Preoperative treatment of uterine fibroids with low-dose mifepristone: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study / 中华妇产科杂志

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.

High-risk HPV genotyping PCR testing as a means of cervical cancer and precancerous lesions early screening / 中华妇产科杂志

Objective To explored high-risk HPV genotyping PCR testing whether as a feasible means for the early screening of cervical cancer and precancerous lesions. Methods From January 2013 to June 2014, 15 192 outpatients in China-Japan Friendship Hospital voluntary were tested by high-risk type HPV genotyping PCR. The average age of them were (33±8) years old. High-risk HPV types genotyping PCR tested by fluorescence PCR technology,in which 13 kinds of high-risk HPV subtypes were detected, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. A total of 4 315 cases of them were tested by the liquid-based cytology (LCT), among them with positive of high-risk HPV genotyping tested by PCR (n=2 366) were biopsy under colposcope (648 cases) in those LCT results were positive or LCT negative but HPV16 positive or LCT negative but had the clear clinical symptoms or and non-HPV16 positive but with clear clinical symptoms. (1) Analysis high-risk HPV infection status of 15 192 women.(2)As the pathological diagnosis was the gold standard in the diagnosis of cervical lesions, analysis of the relationship among high-risk HPV infection,virus loads and cervical lesions. (3) To evaluated the value of high-risk HPV genotyping PCR tested method in screening of cervical cancer and precancerous lesions. Results ⑴ Of 15 192 cases tested by high-risk HPV genotyping PCR, 2 366 cases were HPV positive (HPV infection), the overall infection rate was 15.57%(2 366/15 192), in which a single subtype of HPV infection in 1 767 cases, infection rate was 11.63%(1 767/15 192), and multiple subtypes of HPV infection (two and more subtypes HPV infection) in 599 cases, infection rate was 3.94%(599/15 192). The HPV16, 52 and 58 infections were the most common HPV subtypes in 13 subtypes, the infection rate was 3.95% (600/15 192), 2.86%(435/15 192) and 2.67% (406/15 192), respectively. (2) The most relevant subtypes with cervical intraepithelial neoplasia (CIN)Ⅱand even higher lesion were HPV16, 52 and 58, accounted for 57.7%(154/267) of all above CINⅡlesions. The most relevant subtype with the cervical glandular intraepithelial neoplasia (CGIN) Ⅱ or above lesions was HPV18, 3 cases with CGIN Ⅱ or above lesions were all single HPV18 infection. The pathologic examination positive percentage of patients which HPV virus loads≤103 copys/104 cells was 18.2%(25/137), while the pathologic examination positive proportion was 33.3%(247/742) which HPV virus loads≥104 copys/104 cells , there was statistically significant difference between them (χ2=27.06, P=0.000).(3)Sensitivity, specificity, positive predictive value and negative predictive value for detection of CINⅡ or above using HPV genotyping PCR were 96.11%, 85.76%, 30.94% and 99.70%, respectively. Conclusions There were a guiding significance for high-risk HPV genotyping PCR tested in screening of cervical cancer and precancerous lesion. HPV16, 52 and 58 were related to the severe cervical squamous epithelial lesions, while HPV18 was related to cervical severe glandular cell pathological changes. HPV genotyping is feasible and economical as the first choice of opportunistic screening in tertiary hospitals.

Randomized, blind, parallel-controlled and multiple-centre clinical trial on the effectiveness and safety of leuprolide acetate in the treatment of endometriosis / 中华妇产科杂志

Objective To evaluate the effectiveness and safety of leuprolide acetate in the treatment of endometriosis. Methods From Nov. 2007 to Oct. 2012, the patients who confirmed to be endometriosis were randomly divided into test group of 113 cases and control group of 116 cases. The test drug was the sustained-release agent of leuprolide acetate. The control drug was Enantone. The drugs were used for 3 times in total. After treatment, the ovarian mass volumes measured with type-B ultrasound, the scores of the patient′s subjective symptoms during non-menstrual and menstruation days, the pelvic signs during non-menstrual days, the changes of hormones [estradiol (E2), FSH, LH], and adverse events were observed. Results After the treatment, the rate of changes of ovarian mass volume (among them, at 12 weeks after the first injection, the median was -55.83% in the test group, -68.22% in the control group, P=0.336), the distinct improvement rate of symptom scores and pelvic signs during non-menstrual days [among them, at 12 weeks after the first injection, the rate of lower abdomen pain was 47.5%(48/101) in the test group, 44.0%(44/100) in the control group, P=0.881], the hormone (E2, FSH, LH) levels [among them, at 12 weeks after the first injection, the serum level of E2, was (33±38) pmol/L in the test group, (38± 40) pmol/L in the control group, P=0.414;the serum level of FSH, was (5.1±2.8) U/L in the test group, (5.3± 2.3) U/L in the control group, P=0.666;the serum level of LH, was (0.6±0.8) U/L in the test group, (0.6±0.9) U/L in the control group, P=0.907], had no statistically significant difference between the two groups (all P>0.05). The distinct improvement rate and improvement rate of symptom (lower abdomen pain, low back pain) scores during menstruation days at 12 weeks after the first injection, the rates of lower abdomen pain were 73.9%(34/46), 15.2%(7/46) respectively in the test group, 72.3%(34/47), 2.1%(1/47) respectively in the control group, had statistically significant difference between the two groups (P=0.026). There was no serious adverse event occurred in both two groups. The incidence rate of adverse event was 33.6%(38/113) in test group, 23.2% (27/116) in control group, there was no significant difference between the two groups (P=0.082). Conclusion Leuprolide acetate is effective and safe in the treatment of endometriosis.

