OBJECTIVE: To evaluate the clinical efficacy and safety of Heyan Kuntai capsule(HYKT) in treating women with infertility caused by diminished ovarian reserve(DOR).METHODS: One hundred eight eligible patientsfrom three...OBJECTIVE: To evaluate the clinical efficacy and safety of Heyan Kuntai capsule(HYKT) in treating women with infertility caused by diminished ovarian reserve(DOR).METHODS: One hundred eight eligible patientsfrom three Chinese hospitals were randomly divided into an HYKT treatment group(n = 55) or a dehydroepiandrosterone(DHEA) treatment group(n =53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a3-month period.RESULTS: Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment(P < 0.05) especially in the HYKT group(P < 0.05). Serum follicle stimulating hormone(FSH) levels and FSH/luteinizing hormone ratios decreased(P < 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased(P < 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively(not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer(IVF-ET) and the number of retrieved oocytes was(5.1 ± 1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was(4.2 ± 1.9)(not significant); clinical pregnancy rates were 38% in the HYKT group and 20%in DHEA group(not significant). No significant adverse reactions were observed.CONCLUSION: HYKT can improve the ovarian re-serve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment.HYKT might be an alternative to the treatment of infertility caused by DOR.展开更多
Objective： To evaluate the efficacy and safety of Heyan Kuntai Capsule（和颜坤泰胶囊, HYKT） and hormone therapy（HT） on perimenopausal syndromes（PMSs）. Methods： From 2005 to 2008, 390 women with PMSs were recrui...Objective： To evaluate the efficacy and safety of Heyan Kuntai Capsule（和颜坤泰胶囊, HYKT） and hormone therapy（HT） on perimenopausal syndromes（PMSs）. Methods： From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol（E2） below 30 ng/L, and follicle stimulating hormone（FSH） above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index（KMI） scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life（MENQOL） scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results： After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline（P〈0.01） and there was no significant difference between groups（P〉0.05）, except that KMI of HYKT group was higher after 3-month treatment（P〈0.05）. After treatment, hot flush and insomnia scores were both improved significantly in two groups（P〈0.01）; and HT had a better performance than HYKT in improving hot flush（P〈0.05）. MENQOL were significantly improved in both groups after treatment（P〈0.01）; but there was no significant difference between two groups（P〉0.05）. The incidence of adverse event in the HYKT group was much lower than that in the HT group（P〈0.01）. Conclusions： HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.展开更多
Objective： To evaluate the effect of Heyan Kuntai Capsule （和颜坤泰胶囊, HYKT） on the ovarian function of aged mice and expressions of cohesion complexes in oocytes. Methods： Twenty-five 9-month-old female C57BL/6...Objective： To evaluate the effect of Heyan Kuntai Capsule （和颜坤泰胶囊, HYKT） on the ovarian function of aged mice and expressions of cohesion complexes in oocytes. Methods： Twenty-five 9-month-old female C57BL/6J mice were randomly divided into 5 groups by block randomization method （n=5 per group）, including the control group （saline）, 17β-estradiol group [E2, 100 μg/（kg·d）], and low-, medium-, and high- dose of HYKT groups [0.3, 0.9, 2.7 g/（kg·d）, respectively]. All mice were treated by intragastric administration for 4 weeks. Hematoxylin and eosin staining and anti-VASA staining were used to detect the amounts of follicles. The apoptosis of follicles was measured by anti-gamma H2A histone family member X （γ, H2AX） staining and TdT-mediated dUTP Nick-End Labeling （TUNEL） assay. The density of cohesin subunits, REC8 meiotic recombination protein （REC8）, structural maintenance of chromosome （SMC） 1 β and SMC3 in oocytes were evaluated by immunofluorescent staining. Results： After administration of E2 and