1.A Multicenter Controlled Study on the Evaluation of Aseptic Compounding Operations Ability of PIVAS Personnel by Media Fill Test
Fan ZHANG ; Yuanyuan MA ; Xinyi WANG ; Donghui LAO ; Yongguang SHANG ; Xiaohong ZHU ; Yuzhen ZOU ; Lei JIAO ; Weiyan TANG ; Jianzhong ZHANG ; Wei YANG ; Mei DONG ; Cuilian ZHANG ; Lulu SUN ; Bin ZHAO
Herald of Medicine 2025;44(11):1848-1853
Objective To evaluate the practical application of the Media Fill Test(MFT)in assessing aseptic compounding competency of personnel in Pharmacy Intravenous Admixture Services(PIVAS).Methods A multicenter controlled study was conducted across six tertiary hospitals(center ①-⑥)in China.Participants were divided into an inexperienced group(Group A,n=118)and an experienced group(Group B,n=118),each performing five MFT operations.Positive controls validated medium efficacy.Contamination rates and pass rates were analyzed using chi-square and Fisher's exact tests.Results Valid samples included 584 for Group A and 588 for Group B.The sample pass rate was 66.78%(390/584)in Group A and 91.67%(539/588)in Group B,while personnel pass rates were 46.15%(54/117)and 80.51%(95/118),respectively,with significant intergroup differences(both P<0.01).All centers except Center ⑥ showed significantly higher pass rates in Group B(all P<0.05).Conclusion MFT effectively differentiates technical proficiency levels and is suitable for training evaluation of novice PIVAS staff.
2.A Multicenter Controlled Study on the Evaluation of Aseptic Compounding Operations Ability of PIVAS Personnel by Media Fill Test
Fan ZHANG ; Yuanyuan MA ; Xinyi WANG ; Donghui LAO ; Yongguang SHANG ; Xiaohong ZHU ; Yuzhen ZOU ; Lei JIAO ; Weiyan TANG ; Jianzhong ZHANG ; Wei YANG ; Mei DONG ; Cuilian ZHANG ; Lulu SUN ; Bin ZHAO
Herald of Medicine 2025;44(11):1848-1853
Objective To evaluate the practical application of the Media Fill Test(MFT)in assessing aseptic compounding competency of personnel in Pharmacy Intravenous Admixture Services(PIVAS).Methods A multicenter controlled study was conducted across six tertiary hospitals(center ①-⑥)in China.Participants were divided into an inexperienced group(Group A,n=118)and an experienced group(Group B,n=118),each performing five MFT operations.Positive controls validated medium efficacy.Contamination rates and pass rates were analyzed using chi-square and Fisher's exact tests.Results Valid samples included 584 for Group A and 588 for Group B.The sample pass rate was 66.78%(390/584)in Group A and 91.67%(539/588)in Group B,while personnel pass rates were 46.15%(54/117)and 80.51%(95/118),respectively,with significant intergroup differences(both P<0.01).All centers except Center ⑥ showed significantly higher pass rates in Group B(all P<0.05).Conclusion MFT effectively differentiates technical proficiency levels and is suitable for training evaluation of novice PIVAS staff.
