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.

Efficacy and safety of low-dose levonorgestrel-releasing intrauterine system in Chinese women: a multicenter, single-arm, open labeled interventional trial / 中华妇产科杂志

Objective To evaluate the efficacy,bleeding profile and safety of low-dose levonorgestrel-releasing intrauterine system (LNG-IUS 8) in Chinese healthy women of childbearing age.Methods A multi-center,open-label,single-arm clinical trial conducted at 16 centres in China enrolled 773 healthy women of childbearing age (mean age 31.6 years old,range 18 to 40 years old),who demanded contraception,from April 2006 to June 2013.All women placed LNG-IUS 8 for 3 years and then been followed up at 3,6,9,12,18,24,30,36 months.The efficacy variables including pregnancy rate and expulsion rate were analyzed using life table,while observing adverse events (AE) to evaluate the safety.The bleeding profile happened during the study was assessed using 90-day reference intervals (World Health Organization criteria).Results Eight pregnancies occurred among 773 women,resulting in a overall Pearl index of 0.42 per 100 women years.The 3-year cumulative pregnancy rate was 0.37 per 100 women years and the 3-year cumulative expulsion rate was 1.99 per 100 women years.The number of women with bleeding/spotting reduced and the bleeding/spotting days declined over time.Totally 219 AE were reported related to LNG-IUS 8 placements.The most common AE were vaginal bleeding (8.2％,63/773)and the ovarian cyst (6.2％,52/773).LNG-IUS 8 had an improving effect on dysmenorrhea that the percentage of women with dysmenorrhea as well as the days of dysmenorrhea decreased over time.The percentage of women satisfied or very satisfied with LNG-IUS 8 was 87.2％ (622/713).Conclusion LNG-IUS 8 is highly effective and safe for Chinese healthy women of childbearing age.

Effectiveness research of medicatedγintrauterine device and medicated genefix intrauterine device inserted immediately after abortion / 中华妇产科杂志

Objective To compare the effectiveness of medicated γintrauterine device (IUD) and medicated genefix IUD inserted immediately after abortion. Methods A multicenter clinical trail was performed for the study from Mar. 2012 to Jan. 2013. Totally 840 women who volunteered to participate were randomly allocated to γ-group (medicated γ IUD) or genefix-group (medicated genefix IUD) immediately after abortion. While 464 abortion women who had not used IUD or steroids contraceptive methods were chosen as control group. The effectiveness of the IUD were followed up for 1 year. All women were required to record the number of vaginal bleeding days and blood volume of vaginal bleeding within 3 months after abortion. Results At the 12th month, the expulsion was the most common reason for termination. The expulsion rates of genefix-group and γ-group were 2.48/100 women years and 3.12/100 women years, respectively (P>0.05). For the expulsion reasons, IUD moving down could account for more than seventy percent. The removal rate for IUD usage of two IUD groups were almost equal (3.91/100 women years verus 4.35/100 women years), the differences were not statistically significant (P>0.05). At the 90th day after abortion, comparing with control group, the bleeding and (or) spotting days of genefix-group and γ-group extended by 3.9 and 2.6 days respectively, the differences had statistical significance between the three groups (P0.05). Conclusion The insertion of medicated genefix IUD and medicated γ IUD immediately after abortion is safe, feasible, has slight side effects and could be effective contraception.

Changes of menstruation patterns and adverse effects during the treatment of LNG-IUS for symptomatic adenomyosis / 中华妇产科杂志

