Objective To study the development of conus medullaris by quantitative three-dimensional ultrasound in the second and third trimesters of pregnancy,and to analyze the value of terminal caudal vertebral ossification center count in diagnosis of closed spina bifida.Methods A total of 108 normal fetuses in the second and third trimesters of pregnancy who were admitted to Baoding No.1 Central Hospital from January 2019 to March 2024 were selected and assigned to the normal group.The distance between the fetal conus medullaris and the first sacral vertebra,the distance between the end of the conus medullaris and the end of sacrum,and the number of corresponding vertebrae were measured by three-dimensional ultrasound at different gestational weeks.Meanwhile,54 fetuses who were confirmed to have closed spina bifida after delivery were enrolled into the abnormal group.The number of ossification centers on the median sagittal section of the caudal spine was counted and compared between the two groups.The receiver operating characteristic(ROC)curve was drawn to analyze the value of ossification center count of distal caudal vertebrae in diagnosis of closed spina bifida.Results With the increase of gestational weeks,the distance between the fetal conus medullaris and the first sacral vertebra and the distance between the end of the conus medullaris and the end of the sacral bone were gradually increased.The conus medullaris of normal fetuses was mainly located in L1.5,L2 and L2.5,accounting for 85.19%(92/108).The ossification center count of distal caudal vertebra was slightly increased with the increase of gestational weeks in the normal group.At 17-20 gestational weeks,85.71%(12/14)of the ossification center count of distal caudal vertebra was 5 to 7.At 21-28 gestational weeks,100.00%(45/45)of the ossification center count was 6 and more.At week 29 and above,100.00%(45/45)of the ossification center count was more than 7.In the abnormal group,96.30%(52/54)of the fetuses had the ossification center less than 6,and 85.71%(42/49)of the ossification center count was≤5 at 21-32 gestational weeks.There were significant differences in the ossification center count between the two groups at 17-20,21-24,25-28,29-32,and 33-36 gestational weeks(P<0.05).ROC curve showed that,at 17-20,21-24,25-28,29-32,and 33-36 gestational weeks,the area under the curve(AUC)in prediction of closed spina bifida was 0.804,0.744,0.776,0.819,and 0.722 when the ossification center count of distal caudal vertebra was 5.31,4.59,4.81,4.67,and 5.49 as the cut-off value,respectively.Conclusion The conus medullaris moves upward with the increase of gestational weeks in the second and third trimesters of pregnancy.The ossification center count of the distal caudal vertebra is less than 6 in most fetuses with closed spina bifida,which is conducive to screening for closed spina bifida.

[Objective]To evaluate the efficacy of different traditional Chinese medicine(TCM)appropriate techniques on patients with coronary heart disease and insomnia by network Meta-analysis.[Methods]A computer-based search of China National Knowledge Infrastructure(CNKI),WanFang,China Science and Technology Journal Database(VIP),China Biology Medicine disc(CBM),PubMed,CINAHL,Web of Science,Embase and the Cochrane Library was conducted to retrieve the literature on the improvement of the efficacy of TCM appropriate technology in patients with coronary heart disease and insomnia.The retrieval time limit was from the establishment date of the database to December 2023.Two researchers independently screened the literature,evaluated the quality of the literature and extracted the information.The Cochrane bias assessment tool was used to evaluate the quality of the literature,Review Manager 5.3 was used for traditional Meta-analysis,and Stata 17 software was used for network Meta-analysis.[Results]A total of 31 studies involving 2 977 patients and 14 TCM appropriate techniques were included.Network Meta-analysis showed that in terms of the total effective rate of insomnia,acupoint massage+five-tone therapy[odds ratio(OR)=7.61,95％confidence interval(CI)(2.05,28.30),P＜0.05]was superior to conventional treatment,and had the best effect compared with other TCM appropriate techniques.In terms of sleep quality score,acupoint application[mean difference(MD)=0.51,95％CI(0.04,8.23),P＜0.05]was superior to conventional treatment,and had the best effect compared with other TCM appropriate techniques.[Conclusion]Existing studies have shown that acupoint massage+five-tone therapy can effectively improve the total effective rate of insomnia.Acupoint application can effectively improve the sleep quality of patients.Medical staff can select appropriate TCM appropriate techniques according to the patient's own situation.

Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.