3.Effect of laparoscopic ovarian cystectomy on ovarian reserve and the outcomes of in vitro fertilization patients with benign ovarian cysts
Lina WANG ; Yan ZHAO ; Wenzhu YU ; Yahui HU ; Rui MA ; Baoli YIN ; Cuilian ZHANG
Chinese Journal of Obstetrics and Gynecology 2023;58(2):98-104
Objective:To investigate the effect of laparoscopic ovarian cystectomy on anti-Mullerian hormone (AMH) level, ovarian response to gonadotropin stimulation and pregnancy rate for in vitro fertilization (IVF) patients with benign ovarian cysts.Methods:Patients with benign ovarian cysts who were admitted for cystectomy and had undergone IVF treatment were enrolled in the study. There were 373 participants with ovarian cysts underwent laparoscopic ovarian cystectomy in the experimental group. According to duration of post-surgery, there were four sub-groups: 1 year post-surgery (1Y POST), 2 years post-surgery (2Y POST), 4 years post-surgery (4Y POST) and ≥5 years post-surgery (≥5Y POST) in the experimental group. According to histopathologic types of ovarian cysts, there were two sub-groups: ovarian endometriotic cysts and ovarian non-endometriotic cysts. Two hundreds and three patients with no history of ovarian cysts and ovarian surgery were in the control group. The level of AMH and basic concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH), progesterone (P), estradiol (E 2) were measured. Antral follicle counts (AFC) were calculated. There were other study variables: total dose of gonadotropins, duration of ovarian stimulation, the number of oocyte retrieved, the number of embryo obtained, blastocyst transfer rate and pregnancy rate. Results:The control group was matched as closely as possible to the experimental group, including age, body mass index and menstrual cycle (all P>0.05). Compared to the women in control group, the women in ovarian endometriotic cystectomy sub-group had significantly higher levels of basal FSH and basal P, lower level of AMH (all P<0.05); the women in ovarian endometriotic cysts sub-group had significantly higher dose of gonadotropins (all P<0.05); the women in ovarian endometriotic cysts ≥5Y POST sub-group had significantly lower number of oocyte retrieved, lower number of embryo obtained, lower blastocyst transfer rate, and lower pregnancy rate (all P<0.05). Compared to the women in control group, the women in ovarian non-endometriotic cysts sub-group had a significantly higher level of basal FSH and basal P (all P<0.05). The women in ovarian non-endometriotic cysts sub-group had lower level of AMH, higher dose of gonadotropins, lower number of oocyte retrieved, lower number of embryo obtained, lower rate of blastocyst transfer and lower rate of pregnancy than the control group but there were no statistically significant differences among them (all P>0.05). The women with unilateral ovarian endometriotic cysts had significantly lower number of oocyte retrieved on the side of surgery than another side ( P<0.05). Conclusions:In short term laparoscopic ovarian cystectomy has no significant effect on ovarian reserve. But with long-term follow-up ovarian reserve, ovarian response to gonadotropin stimulation and pregnancy rate are decreased. The effect of laparoscopic ovarian cystectomy in benign cysts on ovarian is associated with whether or not it is the surgical side.
4.Influence of the number of previous spontaneous abortions on the pregnancy outcome of patients undergoing IVF/ICSI-ET
Jingjing FAN ; Fang YUAN ; Tiantian CHENG ; Hua ZHAO ; Cuilian ZHANG ; Qiaohua HE
Chinese Journal of Reproduction and Contraception 2023;43(8):777-783
Objective:To explore the effect of previous different spontaneous abortion times on pregnancy outcomes of patients with the first in vitro fertilization/intracytoplasmic sperm injection and embryo transfer (IVF/ICSI-ET). Methods:A retrospective cohort study was performed on the clinical data of patients with the first IVF/ICSI-ET in the Reproductive Center of Henan Provincial People's Hospital from January 1, 2010 to December 31, 2018. A total of 12 912 patients were included. According to the number of previous spontaneous abortions, the patients were divided into four groups: zero time group ( n=10 948), 1 time group ( n=1 506), 2 times group ( n=345) and ≥3 times group ( n=113). The basic data of patients and pregnancy outcomes after assisted pregnancy were compared among the four groups, and the influence of the number of previous spontaneous abortions on pregnancy outcomes of IVF/ICSI-ET patients was investigated by univariate and categorical multivariate logistic regression analysis. Results:Univariate logistic regression analysis showed that age, infertility duration, previous spontaneous abortion