1.Preoperative treatment of uterine fibroids with low-dose mifepristone: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
Meilu BIAN ; Minli HUANG ; Zhenyu ZHANG ; Shumin LIU ; Jie SUN ; Fang FANG ; Yuping GU ; Chongdong LIU ; Chen YAO
Chinese Journal of Obstetrics and Gynecology 2021;56(5):317-327
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.
2.Surveillance of Creutzfeldt-Jakob diseases cases in Guizhou Province,China, 2010-2015
Weijia JIANG ; Ling JIAO ; He HUANG ; Shijun LI ; Yan LIU ; Yinwu ZHU ; Zhu XU ; Meilu SUN ; Xumin FANG ; Lu HAN ; Jie XIONG ; Lijun CAI
Chinese Journal of Zoonoses 2017;33(5):436-440
We analyze the epidemiology,clinical features,and outcome of the patients with Creutzfeldt-Jakob diseases (CJD) in Guizhou Province from 2010 to 2015.The epidemiology,clinical characteristics and follow-up data of CJD suspected patients obtained from Guizhou CJD surveillance network were analyzed.The testing results of cerebrospinal fluid (CFS) and blood from the patients were also collected and analyzed.Results showed that a total of 11 CJD cases was found from 23 reported CJD suspected patients in Guizhou from 2010 to 2015,including 8 probable sporadic CJD(sCJD) cases,2 possible sCJD cases and 1 genetic CJD(gCJD) case.In 11 cases,rapidly progressive dementia was the major initial symptom,following by mental symptoms,extrapyramidal symptoms,signs and cerebellum cortical blindness.Clinical symptoms of progressive dementia were the main symptoms,following by visual or cerebellar dysfunction,myoclonus,cone system/extrapyramidal dysfunction,and akinetic mutism.Most of cases were abnormal in MRI (45.45%) and 14-3-3 protein detection in CSF(70%).The 14-3-3 blood samples of prion gene 129 amino acids (PRNP)polymorphisms were M/M type,excepting for 1 case gCJD confirmed diagnosis cases with D178N mutation in PRNP gene.Eleven CJD cases did not show season and regional clusterings and vocational tendency.The majority of the cases were male,the median age was 65,and mainly were the Han nationality.For all cases of CJD reported during that year for follow-up,the lost-tofollow-up rate was 27%,and the majority of cases died within one year.The sCJD cases were the majority in CJD cases of Guizhou Province,2010-2015.The epidemiological characteristics were similar to the national monitoring cases in the same period.