Hormonal contraception in Chinese men: variations insuppression of spermatogenesis with injectable testosteroneundecanoate and levonorgestrel implants

Aim: To explore the causes of the difference in spermatogenic suppression between responders and non-responders in Chinese men treated with levonorgestrel (LNG) implants plus testosterone undecanoate (TU) injectable. Methods: The 16 Chinese volunteers treated were divided into two groups in regard to the sperm count during the treatment period, 7 men in the responder group (Group R), including 6 azoospermia and one severe oligozoospermia, and the remaining 9 in the non-responder group (Group N), including 4 oligozoospermia and 5 with sperm counts greater than 20×106/mL. The differences in serum profiles of FSH, LH, T, LNG and T/LH ratio were compared between the two groups and the correlation between the seminal fluid parameters and serum reproductive hormones was analyzed. Results: The serum FSH level was lower in Group R than that in Group N (P<0.05), while the serum LH and LNG levels were higher in Group R than those in Group N (P<0.05). The sperm density (P<0.01, r=0.235), motility (P<0.01, r=0.326) and vitality (P<0.01, r=0.219) showed significantly positive correlation with the serum FSH level. Conclusion: The blood LNG and T levels, the degree of FSH inhibition and/or the sensitivity of the pituitary-testis axis to exogenous steroids, as well as the individual spermatogenetic potential and the functional status of the Leydig cells may be factors bringing about individual differences in spermatogenic suppression in Chinese men treated with LNG and TU.

Giant exophytic cystic adenomyosis with a levonorgestrel containing intrauterine device out of the uterine cavity after uterine myomectomy: A case report

A cystic lesion arising from the myometrium of the uterus,termed as cystic adenomyosis,has chocolate-like,thick viscous contents and contains various amounts of endometrial stroma below the glandular epithelium.It is an extremely rare type of adenomyosis.CASE SUMMARY Herein,we report an unusual case of a giant cystic mass in the pelvic cavity after uterine myomectomy.The patient complained of abnormal uterine bleeding and severe dysmenorrhea.After a levonorgestrel-containing intrauterine device(LNG-IUD)was inserted,her symptoms were greatly alleviated.However,the LNG-IUD was detected in the cystic cavity during the follow-up.For fear of the intrauterine device migrating into and damaging the surrounding viscera,surgical treatment was proposed.Therefore,laparoscopic resection of the lesion and removal of the LNG-IUD were performed and cystic adenomyosis with an LNG-IUD out of the uterine cavity was diagnosed.CONCLUSION We believe that myomectomy breaking through the endometrial cavity may have been a predisposing factor for the development of cystic adenomyosis in this case.

Comparison of ESI–and APCI–LC–MS/MS methods:A case study of levonorgestrel in human plasma

Electrospray ionization(ESI) and atmospheric pressure chemical ionization(APCI) techniques for liquid chromatography–tandem mass spectrometry(LC–MS/MS) determination of levonorgestrel were evaluated.In consideration of difference in ionization mechanism,the two ionization sources were compared in terms of LC conditions,MS parameters and performance of method.The sensitivity for detection of levonorgestrel with ESI was 0.25 ng/m L which was lower than 1 ng/m L with APCI.Matrix effects were evaluated for levonorgestrel and canrenone(internal standard,IS) in human plasma,and the results showed that APCI source appeared to be slightly less liable to matrix effect than ESI source.With an overall consideration,ESI was chosen as a better ionization technique for rapid and sensitive quantification of levonorgestrel.The optimized LC–ESI–MS/MS method was validated for a linear range of 0.25–50 ng/m L with a correlation coefficient ≥0.99.The intra-and inter-batch precision and accuracy were within 11.72% and 6.58%,respectively.The application of this method was demonstrated by a bioequivalence study following a single oral administration of 1.5 mg levonorgestrel tablets in 21 Chinese healthy female volunteers.