Evaluation of variable methods for HPV testing / 中华妇产科杂志

Objective To evaluate clinical efficacy of different HPV methods in screening of cervical cancers.Methods Between August 2011 and November 2011,424 women in the China-Japan Friendship Hospital were enrolled in this study.All participants were undergone liquid-based cytology test (LCT),Hybrid capture Ⅱ (HC-Ⅱ) and real-time (RT)PCR high risk HPV DNA test for HPV16 and HPV18 genotyping.Those results were classified into two group:424 women at HC-Ⅱ group with LCT and HC-Ⅱ test and 421 women at PCR group with LCT and PCR test.All women with atypical squamous cell of undetermined significance (ASCUS) or above in cytological result with high risk HPV positive at two group underwent cervical biopsy by colposcopy.In the mean time,women with negative in cytological results and with HPV 16 and(or) HPV 18 positive also underwent histo-pathological examination by and colposcopy.The results in two groups were discussed:LCT + HC-Ⅱ group (424 patients) and LCT + PCR12+2 group (421 patients).Results (1) There was no significant difference in cervical intraepithelial neoplasia (CIN) Ⅱ or above disease between LCT + HC-Ⅱ group and LCT + PCR12+2 group (x2 =3.35,P ＞ 0.05).Sensitivity,specificity,positive predictive value and negative predictive value for detection of CIN Ⅱ or above using HC-Ⅱ and PCR12 +2 were 77.8％,79.4％,20.4％,98.1％ and 96.3％,78.2％,23.2％,99.7％,respectively.(2) In LCT + PCR12+2 group,it was found 34 women with HPV16 positive,5 women with HPV 18 positive including 1 women combined with HPV 16 positive,74 women with other high risk HPV positive and 309 women with HPV negative.Compared to the infection of other high-risk HPV types,HPV 16 and HPV 18 infection leads to a higher chance of cervical lesions with CIN Ⅱ or above [51.3％(20/39) and 8.1％ (6/74)].(3) A significant difference of causing cervical cancer and CIN Ⅱ or above was found among women who were infected with HPV 16 and/or HPV 18 infection,with other high-risk HPV types and negative in high-risk HPV infection (x2 =93.98,P ＜ 0.01).Conclusion LCT combined with PCR genotyping HPV could identify CIN Ⅱ or above disease efficiently.

