Modified Fixation of Levonorgestrel-releasing Intrauterine System for the Treatment of Adenomyosis / 中山大学学报(医学科学版)

ObjectiveTo introduce a fixation technique with the modified levonorgestrel-releasing intrauterine system （LNG-IUS） and evaluate its efficacy in the treatment of adenomyosis patients with previous LNG-IUS expulsion. MethodsA retrospective analysis was done on 22 adenomyosis patients who underwent modified LNG-IUS fixation due to LNG-IUS expulsion at three hospitals from June 2022 to June 2023. The baseline clinical characteristics， operative and postoperative details were collected and analyzed. The Visual analogu scale （VAS） scores and pictorial blood loss assessment chart （PBAC） scores were measured and compared before， 3 and 6 months after the LNG-IUS fixation. ResultsThe mean operative time was （19.51±7.41） min and intraoperative bleeding was （6.71±5.30） mL. Of the patients， 13 were operated under local anaesthesia and the other 9 under intravenous anaesthesia. There were 4 operations performed by a resident doctor， 15 by an attending doctor and 3 by a senior doctor. No intraoperative or postoperative complication was found. The mean follow-up was 11.51 months and no patient had a recurrence of LNG-IUS expulsion during the follow-up period. The mean level of hemoglobin at 1 month after operation was significantly higher than that before （P<0.001）. VAS scores and PBAC scores at 3 and 6 months postoperatively were all improved significantly than those preoperatively （P<0.001）. ConclusionsEffectively preventing the recurrence of LNG-IUS expulsion， modified LNG-IUS fixation is a safe and efficient method for adenomyosis patients with previous LNG-IUS expulsion. Modified LNG-IUS fixation deserves the clinical application due to its easy operation and wide range of use on women.

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.

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.

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.

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.

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.

Consecutive use of the 52 mg levonorgestrel-releasing intrauterine system: variations in bleeding patterns / Uso consecutivo do sistema intrauterino de levonorgestrel 52 mg: variações no padrão de sangramento

Abstract Objective Changes in bleeding patterns could influence the decisions of healthcare professionals to change the levonorgestrel-releasing intrauterine system (LNG-IUS) before 7 years of use, the recommended period of extended use. We evaluated changes in the bleeding patterns of users of the 52 mg LNG-IUS at the end of use of the first (IUS-1) and during the second device (IUS-2) use. Methods We performed an audit of the medical records of all women who used two consecutive LNG-IUSs at the Family Planning clinic. We evaluated the sociodemographic/gynecological variables, the length of use, and the bleeding patterns reported in the reference periods of 90 days before removal of the IUS-1 and at the last return in use of IUS-2. We used the McNemar test to compare bleeding patterns. Statistical significance was established at p < 0.05. Results We evaluated 301 women aged (mean ± SD) 32 (±6.1) years, with lengths of use of 68.9 (±16.8) and 20.3 (±16.7) months for the IUS-1 and IUS-2, respectively. No pregnancies were reported. Bleeding patterns varied significantly among women who used the IUS-2 for ≥ 7 months to 6 years when compared the bleeding patterns reported in IUS-1 use. Eighty-nine out of 221 (40%) women maintained amenorrhea and infrequent bleeding; 66 (30%) evolved to bleeding patterns with light flow, and 66 (30%) maintained or evolved to heavy flow patterns (p = 0.012). No differences were observed among the 80 women with ≤ 6 months of use. Conclusion Changes in bleeding patterns occur during the use of LNG-IUS and should not be decisive for the early replacement of the device.