Levonorgestrel Intrauterine System (LNG IUS) in Menorrahgia: A Follow-Up Study

Objective: To study the acceptability, efficacy, adverse effect and user satisfaction of Levonorgestrel intrauterine system (LNG IUS) for treatment of menorrahgia.?Method: This was an observational descriptive study conducted in ESI PGIMSR over a period from Jan 2008-June 2011. 70 women presented in O.P.D with heavy menstrual bleeding having no contraindication for device, consenting for LNG IUS underwent its insertion. Menstrual pattern, pictorial blood loss assessment chart score, adverse effects, and rate of acceptability and satisfaction were recorded at 3, 6 and 12 months after procedure. Results: The mean age of the sample was 39.92?yrs ± 3.27.?Indication for device insertion was DUB in 81.42% (57), fibroid 8.57% (6), adenomyosis in 10% (7). The expulsion rate was 4.2% (3), removal rate was 7.14% (5) and continuation rate is 88.57% (62). 2.28% (3) patients underwent hysterectomy because of continuous bleeding even after 3?-?4 months of insertion. On follow-up at one year out of 62 patients, 33.87% (21) were amenorrhic and 51.61% (32) have?regular period, while 3.07% (2) patients had irregular period.?Conclusion: LNG IUS is a less invasive, effective treatment modality for menorrahgia with reasonable efficacy.

Quality of Life in Women with Endometriosis Pelvic Pain Treated with the Levonorgestrel-Releasing Intrauterine System

Objective: To evaluate the quality of life in patients with endometriosis pelvic pain before and after the application of the levonorgestrel-releasing intrauterine system (LNG-IUS). Design: Open non-comparative study. Setting: Obstetrics and Gynecology Hospital at Monterrey, Mexico. Sample: 29 women aged 18 to 40 years with pelvic pain associated with endometriosis confirmed by laparoscopy. Methods: After laparoscopy but before LNG-IUS insertion (basal visit) and 6 months afterwards, modified Endometriosis Health Profile (EHP-30) was applied. Main outcomes measures: Size of change of questionnaire scores, need of additional analgesic therapy and adverse effects. Statistical Analysis: Differences in the questionnaire scores before and after intervention were analyzed by Student t-test. Results: Final analysis set included 29 women aged 31.7 ± 4.7 years years. The ASRM surgical staging of endometriosis was mild in 19.3 moderate in 13.7 and severe in 76% of the patients. The general perception of quality of life improved from 52 at baseline to 98% at six months (p < 0.001). Adverse events were mild in nature, 19 patients reported no adverse events during the study (65.5%). Two patients (6.9%) required the use of concomitant therapy with non-steroidal analgesics for relief of pain. Conclusion: The application of LNG-IUS in patients with pelvic pain associated with endometriosis improved significatively all aspects related with quality of life as measured with Endometriosis Health Profile (EHP-30). We concluded that LNGIUS may be an effective and convenient therapeutic alternative for the management of pain associated with endometriosis.

Study on Differences in Spermatogenic Suppression between Azoospermic and Oligozoospermic Responders Treated with Levonorgestrel Implant Plus Testosterone Undecanoate Injectable in Chinese Men

Objective To investigate possible causes resulting in the differences in the spermatogenesis suppression on individual treated with levonorgestrel (LNG) implants and testosterone undecanoate (TU) injectableMethods Totally 21 Chinese male volunteers were given treatment with LNG implants (four rods, 75 mg/rod) and intramuscular injection of TU (500 mg,bimonthly for 3 times). According to the effects of treatment, they were divided into two groups, namely, azoospermia group (group A) and oligozoospermia group (group O). Then seminal FSH, LH, T and estradiol (E2) were determined by immunoenzymetric assay, while seminal and serum dihydrotachysterol (DHT) and serum sex hormone binding globulin (SHBG) were by radioimmunoassay, and seminal transferrin (Tf) by scatter turbidimetry assay.Results Seminal FSH, LH and serum DHT, SHBG, FTI (T/SHBG ×100) levels were significantly lower in group A than in group O, while higher seminal concentrations ofE2 were observed in azoospermia group.Conclusion The differences in the spermatogenic suppression in Chinese men might be attributed to different rate of peripheral androgen metabolism, variations in serum SHBG levels, 5á-reductase activity and individual aromatase activity during LNG plus TU administration. In addition, seminal sex hormones might be more sensitive indexes to assess the extent of feedback inhibition on hypothalamus-pituitary-testis with exogenous testosterone plus progestogen in the efficacy hormone male contraceptive trials.

