Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

Estrogen, through binding to its receptors in the female endometrium, promotes the proliferation, differentiation, and angiogenesis of endometrial stromal cells, thereby playing a critical role in endometrial injury repair, regeneration, and the prevention and treatment of intrauterine adhesions. Currently, various estrogen-based pharmaceutical formulations are applied in clinical practice, and the development of related products is progressively advancing. This review systematically outlines the etiology of endometrial injury and the mechanisms by which estrogen facilitates endometrial repair and regeneration. Furthermore, it highlights recent research progress and clinical applications of estrogen-based therapies in endometrial regeneration, aiming to provide a valuable reference for relevant scientific research and clinical practice.

Estrogen, through binding to its receptors in the female endometrium, promotes the proliferation, differentiation, and angiogenesis of endometrial stromal cells, thereby playing a critical role in endometrial injury repair, regeneration, and the prevention and treatment of intrauterine adhesions. Currently, various estrogen-based pharmaceutical formulations are applied in clinical practice, and the development of related products is progressively advancing. This review systematically outlines the etiology of endometrial injury and the mechanisms by which estrogen facilitates endometrial repair and regeneration. Furthermore, it highlights recent research progress and clinical applications of estrogen-based therapies in endometrial regeneration, aiming to provide a valuable reference for relevant scientific research and clinical practice.

Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

Objective To evaluate the value of a machine learning-based biparametric magnetic resonance imaging(bpMRI)radiomics model in predicting clinically significant prostate cancer(csPCa)in the transitional zone.Methods A retrospective analysis was con-ducted on 507 cases in two medical centers.All patients underwent prostate MRI examinations before surgery,with complete patho-logical data.The case distribution was as follows:256 cases of csPCa,97 cases of clinically insignificant prostate cancer(ciPCa),and 154 cases of benign prostatic hyperplasia(BPH).Using the R language,the data from Center One was randomly divided into training and test groups at a ratio of 7∶3,and the data from Center Two as an independent external validation group.The image features from T2 WI and diffusion weighted imaging(DWI)were extracted,and the least absolute shrinkage and selection operator(LASSO)was used to reduce dimensionality and filter features.Two datasets were constructed based on T2 WI features alone and combined T2 WI and DWI features.Six prediction models were established using random forest(RF),logistic regression(LR),and support vector machine(SVM).The efficacy of six models of T2 WI features and combined T2 WI and DWI features in the diagnosis of prostate dis-eases through receiver operating characteristic(ROC)curve,area under the curve(AUC),and decision curve analysis(DCA)were compared and evaluated.Results In the training group,feature screening identified 7 and 8 features from the T2WI single sequence and the T2WI with DWI dual sequence for csPCa prediction in the transitional zone.The results showed that the T2WI with DWI dual sequence RF model had the highest AUC performance.The AUC of the training,test,and validation groups were 0.950,0.866,and 0.818,respectively.The test group accuracy was 0.805,sensitivity was 0.690,and specificity was 0.920;the validation group accu-racy was 0.726,sensitivity was 0.661,and specificity was 0.793.DCA showed that within a wide probability threshold range,the T2 WI with DWI dual sequence RF model had the greatest net benefit.Conclusion Based on the bpMRI radiomics model,non-invasive prediction of csPCa in the transitional zone can be achieved before surgery,which helps to make clinical diagnosis and treatment decisions.

Objective To investigate the application value of single nucleotide polymorphism(SNP)linkage analysis based on next-generation sequencing(NGS)technology in preimplantation genetic testing(PGT)of families with autosomal recessive polycystic kidney disease(ARPKD).Methods A family with ARPKD was selected,where the female member had a pregnancy ultrasound revealing polycystic kidney in the fetus.Genetic testing showed compound heterozygous mutations of the polycystic kidney/polycystic liver disease 1 gene(PKHD1),c.10444C>T(paternal)and c.4303del(maternal),with the c.4303del mutation being reported for the first time.Targeting the coding region of the PKHD1 gene,335 high-density tightly linked SNP sites were selected in the upstream and downstream 2M regions using multiplex polymerase chain reaction(PCR)and NGS.The couple′s SNP risk haplotypes carrying gene mutations were constructed.After in vitro fertilization,blastocyst culture was performed.Trophoblastic cells obtained from the biopsy were subjected to whole-genome amplification,and NGS was used for linkage analysis and low-depth chromosomal aneuploidy screening of the embryos.Sanger sequencing was used to verify the results of embryo linkage analysis.Results Among the 6 biopsied embryos,4 were mutation-free and euploid,1 exhibited heterozygous for the mutation and mosaic while another unstable sequencing data,making it impossible to judge.One of the mutation-free and developmentally healthy euploid embryos was implanted into the maternal uterus,resulting in the full-term delivery of a healthy baby.Conclusion Application of NGS-based SNP linkage analysis in PGT can effectively blocking the vertical transmission of ARPKD within families,while avoiding abortion issues caused by aneuploid embryos.This study is also the first PGT report target-ing the PKHD1 gene c.4303del mutation.