times, endometrial thickness, the numbers of embryos transferred and high-quality embryos transferred were all influencing factors of implantation rate, pregnancy rate, early spontaneous abortion rate and live birth rate (all P<0.001, except for the influence of endometrial thickness on early spontaneous abortion rate P=0.002). The types of embryo transferred, follicle-stimulating hormone (FSH) level, luteinizing hormone (LH) level, LH/FSH, and anti-Müllerian hormone (AMH) level all had effects on the implantation rate, the pregnancy rate, and the live birth rate (all P<0.001, except for the effect of AMH on the live birth rate P=0.002). Body mass index (BMI) was the influencing factor of early spontaneous abortion rate and live birth rate ( P=0.006, P=0.002). After adjusting for confounding factors, multiple regression analysis showed that with zero time group as the reference group, the implantation rate of ≥3 times group ( OR=0.63, 95% CI: 0.42-0.94, P=0.025) was significantly decreased; the early spontaneous abortion rate was significantly increased in 1 time group ( OR=1.56, 95% CI: 1.27-1.93, P<0.001), 2 times group ( OR=2.28, 95% CI: 1.61-3.23, P<0.001), and ≥3 times group ( OR=3.32, 95% CI: 1.89-5.82, P<0.001); the live birth rate was significantly reduced in 1 time group ( OR=0.80, 95% CI: 0.71-0.91, P<0.001), 2 times group ( OR=0.66, 95% CI: 0.52-0.84, P<0.001) and ≥3 times group ( OR=0.45, 95% CI: 0.29-0.67, P<0.001). Conclusion:The number of previous early spontaneous abortions is an independent factor affecting the implantation rate, the early spontaneous abortion rate and the live birth rate for patients undergoing IVF/ICSI-ET. With the increase of the number of previous early spontaneous abortions, the implantation rate and the live birth rate after IVF/ICSI were gradually decreased, and the risk of early spontaneous abortion gradually increased.
5.Influence of endometrial thickness on the outcome of spontaneous abortion in IVF-ET cycle and threshold effect analysis
Tiantian CHENG ; Jingjing FAN ; Fang YUAN ; Hua ZHAO ; Lan YU ; Cuilian ZHANG ; Qiaohua HE
Chinese Journal of Reproduction and Contraception 2023;43(7):676-682
Objective:To study the relationship between endometrial thickness (EMT) at the time of human chorionic gonadotropin (hCG) trigger day or endometrial transformation day and spontaneous abortion in in vitro fertilization (IVF) cycle and analyze the threshold effect. Methods:A retrospective cohort study was performed to analyze the clinical data of infertile patients who underwent the first IVF cycle in the Reproductive Center of Henan Provincial People's Hospital from January 2010 to December 2018. The patients were divided into four groups according to EMT, group A: EMT<8 mm, group B: 8 mm≤EMT<10 mm, group C: 10 mm≤EMT<12 mm, and group D: EMT≥12 mm. The effect of EMT on spontaneous abortion rate during IVF cycle was investigated by univariate analysis, multivariate logistic regression analysis, smooth curve fitting and the threshold effect analysis.Results:In all 12 912 IVF cycles, 8 674 cycles got clinical pregnancy, 1 102 cycles resulted in early spontaneous miscarriage and the spontaneous abortion rate was 12.70%. Univariate regression analysis showed that age, body mass index, duration of infertility, type of infertility, male factors in infertility factors, No. of spontaneous abortions, EMT and No. of embryos transferred had influences on the spontaneous abortion rate (all P<0.05). Multivariate logistic regression analysis adjusted for confounding factors and group A was used as control group. The results showed that the spontaneous abortion rate of groups B, C and D was significantly lower than that of group A during embryo transfer at cleavage stage ( P=0.008 , P<0.001, P<0.001); there was no significant difference in spontaneous abortion rate with the increase of EMT during blastocyst stage ( P>0.05). The threshold effect analysis showed that when the EMT was <10.3 mm, the spontaneous abortion rate decreased significantly with the increasing of EMT for cleavage embryo, and the spontaneous abortion rate decreased 14.7% with each 1 mm increment in EMT ( OR=0.853, 95% CI: 0.792-0.918, P<0.001); there was no significant difference in spontaneous abortion rate when EMT was ≥10.3 mm ( OR=1.006, 95% CI: 0.959-1.056, P=0.798). The spontaneous abortion rate changed steadily with the increase of EMT, and the difference was not statistically significant for blastocyst embryo ( P>0.05). Conclusion:In IVF cycle, the relationship between EMT and spontaneous abortion was curvilinear for cleavage embryo. Before the EMT reached the threshold of 10.3 mm, the spontaneous abortion rate decreased significantly with the increase of EMT.
