1.Ethical considerations of using the deceased as medical research subjects
Zhaolong LU ; Xiaoyun CHEN ; Yongchuan CHEN ; Mengjie YANG ; Qiang LIU ; Hui JIANG ; Zhonglin CHEN
Chinese Medical Ethics 2025;38(11):1447-1452
The relevant laws and regulations regarding the utilization of the deceased as medical research subjects are not yet fully developed in China nowadays. Taking the deceased as research subjects as a starting point, this paper discussed the definition of the deceased and the scope of their interest protection from multiple perspectives. It posited that the scope of interest protection for the deceased encompassed two components: spiritual personality interests and material personality interests represented by the remains. The spiritual personality interests of the deceased included identification information such as name, portrait, reputation, honor, privacy, and personal information, as well as medical and health information. The personal information of the deceased was not directly affected by the individual’s life and death status and remained relatively independent. In terms of ethical review, the research team approached from two perspectives: the remains and the personal information of the deceased. Based on the standard of whether the research subjects involve a human body, research with the remains of the deceased as the medical research subjects was classified as non-clinical research. According to the standard of whether a human body is clinically operated, research with the personal information of the deceased (including medical and health information) as the medical research subjects was recognized as clinical research without human research operation. This approach provided evidence for the application of existing laws and regulations in ethical review and record management. The ethical review of investigator-initiated clinical research conducted in medical and health institutions, as well as the regulatory conditions for exemption from ethical review, were examined. The forms, content, and acquisition of informed consent were summarized, and the risk-benefit characteristics of the research activity were evaluated, with a view to providing a basis for the smooth and compliant implementation of research activities involving the deceased as medical research subjects.
2.Analysis on configuration of testing equipment in blood testing laboratories of blood stations in Shandong Province
Xiao-Tong SUN ; Zhong-Si YANG ; Hui-Xia ZHAO ; Shu-Tao PANG
Chinese Medical Equipment Journal 2024;45(3):81-85
Objective To analyze the configuration of testing equipment in blood testing laboratories of blood stations in Shandong Province to facilitate to optimize equipment configuration for blood testing laboratories.Methods Questionnaires were distributed to obtain information on the number,the proportions of domestic and imported equipment,the usage time and the number of annual sample detection for the testing equipment of 17 blood testing laboratories(one laboratory from blood center and 16 laboratories from central blood stations)in Shandong Province,including the equipment for blood group testing,alanine aminotransferase(ALT)testing,sample adding of enzyme-linked immunosorbent assay(ELISA),ELISA micro-plate processing and nucleic amplification test(NAT).The testing equipment in the laboratories with different sizes were analyzed in terms of substitutability,localization,number of annual sample detection and average usage time.Results The blood group and ALT testing equipment had low substitutability;the imported equipment for ALT testing and ELISA sample adding had high proportions;the numbers of yearly sample detection of the equipment for ELISA sample adding,ELISA microplate processing and NAT rose significantly with the increase of laboratory sizes(P<0.05);the equipment for ELISA sample adding and microplate processing had long usage time,and the differences between the usage time of the equipment for ELISA sample adding from the laboratories with different sizes were statistically significant(P<0.05).Conclusion The equipment configuration of blood testing laboratories of blood stations in Shandong Province varies greatly,and each laboratory has to take measures based on their own actual situations,such as increasing the number of equipment,purchasing domestic equipment or accelerating equipment updating.[Chinese Medical Equipment Journal,2024,45(3):81-85]
3.Visual Analysis on Research Hotspots of Cancer Pain Drugs Based on VOS-viewer and CiteSpace
Zhiye ZHANG ; Wei WEI ; Weiting LIU ; Hui DU ; Zhihui LAN ; Tong LI ; Yanbiao YANG
Herald of Medicine 2024;43(7):1127-1134
Objective To analyze the research hotspots and trends in the field of cancer pain drugs based on literature.Methods This article included research literature related to cancer pain and drugs published in the China National Knowledge Infrastructure(CNKI)and Web of Science databases.The visual analysis of the literature was performed by software of VOS-viewer 1.6.18 and CiteSpace 6.2.R3,including drawing the graphs and comparing the number of published articles,journals,institutions,authors and keywords were also analyzed.Results A total of 4 774 literatures were included.The journals with the largest number of articles published were the Chinese Journal of Pain Medicine and the Journal of Pain and Symptom Management.The authors with the highest number of articles published were Liu Duanqi and Bruera Eduardo.The institutions with the highest number of publications were Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,and the University of Texas Anderson Cancer Center.The most frequent keyword was cancer pain.The keywords with the strongest citation bursts included Clinical efficacy average daily cost,and primary care.Conclusion Since the beginning of the 21st century,the research on cancer pain drugs has gradually heated up,and the number of papers has shown an upward trend.From 2019 to 2022,the research on cancer pain drugs at home and abroad mainly focused on the clinical efficacy and average daily cost.This article has clarified the research hotspots of cancer pain drugs in recent years to a certain extent and has certain reference significance for future research.