Objective To investigate the changes of mestruation patterns and adverse effects during the treatment of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis in a prospective cohort study. Methods From December, 2006 to December, 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in Peking Union Medical College Hospital were given LNG-IUS. Before and after placement of IUS, all patients′ parameters were recorded, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Risk factors for changes of menstruation patterns and adverse effects, and their impact on treatment effects were analyzed. Results Totally 1 100 cases met inclusion criteria, with median age 36 years (range 20-44 years), median follow-up 35 months (range 1-108 months). During follow-up changes of menstruation patterns increased significantly with amenorrhea and shortened-menstruation being the most common manifestations. On 3, 6, 12, 24, 36, 48 and 60 months after the placement of LNG-IUS, 0, 5.8%(43/744), 6.9%(47/682), 10.1%(60/595), 17.3%(87/502), 27.2%(104/383) and 29.6%(82/277) patients achieved amenorrhea respectively (P12 months after placement, abdominal pain and body weight increasing ≥5 kg/year were the most common adverse effects. Changes of menstruation patterns, total and subclassifications of adverse effects were neither dependent on patient parameters, treatment modes and treatment effects, nor could predict future LNG-IUS carrying status (all P>0.05). After taking out of LNG-IUS, most changes of menstruation and adverse effects disappeared. Conclusions During the treatment of LNG-IUS for symptomatic adenomyosis, changes of menstruation patterns increase gradually with amenorrhea and shortened-menstruation being the most common manifestations, while adverse effects decrease significantly. Changes of menstruation patterns or adverse effects neither have any risk factor nor have impact on treatment effects.

Clinical study of high intensity focused ultrasound ablation combined with GnRH-a and LNG-IUS for the treatment of adenomyosis / 中华妇产科杂志

Objective To investigate the clinical effect of dysmenorrhea in patients with adenomyosis treated by high intensity focused ultrasound (HIFU) ablation combined with gonadotropin-releasing hormone agonist (GnRH-a) and levonorgestrel-releasing intrauterine system (LNG-IUS). Methods From April 2012 to December 2015, 477 cases of adenomyosis patients with dysmenorrhea were treated by HIFU in the Third Xiangya Hospital. Among them, some patients were treated with HIFU alone, some of them were treated with HIFU combined with GnRH-a and (or) LNG-IUS, thus were classified as H group, H+G group, H+M group and H+G+M group. The improvements of clinical results were compared among the four groups and the influencing factors of HIFU treatment for adenomyosis were also analyzed. Results During the follow-up period, the overall effective rates of the treatment decreased with time, 3 months 89.4% (345/386), 12 months 84.0%(221/263), 24 months 74.2%(98/132), and the overall recurrence rate was 12.9%(39/303). The significant difference in the curative at 3 months [H group 83.7%(170/203), H+M group 95.0%(95/100), H+G group 100.0%(43/43), H+G+M group 96.8%(30/31)], 12 months [H group 79.4%(123/155), H+M group 93.2%(69/74), H+G group 11/12, H+G+M group 15/17], and 24 months [H group 68.0%(51/75), H+M group 96.4% (27/28), H+G group 6/12, H+G+M group 15/15] after HIFU treatment and recurrence rate [H group 19.0%(29/153), H+M group 3.3%(3/90), H+G group 19.4%(6/31), H+G+M group 4.5%(1/22)] were observed among the four groups (P<0.05). Pairwise comparison further showed that, in 3 months after the treatment, the effect of H group was significantly lower than those of H+M group and H+G group (P=0.003, P=0.005);in 12 months after the treatment, the effect of H group was significantly lower than that of H+M group (P=0.006);while in 24 months after treatment, the effect of H group was significantly lower than that of H+G+M group (P=0.005), and the effect of H+G group was lower than that of H+G+M group (P=0.001); and the recurrence rate of H group was significantly higher than that of H+M group (P<0.008). In patients of group H, the effect of HIFU was related to uterine size, the effect of patients with large uterine volume was significantly higher than that of small volume of uterine of patients (P=0.017, OR=2.739, 95%CI:1.200-6.251); with increasing of age, the improvement of dysmenorrhea had a increasing trend (P<0.05). Conclusions HIFU combined with GnRH-a and (or) LNG-IUS could improve the treatment effect in relief of dysmenorrhea. Based on our results, individual treatment protocol should be selected for different patients.

