A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women.

AIM: In a randomized, multicenter, open, controlled trial, we compared the effects of Honglilai Vaginal Cream and Premarin Vaginal Cream in different age subgroups and menopausal year subgroups (trial registration numbers: 02003L00493). METHODS: Postmenopausal women with Genitourinary Syndrome of Menopause (GSM) were divided into Honglilai group (n = 319) and Premarin group (n = 116), while subgroups were divided according to their different characteristics of age and menopausal years. Honglilai Vaginal Cream (0.625 mg/g) or Premarin Vaginal Cream (0.625 mg/g) once daily for 3 weeks. RESULTS: In the subgroup of participates >60 years, there were no significant differences of Vaginal Cell Maturation Index (VMI) between the two groups after treatment (p = .171). In the subgroup of 50-59 years, the VMI of Honglilai group was significantly lower than Premarin group (Honglilai group: 74.37 ± 22.76; Premarin group: 80.06 ± 16.15; p = .02). There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group (p > .05). CONCLUSIONS: Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years.

REBACIN® as a noninvasive clinical intervention for high-risk human papillomavirus persistent infection.

The development of highly sensitive HPV-genotyping tests has opened the possibility of treating HPV-infected women before high-grade lesions appear. The lack of efficient intervention for persistent high-risk HPV infection necessitates the need for development of novel therapeutic strategy. Here we demonstrate that REBACIN®, a proprietary antiviral biologics, has shown potent efficacy in the clearance of persistent HPV infections. Two independent parallel clinical studies were investigated, which a total of 199 patients were enrolled and randomly divided into a REBACIN®-test group and a control group without treatment. The viral clearance rates for the REBACIN® groups were 61.5% (24/39) and 62.5% (35/56), respectively, for the two independent parallel studies. In contrast, the nontreatment groups showed self-clearance rates at 20.0% (8/40) and 12.5% (8/64). We further found that REBACIN® was able to significantly repress the expression of HPV E6 and E7 oncogenes in TC-1 and Hela cells. The two viral genes are well known for the development of high-grade premalignancy lesion and cervical cancer. In a mouse model, REBACIN® was indicated to notably suppress E6/E7-induced tumor growth, suggesting E6 and E7 oncogenes as a potential target of REBACIN®. Taken together, our studies shed light into the development of a novel noninvasive therapeutic intervention for clearance of persistent HPV infection with significant efficacy.

[Diagnosis of Down's syndrome using short tandem repeat loci D21S11, D21S1440 and Penta D].

OBJECTIVE: To investigate the feasibility of genetic diagnosis of Down's syndrome (DS) using short tandem repeat (STR), and to develop a rapid and accurate method for diagnosing DS. METHODS: Quantitative fluorescence polymerase chain reaction (QF-PCR) was used to amplify STR loci D21S11, D21S1440 and Penta D of 719 samples. Three hundred and eighty-nine samples were peripheral blood, 282 were amniotic fluid, 48 were chorionic villous samples. The products were analyzed using eleterophoresis to detect DS. RESULTS: Among 652 samples with a normal karyotype, 635 showed 2 bands with a 1:1 ratio or a single band. The remaining 17 samples showed 3 bands, and were regarded as false positive results. For 67 DS samples, 53 showed 3 bands/peaks with a 1:1:1 ratio and 14 showed 2 bands/peaks with a 2:1 ratio. The sensitivity and specificity of STR loci D21S11, D21S1440 and Penta D were 76.12% and 98.62%, 71.64% and 98.93%, 89.55% and 99.85%, respectively. The overall sensitivity and specificity of 3 STR loci were 100% (67/67) and 97.39% (635/652), respectively. CONCLUSION: Compared with conventional method, author's method is simpler, more stable and rapid, and can be used for large-scale prenatal screening of DS.

OPN gene polymorphisms are associated with susceptibility and clinicopatholigical characteristics of cervical cancer in a Chinese cohort.