A randomized double-blind multicenter study on comparing levonorgestrel and mifepristone for emergency contraception

Objective: To compare the efficacy and side effects of levonorgestrel and low dose mifepristone in emergency contraception. Method: The study is a randomized double--blind multicenter comparative trial. A total of 1, 276 women with unprotected intercourse within 72 hours were allocated to one of the two study groups. In the levonorgestrel (LNG) group, 0. 75 mg LNG was taken twice, 12 hours apart, whereas in the mifepristone (Mife) group, a single dose of 10 mg mifepristone was taken and a placebo 12 hours after. Follow--up visit was paid on the seventh day of the expected next menstruation to evaluate the contraceptive efficacy and side effects. Contraceptive efficacy was calculated by Dixon’s method. Result:In the LNG group 20 pregnancies occurred among 643 women, while in the Mife group 9 pregnancies occurred among 633 women. The pregnancy rates were 3. 10% and 1. 43% respectively. Contraceptive efficacy rate of preventing pregnancy was 59. 16% and 79. 73%, the difference was statistically significant (P<O. 05). The incidence of various side effects, which were mild, was less than 10%. There was no statistical difference between the two groups. The percentage of subjects who had their next menstruation 3 days earlier or later than their expected menstruation in LNG group and Mife group was 77. 7% and 78. 5% respectively. Conclusion: Use of levonorgestrel or low dose mifepristone for emergency contraception is effective and safe.

Study on In Vivo Release of Levonorgestrel-containing Silicon Capsule

The in vivo release rate of levonorgestrel-containing silicon capsule (in vitro releasing rate: 6 μg/d) placed in rabbits was determined.The results showed that the average release per year was 8. 32 μg with r being 0.96000.The release pattern of the levonorgestrel-containing silicon capsule system was proved to be zero-order release. Our study provided some experimental data for clinical use of the system for birth control.

Effect of Domestically－made Levonorgestrel－releasing Intrauterine Device on the Endocrine System and Mensentruation in Monkey

Effect of domestically-made levonorgestrel-releasing intrauterine device (LNG, release rate: 6 μg/day) on the endocrine system and menstruation in mondeys was investigated. The results showed that the Estradiol (E2) and progesterone (P) levels were significantly decreased 2 ovulatory cycles after iusertion of the devices as compared with those before insertion in 3 monkeys (P>0. 001) ,suggesting an evident ovulation-suppressing effect. In 1 monkey, the E2 and P levels were the same before and after insertion,and expulsion of device was found in the monkey later. The plasma LNG concentration in 3 animals was 493. 69-454. 60 pg/ml and plasma LNG was not detected in 1 monkey. The hormone level returned to normal level after removal of the devices.

Electrical Storms after Levonorgestrel (Synthetic Progestin)-Releasing Intra-Vaginal Device Insertion. A Case Report and a Short Review of Literature

We report a case of arrhythmic storm in a patient with recent vaginal insertion of a device with release of levonorgestrel (synthetic progestin). A woman of 60 years was hospitalized for runs of monomorphic sustained ventricular tachycardia. She received a vaginal device levonorgestrel-releasing 2 days before admission. No history of associated cardiovascular or thyroid disease or risk factors was reported. Laboratory parameters as well as ECG and echocardiogram were normal. After 48 hours from removal of the vaginal device, the patient was asymptomatic and showed only single ectopic beats, sometimes in pairs. The subsequent coronary angiography, electrophysiological study and cardiac magnetic resonance resulted negative.

SUSTAINED RELEASE OF LEVONORGESTREL USING POLYPHOSPHATE AS DRUG CARRIER

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A comparative, randomized study of levonorgestrel Intrauterine System (LNG-IUS) vs Copper T 380 A intrauterine device applied during cesarean section