6.Influence of the number of previous spontaneous abortions on the pregnancy outcome of patients undergoing IVF/ICSI-ET
Jingjing FAN ; Fang YUAN ; Tiantian CHENG ; Hua ZHAO ; Cuilian ZHANG ; Qiaohua HE
Chinese Journal of Reproduction and Contraception 2023;43(8):777-783
Objective:To explore the effect of previous different spontaneous abortion times on pregnancy outcomes of patients with the first in vitro fertilization/intracytoplasmic sperm injection and embryo transfer (IVF/ICSI-ET). Methods:A retrospective cohort study was performed on the clinical data of patients with the first IVF/ICSI-ET in the Reproductive Center of Henan Provincial People's Hospital from January 1, 2010 to December 31, 2018. A total of 12 912 patients were included. According to the number of previous spontaneous abortions, the patients were divided into four groups: zero time group ( n=10 948), 1 time group ( n=1 506), 2 times group ( n=345) and ≥3 times group ( n=113). The basic data of patients and pregnancy outcomes after assisted pregnancy were compared among the four groups, and the influence of the number of previous spontaneous abortions on pregnancy outcomes of IVF/ICSI-ET patients was investigated by univariate and categorical multivariate logistic regression analysis. Results:Univariate logistic regression analysis showed that age, infertility duration, previous spontaneous abortion times, endometrial thickness, the numbers of embryos transferred and high-quality embryos transferred were all influencing factors of implantation rate, pregnancy rate, early spontaneous abortion rate and live birth rate (all P<0.001, except for the influence of endometrial thickness on early spontaneous abortion rate P=0.002). The types of embryo transferred, follicle-stimulating hormone (FSH) level, luteinizing hormone (LH) level, LH/FSH, and anti-Müllerian hormone (AMH) level all had effects on the implantation rate, the pregnancy rate, and the live birth rate (all P<0.001, except for the effect of AMH on the live birth rate P=0.002). Body mass index (BMI) was the influencing factor of early spontaneous abortion rate and live birth rate ( P=0.006, P=0.002). After adjusting for confounding factors, multiple regression analysis showed that with zero time group as the reference group, the implantation rate of ≥3 times group ( OR=0.63, 95% CI: 0.42-0.94, P=0.025) was significantly decreased; the early spontaneous abortion rate was significantly increased in 1 time group ( OR=1.56, 95% CI: 1.27-1.93, P<0.001), 2 times group ( OR=2.28, 95% CI: 1.61-3.23, P<0.001), and ≥3 times group ( OR=3.32, 95% CI: 1.89-5.82, P<0.001); the live birth rate was significantly reduced in 1 time group ( OR=0.80, 95% CI: 0.71-0.91, P<0.001), 2 times group ( OR=0.66, 95% CI: 0.52-0.84, P<0.001) and ≥3 times group ( OR=0.45, 95% CI: 0.29-0.67, P<0.001). Conclusion:The number of previous early spontaneous abortions is an independent factor affecting the implantation rate, the early spontaneous abortion rate and the live birth rate for patients undergoing IVF/ICSI-ET. With the increase of the number of previous early spontaneous abortions, the implantation rate and the live birth rate after IVF/ICSI were gradually decreased, and the risk of early spontaneous abortion gradually increased.
