre esse fármaco e sua competência em mulheres com sobrepeso ou obesidade, bem como expor quais medidas devem ser tomadas para evitar a gravidez indesejada nessas pacientes. Embora existam divergências, foi observado que a maior parte dos estudos indica que a composição corporal das pacientes pode influenciar na eficácia contraceptiva da molécula de LNG, de forma sinérgica ou não com outros fatores, especialmente quando considerado o IMC > 25 kg/m² ou peso > 75 kg, uma vez que o risco de gravidez pode aumentar de 1,5 até 4,4 vezes quando comparado aos padrões de normalidade, com tendência de crescimento em relação aos parâmetros de sobrepeso/obesidade.(AU)

The main goal of the emergency contraceptive is to prevent a non-planned pregnancy after the sexual relationship without condom, after the fail of the usual contraceptive or the sexual assault. Among all the currently available methods, the hormonal pill of levonorgestrel (LNG) has its importance as one of the most used strategies, due of its safety, easy access and use. However, in spite of the fact that this molecule has a good effect, some researches suggest that a high level of the body mass reduces the efficacy of the contraceptive pill of LNG. In this context, this study objective is to clarify, by using literature review, the relation between this drug and its competence in overweight/obese women, as well to expose which other options could be taken to avoid a non-planned pregnancy in those patients. Despite of the fact that there are divergences, the most part of the studies shows that patient's body composition can influence on the contraceptive effectiveness of the LNG molecule, sinergically or not to other factors, especially when the IMC > 25 kg/m² or the body weight > 75 kg, once the pregnancy risk can be raised from 1,5 to 4,4 times when compared to regular standards, with growth tendency when related to overweigh/obesity parameters.(AU)