Resumo Objetivo Variações no padrão de sangramento podem afetar a decisão de troca do sistema intrauterino de levonorgestrel (SIU-LNG) antes do período de uso estendido recomendado de 7 anos. Nós avaliamos mudanças no padrão de sangramento de usuárias ao final do uso do primeiro SIU-LNG 52 mg (SIU-1) e durante o uso do segundo dispositivo (SIU-2). Métodos Revisamos os prontuários de todas as mulheres que inseriram consecutivamente o SIU-LNG no ambulatório de Planejamento Familiar. Foram avaliadas as variáveis sociodemográficas/ginecológicas, o tempo de uso, e os padrões de sangramento relatados nos períodos de referência de 90 dias antes da remoção do SIU-1 e no último retorno em uso do SIU-2. Usamos o teste de McNemar para comparar os padrões de sangramento. A significância estatística foi estabelecida em p < 0,05. Resultados Analisamos os dados de 301 mulheres com idade (média ± desvio padrão [DP]) de 32 (±6,1) anos e tempo de uso de 68,9 (±16,8) e 20,3 (±16,7) meses para o SIU-1 e SIU-2, respectivamente. Nenhuma gravidez foi relatada. Os padrões de sangramento variaram significativamente durante o uso do SIU-2 (≥ 7 meses a 6 anos) em relação ao padrão relatado no SIU-1. Oitenta e nove das 221 (40%) mulheres mantiveram amenorreia e sangramento infrequente; 66 (30%) evoluíram para padrões de sangramento com fluxo leve e 66 (30%) mantiveram ou evoluíram para padrões de fluxo intenso (p = 0,012). Não foram observadas diferenças entre as 80 mulheres que utilizavam o SIU-2 há ≤ 6 meses. Conclusão Mudanças nos padrões de sangramento ocorrem durante o uso do LNG-IUS e não devem ser decisivas para a troca precoce do dispositivo.

A prospective study to compare levonogestrol intrauterine system and trans-cervical resection of endometrium for treatment of abnormal uterine bleeding

Background: This article is a study comparing the two most accepted forms of treatment for abnormal uterine bleeding - levonorgestrol intrauterine treatment and transcervical resection of endometrium, with regards to its acceptability, efficacy, adverse effects and user satisfaction. Aim of this study was to compare the acceptability, efficacy, adverse effects and user satisfaction of LNG-IUS and TCRE for treatment for AUB.Methods: A prospective observational study conducted in SKNMC and GH. Forty-nine women with abnormal uterine bleeding after hysteroscopic evaluation were included in this study; where 17 opted for LNG-IUS; 32 opted for TCRE with bipolar electrode. 15 patients in LNG-IUS group and 28 pts in TCRE group completed follow up. Menstrual pattern, pictorial blood loss assessment chart score, adverse effects, acceptability, satisfaction and reason for discontinuation were recorded at 6 weeks, 6 months and 12 months after the procedure. Prior to LNG-IUS insertion or endometrial ablation, endometrial and cervical pathology were excluded by D and C and cervical smear, respectively. TVUS was used to exclude possible causes of menorrhagia, including myomas and endometrial polyp as well as adnexal pathology. LNG-IUS insertion was performed as an office procedure one day after cessation of menstrual bleeding with a negative urine pregnancy test.Results: Menstrual blood loss reductions in TCRE and LNG-IUS groups were by 85.7% and 87.6% respectively after a year. Amenorrhoea was more common in TCRE group while spotting and systemic effects were more common in LNG-IUS group. Satisfaction and acceptance rates are higher in TCRE group.Conclusions: The TCRE and LNG-IUS are equally effective in reducing bleeding in AUB patients. Acceptance and satisfaction are better with TCRE, as a modality of treatment for AUB.

Análisis de la costo-efectividad del sistema intrauterino liberador de levonorgestrel, como alternativa a histerectomías, en dos países latinoamericanos / Analysis of the cost-effectiveness of the levonorgestrel intrauterine system as alternative to histerectomies in two latin american countries