Pregnancy related cervical cytological changes and clinical management / 中华妇产科杂志

Objective To investigate characteristics of cervical cytology and management in pregnant women. Methods From Aug. 2006 to Jan. 2010, 5152 pregnant women who received antenatal and postpartum examination underwent cervical cytological screening by liquid-based cytological test (LCT)in China-Japan Friendship Hospital. The cytological diagnosis was in accordance with the Bethesda system (TBS) 2001 diagnosis and classification system.The abnormal LCT results were followed up at 3 months after postpartum. The diagnosis of high-grade squamous intraepithelial lesions (HSIL) and squamous cell carcinoma (SCC) were based on colposcopic examination and biopsy during pregnant. The diagnosis of atypical glandular cells(AGC) was based on curettage and biopsy at postpartum 6 weeks. The histopathology of biopsy were compared and analyzed. Results ( 1 ) Cervical cytological changes related with pregnancy:among 5152 cases, it was found navicular cells in 3215 cases (62. 40% ), decidual cells in 783 cases ( 15.20% ), reactive glandular cells in 369 cases (7. 16% ), and trophoblastic cells in 55 cases (1.07%). (2) LCT results: among 5152 cases, the normal samples were 4125 cases (80.07%), the inflammatory samples were 542 cases (10.52%), and the samples of abnormal epithelial cells were 485cases (9.41%). Among those abnormal cases, 291 cases (5.65%) were in atypical squamous cells (ASC), 153 cases (2. 97%) were in low-grade squamous intraepithelial lesions (LSIL), 33 cases (0. 64%) were in HSIL, 1 case ( 0. 02% ) were in SCC and 7 cases (0. 14% ) were in AGC. (3)Histological pathology results: all women with HSIL and SCC underwent colposcopic examination and biopsy,it was found 28 cases in cervical intraepithelial neoplasia (CIN) Ⅱ - Ⅲ, 1 cases in adenosquamous carcinoma. 7 women underwent curettage and biopsy at postpartum 6 weeks which were diagnosed by AGC,the histopathological diagnosis was all negative. The concordance rate of cytopathologic and histopathologic diagnosis was 71%(29/41). (4) Follow-up: 485 women with abnormal LCT results were all followed up to 3 months at postpartum. Women with HSIL, SCC and AGC undergoing biopsy showed normal LCT results during follow-up. Those women with ASC and LSIL did not undergo colposcopic examination and biopsy. The regression rate was 72.3% (321/444) at postpartum 3 months. Conclusions The navicular cells were primarily morphological characteristics of cytology during pregnant and postpartum women. Some changes were easily confused with malignant lesions. It should be careful discrimination, and avoid excessively diagnosis and misdiagnosis. It suggested that we should follow up those women closely and expand the indication of colposcopic biopsy.

Detection of human papillomavirus L1 capsid protein expression in liquid-based cytology samples with abnormal cytology / 中华妇产科杂志

Objective To investigate the possibility of detection of the human papillomavirus (HPV)L1 capsid protein to predict the coarse of mild or moderate cervical intraepithelial neoplasia(CIN).Methods Immunocytochemical analysis using antibody against HPV L1 capsid protein was carried out on 274 samples obtained from women performed Tri Path Pap tests.positive for high-risk HPV DNA detected by hybrid capture Ⅱ (HC-Ⅱ)or cytologic diagnosed atypical squamous cells of undetermined significance (ASCUS)or more severe.For cytological diagnosed,there were ASCUS 105 cases,low-grade squamous intraepithelial lesions (LSIL) 119 cases,atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H)9 cases,high-grade squamous intraepithelial lesions(HSIL)36 cases,and squamous cell carcinoma(SCC)5 cases.But for the pathologic diagnosed,there were chronic cervicitis 96 cases.CIN Ⅰ 55 cases,CIN Ⅱ 55 cases,CIN Ⅲ 32 cases,and SCC 6 cases.Results Of the 274 cases,HPV L1 capsid protein was positive in 69.8%(67/96) of cervicitis,83.5%(71/85)of CIN Ⅰ,41.8% (23/55)of CIN Ⅱ,3.1%(1/32)of CIN Ⅲ and 0(0/6)of SCC.Cytologic diagnosis revealed a higher expression rate in LSIL(75.6%.90/119) than that in ASCUS(63.8%,67/105)or in HSIL + SCC (9.8%,4/41;all P<0.01).Of 71 cases with ASCUS and ISIL without treated,none of HPV L1 positive cases(0/55)progressed in cytology,while 19%(3/16)of HPV L1 negative cases progressed to ASC-H,HSIL(P<0.01).Conclusion The expression rates of HPV L1 protein in liquid-based cell specimen is decreased as the cytopathology diagnosis severe degree.which may imply the histopathology diagnosis of cervix,predict the progression of cervical lesion,and help to treat the cases with ASCUS and LSIL.

Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy Chinese women: a multicenter randomized controlled trial / 中华妇产科杂志

Objective To evaluate the contraception efficacy, mode of bleeding, side effects and other positive effects of drospirenone-ethinylestradiol (Yasmin) in healthy Chinese women. Methods This was a multicenter, randomized, control study of 768 healthy Chinese women who consulted about contraception. The subjects were randomized into Yasmin group (30 μg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 μg ethinylestradiol plus 150 μg desogestrel, 195 cases) with the ratio of 3: 1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height, body mass index were evaluated at each visit. The menstrual distress questionnaire (MDQ) was given to the women at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Results The values of basal features were similar between two groups (P> 0.05). The Pearl index (method failure) of Yasmin was 0. 208/hundred women year which was lower than that of desogestrel (0. 601/hundred women year). The mode of bleeding was similar between two groups after trial without showing any significant difference. According to MDQ subscale, the improvement of water retention and increasing appetite during inter-menstrual period and water retention and general well-being during menstrual period in the Yasmin group ( -0. 297, -0. 057, 0. 033, 0. 150 respectively) was more obvious than that in the desogestrel group ( - 0. 108, 0. 023, 0. 231, - 0. 023 respectively) with a significant difference (P < 0. 05 ). Some other values which improved in beth two groups, especially the improvement of breast tenderness and pain and skin abnormality in Yasmin group (18.0%, 89/494; 12. 6%, 62/494) was more distinct than that in desogestrel group (11.3%, 19/168; 5.4%, 9/168). The mean weight increased in desogestrel group (0. 57 kg) while it decreased in Yasmin group ( -0. 28 kg) with a significant difference (P < 0. 01 ). Conclusions Both Yasmin and desogestrel have good efficacy on contraception and similar modes of menstrual bleeding. Yasmin is better than desogestrel in terms of weight control and premenstrual syndrome of oral contraceptive.