Objective To compare the safety and clinical efficacy of lesion removal combined with percutaneous pedicle screw fixation with classical posterior lesion removal in the treatment of lumbar brucelli spondylitis(LBS)by unilateral biportal endoscopic technique with transforaminal lumbar interbody fusion(UBE-LIF)technique.Methods The clinical data of 32 patients with LBS admitted by the Department of Spine and Orthopedics of Gansu Provincial Hospital of Traditional Chinese Medicine from January 2020 to January 2022 were retrospectively analyzed,and the clinical data of the 32 LBS patients were divided into 15 cases in the UBE-LIF group and 17 cases in the posterior group.The general data,surgery-related indexes,and postoperative pathological HE staining of the two groups were recorded and analyzed.The patients'clinical recovery was assessed according to their erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP),low back pain visual analogue score(VAS),Japanese Orthopaedic Association(JOA)score,and Oswestry Dysfunction Index(ODI)preoperative,1 week after surgery,1,3,6 months and 1 year after surgery.Lumbar lordosis angle(LL)and intervertebral space height(DH)were measured by imaging before surgery and at the last follow-up,and intervertebral bone graft fusion was assessed using Suk grading criteria.Results Both groups successfully completed the operation and no serious postoperative complications occurred.There were no significant differences in gender,age,surgical segment,operation time,preoperative ESR and CRP,preoperative VAS,JOA score and ODI index,preoperative LL and DH(P＞0.05).The intraoperative blood loss,postoperative drainage,postoperative getting out of bed,and postoperative hospital stay in UBE-LIF group were significantly lower than those in the posterior group(P＜0.001).Pathological examination of diseased tissues was performed during surgery,all of which was consistent with brucellosis changes.Patients in both groups were followed up for 12-18 months,with an average of 14.8 months.The VAS,JOA score,and ODI index at all postoperative time points in the two groups were significantly improved compared with the preoperative period(P＜0.05).The difference between the two groups was significantly greater than that in the postoperative group:VAS score was lower in UBE-LIF group than in the posterior group(P＜0.01),CRP in both groups was higher than that in the preoperative group,and the elevation level was significantly lower in UBE-LIF group than in the posterior group(P＜0.001).There was no significant difference in ESR between the two groups compared with that before surgery(P＞0.05).There were no significant differences in VAS,JOA score,ODI index,CRP or ESR between the remaining time points after surgery(P＞0.05).At the last follow-up,imaging examination showed that the overall fusion rate of intervertebral bone graft in UBE-LIF group was 93.3％and 94.1％in the posterior group,without significant difference(x2=0.246,P=0.884).LL and DH were significantly improved in both groups compared with preoperative ones(P＜0.01),and the two groups did not significantly differ before and after surgery(P＞0.05).Conclusion Both surgical treatments for LBS are safe effect.Compared with posterior lesion removal bone graft fusion internal fixation,UBE-LIF technology combined with percutaneous pedicle screw internal fixation has the advantages of clear intraoperative vision,less blood loss,faster early postoperative recovery,and shorter postoperative hospital stay,and thus is a feasible surgical method for the minimally invasive treatment of LBS.

