1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Quality evaluation of Chinese and global guidelines/consensus for TDM of anti-TNF-α agents in patients with inflammatory bowel disease
Tanghui JIN ; Mengxin ZHU ; Cheng XIE ; Fan XIA ; Di YU ; Yue LI ; Yun LI ; Qinhua XI ; Jianguo ZHU
China Pharmacy 2024;35(4):481-487
OBJECTIVE To evaluate the quality of guidelines/consensus on therapeutic drug monitoring (TDM) of anti-tumor necrosis factor-α (TNF-α) in patients with inflammatory bowel disease (IBD) in China and globally. METHODS PubMed, Embase, CNKI, Wanfang data, VIP, and release websites of guidelines/consensus in China and globally were searched to collect guidelines/expert consensus on TDM with anti-TNF-α for IBD patients. The search period was from database establishment to June 2023. After two investigators independently screened the literature and extracted the data, the methodological quality of the included guidelines/consensuses was evaluated using the Appraisal of Guidelines for Research and Evaluation Ⅱ. The main recommendations of the included guidelines/consensuses were summarized. RESULTS A total of 9 articles were included, 3 were guidelines and 6 were expert consensus. The standardized percentages of the 9 guidelines/consensus in the 6 dimensions (scope and aims, participants, rigor of formulation, clarity of expression, application, and editorial independence) were 90.43%, 41.98%, 52.55%, 85.49%, 19.00%, and 76.85%, respectively. Eight guidelines/consensus had a recommendation of grade B and one consensus of grade C. The main recommendations involve TDM application scenarios, threshold ranges, strategy adjustments, detection methods, and interpretation of results. Most guidelines/consensus recommend passive TDM for non-responders. It is recommended to set the TDM concentration range according to the expected treatment results and make strategy adjustments in combination with the disease condition and TDM results. Additionally, the same test method is recommended for the same patient. Some guidelines/consensus hold that no differences were noted in the interpretation of results between biosimilar and original drug. CONCLUSIONS The overall quality of the included guidelines/consensus was fair, with relatively consistent recommendation. Clinicians need to understand the characteristics and limitations of TDM with this class of drugs, and interpret and apply results of TDM in combination with specific clinical treatment goals.
3.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
4.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
5.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
6.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
7.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
8.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
9.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
10.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.

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