4.A new suberin from roots of Ephedra sinica Stapf
Bo-wen ZHANG ; Meng LI ; Xiao-lan WANG ; Ying YANG ; Shi-qi ZHOU ; Si-qi TAO ; Meng YANG ; Deng-hui ZHU ; Ya-tong XU ; Wei-sheng FENG ; Xiao-ke ZHENG
Acta Pharmaceutica Sinica 2024;59(3):661-666
Six compounds were isolated from the roots of
5.Anatomic classification and reconstruction of right intrahepatic bile duct in the donor liver of split liver trans-plantation
Jinming WEI ; Binsheng FU ; Qing YANG ; Tong ZHANG ; Xiao FENG ; Kaining ZENG ; Jia YAO ; Hui TANG ; Guihua CHEN ; Yang YANG ; Shuhong YI
Chinese Journal of Digestive Surgery 2024;23(2):272-279
Objective:To investigate the anatomic classification and reconstruction of right intrahepatic bile duct in the donor liver of split liver transplantation (SLT).Methods:The retrospective and descriptive study was constructed. The clinical data of 85 patients who underwent SLT in the Third Affiliated Hospital of Sun Yat-sen University from July 2014 to January 2022 were collected. There were 65 males and 20 females, aged 45(range, 1-82)years. Observation indicators: (1) surgical conditions; (2) anatomy of right intrahepatic bile duct; (3) bile duct reconstruction; (4) postoperative biliary complications; (5) follow-up. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range) or M( Q1, Q3).Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Results:(1) Surgical conditions. Of the 85 donor livers, 11 donor livers were split between the left and right hemilivers, and 74 donor livers were split between the classic right trilobe and left lateral lobe. The cold ischemia time of 85 donor livers was 291(273, 354)minutes, and the operation time, anhepatic phase time and volume of intraoperative blood transfusion of 85 recipients were (497±97)minutes, 51(40, 80)minutes and 8(7, 12)U. (2) Anatomy of right intrahepatic bile duct. Of the 85 donor livers, there were 47 donor livers with classic bile duct anatomical model (type 1), of the ratio as 55.3%(47/85), and 38 donor livers with anatomical variants, of the ratio as 44.7%(38/85). Of the 38 donor livers with anatomical variants, 7 donor livers were type 2, 16 donor livers were type 3a, 2 donor livers were type 3b, 2 donor livers were type 3c, 1 donor liver was type 4, 3 donor livers were type 5a, 4 donor livers were type 5b, 3 donor livers were type 6. For bile duct splitting patterns of the 85 donor livers, 84 donor livers were split with the main trunk of common hepatic duct preserving in the right hemiliver or right trilobe, and 1 donor liver were treated with complete left and right hemiliver splitting to preserve the main trunk of the common hepatic duct in the left hemiliver and the right hemiliver in the right hepatic duct (type 1 bile duct anatomical model). There were 84 donor livers with only one bile duct opening, and 1 donor liver with two bile duct openings (type 3c bile duct anatomical model). (3) Bile duct reconstruction. Of the 85 recipients, there were 69 recipients with common bile duct end-to-end anastomosis to common bile duct of donor liver (38 donor livers with type 1 bile duct anatomical model, 5 donor livers with type 2 bile duct anatomical model, 14 donor livers with type 3a bile duct anatomical model, 2 donor livers with type 3b bile duct anatomical model, 1 donor liver with type 4 bile duct anatomical model, 3 donor livers with type 5a bile duct anatomical model, 4 donor livers with type 5b bile duct anatomical model, 2 donor livers with type 6 bile duct anatomical model), 11 recipients with jejunum anastomosis to common bile duct of donor liver (7 donor livers with type 1 bile duct anatomical model, 2 donor livers with type 2 bile duct anatomical model, 1 donor liver with type 3c bile duct anatomical model, 1 donor liver with type 6 bile duct anatomical model), 3 recipients with jejunum anastomosis to common hepatic duct of donor liver (1 donor liver with type 1 bile duct anatomical model, 2 donor livers with type 3a bile duct anatomical model), 1 recipient with jejunum