左炔诺孕酮宫内缓释系统临床应用研究

左炔诺孕酮宫内缓释系统（LNG-IUS）是一种安全、高效的宫内节育器（IUD），其通过每天释放小剂量的左炔诺孕酮至宫腔实现孕激素的非全身给药，从而开辟了在非避孕领域的许多新的应用。现就其在治疗月经过多、子宫内膜异位症和腺肌症、激素替代治疗期间的子宫内膜保护等方面进行综述。     

Endometrial thermal balloon ablation by a simple technique using Foley’s catheter with or without pre ablation endometrial curettage to treat cases with intractable menorrhagia

ObjectivesTo assess the efficacy and safety of endometrial thermal ablation by a technique using Foley’s catheter to treat cases with intractable menorrhagia and to compare between results with and without pre procedure curettage.Study designProspective randomized controlled study.Patients and methodsForty eight patients aged from 39 to 52 years complaining of menorrhagia not responding to treatment for at least 6 months were included in the study, pre ablation endometrial curettage was done for 24 randomly selected cases (group 1) and ablation without curettage for the other 24 cases (group 2). A latex silicon coated Foley’s catheter with 30–50 ml capacity was tested and inserted into uterine cavity then inflated by a variable volume of boiling saline as the uterine cavity permits under moderate pressure and replaced every 2 min with a new boiling saline, for 8 min duration. Then follow up for 6 months and hysteroscopic examination were done to detect endometrial scarring.Outcome measuresPatients satisfaction, menstrual outcome, hysteroscopic diagnosed scarred endometrium.ResultsThis study showed a satisfaction rate of 83.3%, improvement in menstrual bleeding (79.2%) and hysteroscopic diagnosed scarring of the endometrium (75%). Cases in group 1 had a significantly higher satisfaction rate (95.8%) than in group 2 (70.8%) and significantly lower incidence of persistent menorrhagia after ablation than cases in group 2 (4.2% versus 37.5%, respectively). Hysteroscopic diagnosed endometrial scarring was significantly higher in group 1 (91.7%) versus (53.8%) for group 2.ConclusionEndometrial thermal balloon ablation by a technique using Foley’s catheter is a safe, simple, cheap and effective procedure as an alternative to hysterectomy for treatment of menorrhagia in properly selected cases. Pre ablation endometrial curettage increases the satisfaction rate and improves menstrual outcome.     

“Evaluation of the effect of roasted lentil flour (lentil savigh) as a functional food in menstrual bleeding reduction”

BackgroundMenorrhagia is a regular menstrual cycle lasting more than seven days and/or blood loss over 80 mL per cycle. One of the herbs recommended in Iranian traditional medicine for menorrhagia treatment is lentil savigh, which is the flour made from roasted lentil (Lens culinaris medic).MethodsThe current randomized clinical trial was conducted on 54 patients within the age range of 18 to 50 years randomly divided into two groups. The treatment group took three 10-gram lentil savigh sachets in the morning. The control group was treated with 500 mg tranexamic acid capsule every eight hours, both from the first day of menstruation for seven days. Patient's bleeding was evaluated by the pictorial blood loss assessment chart (PBAC), before and in each of the three treatment cycles. Quality of life was evaluated by the menorrhagia questionnaire (MQ) at the beginning and the end of the study for each patient.ResultsThe mean (SD) of PBAC scores significantly decreased before and after three cycles from 383.5(163) to 222.1(128.6) in the lentil savigh group (P < 0.0001), and from 333.8(141.3) to 239.1(132.6) in the tranexamic acid group (P < 0.0001). There was no significant difference between the two groups (P < 0.6).Quality of life significantly improved in the lentil savigh group from 61.5(12.3) to 34.4(14.6) in comparison with that of the tranexamic acid group changing from 56.3(11.1) to 46.8(12.7) (P < 0.004).ConclusionBoth products were effective in menstrual bleeding reduction, but lentil savigh improved the quality of life more effectively. Therefore, lentil savigh, as a functional food, could be introduced as a good initial choice for menorrhagia treatment.     

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids.The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated.Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless.It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.     

Microwave endometrial ablation for menorrhagia in patients with systemic disorders.

OBJECTIVE: To evaluate the effectiveness of microwave endometrial ablation (MEA) in the treatment of menorrhagia in patients with severe systemic disease or medical conditions. METHODS: Forty-two menorrhagic women undergoing systemic disorders with failure of medical management were treated with MEA under local or general anesthesia, and were followed-up for 1 year. RESULTS: The women had a mean age of 39.4 years (range, 17-49). The procedure was successfully completed in all patients, and no intraoperative complications occurred. Two cases died of their primary severe medical diseases within 2 months of treatment but these cases were not associated with MEA. Among the remaining 40 patients, 24 (60.0%) had amenorrhea within 12 months. The duration of hospitalization and the amount of blood transfusion were significantly reduced after treatment, and the quality of life of these patients was improved significantly. CONCLUSIONS: MEA is a safe and effective treatment for the management of severe menorrhagia in patients undergoing systemic illness or severe medical conditions.     