high-dose of HYKT, the total number of follicles as well as the number of primordial and primary follicles were significantly increased （P〈0.05）. Anti-γ/H2AX staining and TUNEL assay demonstrated that high-dose of HYKT and E2 partly suppressed the apoptosis of follicles （P〈0.05）. Furthermore, it showed an increased trend in the levels of REC8 and SMC1 β, after administration with E2 and HYKT, and no obvious change in the level of SMC3. Conclusion： HYKT could enhance the number of follicles, suppress apoptosis of oocytes and have a trend to elevate the meiotic-specific cohesin subunits （REC8 and SMC1 β） in oocytes of aged mice, indicating a beneficial effect on the ovarian function in terms of the quantity and quality of follicles.展开更多
[目的]研究和颜坤泰胶囊对卵巢去势模型大鼠子宫形态及细胞凋亡的影响。[方法]以雌性去势大鼠为动物模型,分为空白对照组,假手术组,模型组,补佳乐组,莉芙敏组,和颜坤泰胶囊8、4、2 g生药/kg剂量组。给药8周后,观察药物对子宫病理学的影...[目的]研究和颜坤泰胶囊对卵巢去势模型大鼠子宫形态及细胞凋亡的影响。[方法]以雌性去势大鼠为动物模型,分为空白对照组,假手术组,模型组,补佳乐组,莉芙敏组,和颜坤泰胶囊8、4、2 g生药/kg剂量组。给药8周后,观察药物对子宫病理学的影响,检测子宫细胞凋亡率及Bcl-2 m RNA、Bax m RNA和蛋白的表达。[结果]和颜坤泰胶囊可增加去势大鼠子宫横截面及壁厚,肌层面积及厚度,内膜面积及厚度,上皮厚度和腺体数(P<0.01,P<0.05);能降低去势大鼠子宫细胞的凋亡率(P<0.01,P<0.05),升高子宫Bcl-2 m RNA和蛋白的表达(P<0.01,P<0.05),降低Bax m RNA和蛋白的表达(P<0.01,P<0.05)。[结论]和颜坤泰胶囊有一定的子宫营养作用,可通过调控Bcl-2和Bax基因与蛋白的表达来抑制子宫细胞的凋亡。展开更多
基金Supported by The Scientific research project of Administration of Traditional Chinese Medicine of Hebei Province:The Clinical Study of Kuntai Capsule in the Treatment of Infertility Women with Diminished Ovarian Reserve Diagnosed Liver-kidney Yin Deficiency and Heart-kidney Imbalance Syndrome(No.2016068)
文摘OBJECTIVE: To evaluate the clinical efficacy and safety of Heyan Kuntai capsule(HYKT) in treating women with infertility caused by diminished ovarian reserve(DOR).METHODS: One hundred eight eligible patientsfrom three Chinese hospitals were randomly divided into an HYKT treatment group(n = 55) or a dehydroepiandrosterone(DHEA) treatment group(n =53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a3-month period.RESULTS: Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment(P < 0.05) especially in the HYKT group(P < 0.05). Serum follicle stimulating hormone(FSH) levels and FSH/luteinizing hormone ratios decreased(P < 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased(P < 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively(not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer(IVF-ET) and the number of retrieved oocytes was(5.1 ± 1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was(4.2 ± 1.9)(not significant); clinical pregnancy rates were 38% in the HYKT group and 20%in DHEA group(not significant). No significant adverse reactions were observed.CONCLUSION: HYKT can improve the ovarian re-serve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment.HYKT might be an alternative to the treatment of infertility caused by DOR.
基金Supported by the"Tenth-Five"National Medical Science and Technique Foundation,China(No.2004BA720A08)
文摘Objective： To evaluate the efficacy and safety of Heyan Kuntai Capsule（和颜坤泰胶囊, HYKT） and hormone therapy（HT） on perimenopausal syndromes（PMSs）. Methods： From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol（E2） below 30 ng/L, and follicle stimulating hormone（FSH） above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index（KMI） scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life（MENQOL） scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results： After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline（P〈0.01） and there was no significant difference between groups（P〉0.05）, except that KMI of HYKT group was higher after 3-month treatment（P〈0.05）. After treatment, hot flush and insomnia scores were both improved significantly in two groups（P〈0.01）; and HT had a better performance than HYKT in improving hot flush（P〈0.05）. MENQOL were significantly improved in both groups after treatment（P〈0.01）; but there was no significant difference between two groups（P〉0.05）. The incidence of adverse event in the HYKT group was much lower than that in the HT group（P〈0.01）. Conclusions： HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.
