Current Situation of Human Experience of Traditional Chinese Medicine and the Key Point of Ethical Review / 中国医学伦理学

In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.

Innovative insights into extrachromosomal circular DNAs in gynecologic tumors and reproduction

Originating but free from chromosomal DNA, extrachromosomal circular DNAs (eccDNAs) are organized in circular form and have long been found in unicellular and multicellular eukaryotes. Their biogenesis and function are poorly understood as they are characterized by sequence homology with linear DNA, for which few detection methods are available. Recent advances in high-throughput sequencing technologies have revealed that eccDNAs play crucial roles in tumor formation, evolution, and drug resistance as well as aging, genomic diversity, and other biological processes, bringing it back to the research hotspot. Several mechanisms of eccDNA formation have been proposed, including the breakage-fusion-bridge (BFB) and translocation-deletion-amplification models. Gynecologic tumors and disorders of embryonic and fetal development are major threats to human reproductive health. The roles of eccDNAs in these pathological processes have been partially elucidated since the first discovery of eccDNA in pig sperm and the double minutes in ovarian cancer ascites. The present review summarized the research history, biogenesis, and currently available detection and analytical methods for eccDNAs and clarified their functions in gynecologic tumors and reproduction. We also proposed the application of eccDNAs as drug targets and liquid biopsy markers for prenatal diagnosis and the early detection, prognosis, and treatment of gynecologic tumors. This review lays theoretical foundations for future investigations into the complex regulatory networks of eccDNAs in vital physiological and pathological processes.

Protective effect of salvianolic acid B on retina and its influence on angiogenesis in retinal vein occlusion injured rat model / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To investigate the protective effect of salvianolic acid B on retina and its influence on angiogenesis in retinal vein occlusion(RVO)injured rats.METHODS: SD rats were randomly divided into control group, model group and salvianolic acid B group, with 10 rats in each group. In addition to the control group, rats in model group and salvianolic acid B group were induced RVO by Bengal red combined with laser photodynamic method. The rats in salvianolic acid B group were intraperitoneally injected with salvianolic acid B 50 mg/(kg·d), while the rats in control group and model group were only given the same amount of normal saline for 21 consecutive days. Fundus fluorescein angiography(FFA)was used to observe the retinal vein structure before and after administration. HE staining was used to observe the pathological changes of rat retina. The retinal function of rats was evaluated by electroretinogram(ERG). The fluorescence expression of vascular endothelial growth factor A(VEGFA)in retina of rats in each group was detected by immunofluorescence staining. The relative expression of HIF-1α, STAT3, p-STAT3 and VEGFA proteins in retinal tissue were detected by Western blotting.RESULTS: Compared with the control group, the blood flow at the retinal obstruction in the model group was recanalized, and the effective collateral circulation was abundant, but the shape was irregular, and there was fluorescence leakage. In salvianolic acid B group, the retinal vein circulation recovered, the shape became regular gradually, and the collateral vessels decreased. The retina of the model group and salvianolic acid B group showed different degrees of pathological damage. At the same time, the amplitude of ERG a wave and b wave, the thickness of retinal total layer(RTL), inner nuclear layer(INL)and outer nuclear layer(ONL)decreased, the fluorescence intensity of VEGFA enhanced, and the relative expression of HIF-1α, p-STAT3 and VEGFA protein increased(P<0.05). Compared with the model group, the retinal histopathological damage of salvianolic acid B rats was alleviated, the amplitude of ERG a-wave and b-wave, the thickness of RTL, INL and ONL were increased, the fluorescence intensity of VEGFA was weakened, and the relative expression of HIF-1α, p-STAT3 and VEGFA proteins was decreased(P<0.05).CONCLUSION: Salvianolic acid B can alleviate the retinal histopathological injury and improve retinal function in RVO rats, which may be related to inhibiting the activation of HIF-1α/STAT3/VEGFA pathway and reducing angiogenesis.