Objective: To assess levonorgestrel-releasing intrauterine system LNG-IUS (Mirena?) application at caesarean section (CS). Design: Randomized, comparative study. Setting: Department of obstetrics and gynecology in a primary reference hospital at Puebla City, Mexico. Sample: 396 women requiring CS signed informed consent and were randomly allocated to the post-placental application of LNG-IUS (198) or Copper T 380 A (198). Methods: Follow up visits at 6 weeks, and 6 and 12 months were performed. Main Outcomes Measures: IUDs expulsion, maternal and babies’ health conditions, breastfeeding and menstrual patterns, adverse effects and pregnancies. Differences between groups were analyzed by Fisher and X2 tests, Odds ratios, relative risk and 95% confidence limits, as appropriate. Results: After one year of follow up, no pregnancies were reported. The IUD expulsion rate was 4.5% in each group. LNG-IUS users had a higher incidence of amenorrhea (OR 2.5 95% CI 2.2 - 3) and menstrual patterns significantly brief and lighter than Copper T 380 A (p < 0.001) with lower incidence of dysmenorrhea (OR 0.1 95% CI 0.04 - 0.2). No detrimental effects of LNG-IUS on breastfeeding was observed and interestingly babies weights of LNG-IUS users was slightly above the average for age compared with Copper T 380 A users. This was probably related with a major proportion of women with normal ferritin serum levels (94% vs 68%) leading to better mother’s general condition. Conclusions: LNG-IUS inserted during CS provides high efficacy contraception with additional benefits, mainly reducing menstrual bleeding and doing so, faster recovery of ferrous homeostasis after CS.

Levonorgestrel in postcoital contraception

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Antifertility effects of EP-1 (quinestrol and levonorgestrel) on Pacific rats (Rattus exulans)

Pest rodents pose a serious threat to island biodiversity.Fertility control could be an alternative approach to control the impact of rodents on these islands.In this study,we examined the antifertility effects of EP-1 baits containing quinestrol(E)and levonorgestrel(P)using a dose of 50 ppm E and P at three different ratios(E:P ratio=1:2,1:1,and 2:1)on Pacific rats(Rattus exulans)in the Xisha Islands,Hainan,China.Compared to the control group,all animals in EP-1 treatment groups showed significantly decreased food intake and body weight.In treated males,there were obvious abnormalities in testis structure and a significant decrease of relative seminal vesicle weight,but no significant effect on relative uterine and ovarian weights(g kg-1 body weight),or ovarian structure in females.Adding 8%sucrose to the original 50-ppm baits(E:P ratio=1:1)significantly increased bait palatability for males and females.This dose induced uterine edema and abnormalities of ovarian structure in females but had no significant negative effect on the relative testis,epididymis,and seminal vesicle weights(g kg-1 body weight)or sperm density in males.In summary,50-ppm EP-1(1:1)baits have the potential to disrupt the fertility of females,and 8%sucrose addition to the EP-1 baits(E:P ratio=1:1)could improve bait palatability.This dose disrupted the testis structure in males.Future studies are needed to improve bait acceptance and assess the antifertility effects of EP-1(1:1)on Pacific rats in captive breeding trials and underfield conditions.

左炔诺孕酮宫内节育系统放置对宫腔镜下息肉切除术患者子宫内膜厚度、性激素及炎症因子水平的影响

目的:探讨左炔诺孕酮宫内节育系统放置对宫腔镜下息肉切除术患者性激素、子宫内膜厚度以及炎症因子水平的影响。方法:选取2020年1月—2022年12月于酒泉市人民医院接受宫腔镜下息肉切除术治疗的160例患者作为研究对象,按信封随机法分为试验组(n=80)与对照组(n=80)。对照组施行黄体酮胶囊治疗,试验组施行左炔诺孕酮宫内节育系统放置治疗,比较两组月经量、子宫内膜厚度、性激素指标和炎症因子等。结果:两组术后月经量减少,子宫内膜厚度降低,且试验组术后4个月、8个月月经量少于对照组,子宫内膜厚度低于对照组,差异有统计学意义(P<0.05)。术后8个月,两组性激素指标和炎症因子水平降低,且试验组孕酮、促黄体生成素、雌二醇、γ干扰素(IFN-γ)、白细胞介素(IL)-1与基质金属酶-3(MMP-3)水平低于对照组,差异有统计学意义(P<0.05)。结论:左炔诺孕酮宫内节育系统放置用于宫腔镜下息肉切除术后的疗效显著,有助于减少患者经期出血量,降低炎症因子水平,改善性激素指标,并促进子宫内膜厚度降低。