基金Supported by the National Natural Science Foundation of China(No.31571196,81401171,30801502)the 2015 Program to Guide Medicine of the Shanghai Municipal Science and Technology Commission(No.15401932200)+4 种基金the FY2008 JSPS Postdoctoral Fellowship for Foreign Researchers(No.P08471)the Shanghai Pujiang Program(No.11PJ1401900)the Development Project of Shanghai Peak Disciplines-Integrated Chinese and Western Medicinethe Program for Outstanding Medical Academic LeaderDevelopment Project of Shanghai Peak Disciplines-Integrated Chinese and Western Medicine(No.20150407)
文摘Objective： To evaluate the effect of Heyan Kuntai Capsule （和颜坤泰胶囊, HYKT） on the ovarian function of aged mice and expressions of cohesion complexes in oocytes. Methods： Twenty-five 9-month-old female C57BL/6J mice were randomly divided into 5 groups by block randomization method （n=5 per group）, including the control group （saline）, 17β-estradiol group [E2, 100 μg/（kg·d）], and low-, medium-, and high- dose of HYKT groups [0.3, 0.9, 2.7 g/（kg·d）, respectively]. All mice were treated by intragastric administration for 4 weeks. Hematoxylin and eosin staining and anti-VASA staining were used to detect the amounts of follicles. The apoptosis of follicles was measured by anti-gamma H2A histone family member X （γ, H2AX） staining and TdT-mediated dUTP Nick-End Labeling （TUNEL） assay. The density of cohesin subunits, REC8 meiotic recombination protein （REC8）, structural maintenance of chromosome （SMC） 1 β and SMC3 in oocytes were evaluated by immunofluorescent staining. Results： After administration of E2 and high-dose of HYKT, the total number of follicles as well as the number of primordial and primary follicles were significantly increased （P〈0.05）. Anti-γ/H2AX staining and TUNEL assay demonstrated that high-dose of HYKT and E2 partly suppressed the apoptosis of follicles （P〈0.05）. Furthermore, it showed an increased trend in the levels of REC8 and SMC1 β, after administration with E2 and HYKT, and no obvious change in the level of SMC3. Conclusion： HYKT could enhance the number of follicles, suppress apoptosis of oocytes and have a trend to elevate the meiotic-specific cohesin subunits （REC8 and SMC1 β） in oocytes of aged mice, indicating a beneficial effect on the ovarian function in terms of the quantity and quality of follicles.
文摘[目的]研究和颜坤泰胶囊对卵巢去势模型大鼠子宫形态及细胞凋亡的影响。[方法]以雌性去势大鼠为动物模型,分为空白对照组,假手术组,模型组,补佳乐组,莉芙敏组,和颜坤泰胶囊8、4、2 g生药/kg剂量组。给药8周后,观察药物对子宫病理学的影响,检测子宫细胞凋亡率及Bcl-2 m RNA、Bax m RNA和蛋白的表达。[结果]和颜坤泰胶囊可增加去势大鼠子宫横截面及壁厚,肌层面积及厚度,内膜面积及厚度,上皮厚度和腺体数(P<0.01,P<0.05);能降低去势大鼠子宫细胞的凋亡率(P<0.01,P<0.05),升高子宫Bcl-2 m RNA和蛋白的表达(P<0.01,P<0.05),降低Bax m RNA和蛋白的表达(P<0.01,P<0.05)。[结论]和颜坤泰胶囊有一定的子宫营养作用,可通过调控Bcl-2和Bax基因与蛋白的表达来抑制子宫细胞的凋亡。