Resumen Objetivo: El sistema intrauterino con levonorgestrel ha demostrado un fuerte efecto supresor endometrial de mucha utilidad en gran variedad de problemas ginecológicos. Existen numerosos estudios y revisiones del sistema intrauterino con levonorgestrel que avalan su uso en sangrado uterino anormal, como también bastantes publicaciones que demuestran su costo-efectividad. No se encontraron publicaciones latinoamericanas. El objetivo del estudio es desarrollar un modelo para valorar el beneficio en costos del uso del dispositivo como manejo alternativo del sangrado uterino anormal. Métodos : Se realizó modelo fármaco-económico que ayudará a comparar costos y efectividad de sistema intrauterino con levonorgestrel, inserción, controles clínicos más ultrasonido transvaginal al mes, y anuales, y se comparó con los costos directos de histerectomía. Los costos de histerectomía se obtienen mediante GRD-WinSIG en Chile y los costos reales directos en Costa Rica. El modelo es básicamente comparar los costos de la inserción de sistema intrauterino con levonorgestrel más las fallas del tratamiento versus histerectomías. Resultados: El modelo permite demostrar que al utilizar el sistema intrauterino con levonorgestrel como alternativa a la histerectomía en pacientes seleccionadas, se produce un ahorro en costos, aun asumiendo el costo de las fallas. Estos modelos no consideran los costos asociados a las complicaciones eventuales de todo acto quirúrgico, de tal forma que el ahorro generado por el uso del sistema intrauterino con levonorgestrel podría ser mayor. Conclusión: La inclusión del sistema intrauterino con levonorgestrel en guías de práctica clínica permite la posibilidad de disminuir las histerectomías en pacientes refractarias a tratamiento médico convencional, y que cumplan con criterios de inclusión y exclusión estrictos. El modelo permitió demostrar que al utilizar el sistema intrauterino con levonorgestrel como alternativa a la histerectomía, se produce un gasto que es solo un tercio del generado al realizar histerectomías.

Summary Objective: The intrauterine system with levonorgestrel has demonstrated a strong endometrial suppressive effect that is useful in a wide variety of gynecological problems. There are numerous studies and reviews of the levonorgestrel intrauterine system that support its use in abnormal uterine bleeding, as well as numerous publications that demonstrate its cost-effectiveness. As far as we know, there are no Latin American publications in this regard. The objective of the present study was to develop a model to assess the costs benefits of the use of the devices as alternative management of abnormal uterine bleeding. Methods: A pharmacoeconomic model was performed comparing costs and effectiveness with costs of levonorgestrel intrauterine system, insertion, clinical controls plus ultrasounds per month and annually, compared with the direct costs of hysterectomy. Hysterectomy costs were obtained through DRG-WinSIG or direct real costs in Chile and Costa Rica respectively. Results: Our model demonstratde that when using the levonorgestrel intrauterine systsem as an alternative to hysterectomy in selected patients there is an expenditure of only one third of the costs of performing the hysterectomies in the same patients, even assuming failures with the dispositive. These model did not consider the costs associated with the eventual complications of any surgical act, thus, savings generated by use of the levonorgestrel intrauterine system in these patients could be even greater. Conclusión: The inclusion of the levonorgestrel intrauterine system in clinical practice guidelines could allow the possibility of reducing hysterectomies in patients refractory to conventional medical treatment and who meet strict inclusion and exclusion criteria. Our models demonstrate that when using the levonorgestrel intrauterine system as an alternative to hysterectomy in selected patients there is a reduction in costs.

Mirena: a novel alternative to hysterectomy

Background: To study the awareness and efficacy of Mirena (Levonorgestrel intrauterine system) in treatment of abnormal uterine bleeding.Methods: A prospective analytical study was conducted from January 2012 to June 2018 at Smt. Kashibai Navale medical college and general hospital, Pune, Maharashtra, India. Total 30 women between age of 35 to 45 yrs age were included in the study. Mirena was inserted post-menstrually in the operation room under sedation was done. The women were called for follow-up after 1 month, then 4 months, and then yearly (for maximum 2 years); and asked regarding the relief they have obtained from the antecedent menstrual complaints.Results: At end of study, Overall satisfaction rate among women was 76.67% and decrease menstrual blood flow observed in 20 (74.07%) cases. Most common side effect observed was irregular menses in 6 (22.22%) cases. Hysterectomy was required in 3 (11.11%) cases.Conclusions: Menorrhagia is a common gynaecologic problem often needing hysterectomy. The LNG-IUS reduces bleeding in women with menorrhagia due to benign causes. The patient acceptance and satisfaction is high. Main problem is irregular bleeding especially for the first 3 months after insertion. If the patients can be counseled before insertion, continuation rates for LNG-IUS are high. It has the potential to replace hysterectomy as treatment of choice in certain patients.