子宫热球仪治疗月经过多30例临床分析

目的 探讨子宫热球仪治疗月经过多的效果.方法 采用美国Gynnecare公司研制的TBEA系统,在宫腔内放置特别的乳胶球囊,通过加热的介质使球囊膨胀和加热,以热能均匀地作用于宫腔表面,使子宫内膜组织蛋白凝固,坏死,剥离,以去除足够深度的子宫内膜,达到治疗月经过多的目的.手术前行宫腔镜检查、诊断性刮宫排除宫内占位病变,对30例年龄41～56岁已生育、经保守治疗无效而不愿切除子宫月经过多的病人实行子宫热球仪治疗.结果 30例中有效率96.67%,出现闭经10例(占33.33%),点滴出血10例(占33.33%),少量月经8例(占26.67%),正常月经1例(占3.33%),无明显效果1例(占3.33%).术后除10例出现低热外无子宫穿孔、破裂、邻近组织热损伤、感染及血肿等并发症.结论 子宫热球仪治疗月经过多疗效高,简便,无并发症,是一种安全而微创的手术.     

A Heat Transfer Model of Thermal Balloon Endometrial Ablation

A heat transfer model was developed for thermal balloon endometrial ablation treatment for menorrhagia. The model includes heat conduction through the uterus wall, cooling due to blood perfusion through the uterine tissue and the contribution of metabolic heat generation. A parameter sensitivity study indicated that metabolic heat generation had a minimal effect, but model predictions were sensitive to blood perfusion rate. However, within the range of expected perfusion rates, the model calculates damage depths (3–6 mm) close to the range for effective treatment. Using a blood perfusion rate of 0.0028 m _t ³ m _b ^-3 s _s ^-1 the predicted burn depth (4 mm) correlated well with experimental measurements (4.2 ± 0.6 mm) reported elsewhere for a treatment temperature of 92°C and time of 6 mins (Neuwirth, R. S. et al. The endometrial ablator: A new instrument. Obstet. Gynecol. 83:792–796, 1994). If no vaporization of water in the tissue occurs, the model predicts that the same burn depth of 4 mm can be obtained with increased treatment temperature (130°C) and shorter treatment time (1.4 min). Steeper temperature profiles through the uterine wall suggest that, in the absence of other changes due to higher temperatures, the deeper layers of the myometrium and the serosa would be protected from thermal damage when using higher treatment temperatures for a shorter duration. However, if vaporization occurs at 105°C, the model predicts little benefit in using treatment temperatures above 120°C up to 160°C. For further validation of the model, in vivo studies using the high temperature treatments are needed to measure temperature profiles through the uterine wall, blood perfusion rates, and the other effects of temperature on uterine tissue. © 2001 Biomedical Engineering Society. PAC01: 8719Pp, 8710+e, 8780-y, 8719Tt     

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on cardiovascular disease risk factors in menorrhagia patients: a 10-year follow-up of a randomised trial

Objective

To compare, whether women with menorrhagia, treated with either hysterectomy or LNG-IUS, differ in their cardiovascular risk profile during 10-year follow-up.

Study design

A total of 236 women were randomized to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). Their cardiovascular risk factors were analyzed at baseline, at 5 years, and at 10 years. As 55 originally randomized to the LNG-IUS group had hysterectomy during the follow-up, all analyzes were performed by actual treatment modality.

Main outcome measures

Waist circumference, body-mass index (BMI), blood pressure, and the levels of blood lipids, serum high-sensitivity CRP (hsCRP) and tumor necrosis factor alpha (TNF-α) were measured, and the use of medication for hypertension, diabetes, hypercholesterolemia, and ischemic heart disease was analyzed.

Results

After 5 years, an increase in the use of diabetes medication during the follow-up was only detected in the hysterectomy group (from 1.7% to 6.7%, P = 0.008 vs from 5.1% to 8.4%, P = 0.08), as well as they had significantly higher serum levels of TNF-α (108.59 pg/ml vs 49.02 pg/ml, P = 0.001) and hsCRP (1.55 μg/ml vs 0.78 μg/ml, P = 0.038) at 5- and 10-years. There was no difference between the groups in the use of cardiovascular medication, neither was there difference in blood pressure, waist circumference, BMI, or concentrations of blood lipids.

Conclusions

Hysterectomy seems to be associated with increased levels of serum inflammatory markers and increased diabetes medication, which in turn, may predispose individual to future cardiovascular events.     

Menorrhagia and minor bleeding symptoms in women on oral anticoagulation

Background

Oral anticoagulation (OA) is a common treatment with a known risk of fatal or major bleeding, but also minor bleeding symptoms and menorrhagia can cause substantial discomfort and necessitate medical or surgical interventions. The extent of these side effects is however not previously reported. The objective of this study is to assess the frequency of minor bleeding symptoms and menorrhagia attributed to OA treatment.

Methods

Ninety fertile women between 15 and 49 years-of-age on OA treatment completed an inquiry at the anticoagulation clinics of Malmö, Lund and Gothenburg, Sweden.

Results

The frequency of minor bleeding symptoms was significantly increased during OA treatment (P < 0.05) except for hematuria. The incidence of bleeding after tooth extraction (>3 h) increased from 3.0 to 45.2%, easy bruising 17.8–75.6%, epistaxis 11.1–23.6%, gingival bleeding 22.2–48.3% and hematuria 10.0–15.6% (Table 1). Hematemesis was reported in 5.6% prior to as compared to 14.4% during OA treatment, blood in the feces in 8.9 and 18.9%, respectively. Mean duration of menses increased from 5.6 to 6.1 days (P < 0.01) and reported menorrhagia from 44.2 to 70.8% (P < 0.001). Eighteen percent were treated for menorrhagia before and 29.9% during OA treatment (P < 0.01).

Conclusions

OA treatment is known to confer increased risk of fatal or major bleeding. This study shows that fertile women on OA also experience significantly increased minor bleeding symptoms including menorrhagia that may considerably impair quality of life.