Resolución laparoscópica de translocación abdominal de dispositivo intrauterino: Reporte de un caso / Laparoscopic removal of an intra-abdominal translocated intrauterine device: Case report

A partir de que Richter R, en 1909, realizó la primera publicación sobre el uso de dispositivos intrauterinos con fines anticonceptivos, la forma, los materiales, las indicaciones, así como las contraindicaciones han evolucionado hasta convertirse en el método de planificación familiar más usado en el mundo. El riesgo de perforación durante la inserción es bajo; sin embargo, ha sido referida. En la literatura se ha descrito el uso de la laparoscopia para la extracción de dispositivos intrauterinos migrados a cavidad abdominal. En la presente publicación se reporta el caso clínico de una mujer de 29 años de edad, con antecedente de colocación de dispositivo intrauterino, dos años previos, por vía vaginal sin complicación aparente; comenta sólo dolor de cólico posterior a la colocación que va cediendo a analgésicos vía oral no especificados, sin sintomatología hasta la fecha. Acude a revisión y realización de citología cervical donde no se encuentran hilos guía del dispositivo intrauterino. Mediante radiografía simple de abdomen y bajo fluoroscopia se determina la localización intraabdominal del testigo radiopaco del dispositivo, es valorada por el Servicio de Cirugía General y se determina a realizar la extracción del mismo por vía laparoscópica sin complicaciones; se encontró el dispositivo con adherencias a omento mayor, sin afección aparente de órganos intraabdominales. La Organización Mundial de la Salud recomienda la extracción inmediata de los dispositivos intrauterinos que han migrado. La migración del dispositivo intrauterino a la cavidad abdominal es una complicación poco frecuente, y la presentación como hallazgo en pacientes asintomáticas es aún menos frecuente; en una revisión sistemática de la literatura, Richdeep S y cols. valoraron 49 artículos en los que encontraron 179 casos de manejo laparoscópico, reportando al omento como el sitio más frecuente de localización (26.7%). La relevancia del presente caso radica en la presentación asintomática dos años posteriores a su inserción, la ruta diagnóstica utilizando radiografías simples y fluoroscopia, así como la extracción sin complicaciones y con excelente resultado, vía laparoscópica.

Since Richter R. in 1909 performed the first publication on the use of intrauterine devices; materials, forms, indications and contraindications of these have evolved to become the method most widely used family planning in the world. Although the risk of perforation during insertion is low, it exists. The literature has described the use of laparoscopy for removal of intrauterine devices migrated to the abdominal cavity. Case report: 29 years old woman who two years before suffers colic pain posterior to application of an intrauterine device with no complications, and diminishes with the use of unspecified analgesics, and stays asymptomatic to date. She attended a review, and underwent to cervical cytology, during the procedure, was impossible to see the strings of the intrauterine device. Plain abdominal radiography and fluoroscopy were done to determine the location of the radiopaque intraabdominal witness. Assessed by the General Surgery Service we determined extraction of the device by laparoscopy and was done without any complication. Findings: strong omentum adhesions to the device, but no apparent damage to other abdominal organs. The World Health Organization recommends the immediate removal of intrauterine devices that have migrated. The migration of the intrauterine devices into the abdominal cavity is a rare complication, and the presentation as an incidental finding in asymptomatic patients is even less common, a systematic review of literature, Richdeep S. et al, evaluated 49 items found 179 cases of laparoscopic management reporting the omentum as the most common site of localization (26.7%). The relevance of this case lies in the asyntomatic presentation two years after insertion, the diagnostic route using radiographs and fluoroscopy, and extraction without complications and with excellent results laparoscopically.