Lipid metabolism in late pregnancy and its correlation with adverse perinatal outcome among Tibetan pregnant women in high altitudes / 中华围产医学杂志

Objective:To analyze the lipid levels, adverse perinatal outcome and their correlation in Tibetan pregnant women in high altitudes in late pregnancy.Methods:Retrospective analysis was performed on clinical and laboratory data of 523 Tibetan singleton pregnant women who delivered after 28 weeks at the Department of Obstetrics and Gynecology, Chaya People's Hospital, Changdu City. The subjects were divided into three groups according to the altitude of their long-term residence, including altitude<3 500 m (Group A, n=161), altitude ≥3 500 m and <4 000 m (Group B, n=203) and altitude≥4 000 m (Group C, n=159). In addition, the subjects were also grouped into high TG group (TG≥3.23 mmol/L, n=80) and control group (TG<3.23 mmol/L, n=443). The baseline information, levels of lipid and perinatal outcome were compared among Group A,B and C, and also between the high TG and control group, respectively, using Mann-whitney U test, Kruskal-Wallis H test, LSD- t, Chi-square test, or Fisher exact test. Multivariate logistic regression analysis was also applied to analyze the correlation between hypertriglyceridemia and adverse perinatal outcome. Results:The maternal age, gravidity and parity, body mess index, blood pressure on admission and total cholesterol (TC), TG, high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), TG/HDL-C ratio and LDL-C/HDL-C ratio in late pregnancy and the occurrence of adverse perinatal outcome did not show any significant differences among Group A, B and C (all P>0.05). However, the hemoglobin (Hb) level increased with the elevation of altitude as expected, and that in Group C was higher than that in Group A and B [121.0 g/L (108.0-132.0 g/L) vs 115.0 g/L (103.5-128.0 g/L) and 117.0 g/L (101.0-127.0 g/L), H=2.37 and 1.97, both P<0.05]. The proportion of women with hypertriglyceridemia, the high TG group, in late pregnancy was 15.3% (80/523), and no significant difference was found in HDL-C or Hb levels between the high TG and control group [1.7 mmol/L (1.5-2.0 mmol/L) vs 1.8 mmol/L (1.5-2.1 mmol/L), Z=－1.51;123.5 g/L (110.0-131.8 g/L) vs 117.0 g/L (104.0-128.0 g/L), Z=1.69; both P>0.05]. Higher rates of cesarean section [13.8% (11/80) vs 6.6% (29/443), χ2＝4.98], hypertensive disorders of pregnancy (HDP) [16.3% (13/80) vs 7.5% (33/443), χ2＝6.54], preeclampsia (PE) [8.8% (7/80) vs 1.6% (7/443), χ2＝13.37], hyperglycemia during pregnancy [11.3%( 9/80) vs 3.6% (16/443), χ2＝8.69], preterm birth (PB) [7.5% (6/80) vs 2.0% (9/443), χ2＝7.27], microsomia [5.0% (4/80) vs 0.9% (4/443), Fisher exact test] and neonatal asphyxia [8.8%(7/80) vs 2.5% (11/443), χ2＝8.01] were observed in the high TG group than in the control group (all P<0.05). Regarding the pregnant women at different altitude, TG was negatively correlated with Hb ( r=－0.17, P=0.037) only in Group C .Multivariate logistic regression analysis revealed higher risk of HDP ( OR=2.42,95% CI:1.17-5.00), PE ( OR=5.25, 95% CI:1.73-16.00), hyperglycemia during pregnancy ( OR=3.77, 95% CI:1.56-9.09), PB ( OR=4.33, 95% CI:1.42-13.22), microsomia ( OR=4.33, 95% CI:1.42-13.22), neonatal asphyxia ( OR=3.45, 95% CI:1.27-9.35) and fetal demise ( OR=4.94, 95% CI:1.01-24.21) in women with high TG level in late pregnancy (all P<0.05). Conclusions:There were no differences in adverse perinatal outcomes or serum lipid levels in late pregnancy among women living at different high altitudes. However, hypertriglyceridemia at the third trimester is closely associated with the incidence of HDP, PE, hyperglycemia during pregnancy, PB, microsomia, neonatal asphyxia and fetal demise in this group of women.