7.Influence of endometrial thickness on the outcome of spontaneous abortion in IVF-ET cycle and threshold effect analysis
Tiantian CHENG ; Jingjing FAN ; Fang YUAN ; Hua ZHAO ; Lan YU ; Cuilian ZHANG ; Qiaohua HE
Chinese Journal of Reproduction and Contraception 2023;43(7):676-682
Objective:To study the relationship between endometrial thickness (EMT) at the time of human chorionic gonadotropin (hCG) trigger day or endometrial transformation day and spontaneous abortion in in vitro fertilization (IVF) cycle and analyze the threshold effect. Methods:A retrospective cohort study was performed to analyze the clinical data of infertile patients who underwent the first IVF cycle in the Reproductive Center of Henan Provincial People's Hospital from January 2010 to December 2018. The patients were divided into four groups according to EMT, group A: EMT<8 mm, group B: 8 mm≤EMT<10 mm, group C: 10 mm≤EMT<12 mm, and group D: EMT≥12 mm. The effect of EMT on spontaneous abortion rate during IVF cycle was investigated by univariate analysis, multivariate logistic regression analysis, smooth curve fitting and the threshold effect analysis.Results:In all 12 912 IVF cycles, 8 674 cycles got clinical pregnancy, 1 102 cycles resulted in early spontaneous miscarriage and the spontaneous abortion rate was 12.70%. Univariate regression analysis showed that age, body mass index, duration of infertility, type of infertility, male factors in infertility factors, No. of spontaneous abortions, EMT and No. of embryos transferred had influences on the spontaneous abortion rate (all P<0.05). Multivariate logistic regression analysis adjusted for confounding factors and group A was used as control group. The results showed that the spontaneous abortion rate of groups B, C and D was significantly lower than that of group A during embryo transfer at cleavage stage ( P=0.008 , P<0.001, P<0.001); there was no significant difference in spontaneous abortion rate with the increase of EMT during blastocyst stage ( P>0.05). The threshold effect analysis showed that when the EMT was <10.3 mm, the spontaneous abortion rate decreased significantly with the increasing of EMT for cleavage embryo, and the spontaneous abortion rate decreased 14.7% with each 1 mm increment in EMT ( OR=0.853, 95% CI: 0.792-0.918, P<0.001); there was no significant difference in spontaneous abortion rate when EMT was ≥10.3 mm ( OR=1.006, 95% CI: 0.959-1.056, P=0.798). The spontaneous abortion rate changed steadily with the increase of EMT, and the difference was not statistically significant for blastocyst embryo ( P>0.05). Conclusion:In IVF cycle, the relationship between EMT and spontaneous abortion was curvilinear for cleavage embryo. Before the EMT reached the threshold of 10.3 mm, the spontaneous abortion rate decreased significantly with the increase of EMT.
8.Analysis of endometrial thickness threshold and optimal thickness interval measured by transvaginal ultrasound in blastocyst hormone replacement freeze-thawed embryo transfer
Shaodi ZHANG ; Zhiming ZHAO ; Qiuyuan LI ; Yisha YIN ; Shuna WANG ; Cuilian ZHANG
Chinese Journal of Ultrasonography 2020;29(3):260-265
Objective:To investigate the effect of endometrial thickness(EMT) on the clinical outcome of blastocyst hormone replacement freeze-thawed embryo transfer (HRT-FET) on the first progesterone day, and to analyze the threshold and optimal thickness interval corresponding to ideal clinical pregnancy rate by statistical method.Methods:The endometrial preparation protocols of 2 825 blastocyst HRT-FET cycles from January 2013 to December 2016 in Henan Provincial People′s Hospital and the Second Hospital of Hebei Medical University were studied retrospectively. According to EMT on the first progesterone day, they were divided into 5 subgroups: group Q1(EMT: 3.5-7.9 mm), group Q2(EMT: 8.0-8.9 mm), group Q3(EMT: 9.0-9.5 mm), group Q4(EMT: 9.6-10.7 mm), group Q5(EMT: 10.8-21.0 mm). Univariate analysis, classification multivariate Logistic regression analysis, curve fitting and threshold effect analysis were used to investigate the effect of endometrial thickness on clinical outcome of blastocyst HRT-FET.Results:Group Q1 was set as the control group in classification multivariate Logistic regression analysis, after adjusting for confounding factors, the clinical pregnancy rate and live birth rate in other groups were higher than the control group. The clinical pregnancy rate and live birth rate in group Q3 and Q4 were significantly increased and the differences were statistically significant(all P<0.05). The cut-off value of the endometrial thickness was 9.6 mm. When endometrial thickness was less than 9.6 mm, with 1 mm increase of endometrial thickness, the clinical pregnancy rate increased by 23%( OR=1.23, 95% CI=1.11-1.36) and the live birth rate increased by 21%( OR=1.21, 95% CI=1.10-1.33). When the endometrial thickness was thicker than the threshold, the clinical pregnancy rate did not increase significantly( OR=0.92, 95% CI=0.84-1.02), and the live birth rate showed a downward trend( OR=0.88, 95% CI=0.81-0.96). Conclusions:In the blastocyst HRT-FET cycle, endometrial thickness showes a curvilinear relationship with clinical outcome. The optimal endometrial thickness range for ideal clinical outcome is 9.0-11.0 mm.