Clinical Analysis of 13 cases of Placenta Increta / 国际中医中药杂志

Objective To investigate the clinical characteristics, diagnosis and treatment of placenta increta.Methods A retrospective analysis was carried out on 13 admitted cases of placenta increta from 1989～2006. Results Among the 13 cases analysed, 5 cases with a history of Caesarian section had a 0% success rate of treatment with conservative care (0/5), 100% less than that of cases with no history of Caesarian section (8/8), P＜0.05; the success rate of treatment of partial placenta increta with methotrexate with Jia Wei Sheng Hua Tang was 100%. Conclusion Caesarian section is a risk factor of placenta increta, and its prognosis is poor; however, Jia Wei Sheng Hua Tang has proven satisfactory as a supplementary treatment for placenta inereta.

Comment on diagnosis of atypical squamous cells using new the Bethesda system (2001) / 中华妇产科杂志

Objective To evaluate the criteria for diagnosis of atypical squamous cells(ASC)and its two subtypes: undetermined significance ASC (ASC US) and atypical squamous cells cannot exclude high grade intraepithelial lesion (HSIL, ASC H) defined in 2001 the Bethesda system(TBS) Method One thousand one hundred and eighty six pap smears and liquid based thin layer preparations with diagnosis of atypical squamous cells of undetermined signification (ASCUS) according to TBS 1991 criteria, were re classified by a cytopathologist using TBS 2001 criteria Results The cytologic diagnosis according to TBS 2001 criteria was: negative in 285 cases(24 0 %), ASC US in 627 cases (52 9 %), ASC H in 254 cases(21 4 %), low grade intraepithelial lesion (LISL) in 16 cases(1 3 %), and HISL in 4 cases (0 3 %), respectively Out of 1186 cases, 168 received histological examination Cervical intra epithelial neoplasia (CIN) II III were diagnosed in 18 9 % of patients with ASC H, 5 2% of patients with ASC US, and 14 3% of patients with ASCUS defined by using TBS 1991 criteria, respectively ( P

A comparison between microwave endometrial ablation and total hysterectomy / 中国微创外科杂志

Objective To compare the curative effects between microwave endometrial ablation (MEA) and total hysterectomy for the treatment of menorrhagia. Methods Sixty patients with menorrhagia were divided into 2 groups with 30 patients in each group, either to MEA or to total hysterectomy (control group). The intraoperative blood loss, operating time, sparing or unsparing of uterus, and length of recovery of the 2 groups were compared. Results The effective rates for menorrhagia, operating time, and mean blood loss of MEA group and control group was 96% (29/30) and 100% (30/30) (?2=0,P=1.0), (4.0?1.1) min and (68.3?1.9) min (t=-160.42, P=0.00), 0 ml and 50 ml, respectively. Conclusions MEA is a novel minimally invasive method for menorrhagia, and its curative effects are similar to that of total hysterectomy. When considered in terms of sparing of uterus and postoperative recovery, MEA is obviously superior to total hysterectomy.

Analysis of pregnancy rates after treatment of tubal pregnancy with systemic methotrexate / 中华妇产科杂志

Objective To analyse the pregnancy rate after treatment of tubal pregnancy with the systemic methotrexate (MTX) injection Methods From March 1985 to August 1999, 129 women with confirmed unruptured tubal pregnancy,and desiring to conceive were selected Among them 60 women were successfully treated with systemic MTX, and 69 with unilateral salpingectomy All cases were followed up for 1～15 years Results The rates of subsequent intrauterine pregnancies (IUP) in the MTX group was 73% (44 cases) and of recurrent extrauterine pregnancies (EP) was 8% (5 cases) Among 69 patients treated by salpingectomy, the rates of IUP and EP was 70% (48 cases) and 4% (3 cases) respectively The differences between the two groups were not statistically significant Conclusions The effect of conservative management with MTX was similar to those of salpingectomy The rate of subsequent pregnancy did not increased