anastomosis to right hepatic duct of donor liver (type 1 bile duct anatomical model), 1 recipient with common hepatic duct end-to-end anastomosis to right posterior branch of donor liver combined with jejunum of the recipient Roux-en-y anastomosis to common hepatic duct of donor liver (type 3c bile duct anatomical model). (4) Postoperative biliary complications. Of the 85 recipients, 6 cases had postoperative biliary complications, with an incidence of 7.1% (6/85). Of the 6 recipients with postoperative biliary complications, there were 5 recipients with donor liver with type 1 bile duct anatomical model, including 3 cases undergoing postoperative biliary stricture with biliary leakage and 2 cases undergoing postoperative biliary anastomotic stricture, 1 recipient with donor liver with type 3b bile duct anatomical model and undergoing postoperative biliary anastomotic stricture and bile leakage in the liver section. Cases with biliary complications were 5 in the 47 recipients with donor liver with classic bile duct anatomical model and 1 in the 38 recipients with donor liver with anato-mical variants, showing no significant difference between them ( P>0.05). (5) Follow-up. There were 83 recipients receiving followed up for 52(12,96)months. During the follow-up period, 2 recipients died due to non-biliary complication factors (1 donor liver with type 1 bile duct anatomical model and 1 donor liver with 3a bile duct anatomical model). Conclusion:The anatomical classification of right intrahepatic bile duct of donor liver in SLT is mainly classical bile duct anatomical model, and the bile duct reconstruction scheme is mainly common bile duct of donor liver end-to-end anasto-mosis to common bile duct of recipient.
6.Effect of family integrated ward on maintaining optimal oxygen saturation targets in premature infants with bronchopulmonary dysplasia: a single-center retrospective cohort study
Fei SHEN ; Hui RONG ; Hui XU ; Xing TONG ; Xiao WU ; Yang YANG
Chinese Journal of Neonatology 2024;39(1):13-17
Objective:To study the application effect of family integrated ward in maintaining the optimal target pulse oxygen saturation (SpO 2) in premature infants with bronchopulmonary dysplasia (BPD). Methods:This was a retrospective cohort study. Premature infants with BPD admitted to the neonatal intensive care unit of Children's Hospital of Nanjing Medical University from June 2019 to January 2022 were enrolled. Based on whether to stay in family integrated ward and implement family integrated care (FICare), these premature infants were divided into the family ward group and the control group. The ratio of optimal target SpO 2 within 24 h before discharge, the duration of home oxygen therapy, and ratio of readmission due to respiratory disease within 6 months after discharge were analyzed between the two groups. Results:During the study period, a total of 167 premature infants with BPD were admitted, including 101 in the family ward group and 66 in the control group. Compared with the control group, the family ward group showed a higher proportion of achieving the optimal target SpO 2 within 24 h before discharge (58.0% vs. 24.0%), shorter duration for home oxygen therapy (7.0 d vs. 12.0 d), and a lower readmission rate within 6 months after discharge (16.5% vs. 30.2%), which had statistically significant difference (all P<0.05). Further regression analysis showed that participating in the family integrated ward significantly reduced the demand for home oxygen therapy and the duration of home oxygen therapy, but had no significant impact on the readmission rate within 6 months after discharge. Conclusions:Family integrated ward can effectively increase the proportion of achieving the optimal target SpO 2 for premature infants with BPD within 24 h before discharge, reduce the demand for home oxygen therapy, and shorten the time of home oxygen therapy after discharge, which is beneficial for improving the living quality of premature infants with BPD.