Role of LNG-IUS in adenomyosis in reproductive age group women: a prospective interventional study

Background: The objective of the present study was to observe the efficacy of LNG-IUS in the treatment of heavy menstrual bleeding and dysmenorrhoea associated with adenomyosis.Methods: LNG-IUS was inserted in forty women between 20-50 years of age presenting with heavy menstrual bleeding and dysmenorrhoea associated with adenomyosis diagnosed on transvaginal ultrasonography and followed up after 1 month, 3 months and 6 months of insertion. Subjective assessment of menstrual blood loss was done by pictorial blood loss assessment chart and dysmenorrhoea was assessed on the basis of universal pain assessment tool and side effects were noted at each visit.Results: Mean patients’ age was between 31-40 years (72.5%) and the follow up duration was 6 months. Significant improvements in dysmenorrhea, HMB and haemoglobin levels were observed. There was no significant change in the uterine volume. The most common side effect was prolonged vaginal spotting (n=26, 65%) and pain abdomen (n=13, 32.5%). LNG-IUS expulsion was observed in 1 patient (n=1, 2.5%). 3 patients underwent hysterectomy (n=3, 7.5%). The overall success rate of LNG-IUS was 82.5%.Conclusions: The LNG-IUS appears to be an effective method in alleviating dysmenorrhoea and heavy menstrual bleeding associated with adenomyosis during 6 months of study. It may be a valuable long-term alternative for the treatment of adenomyosis in young and perimenopausal women and it is a good strategy to reduce the number of hysterectomies in women with adenomyosis.

Impact of levonorgestrel intrauterine system on metabolic parameters

Background: Hormonal contraceptive is suggested to affect parameters like body mass index, body weight, blood pressure (BP), blood sugar, lipid protein, and liver function test (LFT) but effect of LNG-IUS on those parameters is still uncertain. The aim of the present study was to study the effects of LNG-IUS on the metabolic parameters.Methods: Sixty women who opted for LNG-IUS for various indications were included in the study. Lipid profile, liver function tests (LFT), glucose levels [fasting and post prandial (PP)], and hemoglobin (Hb) were tested. Bimanual genital examination and transvaginal-ultrasonography was done prior to LNG-IUS insertion. Any problems observed were recorded. The subjects were re-evaluated after 6 and 9 months on their subsequent visits. Data were analyzed using paired “t” test. P value of <0.05 was considered statistically significant.Results: Mean age of the patients was 35.5±6.79 years. Maximum number 50 (83.3%) had abnormal uterine bleeding (ovulatory dysfunction, endometrial, iatrogenic, not yet classified) [AUB (OEIN)]. Mean pictorial blood loss assessment chart (PBAC) score of patients was 164.7±56.72 and mean Hb level 11.15±1.75g/dL. LNG-IUS showed no significant adverse effects on anthropometric parameters at 6- and 9-month follow-up. Significant change was seen in total cholesterol (TC), very low-density lipoprotein (VLDL) and high density lipoproteins (HDL) values at follow-up (p<0.0001).Conclusions: In conclusion, amongst Asian population, the LNG-IUS does not have any adverse effects on metabolic parameters, TGs, LDL and blood sugar levels.

Clinical analysis of GnRH-a combined with LNG-IUS in the treatment of adenomyosis by different uterine volume / 中国实用妇科与产科杂志