Objective : To analyze the data related to the clinical outcome of preimplantation genetic testing (PGT) for double frozen , double biopsied blastocysts and double frozen , once biopsied blastocysts , in order to expand the existing data and provide some guidance for the clinical value and safety of PGT for frozen⁃thawed embryos . Methods : Retrospective analysis was made on the 38 PGT cycles of frozen⁃thawed blastocysts . According to the frequency of biopsy , cases in the study were divided into two groups : double frozen , double biopsy ( DFDB) group and double frozen , single biopsy ( DFSB) group . The freezing method was vitrification . Results : There were 24 patients in DFDB group , 34 blastocysts were not diagnosed in the last PGT cycle , 32 blastocysts survived after thawing , and the survival rate of thawed blastocysts was 94. 12% . After the second biopsy of these 32 blastocysts , genetic testing was performed , and all of them were definitely diagnosed , including 15 normal blastocysts (46. 88% ) and 17 abnormal blastocysts (53 . 13% ) . There were 14 patients in DFSB . The remaining 50 blastocysts in the last ICSI cycle were thawed and all blastocysts survived after thawing . Biopsy of these 50 blastocysts and genetic analysis showed that 47 blastocysts were diagnosed , including 9 normal blastocysts (18 . 00% ) , 28 abnormal blastocysts (56. 00% ) , 10 mosaic blastocysts (20. 00% ) , and 3 undiagnosed blastocysts (6. 00% ) . In DFDB group and DFSB group , 8 patients and 5 patients transferred the normal blastocystswhich all survivedafter thawing . There were 5 clinical pregnancies and 3 clinical pregnancies , respectively . One healthy live birth was obtained respectively in each group . Conclusion Acceptable pregnancy rate can be obtained whatever DFSB or DFDB blastocyst , which is of clinical value . However , due to the small sample size , we need to expand the sample size to further explore its safety .

Objective:To investigate the clinical value of zoledronic acid in improving the prognosis of osteoporotic hip fracture and preventing its sequential contralateral hip fracture.Methods:A retrospective study of 206 patients diagnosed with hip fragile fractures in China Medical University Affiliated Shengjing Hospital and treated with anti-osteoporotic drugs after surgery was conducted. The prognosis of patients with hip fracture using survival rate analysis and the risk factors of acute febrile complications with multivariate analysis after zoledronic acid treatment were evaluated. Furthermore, chi-square test and multivariate analysis was used to explore whether zoledronic acid decreases the occurrence of the contralateral sequential fracture.Results:The 3-year survival rate of patients with overall hip fracture was higher in zoledronic acid treatment group compared with control group( P=0.026), with the incidence of fever at 53.3%. The age [ OR=0.786, P=0.027, the area under receiver operating characteristic (ROC) curve was 0.724] and cardiopulmonary complications ( OR=0.043, P=0.025, the area under ROC curve was 0.628) were significantly correlated with the occurrence of acute febrile response. The incidence of sequential contralateral fractures in zoledronic acid treatment group was significantly lower than that in control group ( χ2=4.356, P=0.037). The application of zoledronic acid ( OR=0.160, P=0.007, the area under ROC curve is 0.586) and the type of femoral neck fracture ( OR=0.196, P=0.001, the area under ROC curve is 0.607) were statistically associated with the occurrence of sequential fractures. Conclusion:Zoledronic acid treatment improves the outcome of patients with osteoporotic hip fracture and reduces the incidence of sequential hip fractures, especially femoral neck fracture. Senile age and cardiopulmonary complications might be associated with lower risk of acute febrile reactions after zoledronic acid treatment.

ObjectiveTo investigate chlorate contamination level in infant formula sold in Shanghai， and to evaluate the dietary exposure risk to infants in Shanghai. MethodsWith the risk monitoring data of chlorate in infant formula sold in Shanghai in 2020， combined with the dietary consumption data of infants， the dietary exposure of chlorate in infant formula was assessed via the point assessment method. ResultsIn 2020， the overall detection rate of chlorate in 120 infant formula samples was 98.3% （118/120）， the mean content was 124.5 μg⋅kg^-1， the 50 percentile value was 64.6 μg⋅kg^-1， and the maximum value was 1 475.0 μg⋅kg^-1. The mean and 95 percentile value of daily chlorate intake from infant formula for infants aged 0‒36 months in Shanghai were 1.10 and 1.84 μg⋅kg^-1， accounting for 36.7% and 61.3% of the tolerable daily intake （TDI） of chlorate （3μg⋅kg^-1）， respectively. The mean， 50 percentile value and 95 percentile value of daily chlorate exposure of infants in different month-age groups （0‒6 months， 6‒12 months， 12‒36 months） through infant formula were lower than the TDI value. ConclusionThe health risk of daily chlorate intake from infant formula for infants and young children aged 0‒36 months in Shanghai is at an acceptable level.