7.Application of droplet digital PCR in etiological diagnosis of severe acute pancreatitis patients with suspected bloodstream infection
Xin-Yu WANG ; Gang LI ; Wen-Jian MAO ; Jie YANG ; Jing-Zhu ZHANG ; Lu KE ; Wei-Qin LI ; Zhi-Hui TONG
Chinese Journal of Infection Control 2024;23(1):9-15
Objective To explore the value of droplet digital polymerase chain reaction(ddPCR)in the etiological diagnosis of severe acute pancreatitis(SAP)patients with suspected bloodstream infection(BSI).Methods SAP patients admitted to the department of critical care medicine in a hospital July to September 2022 were enrolled.When BSI was suspected,venous blood was collected for both ddPCR detection and blood culture(BC)with antimi-crobial susceptibility testing(AST)simultaneously.The time required for two detection methods was recorded,and the detection results of ddPCR and BC were compared.The etiological diagnostic efficacy of ddPCR was calculated,and the correlation between the value of pathogen load detected by ddPCR and the level of infection parameters was explored.Results A total of 22 patients were included in the analysis,and 52 venous blood specimens were collec-ted for detection.BC revealed 17 positive specimens(32.7%)and 29 pathogenic strains,while ddPCR showed 41 positive specimens(78.8%)and 73 pathogenic strains.Detection time required for ddPCR was significantly lower than that of BC([0.16±0.03]days vs[5.92±1.20]days,P<0.001).Within the detection range of ddPCR and taking BC results as the gold standard,the sensitivity and specificity of ddPCR were 80.0%and 28.6%,respective-ly.With the combined assessment of BSI based on non-blood specimen microbial evidence within a week,the sensi-tivity and specificity of ddPCR detection increased to 91.9%and 76.9%,respectively.ddPCR detected resistance genes of blaKPC,blaNDM/IMP,VanA/VanM,and mecA from 19,9,6,and 5 specimens,respectively.Correlation analysis showed a positive correlation between pathogen load and levels of C-reactive protein as well as procalcitonin(r=0.347,0.414,P<0.05).Conclusion As a supplementary detection method for BC in BSI diagnosis,ddPCR has the advantages of higher sensitivity and shorter detection time,and is worthy of further exploration in clinical application.
8.Study on Data Mining of Cough Medical Records Treated by Xin'an Doctors Based on Syndrome-drugs
Hui WANG ; Huanzhang DING ; Qinjun YANG ; Cheng YANG ; Jiabing TONG ; Zegeng LI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(3):34-41
Objective To study the syndrome-drug association rule and the medication law of cough medical cases treated by Xin'an doctors using the data mining method;To provide reference for the treatment of cough.Methods The medical records of Xin'an doctors were collected and summarized.The frequency analysis,topology analysis and Louvain clustering analysis were used to conduct data mining research on syndrome types and prescriptions,and the relationship between syndrome types and prescriptions in cough treatment medical records and the law of drug composition in prescriptions were discussed.Results A total of 525 medical cases were included,and 26 kinds of syndromes were obtained,such as wind-heat invading lung,phlegm-dampness holding lung,lung qi deficiency.There were 243 kinds of Chinese materia medica involved,and 18 kinds of Chinese materia medica were with more than 70 times in frequency.The main properties were cold,warm and mild,and the main tastes were sweet,bitter and pungent,mainly in lung meridian,or the main properties were mild and warm and the main taste was sweet,mainly in spleen and stomach meridian.There were 25 categories in efficacy,which were mainly tonics and heat-clearing medicine.30 core medicines and core medicinal networks were obtained,such as Glycyrrhizae Radix et Rhizoma,Poria and Armeniacae Semen Amarum.The core drug combination of main syndromes of exogenous cough and excess syndrome and deficient syndrome of endogenous cough were obtained by syndrome-drug clustering analysis.Conclusion Xin'an doctors have distinctive characteristics in the diagnosis and treatment of cough diseases,and pay attention to the use of the methods of"strengthening the basic and promoting original qi","nourishing yin and protecting yin","cultivating the soil and promoting gold"and the inheritance of the prescriptions on the basis of cough relieving,phlegm resolving,and syndrome-based treatment.
9.TSHR Variant Screening and Phenotype Analysis in 367 Chinese Patients With Congenital Hypothyroidism
Hai-Yang ZHANG ; Feng-Yao WU ; Xue-Song LI ; Ping-Hui TU ; Cao-Xu ZHANG ; Rui-Meng YANG ; Ren-Jie CUI ; Chen-Yang WU ; Ya FANG ; Liu YANG ; Huai-Dong SONG ; Shuang-Xia ZHAO
Annals of Laboratory Medicine 2024;44(4):343-353
Background:
Genetic defects in the human thyroid-stimulating hormone (TSH) receptor (TSHR) gene can cause congenital hypothyroidism (CH). However, the biological functions and comprehensive genotype–phenotype relationships for most TSHR variants associated with CH remain unexplored. We aimed to identify TSHR variants in Chinese patients with CH, analyze the functions of the variants, and explore the relationships between TSHR genotypes and clinical phenotypes.
Methods:
In total, 367 patients with CH were recruited for TSHR variant screening using whole-exome sequencing. The effects of the variants were evaluated by in-silico programs such as SIFT and polyphen2. Furthermore, these variants were transfected into 293T cells to detect their Gs/cyclic AMP and Gq/11 signaling activity.
Results:
Among the 367 patients with CH, 17 TSHR variants, including three novel variants, were identified in 45 patients, and 18 patients carried biallelic TSHR variants. In vitro experiments showed that 10 variants were associated with Gs/cyclic AMP and Gq/11 signaling pathway impairment to varying degrees. Patients with TSHR biallelic variants had lower serum TSH levels and higher free triiodothyronine and thyroxine levels at diagnosis than those with DUOX2 biallelic variants.