OBJECTIVE: To investigate the effect of different uterine volume on the therapeutic effect of GnRH-a combined with levonorgestrel-releasing intrauterine system(LNG-IUS)in the treatment of adenomyosis.METHODS: From July 2014 to December 2017 in Center of Minimally Invasive Gynecology,Beijing Obstetrics and Gynecology Hospital,160 patients with adenomyosis were divided into experimental group and control group according to the volume of uterine cavity before inserting LNG-IUS.The experimental group(n=80)was inserted LNG-IUS when the uterine volume ≥100 cm~3.The control group(n=80)was inserted LNG-IUS when the uterine volume0.05).(3)The fall-off rate and LNG-IUS drop rate in the experimental group were higher than those in the control group(The fall-off rate was 15.0% and 5.0% in the two groups,P=0.035.The LNG-IUS drop rate was 25.0% and 12.5% in the two groups,P=0.043).(4)The uterine volume,the depth of uterine cavity and the amount of menstruation before insertion were risk factors which affected the fall-off/drop rate of LNG-IUS.When the uterine volume was greater than 97.33 cm~3,the prediction sensitivity was 96.0% and the specificity was 58.3%.When the depth of uterine cavity was greater than 8.75 cm,the prediction sensitivity was 92.0% and the specificity was 53.3%.CONCLUSION: Excessive uterine volume affects the efficacy of LNG-IUS in the treatment of adenomyosis.When the uterine volume is greater than 97.33 cm~3,or the depth of uterine cavity is greater than 8.75 cm before placement of LNG-IUS,the fall-off/drop rate is significantly increased.

Therapeutic efficacy of Mirena in gynecologic disease

The levonorgestrel-releasing intrauterine system (LNG-IUS) was originally developed as a method of contraception and was first marketed in Finland in 1990. In Korea, the only LNG-IUS approved for non-contraceptive use is Mirena, a T-shaped device with a vertical stem containing a reservoir of 52 mg of levonorgestrel, which releases 20 µg of levonorgestrel per day. The device's strong local effects on the endometrium benefit women with gynecological conditions such as heavy menstrual bleeding, dysmenorrhea, leiomyoma, adenomyosis, and endometriosis. There is also evidence to support its role in endometrial protection during postmenopausal estrogen therapy and in the treatment of endometrial hyperplasia without atypia and, possibly, early endometrial cancer. Because of its effectiveness, safety, and high patient satisfaction, the LNG-IUS will continue to provide important benefits in women's reproductive health.

Clinical effect of MR-guided high intensity focused ultrasound and gonadotropin releasing hormone agonist combined with levonorgestrel-releasing intrauterine system in the treatment of recurrent uterine fibroids / 中国综合临床

Objective To explore the clinical effects of magnetic resonance guided high intensity focused ultrasound ( MRgHIFU ) and gonadotropin releasing hormone agonist ( GnRH-a ) combined with levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of recurrent uterine fibroids. Methods Eighty patients of recurrent uterine fibroids from April 2015 to June2017 in the First Hospital of Harbin were collected and randomly divided into the observation group and control group. MRgHIFU was used in the observation group were employed,and patients in the control group were treated with ING-IUS after first injecting GnRH-a. The tumor volume,hemoglobin level,menstrual quantity and adverse reactions were compared before and at 3 months,6 months after treatment. Results After 6 months,the size of the uterine myoma in the observation group was ((80. 23 ± 4. 35) cm3 ),significantly lower than that of the control group (( 135. 46 ±9. 25) cm3 ),and the difference was statistically significant ( t = 6. 01,P < 0. 05) . At 3 and 6 months after treatment,the amount of menstruation in the observation group was significantly lower than that of the control group( (66. 37 ± 12. 12) points vs. (40. 46 ± 10. 15) points; (98. 42 ± 14. 12) points vs. ( 68. 26 ± 11. 38) points). The difference was statistically significant (t at 3 months after treatment= 4. 52,P<0. 05,t at 6 months after treatment= 3. 53,P<0. 05). After 6 months of treatment,the hemoglobin value of the observation group was significantly higher than that of the control group (( 142. 12 ± 4. 24) g/ L vs. ( 108. 27 ± 3. 09) g/ L), the difference was statistically significant (t= 5. 02,P<0. 05),while the adverse reactions such as vaginal bleeding, hot flashes and night sweats were lower than those of the control group (2. 5% (1/ 40) vs. 7. 5% (3/ 40)) (χ2= 3. 99,P<0. 05). Conclusion Magnetic resonance guided high intensity focused ultrasound was considered as safe and effective in treating uterine fibroids,which is a new and noninvasive therapeutic methed,

Clinical Observation of Goserelin in the Treatment of Adenomyosis Complicated with Severe Dysmenor-rhea before Placing Levonorgestrel Intrauterine System / 中国药房

