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Objective:To evaluate the clinical efficacy and safety of oral mifepristone (10 mg/day) versus placebo in the preoperative treatment of uterine fibroids.Methods:This study was a multi-center, randomized, double-blind, placebo, parallel controlled trial. A total of 132 patients with uterine fibroids were randomly divided into study group and control group, with 66 cases in each group. The patients in the study group orally took 1 tablet/day of mifepristone (dose of 10 mg/tablet), the patients in the control group orally took 1 tablet/day of placebo, and both groups were treated for 3 months. The primary efficacy evaluation indicators were the change rate of maximum fibroid volume; the secondary efficacy evaluation indicators included amenorrhea rate, improvement of subjective symptoms and anemia; the safety evaluation indicators included the analysis of adverse events and changes in laboratory biochemical indicators.Results:At the end of treatment, the maximum leiomyoma volume was reduced by 25.97% (95% CI: -34.79%--15.95%) in the study group and reduced by 1.51% (95% CI: -13.03%-11.54%) in the control group. The change rate of the maximum leiomyoma volume before and after treatment in the study group was significantly greater than that in the control group, and the difference in the change rate of the maximum leiomyoma volume between the two groups was -24.84% (95% CI: -36.56%--10.94%), which was much higher than the 10% superiority threshold goal set by this study within the 95% CI interval. At the end of treatment, the complete amenorrhea rate [84% (52/62)], dysmenorrhea elimination rate [98% (61/62)], and menstrual blood loss disappearance rate [87% (54/62)] in the study group were significantly higher than those in the control group (all P<0.05). At the end of treatment, the mean hemoglobin [(131±13) g/L], red blood cell count [(4.5±0.4)×10 12/L] and hematocrit (0.39±0.03) in the study group were significantly increased compared with the baseline, and the differences had statistical significance (all P<0.05); after treatment, the differences in the above three indicators between the two groups had statistical significance (all P<0.01). The serum estradiol level in the study group was significantly lower than that in the control group at the end of treatment, and the difference was statistically significant ( P<0.01). There were no significant differences in follicle-stimulating hormone and cortisol levels before and after treatment between the two groups ( P>0.05). The overall incidences of any adverse event were not significantly different between the two groups (all P>0.05). Abdominal pain was the most common adverse event in the study group [9% (6/65)], but the incidence was not significantly increased compared with the control group [3% (2/64); P>0.05]. Conclusion:Compared with placebo, oral mifepristone 10 mg/day is significantly superior to placebo in reducing the size of uterine fibroids and improving anemia, without significant adverse reactions, and could be used as a drug treatment for patients with of uterine fibroids before surgery.
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Objective@#To analyze the application of difficulty degree index (DDI) in predicting patients′s fertility outcome after laparoscopic myomectomy.@*Methods@#A retrospective study was carried out on 118 patients with subserous myoma or intramural myoma undergoing laparoscopic myomectomy from January 2005 to December 2014. The rate of post-operative pregnancy, delivery outcome and disease recurrence were investigated. Logistic regression analysis was used to analyze the impact of DDI, the age of patients undergoing surgery, presence of infertility history etc, on the patients′ reproductive outcome following the surgery.@*Results@#Follow-up for 1 to 10 years,118 cases were included in the study, the rate of post-operative pregnancy, live birth, vaginal delivery were 72.9% (86/118) , 52.5% (62/118) and 24.2% (15/62) respectively. No cases of uterine rupture and obstetric complications occurred. Univariate analysis showed that the independent variables of post-operative pregnancy rate were DDI, patient′s age at the time of surgery, presence of infertility history and myoma recurrence (all P<0.05) . In multivariate analysis, the factors of post-operative pregnancy rate were DDI (OR=3.131, 95%CI:1.012-8.894) , patient′s age at the time of surgery (OR=2.722, 95%CI:1.048-7.067) and presence of infertility history (OR=8.509, 95%CI: 2.102-34.445) .@*Conclusions@#DDI could be applied to predict post-operative pregnancy rate, with the increasing of DDI the post-operative pregnancy rate decreasing. The patients with high DDI scores, age>35 years old or presence of infertility history should get ready for pregnancy positively.