Conclusions
We found a high frequency of TSHR variants in Chinese patients with CH (12.3%), and 4.9% of cases were caused by TSHR biallelic variants. Ten variants were identified as loss-of-function variants. The data suggest that the clinical phenotype of CH patients caused by TSHR biallelic variants is relatively mild. Our study expands the TSHR variant spectrum and provides further evidence for the elucidation of the genetic etiology of CH.
10.Comparison of two types of pedicled homodigital flap in reconstruction of thumb-tip or thumb-pulp defects
Hui WANG ; Haifeng WANG ; Weifei BAI ; Tong ZHOU ; Lin CHEN ; Bin WANG ; Xiaoxi YANG
Chinese Journal of Microsurgery 2024;47(1):71-77
Objective:To compare the clinical effects between the homodigital radial flap of the dorsal cutaneous branch of radial palmar proper digital artery (PPDA) and the homodigital reverse island flap of the ulnar dorsal digital artery (DDA) on reconstruction of defects in thumb-tip or thumb-pulp.Methods:The retrospective case-control study method was used. From January 2016 to August 2022, a total of 65 thumb-tip or thumb-pulp defects were treated in the Department of Hand Surgery of the Second Hospital of Tangshan. Thirty-five defects of thumbs were reconstructed with the homodigital radial flap pedicled with dorsal cutaneous branch of radial PPDA (PPDA group) and the other 30 thumbs were treated by the homodigital ulnar reverse island flap pedicled with ulnar DDA (DDA group). Sizes of the wounds and flaps in PPDA group were 1.9 cm×1.5 cm to 2.9 cm×2.4 cm and 2.1 cm× 1.7 cm to 3.1 cm×2.6 cm, respectively, and the dimensions of the wounds and flaps in DDA group were 2.0 cm× 1.7 cm to 2.9 cm×2.5 cm and 2.2 cm×1.9 cm to 3.2 cm×2.8 cm, respectively. The wounds of donor site in both groups were all directly closed. Survival of the flaps and wound healing of donor sites were observed in both groups. The time of surgery and duration of follow-up of the 2 groups were recorded. Postoperative follow-up included outpatient clinic visits, telephone reviews and WeChat video-clips. At the final follow-up, record of total active motion (TAM) of the injured thumbs, angle of first web of the affected hands, static TPD of the flaps, patient satisfaction of the appearance of flaps and donor sites were taken. According to the Michigan Hand Function Questionnaire (MHQ) evaluation criteria, the patient satisfaction of the appearance of flaps and donor sites were evaluated. The measurement and count data acquired from both groups were compared by independent sample t-test and χ2 tests or Fisher's exact test, respectively. P<0.05 was considered statistically significant. Results:All 35 flaps in PPDA group and 26 flaps in DDA group survived primarily, except 4 flaps in the DDA group that showed blisters and healed with dressing changes. The primary survival rate of flap in PPDA group (100%) was higher than that of DDA group (87%), and the difference was statistically significant ( P<0.05). Donor sites of both groups healed primary. The time of surgery and duration of follow-up in PPDA and DDA groups were 59.11 minutes±5.42 minutes and 15.37 months±3.32 months, and 61.27 minutes±5.96 minutes and 16.17 months±3.60 months, respectively. There was no statistically significant difference between the 2 groups ( P>0.05). At the final follow-up, the thumb TAM and angle of thumb web in PPDA and DDA groups were 135.14°±10.04° and 90.29°±4.36° and 132.17°±11.04° and 89.00°±4.81°, respectively. There was no statistically significant differences between the 2 groups ( P>0.05). The static TPD, patient satisfaction of the appearance of flaps and donor sites in PPDA group were 7.11 mm±1.21 mm, 4.69 point±0.47 point and 4.43 point±0.50 point, which were better than DDA group [8.20 mm±1.47 mm, 4.40 point±0.50 point and 4.13 point±0.57 point, respectively] with a statistically significant difference ( P<0.05). Conclusion:The homodigital radial flap of the dorsal cutaneous branch of radial PPDA and the homodigital ulnar reverse island flap of the ulnar DDA are both suitable for reconstruction of defects in thumb-tip or thumb-pulp. Compared with the homodigital reverse island flap with the DDA, a homodigital radial flap with the dorsal cutaneous branch of PPDA has advantages in higher primary survival rate, better flap sensation and appearance at both of recipient and donor sites.

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