OBJECTIVE:To investigate clinical efficacy and safety of goserelin in the treatment of adenomyosis complicated with severe dysmenorrheal before placing levonorgestrel intrauterine system (LIS). METHODS:A total of 140 adenomyosis pa-tients with severe dysmenorrheal were selected from Sanya Family Planning Technology Service Center during Jan. 2014-Jan. 2016, and then divided into control group and observation group according to lottery method,with 70 cases in each group. Both groups re-ceived LIS within first 7 d of menstruation,and observation group was given Goserelin acetate sustained-release implant 10.8 mg subcutaneously via anterior abdominal wall one week before placing. Therapeutic efficacy was evaluated 6 months later. The im-provement of dysmenorrhea was compared between 2 groups. The uterine volume,COX dysmenorrhea score (CMSS),menstrual volume,hemoglobin (Hb) and CA125 content were compared between 2 groups before and after treatment. The occurrence of ADR was also compared. RESULTS:The rate of dysmenorrheal improvement in observation group was 95.71％,which was signifi-cantly higher than 81.43％of control group,with statistical significance(P0.05). Compare to before treatment,CMSS score,menstrual volume and CA125 content of 2 groups were decreased significantly after treatment,while Hb content was increased significantly;the observation group was significantly better than the control group,with statistical significance(P0.05). There was no statistical significance in the incidence of ADR(10.00％ vs. 14.29％)between 2 groups(P>0.05). CONCLUSIONS:Goserelin in the treatment of adenomyosis complicated with severe dysmenorrheal before placing LIS can effectively relieve dysmenorrheal,reduce menstrual volume and improve Hb and CA125 levels,but do not increase the risk of ADR.

Prospective study of the treatment of adenomyosis by combining hysteroscopic transcervical resection of endometrium with levonorgestrel-releasing intrauterine system / 上海交通大学学报（医学版）

Objective · To explore the clinical application value of hysteroscopic transcervical resection of endometrium (TCRE) combined with levonorgestrel-releasing intrauterine system (Mirena) in the treatment of adenomyosis. Methods · A total of 112 cases of adenomyosis patients were divided randomly into the combination group and Mirena group. The combination group (56 cases) was treated by TCRE endometrium endometrial resection, assisted Mirena treatment after operation. Mirena group (56 cases) was treated by Mirena only. The follow-up lasted 36 months after treatment, including measures of the volumes of menstrual bleeding, hemoglobin levels, dysmenorrhea scores, uterine volume, serum CA125 levels and incidences of complications.Results · The median follow-up duration was 42 months, and the three-year follow-up rate was 73.21% for the combination group and 50% for the Mirena group. After surgery, the volumes of menstrual bleeding of patients in 3-36 months decreased significantly, with an increase in hemoglobin level and a decrease in serum CA215 level and dysmenorrhea scores. Compared with their situations before surgery, the difference was significant (P<0.05). A comparison of uterine volume before and after surgery showed that there is a significant decrease in the uterine volume in both groups in6-12 months after surgery (P<0.05).Twenty-four months after surgery, it shows thatthe combination group has a much more significant decrease in uterine volume [(171.3±34.8) mm3] than Mirena group [(213.7±38.6) mm3] (P<0.05). The hysterectomy rate in Mirena group was significantly higher than that in the combination group (12.50% vs 5.36%); the ring expulsion rate was 16.07% in Mirena group and 5.36% in the combination group, and the break through bleeding happeningrate was 8.93% in Mirena group and 3.57% in the combination group. After 36 months an irregular small amount of vaginal bleeding rate was 62.25% in Mirena group, while it was only 12.50% in the combination group. There was significant differencewhen comparing above indices between two groups (P<0.05). There was no obvious differences in most common side effects of both groups. Conclusion · HysteroscopicTCRE combined with Mirena reduces significantly the irregular menstrual bleeding caused by merely applying Mirena. It has a prominent clinical efficacy and can be an effective approach in treatment of adenomyosis.

