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BACKGROUND:Currently,hormone replacement therapy is the main treatment in Western medicine for patients with decreased ovarian function,but these patients are not sensitive to exogenous hormones,leading to unsatisfactory therapeutic effect.Zishen-Yutai pills can nourish the blood and calm the fetus,tonify the kidney and spleen,invigorate qi and strengthen the body.Studies have confirmed that Zishen-Yutai pill is effective in reducing follicle-stimulating hormone index and improving traditional Chinese medicine symptoms in patients with diminished ovarian reserve.However,few studies have been conducted to improve the implantation rate of patients by improving endometrial receptivity. OBJECTIVE:To evaluate the effect of Zishen-Yutai pills on the clinical outcome of patients with diminished ovarian reserve undergoing frozen-thawed embryo transfer again. METHODS:A total of 300 patients with diminished ovarian reserve who underwent frozen-thawed embryo transfer to assist pregnancy after the first failure in the Center of Reproductive Medicine,Changzhou Maternal and Child Health Care Hospital from January 2019 to December 2021 were selected as the study subjects.Subjects were randomly treated with a placebo or Zishen-Yutai pills in a ratio of 1:2,with 100 cases in the treatment group and 200 cases in the control group.However,13 patients fell off due to lack of contact,refusal to take medicine or other reasons.Finally,90 cases in the treatment group and 197 cases in the control group were included in the study.Oral medication was administered 7 days before frozen-thawed embryo transfer transplantation at a dose of 5 g/time,3 times/day.To investigate whether taking Zishen-Yutai pills could improve the clinical outcome of patients with diminished ovarian reserve after frozen-thawed embryo transfer again,the primary outcome measures included clinical pregnancy rate,implantation rate,abortion rate,live birth rate,offspring birth weight and birth defects. RESULTS AND CONCLUSION:Compared with the control group,the clinical pregnancy rate(P<0.05)and implantation rate(P=0.009)were significantly increased after the oral administration of Zishen-Yutai pills.Correlation analysis showed that taking the Zishen-Yutai pill was positively correlated with the number of implanted embryos(r=0.200,P=0.001)and clinical pregnancy(r=0.235,P=0.000).There was no correlation between taking Zishen-Yutai pills and indexes of endometrial thickness and blood flow.It is indicated that Zishen-Yutai pills can improve the clinical pregnancy rate and implantation rate of frozen-thawed embryo transfer recurrence in patients with diminished ovarian reserve.
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To study the chronic hepatotoxicity of Chinese medicine Zishen Yutai pill (ZYP) prepared from Polygonum multiflorum with the recommended dosage in normal Beagle dogs. Low, middle and high doses of ZYP (1.5, 3.0, 6.0 g·kg⁻¹; i.e. 3×, 6× and 12× equivalent doses) were given orally to dogs for 39 consecutive weeks. At the same time, the same volume of deionized water was used as the solvent control group, one time a day. The general condition of the animals was observed every day during the period of administration, and the blood was collected before and 13, 26, 39, 43 weeks after administration to detect the biomarkers related to the hepatotoxicity of the dog serum. 2/7, 3/7 and 2/7 animals were dissected after 13, 39, and 43 weeks of administration to observe the pathological changes of the animal organs, weigh the mass of main organs and conduct pathological examination of the liver. As compared to the solvent control group, 11 liver hepatotoxicity traditional biomarkers such as ALT, AST were found no ZYP-related changes at month 3, 6, 9 of the administration and month 1 in recovery period; There was no significant difference in liver viscera index and liver pathology. Therefore, no obvious hepatotoxicity was shown by ZYP administered up to 6.0 g·kg⁻¹ for 9 months in normal dogs at doses of 1.5, 3.0, and 6.0 g·kg⁻¹.