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Objective To investigate the changes of serum retinol binding protein 4 (RBP4) concentration in peripheral blood of normal gravidas at different stages during pregancy and the differential expression of serum RBP4 in gravidas with fetal growth restriction (FGR) in second trimester.Methods This study enrolled 80 gravidas who received routine prenatal examination and delivered in the Beijing Luhe Hospital Affiliated to Capital Medical University from January 2014 to January 2015,Forty gravidas were classified to FGR group as the birth weight of their fetuses was below two standard deviations or below the 10th percentile for the corresponding gestationas and same sex,or less than 2 500 g after 37 weeks.The other 40 gravidas who delivered newborns with normal birth weight (2 500 g ＜ birth weight ＜ 4 000 g) were used as control group.Levels of serum RBP4,plasma albumin,fasting blood glucose,triglyceride,total cholesterol,low density lipoprotein-cholesterol (LDL-C),hemoglobin,fasting insulin and vitamin A were determined before pregnancy and at 12-16,20-24,28-32 and 36-40 weeks of gestation.Homeostasis model assessment-insulin resistance (HOMA-IR) was calculated.Independent sample t test or analysis of variance,Chi-square test or Fisher exact test was used for statistical analysis.Pearson correlation was used to analyze the relationship between peripheral blood RBP4 level and neonatal birth weight at 20-24 weeks.Results (1) Serum RBP4 levels in normal gravidas were (24.65± 10.02),(29.86±23.40),(56.10± 12.28),(65.80±20.56) and (53.71 ±24.17) μg/ml before pregnancy and at 12-16,20-24,28-32 and 36-40 weeks of gestation,respectively,showing a gradually increasing trend with gestational week until a peak at 28-32 weeks and then followed by a decrease (F=14.173,P＜0.001).(2) The body mass index and placental weight of gravidas in FGR group were lower than those in control group [20.7±3.3 vs 22.9±2.1,(401.3±56.2) vs (501.3±64.7) g;t=22.590 and 2.487,both P＜0.05].(3) The fasting blood glucose,fasting insulin,HOMA-IR,RBP4 and plasma albumin in FGR group were lower than those in control group [(4.06± 0.4) vs (4.38 ± 0.4) mmol/L,(21.84± 15.2) vs (31.76 ± 1.5) μ U/ml,0.5 ± 0.2 vs 0.7±0.2,(41.78± 12.8) vs (65.80±20.5) μg/ml,(35.1 ±2.7) vs (36.5±2.3) g/L;t=3.419,2.355,3.419,6.263 and 2.462,all P＜0.05].Maternal serum RBP-4 at 20-24 weeks of normal gravidas and FGR gravidas were positively correlated with the birth weight of newborns (r=0.717 and 0.748,both P＜0.05).Conclusions Serum RBP4 of gravidas may be associated with the occurrence of FGR.
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Objective To investigate the necessity,safety and efficacy of transobturator tension-free vaginal tape (TVT-O) for treatment of stress urinary incontinence (SUI) during transvaginal corrective operation of pelvic organ prolapse (POP).Methods From Jan.2005 to Dec.2010,92 patients undergoing transvaginal pelvic reconstruction surgery for correction of POP concomitant TVT-O for treatment of SUI in Department of Obstetrics and Gynecology affiliated to Beijing Chaoyang Hospital as concomitant surgery group were enrolled in this retrospective study matched with 90 patients with mild SUI without SUI surgery as nonconcomitant surgery group and 120 patients without SUI as control group.Variable clinical index,clinical efficacy and complications were compared among those three groups.Results Compared with those in the other two groups,the mean age [(62 ± 11) years] was lower (P =0.007,0.038),the operation time only slightly increased (12.8 min and 12.9 min respectively) significantly in concomitant TVT-O group.The bleeding loss and the length of staying hospital after operation all exhibited no significant differences within three groups (P ＞ 0.05).The effective rate for SUI was 96.7％ (89/92) in concomitant TVT-O group,corrective operation of POP was ineffective for 74.4％ (67/90) SUI,9.2％ (11/120) patients presented new SUI in the patients without SUI preoperatively.Conclusions TVT-O is a simple,safe and effective method in the treatment of SUI,which is more suitable for performing simultaneously during the corrective operation of POP.Efficacy of SUI correction was limited in those patients undergoing only pelvic reconstructive surgery.However,a preventive anti-incontinence procedure is not recommended because of the lower incidence in POP patients without SUI preoperatively.
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Objective To investigate the morbidity, relevant factors and diagnostic methods of lower extremity deep venous thrombosis (LEDVT) after gynecological pelvic surgeries. Methods A prospective study was carried out investigating the morbidity, characteristics, risk factors, the coagulation function changes and diagnostic methods of LEDVT post-gynecological pelvic operations in 141 cases. Platelet, prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, D-dimer, antithrombin-Ⅲ, tissue plasminogen activator, plasminogen activator inhibitor were measured within 1 week before surgeries,48 hours and 5-7 days post-surgeries respectively. Color Doppler flow imaging was performed simultaneously. Results (1)Twenty-two cases were found with LEDVT, the morbidity of LEDVT after gynecological procedures was 15.6%. It occurred 2-7 days post operation.(2)The risk factors were bedfasting, coagulant prescription post-operation, cardiovascular disease, ageing, pelvic lymphadenectomy, general anesthesia, and malignancy. Multivariate regression showed only age and coagulant prescription post-operation were independent factors. (3)The level of D-dimer was (0.9?0.6) mg/L in LEDVT group, significantly higher than that of non-LEDVT group[(0.5?0.4) mg/L, P