9.Effects of vitamin D on learning and memory and expression of Mcoln-1 in brain tissue of rats with traumatic brain injury
Guangkui HAN ; Yueshu ZHAO ; Cuilian SUN ; Changmeng CUI
Chinese Journal of Behavioral Medicine and Brain Science 2020;29(7):589-593
Objective:To explore the effects of vitamin D (VD) on lysosome activity and calcium channel protein Mcoln-1 in hippocampus and cortex of rats after traumatic brain injury (TBI).Methods:Forty-five SD rats were randomly divided into control group (Sham group), TBI model group (TBI group) and calcitriol treatment group (Calcitriol group). TBI models were established by electronic cortical impactor in TBI group and Calcitriol group. The rats in Calcitriol group were given of calitriol (1 μg/kg) by intraperitoneal injection at 30 min, 24 h and 48 h after TBI.Western blot was used to detect the expression of Mcoln-1, LAMP-1 and cathepsin-B in hippocampus and cortex region of rats. Immunofluorescence was used to detect the co-localization of Mcoln-1 and neurons three days later. Morris water maze test was performed on the 8th, 9th and 10th day after surgery in all groups.Results:Morris water maze results showed that compared with sham group((19.54±3.54)s, (18.64±4.63)s, (17.64±5.88)s), the latency of seeking platform escape ((58.75±6.65)s, (50.64±5.56)s, (42.64±5.87)s) were significantly increased in TBI group ( t=18.042, 14.325, 10.117; all P<0.05). On the 8th, 9th and 10th day after modeling, the escape latency of Calcitriol group((44.54±3.75)s, (30.74±4.74)s, (24.43±4.75)s)were significantly lower than those of TBI group ( t=6.539, 8.909, 7.369, all P<0.05). Western blot results showed that the expression of Mcoln-1 in cortex and hippocampus of TBI group were not significantly different from those of Sham group (both P>0.05). Compared with TBI group, the expression of Mcoln-1 protein in cortex and hippocampus of rats in Calcitriol group were significantly increased ( t=18.862, 17.336, both P<0.05). Immunofluorescence showed that the expression of Mcoln-1 and NeuN (neuron marker) co-located in the cortex and hippocampus of rats in the Calcitriol group. Conclusion:VD can improve learning and memory dysfunction after TBI in rats, and its mechanism may be related to the activation of Mcoln-1 calcium channel.
10.Onset detection of surface diaphragmatic electromyography based on sample entropy and individualized threshold.
Cuilian ZHAO ; Shuangchi MA ; Yexiao LIU
Journal of Biomedical Engineering 2018;35(6):852-859
The diaphragm is the main respiratory muscle in the body. The onset detection of the surface diaphragmatic electromyography (sEMGdi) can be used in the respiratory rehabilitation training of the hemiparetic stroke patients, but the existence of electrocardiography (ECG) increases the difficulty of onset detection. Therefore, a method based on sample entropy (SampEn) and individualized threshold, referred to as SampEn method, was proposed to detect onset of muscle activity in this paper, which involved the extraction of SampEn features, the optimization of the SampEn parameters and , the selection of individualized threshold and the establishment of the judgment conditions. In this paper, three methods were used to compare onset detection accuracy with the SampEn method, which contained root mean square (RMS) with wavelet transform (WT), Teager-Kaiser energy operator (TKE) with wavelet transform and TKE without wavelet transform, respectively. sEMGdi signals of 12 healthy subjects in 2 different breathing ways were collected for signal synthesis and methods detection. The cumulative sum of the absolute value of error was used as an judgement value to evaluate the accuracy of the four methods. The results show that SampEn method can achieve higher and more stable detection precision than the other three methods, which is an onset detection method that can adapt to individual differences and achieve high detection accuracy without ECG denoising, providing a basis for sEMGdi based respiratory rehabilitation training and real time interaction.

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