宫腔镜手术联合左炔诺孕酮宫内缓释系统治疗子宫内膜息肉对患者阴道微生态环境的影响

目的分析宫腔镜手术联合左炔诺孕酮宫内缓释系统治疗子宫内膜息肉(EP)对患者阴道微生态环境的影响。方法选取2019年1月至2021年1月九江市妇幼保健院/九江市儿童医院妇产科收治的60例接受宫腔镜手术治疗的EP患者作为研究对象,按照随机数字表法分为观察组与对比组,每组30例。对比组联合口服孕激素治疗,观察组联合左炔诺孕酮宫内缓释系统(LNG-IUS)治疗。比较两组阴道微生态环境、月经失血图(PBAC)评分、子宫内膜厚度,间质、腺皮质孕激素受体(PR)、雌激素受体(ER)表达及6个月复发率。结果观察组阴道微生态环境优于对比组,差异有统计学意义(P<0.05)。观察组阴道菌群多样性和菌群密度1级、2级占比均高于对比组,而3级、4级占比均低于对比组,差异有统计学意义(P<0.05)。治疗后,观察组PBAC评分低于对比组,子宫内膜厚度薄于对比组,差异有统计学意义(P<0.05)。治疗后,观察组间质、腺皮质PR、ER表达量均低于对比组,差异有统计学意义(P<0.05)。观察组6个月内复发率低于对比组,差异有统计学意义(P<0.05)。结论宫腔镜手术联合LNG-IUS可有效改善EP患者阴道微生态环境,减少月经量,降低子宫内膜厚度及复发率,值得临床推广应用。

他莫昔芬联合左炔诺孕酮对大鼠子宫肌瘤的影响及机制研究

目的:探讨他莫昔芬联合左炔诺孕酮对大鼠子宫肌瘤的影响及其作用机制。方法:选择SPF级成年雌性SD大鼠30只,采用苯甲酸雌二醇联合黄体酮腹腔注射建立子宫肌瘤模型。将大鼠随机分为对照组(正常大鼠2 ml 0.9%氯化钠溶液灌胃)、模型组(子宫肌瘤大鼠2 ml 0.9%氯化钠溶液灌胃)、他莫昔芬组(子宫肌瘤大鼠1.70 mg/kg他莫昔芬灌胃)、左炔诺孕酮组(子宫肌瘤大鼠0.1 mg/kg左炔诺孕酮灌胃)和联合组(子宫肌瘤大鼠他莫昔芬联合左炔诺孕酮灌胃),每组6只,连续灌胃30 d。ELISA检测大鼠血清雌二醇(E2)、孕激素、促卵泡激素(FSH)、促黄体生成素(LH)水平。测量子宫系数、左右宫颈角长度及宫角最大直径。HE染色观察子宫组织结构及内膜厚度。Western blot检测子宫组织Wnt5b、β-连环蛋白(β-catenin)蛋白表达。结果:与对照组比较,模型组血清E2、孕激素、FSH、LH水平升高(均P<0.05)。联合组血清E2、孕激素、FSH、LH水平低于他莫昔芬组和左炔诺孕酮组(均P<0.05)。模型组子宫系数、左右宫颈角长度、宫角最大直径及子宫内膜厚度较对照组增加(均P<0.05)。联合组子宫系数、左右宫颈角长度、宫角最大直径及子宫内膜厚度低于他莫昔芬组和左炔诺孕酮组(均P<0.05)。联合组子宫损伤程度较模型组减轻。模型组子宫组织Wnt5b、β-catenin蛋白表达高于对照组(均P<0.05)。联合组Wnt5b、β-catenin蛋白表达低于他莫昔芬组和左炔诺孕酮组(均P<0.05)。结论:他莫昔芬联合左炔诺孕酮能够缩小大鼠子宫肌瘤,改善子宫形态,抑制子宫平滑肌细胞增大,其机制可能与抑制Wnt/β-catenin通路有关。

Anti-fertility effect of levonorgestrel and quinestrol in Brandt’s voles(Lasiopodomys brandtii)