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OBJECTIVE@#To observe preventive and therapeutic effects and the mechanism of actions on Zishen Yutai pill combined with progesterone on threatened abortion in rats.@*METHODS@#After pregnancy, 50 SPF female SD rats were selected and divided into control group, model group, progesterone group, Zishen Yutai pill group, and progesterone plus Zishen Yutai pill group (combination group), with 10 rats in each group. The rats of control group and abortion model group were lavaged with 2 mL/kg normal saline on pregnancy day 1 for continuous 10 days. Rats in Zishen Yutai pill group were given 1.575 g/kg/d of Zishen Yutai pill for intragastric administration for continuous 10 days. Rats in progesterone group were given intramuscular injection treatment of 0.1 mL/d progestin, continuous for 10 days. Rats in combination group were given injection therapy of aqueous solution of Zishen Yutai pill for continuous 10 days, and other treatments were the same as previous two groups. Abortion model were established then and live births, numbers of abortion and average rate of abortion were compared between the five groups. Peripheral blood was collected to detect the estradiol (E2) and progestational hormone (P), and obtain ratio of Th1/Th2 cytokines (IL-2, INF-γ, IL-4, IL-10).@*RESULTS@#Significant more live births of rats were found in the control group compared with other four groups (P 0.05) but these levels in the control group and Zishen Yutai pill group were significant lower than that of progesterone group and joint group (P < 0.05). The maternal-fetal interface IL - 4/IL - 2, IL - 10/IL - 2 of model group were balanced deviating to Th1, while the IL-4/IL-2, IL-10/IL-2 of progesterone group, Zishen Yutai pill group and joint group were balanced deviating to Th2, and joint group' deviation was better than progesterone group and Zishen Yutai pill group (P < 0.05).@*CONCLUSIONS@#Zishen Yutai pill combined with progesterone has a significant control effect for threatened abortion, which can obviously increase contents of maternal serums E2 and P, and regulate the Th1/Th2 balance with a remarkable effect.
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Objective To observe preventive and therapeutic effects and the mechanism of actions on Zishen Yutai pill combined with progesterone on threatened abortion in rats. Methods After pregnancy, 50 SPF female SD rats were selected and divided into control group, model group, progesterone group, Zishen Yutai pill group, and progesterone plus Zishen Yutai pill group (combination group), with 10 rats in each group. The rats of control group and abortion model group were lavaged with 2 mL/kg normal saline on pregnancy day 1 for continuous 10 days. Rats in Zishen Yutai pill group were given 1.575 g/kg/d of Zishen Yutai pill for intragastric administration for continuous 10 days. Rats in progesterone group were given intramuscular injection treatment of 0.1 mL/d progestin, continuous for 10 days. Rats in combination group were given injection therapy of aqueous solution of Zishen Yutai pill for continuous 10 days, and other treatments were the same as previous two groups. Abortion model were established then and live births, numbers of abortion and average rate of abortion were compared between the five groups. Peripheral blood was collected to detect the estradiol (E2) and progestational hormone (P), and obtain ratio of Th1/Th2 cytokines (IL-2, INF-γ, IL-4, IL-10). Results Significant more live births of rats were found in the control group compared with other four groups (P 0.05) but these levels in the control group and Zishen Yutai pill group were significant lower than that of progesterone group and joint group (P < 0.05). The maternal–fetal interface IL – 4/IL – 2, IL – 10/IL – 2 of model group were balanced deviating to Th1, while the IL-4/IL-2, IL-10/IL-2 of progesterone group, Zishen Yutai pill group and joint group were balanced deviating to Th2, and joint group’ deviation was better than progesterone group and Zishen Yutai pill group (P < 0.05). Conclusions Zishen Yutai pill combined with progesterone has a significant control effect for threatened abortion, which can obviously increase contents of maternal serums E2 and P, and regulate the Th1/Th2 balance with a remarkable effect.
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Objective To observe the curative effects of zishen yutai pill combined with dydrogesterone and vitamin E in the treatment of recurrent spontaneous abortion. Methods A total of 123 patients with recurrent spontaneous abortion who were admitted to our hospital from January 2011 to December 2013 were selected as research subjects. They were randomly assigned to a control group of 60 patients and a treatment group of 63 patients. Patients in the control group were not given any medication before pregnancy and were given dydrogesterone and vitamin E after pregnancy for mis-carriage prevention;patients in the treatment group were given medication before pregnancy: patients were given zishen yutai pill from the end of monthly menstruation to the beginning of the next menstruation continuously for 3 months. They were continuously given zishen yutai pill, dydrogesterone and vitamin E after pregnancy for miscarriage preven-tion; difference of successful rate of the treatment between the two groups were compared. Results The rates of vaginal bleeding, lumbar pain, abdominal pain, or bulge during pregnancy of treatment group were significantly lower than those of control group, the differences were significant (P<0.05).The successful rate in the treatment group was 92.06%, and the successful rate in the control group was 66.67%. The two groups were compared, and the successful rate in the treatment group was significantly higher than that in the control group. The difference was statistically significant (P<0.05). Conclusion Zishen yutai pill combined with dydrogesterone and vitamin E in the treatment of recurrent sponta-neous abortion is safe and highly successful, which is worthy of clinical promotion.