Comparison of the effect between gestrinone and levonorgestrel intrauterine system in the treatment of patients with endometrial polyps after transcervical resection of polyp / 新乡医学院学报

Objective To compare the clinical effect between gestrinone and levonorgestrel intrauterine system in the treatment of patients with endometrial polyps after transcervical resection of polyp (TCRP).Methods A total of 225 endometrial polyps patients underwent TCRP were selected from January 2014 to January 2017 in Zhengzhou Central Hospital.The patients were divided into group A,B and C according to the postoperative treatment,75 cases in each group.The patients in group A were treated with gestrinone from the fifth day after operation.The patients in the group B were treated with levonorgestrel intrauterine system at the 3-5 days of the first menstruation after operation.The patients in group C were not given any treatment after operation.All patients were followed up for 6 months.The endometrial thickness,the recurrence of endometrial polyps and the improvement of abnormal uterine bleeding of patients in the three groups were observed.Results The recurrence rate of endometrial polyps in group A,B and C was 16.00％ (12/75),1.33％ (1/75) and 38.67％ (29/75) respectively;the improvement rate of abnormal uterine bleeding was 92.00％ (69/75),86.67％ (65/75) and 88.00％ (66/75) respectively.The recurrence rate of endometrial polyps in group A and B was significantly lower than that in group C (x2 =9.700,32.667;P ＜ 0.05),and the recurrence rate of endometrial polyps in group B was significantly lower than that in group A (x2 =10.191,P ＜ 0.05).There was no significant difference in the improvement rate of abnormal uterine bleeding among the three groups (x2 =1.170,P ＞ 0.05).There was no significant difference in endometrial thickness among the three groups before and one month after operation (P ＞ 0.05).Three months after operation,the endometrial thickness in group A and B was significantly less than that in group C (P ＜ 0.05),but there was no significant difference in endometrial thickness between group A and B (P ＞ 0.05).Six months after operation,the endometrium thickness in group B was significantly less than that in group A and C (P ＜ 0.05),but there was no significant difference in endometrial thickness between group A and C (P ＞ 0.05).Conclusion Gestrinone and levonorgestrel intrauterine system assisted TCRP for endometrial polyps can significantly reduce the recurrence rate of endometrial polyps,inhibit endometrial hyperplasia,and the effect of levonorgestrel intrauterine system is better than that of gestrinone.

Efficacy of the Levonorgestrel-releasing Intrauterine System to Prevent Recurrence of Endometriosis after Conservative Surgery / 中国医科大学学报

Objective To evaluate the efficacy and safety of the levonorgestrel-releasing intrauterine system (LNG-IUS) for the prevention of endometriosis recurrence after conservative surgery.Methods We enrolled patients with medium and severe endometriosis who underwent conservative surgical treatment.All patients were divided into 3 groups:group A in which the patients were administered with 3 cycles of gonadotropin-releasing hormone agonist (GnRH-a) 5 days postoperatively,group B in which the patients were administered with the LNG-IUS 5 days postoperatively,and group C in which the patients were administered with 3 cycles of GnRH-a 5 days postoperatively and the LNG-IUS on the day of the third GnRH-a injection.All patients were followed up at 3,6,12,and 24 months postoperatively.Dysmenorrhea relief was evaluated,and pelvic ultrasound and serum CA125 detection were performed.All treatment-related adverse reactions were recorded.Results Eighty-three patients were included with 21,29,and 33 in groups A,B,and C,respectively.The VAS scores in all 3 groups after 3 months were significantly lower than those obtained preoperatively (P ＜ 0.05).No significant difference was found in the VAS scores after 6 and 12 months among the 3 groups (P ＞ 0.05).After 24 months,the VAS scores in group A were significantly higher than those in the other 2 groups (P ＜ 0.05).Endometriosis recurrence was found in 8 patients after 24 months,with 4 (19.05％),3 (10.71％),and 1 (3.13％) such patient in groups A,B,and C,respectively (P ＜ 0.05).No serious side effects were found.Conclusion Postoperative application of LNG-IUS can effectively prevent recurrence and relieve pain caused by endometriosis,and its combined application with GnRH-a can improve efficacy.