Objective:To investigate the risk factors for progression to castration-resistant prostate cancer (CRPC) in metastatic prostate cancer (mPCa) patients who underwent androgen deprivation therapy (ADT).Methods:One hunred mPCa patients underwent ADT were followed up from January 2014 to December 2020 in the Affiliated Central Hospital of Shenyang Medical University. Retrospective analyze the patient′s Gleason score, initial PSA value, minimum prostate specific antigen (nPSA) and time when PSA drops to the lowest point (TTN), and record the state of lymph node metastasis and bone metastasis. Single factor Kaplan-Meier analysis and multivariate Cox regression analysis were used to explore the related risk factors affecting the progress of CRPC.Results:A total of 82 cases (82%) of ADT patients progressed to CRPC. Univariate Kaplan-Meier analysis showed that Gleason score, PSA initial value, lowest nPSA and time to TTN, lymph node metastasis and bone metastasis are risk factors for CRPC ( P<0.01 or<0.05); Multivariate Cox regression analysis showed that Gleason score, initial PSA value, nPSA and TTN are independent risk factors for PCa patients to progress to CRPC ( P<0.01 or<0.05). Conclusions:This study demonstrated that Gleason score, lymph node metastasis, bone metastasis, initial PSA value, nPSA and TTN are risk factors for the progression of CRPC. Patients with higher Gleason grade, higher nPSA, shorter TTN, lymph node and bone metastasis have shorter PFS and higher risk of progression to CRPC.

OBJECTIVE: Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China. METHODS: Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years. RESULTS: The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures. CONCLUSIONS During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
China ; United States ; United States Food and Drug Administration

Objective:To investigate the effect of three-dimensional printing technique assisted knee arthroplasty in the treatment of knee osteoarthritis with extraarticular deformities.Methods:Twelve patients with knee osteoarthritis and extraarticular deformities in the Sixth People's Hospital of Fuyang were selected as the study subjects from January 2016 to June 2018, and all patients were treated with total knee arthroplasty assisted by 3D printing.The operation time, intraoperative blood loss, preoperative simulated osteotomy value, intraoperative osteotomy value, postoperative drainage volume, joint activity score and Hospital for Special Surgery (HSS) score before treatment, 6 months after replacement and at the last follow-up were observed.Results:The intraoperative blood loss of patients was an average of (389.9±32.6)mL, and the drainage volume of patients was an average of (405.2±85.4)mL.There were no statistically significant difference between preoperative analogue value and intraoperative osteotomy value (all P>0.05). The HSS score ( P<0.001) and knee joint mobility ( P<0.001) were significantly higher at 6 months after operation and the last follow-up, and the mechanical axis deviation of lower limbs was significantly lower than that before operation ( P<0.001). Conclusion:Treatment of knee osteoarthritis with extra-articular deformity by using 3D printing assisted technique can restore the lower limbs and promote the recovery of knee joint function, which has satisfactory short-term effect and deserves further study and discussion.

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
Equipment and Supplies ; classification ; European Union ; Government Regulation ; Industry

Objective To investigate the training needs of evidence implementation of clinical nurses and its influencing factors.Methods A total of 645 clinical nurses were investigated on training needs of evidence implementation by field and web survey with self-designed questionnaire about training needs of evidence implementation.Results The demand rates on training needs (17 entries) of evidence implementation in nurses were higher than 90.0%. The training methods and assessment methods of evidence implementation were diversified. There were statistically significant differences in some of the demand rates among different educational background, duties, research experiences (with or without), and attending time of evidence-based nursing training (t=26.990, 10.020, 8.719, 14.600;P<0.05).Conclusions The evidence implementation training should be carried out according to different educational background, duties, research experiences and the length of evidence-based nursing training of nurses. Besides, the training methods and assessment methods should be diversified.

Objective To develop training program of evidence implementation(EI) based on PARIHS model and to evaluate the effectiveness on clinical nurses for evidence-based nursing knowledge,attitudes and ability,and to understand the evaluation of participants about the methodological training.Methods A quasi-experiment design was conducted.A 6-month comprehensive evidence implementation training program was developed including methodological lecture,group discussion,EI case analysis,EI project development and implementation,and was carried out among 44 clinical nurses from 11 tertiary hospitals in Shanghai.The participants' EBN knowledge,attitudes and ability were measured by EBN knowledge,attitudes and ability questionnaire at 3 months and 6 months after training.Results Participants' EBN knowledge and ability were significantly improved at 3 months and 6 months after training(P＜0.05),and participants' EBN attitude had no significant difference before and after training (P＞0.05).The level of training satisfaction among participants was higher than 80.0％,and participants had finished 22 evidence implementation programs.Conclusion Evidence implementation training based on PARIHS can enhance clinical nurses' EBN knowledge and ability.Participants' EBN attitude hasn't been significantly improved.Participants have high satisfaction towards methodological training.

Objective To establish WeChat official account-based platform for evidence dissemination,and to evaluate the effects of the platform.Methods The WeChat official account-based platform for evidence dissemination was established,and big data analysis and sampling survey were adopted to analyze information and its communication effects published from December,2014 to September,2016.Results Totally 22 369 followers used the platform and conducted 404 232 hits on its pages in total.The most frequent searches were Evidence and Knowledge of evidence-based nursing.The WeChat Communication Index was 433.07.The overall evaluation score was 4.34± 0.67.Conclusion WeChat official account-based platform for evidence dissemination can promote the accessibility of evidence and receives high evaluation score from followers.