The combination of levonorgestrel and quinestrol(EP-1)has been shown to have anti-fertility effects on several wild rodents,but the mechanism underlying these effects is poorly understood.We investigated the effects of EP-1 and each of its components,levonorgestrel(P)and quinestrol(E),on the fertility of Brandt’s voles(Lasiopodomys brandtii)by using a gastric gavage method.The doses for EP-1,E and P were 1,0.34 and 0.66 mg/kg body weight,respectively.Male voles(n=98)were treated daily for 5 or 14 days,then the testes and epididymides were collected,weighed and examined histologically at 30(D30),60(D60)or 90(D90)days after the end of treatment.Four males were allowed to mate with normal females at D90.Female voles(n=75)were treated for 3 days and a further 3 days after a 7-day interval.The uteri and ovaries were weighed and examined histologically at 15(D15),30(D30)or 75(D75)days after the end of treatment.Each of three females were mated with fertile males at D30 and D75,respectively.Our results indicated that quinestrol(E)significantly decreased the sperm numbers in the testes as well as the weight of the testes and epididymides,with both of these tissues showing obvious structural abnormalities,and significantly reduced the litter size and the pup weight for females mated with males of the E treatment group.For female voles,treatment with E,P or EP-1 resulted in no marked influence on the fertility status.These data indicate that quinestrol(E)alone has a significant anti-fertility effect on male Brandt’s voles,but is ineffective in combination with levonorgestrel(P).

左炔诺孕酮宫内缓释节育系统治疗围绝经期妇女异常子宫出血的效果

目的:观察围绝经期妇女异常子宫出血应用左炔诺孕酮宫内缓释节育系统治疗的临床效果。方法:选取2020年8月—2022年8月滕州市工人医院收治的80例围绝经期异常子宫出血患者作为研究对象,随机分为两组,各40例。两组均进行诊断性刮宫治疗,对照组给予宫血宁胶囊,研究组给予左炔诺孕酮宫内缓释节育系统。比较两组治疗效果、临床指标及激素水平。结果:研究组治疗总有效率高于对照组,差异有统计学意义(P=0.043)。治疗后,两组经期时长短于治疗前,且研究组短于对照组,子宫内膜厚度小于治疗前,且研究组小于对照组,月经量少于治疗前,且研究组少于对照组,差异有统计学意义(P<0.05)。治疗后,两组卵泡刺激素、雌二醇、孕酮水平低于治疗前,且研究组低于对照组,两组黄体生成素水平高于治疗前,且研究组高于对照组,差异有统计学意义(P<0.05)。结论:左炔诺孕酮宫内缓释节育系统治疗围绝经期妇女异常子宫出血的效果显著,可改善患者临床症状,调节激素水平。

宫腔镜下子宫内膜息肉电切术联合不同药物治疗对子宫内膜息肉患者月经恢复情况及复发率的影响

目的探究宫腔镜下子宫内膜息肉电切术联合不同药物治疗对子宫内膜息肉患者月经恢复情况及复发率的影响。方法将淮南新华医疗集团新华医院妇科2020年1月至2022年10月期间收治的102例子宫内膜息肉患者作为研究对象,均接受宫腔镜下子宫内膜息肉电切术治疗。根据随机数字表法将患者分为地屈孕酮组与左炔诺孕酮宫内节育系统组,各51例。观察并比较两组患者手术前后月经恢复情况、子宫内膜厚度、性激素水平、血液相关生化指标,以及术后12个月内复发率及不良反应发生情况。结果左炔诺孕酮宫内节育系统组月经恢复时间显著短于地屈孕酮组(P<0.05)。术后6个月,左炔诺孕酮宫内节育系统组月经天数显著少于地屈孕酮组(P<0.05),月经周期显著长于地屈孕酮组(P<0.05)。术后,两组患者子宫内膜厚度显著降低(P<0.05),随时间推移两组子宫内膜厚度逐渐增加(P<0.05),左炔诺孕酮宫内节育系统组各时间段显著小于地屈孕酮组(P<0.05)。术后6个月,两组患者黄体生成素(LH)、雌二醇(E_(2))、卵泡刺激素(FSH)水平均显著下降(P<0.05),且左炔诺孕酮宫内节育系统组均显著低于地屈孕酮组(P<0.05);两组患者C反应蛋白(CRP)显著下降(P<0.05),且左炔诺孕酮宫内节育系统组显著低于地屈孕酮组(P<0.05);血红蛋白(Hb)与D-二聚体显著升高(P<0.05),且左炔诺孕酮宫内节育系统组显著高于地屈孕酮组(P<0.05)。左炔诺孕酮宫内节育系统组1年内复发率显著低于地屈孕酮组(P<0.05);两组不良反应发生率差异不显著(P>0.05)。结论宫腔镜下子宫内膜息肉电切术联合地屈孕酮或左炔诺孕酮宫内节育系统均可有效改善子宫内膜息肉患者月经情况,但左炔诺孕酮宫内节育系统治疗效果更好,复发率更低。