AIM: To explore the possible association between Osteopontin (OPN) genetic polymorphisms and cervical cancer risk, which remains undocumented yet. METHOD: We enrolled 300 patients with histologically confirmed cervical squamous cell carcinoma and 774 age-matched healthy, unrelated, cancer-free female healthy subjects as control subjects. Three OPN gene polymorphisms were determined. Reulsts: The genotype distributions and allele frequencies of -156 GG/G and -443 T/C polymorphisms were significantly differed between cervical cancer patients and controls. The cervical cancer cases had markedly higher percentage of -156 GG carriage and significantly lower TT and TC of -443 genotypes than controls. The Logistic regression analysis showed that the -156 GG carriage was associated with significantly elevated OR of 2.492 for cervical cancer while the TT and TC of -443 represented lower risks. This trend was not seen in subjects without human papillomavirus infections. In addition, the -156 GG carriages was significantly associated with poorer clinical conditions, including higher clinical stage, poorer tumor differentiation, higher positive lymph node status and higher chance of parametrical invasion. The -443 T/C and -66 T/G polymorphisms did not show any association with the clinicopathological feature. CONCLUSION: These results suggest that the -156 GG/G and -443T/C polymorphisms might be used as a genetic marker for cervical cancer susceptibility.

[Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy Chinese women: a multicenter randomized controlled trial].

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 microg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 microg ethinylestradiol plus 150 microg 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 both 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.

[Cryopreservation of mouse morula and blastocysts by vitrification].

OBJECTIVE: To compare the survival and developmental potential of mouse morula, early blastocysts and blastocysts cryopreserved by vitrification. METHODS: One hundred and forty-two mouse morula, 135 early blastocysts and 148 blastocysts were cryopreserved by 6 mol/L ethylene glycol and 1 mol/L sucrose vitrification solutions. The survival rates and blastocysts hatching rates after thawing were observed. RESULTS: The survival rates of morula, early blastocysts and blastocysts groups were 88.0%, 73.3%, and 60.1% respectively. The blastocyst hatching rates were 73.9%, 61.5%, and 49.3% respectively. Both the survival rates and blastocyst hatching rates in morula group were higher than those in early blastocysts group (P < 0.05), and they were higher in early blastocysts group than in blastocysts group (P < 0.05). CONCLUSIONS: In these three embryo stages, the survival and developmental potential of mouse morula cryopreserved by vitrification are better than those of early blastocysts and blastocysts. Morula is likely the most feasible stage for embryo vitrification.

[Effect of luteinized granulosa cell conditioned medium on cortical granule of mouse oocytes matured in vitro].

OBJECTIVE: To study the effect of luteinized granulosa cell conditioned medium on cortical granule (CG) of the mouse oocytes matured in vitro. METHODS: Oocytes in germinal vesicle (GV) stage of Kunming mice were randomly divided into 2 groups according to different in vitro maturation (IVM) culture media. The study group medium contained 50% granulosa cell condition medium, follicle stimulating hormone 75 U/L and estrodial 1 nmol/L. The control group medium contained follicle stimulating hormone 75 U/L and estrodial 1 nmol/L. Oocytes were cultured for 16 or 18 hours. CG was examined by fluorescein isothiocyanate labeled Lens culinaris agglutinin under a confocal scanning laser microscope. RESULTS: After cultured for 16 hours, the nuclear maturation rates of control and study groups were 70.0% and 76.5%. After cultured for 18 hours, the maturation rates were 75.1% and 83.1%, respectively. There was no significant difference between the two groups. After cultured for 16 hours, there was no pronuclear formation in both groups. When culture was extended to 18 hours, fertilization occurred. After cultured for 16 hours, the rates of CGs forming a line under membrane were 10.0% and 50.0% in control and study groups respectively. When culture was extended to 18 hours, the rates rose to 57.1% and 91.6% accordingly. The rate of 18 h of each group was significantly higher than that of 16 h (both P < 0.001). The rate of study group of 18 h was significantly higher than that of control group (P < 0.05). CONCLUSION: Granulosa cell conditioned medium could improve the mouse oocytes maturation competence in vitro.