Chinical effects of three kinds of active IUD inserted immediately after induced abortion / 中国基层医药

Objective To compare the effects of three types intrauterine device(IUD)insertion immediately after vacuum aspiration.Methods 120 cases of artificial abortion immediately placed IUD women were selected.According to the IUD type,the patients were divided into the TCu3s0AIUD group 40 cases,active gamma type 40 cases in group IUD,palace copper 40 cases in ZooIUD group,followed up for 12 months.Results All of the subjects were not with IUD pregnancy.The termiration rate was Palace copper ZooIUD group 27.5％,active gamma type IUD group7.5％ TCu3s0AIUD 15.0％,three groups of termination rate had a significant difference(F=5.88,P＜0.05);threegroup IUD complications had no statistical difference(all P＞0.05).Follow-up for 12 months,palace copper group ZooIUD menstruation increase incidence rate of 42.5％,significantly higher than the other two groups 15.0％,20.0％(F=8.96,P＜0.05);the difference between the three groups in irregular bleeding was significant(F=17.77,P＜0.01).Conclusion The three kinds of IUD has good contraception effect,wherein the active gamma IUD has smaller adverse reaction,continue to use rate is high,so it is worthy of clinical application.

A randomized clinical trial of intrauterine device MYCu / 中华全科医师杂志

Objective To observe safety and efficacy of intrauterine device MYCu IUD that releases indomethacin. Methods In total, 2000 women requiring IUD for contraception were chosen from domestic multiple clinical centers according to an unified standard. MYCu IUD and TCu380A IUD were randomly inserted for 1000 women each, respectively. All women were regularly followed-up one, three, six and 12 months after insertion. Results All the women were followed-up for 11 985.9 and 11 753.6 person-months in MYCu IUD and TCu380A IUD groups, respectively, with cumulative IUD application rates of 97. 80% and 94. 70%, and cumulative pregnancy rates with IUD of 0. 10% and 0. 31%, respectively. Cumulative expulsion (or partial expulsion) rate in MYCu IUD group was 0. 10%, significantly lower than that in TCu380A IUD one (1.73%), P ＜0. 01, and cumulative removal rate due to medical reasons (bleeding or pain) was 1.51 % and 2. 94%, respectively, P ＜ 0. 05. Rate of IUD-associated termination and overall rate of termination differed significantly between the two groups, P ＜0. 01. Adverse reactions one, three, six and twelve months after IUD insertion included irregular bleeding, prolonged menstruation, increased menstrual blood volume and pain, less in indomethacin-containing MYCu IUD group than those in TCu380A IUD without containing it, P ＜ 0. 01. Conclusions MYCu IUD is a comparatively ideal IUD that should be promoted for extensive use, with extremely low expulsion rate, good contraceptive effect, convenience and safety in insertion and removal, and less adverse effects.

Clinical effects of delayed levonorgestrel-releasing intrauterine system on leiomyoma accompanied by menorrhagia / 解放军医学杂志

Objective To observe the clinical effect of delayed levonorgestrel-releasing intrauterine system(Manyuele) on leiomyoma accompanied by menorrhagia.Methods Thirty-two patients with uterine leiomyoma accompanied by menorrhagia and moderate or severe anemia were involved in present study.The Manyuele intrauterine contraceptive device was applied at the 5th to 7th day of menstrual cycle,the menstrual blood volume was observed and assessed by PABC scale,and hemoglobin concentration,uterus volume,tumor size,levels of estradiol(E2),lutropin(LH),follicle stimulating hormone(FSH) in serum,and four items of blood lipid index(cholesterol,triglyceride,high and low density lipoprotein) were determined before and 3 and 12 months after Manyuele applied.The adverse reactions such as vaginal bleeding were recorded.Result The scores of menstrual blood volume was 201.5?78.1 before Manyuele application,and declined to 52.2?13.7 and 20.3?6.3,respectively,on the 3rd and 12th months after Manyuele application(P0.05).After being followed-up for 3months,irregular dropwise bleeding was found in 15 cases,and 10 cases had regular bleeding with prolonged menstruation.Only 2 cases had irregular dropwise bleeding one year later.Conclusion Manyuele intrauterine contraceptive devices can effectively decrease menstrual blood volume,correct anemia,reduce the volume of leiomyoma,and throw no significant influence on ovular function and blood lipid metabolism.