Clinical characteristics of acute renal infarction: an analysis of 15 cases / 中华全科医师杂志

Clinical data of 15 patients diagnosed with acute renal infarction (ARI) in Affiliated Zhongshan Hospital of Dalian University from Jan 2011 to Dec 2021 were retrospectively analyzed. Of the included 15 patients, there were 14 cases of cardiac origin and 1 case of antiphospholipid syndrome. We found that there were 12 cases of atrial fibrillation, 2 cases of atrial premature beats, 12 cases of elevated level of D-dimer, 15 cases of elevated level of LDH, 11 cases of positive urine occult blood and positive urine protein. Among the 15 patients, catheter-directed thrombolysis was performed in 4 cases, of which 3 cases were revascularized successfully, intravenous thrombolysis in 2 cases and alone anticoagulation therapy in 9 cases. It is suggested that CECT or CTA can assist the early diagnosis of ARI especially in patients with acute onset and persistent abdominal pain with high risk factors of thromboembolism, high levels of LDH, microscopic hematuria and/or proteinuria. Despite prolonged embolic ischemia, try to reconstruct blood flow to save the kidney as much as possible. Late standardized anticoagulant therapy is of critical importance to prevent recurrent embolic episodes.

BRICS report of 2021: The distribution and antimicrobial resistance profile of clinical bacterial isolates from blood stream infections in China / 中华临床感染病杂志

Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical bacterial isolates from bloodstream infections in China in 2021.Methods:The clinical bacterial strains isolated from blood culture from member hospitals of Blood Bacterial Resistant Investigation Collaborative System (BRICS) were collected during January 2021 to December 2021. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical Laboratory Standards Institute (CLSI). WHONET 5.6 was used to analyze data.Results:During the study period, 11 013 bacterial strains were collected from 51 hospitals, of which 2 782 (25.3%) were Gram-positive bacteria and 8 231 (74.7%) were Gram-negative bacteria. The top 10 bacterial species were Escherichia coli (37.6%), Klebsiella pneumoniae (18.9%), Staphylococcus aureus (9.8%), coagulase-negative Staphylococci (6.3%), Pseudomonas aeruginosa (3.6%), Enterococcus faecium (3.6%), Acinetobacter baumannii (2.8%), Enterococcus faecalis (2.7%), Enterobacter cloacae (2.5%) and Klebsiella spp (2.1%). The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococcus aureus were 25.3% and 76.8%, respectively. No glycopeptide- and daptomycin-resistant Staphylococci was detected; more than 95.0% of Staphylococcus aureus were sensitive to ceftobiprole. No vancomycin-resistant Enterococci strains were detected. The rates of extended spectrum B-lactamase (ESBL)-producing isolated in Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis were 49.6%, 25.5% and 39.0%, respectively. The prevalence rates of carbapenem-resistance in Escherichia coli and Klebsiella pneumoniae were 2.2% and 15.8%, respectively; 7.9% of carbapenem-resistant Klebsiella pneumoniae was resistant to ceftazidime/avibactam combination. Ceftobiprole demonstrated excellent activity against non-ESBL-producing Escherichia coli and Klebsiella pneumoniae. Aztreonam/avibactam was highly active against carbapenem-resistant Escherichia coli and Klebsiella pneumoniae. The prevalence rate of carbapenem-resistance in Acinetobacter baumannii was 60.0%, while polymyxin and tigecycline showed good activity against Acinetobacter baumannii (5.5% and 4.5%). The prevalence of carbapenem-resistance in Pseudomonas aeruginosa was 18.9%. Conclusions:The BRICS surveillance results in 2021 shows that the main pathogens of blood stream infection in China are gram-negative bacteria, in which Escherichia coli is the most common. The MRSA incidence shows a further decreasing trend in China and the overall prevalence of vancomycin-resistant Enterococci is low. The prevalence of Carbapenem-resistant Klebsiella pneumoniae is still on a high level, but the trend is downwards.

Risk analysis of blood glucose variation in type 2 diabetic STEMI patients with different HbA 1c levels undergoing emergency PCI / 中国医师杂志

Objective:To investigate the impact of short-term variability in fasting blood glucose (FPG) on the recent major cardiovascular adverse events (MACE) in patients with ST segment elevation myocardial infarction (STEMI) with different levels of glycated hemoglobin (HbA 1c) . Methods:Retrospective analysis was made on the patients with type 2 diabetes mellitus who underwent emergency percutaneous coronary intervention (PCI) due to STEMI from January 2016 to March 2020 in Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences. The patients were divided into HbA 1c compliant group (<6.5%) and non-compliant group (≥6.5%). The blood glucose variability indexes defined included FPG variability score (FPG-VS), variability index independent of FPG mean (VIM) and mean fast plasma glucose (FPG-M). The logistic regression model was used to evaluate the relationship between different HbA 1c levels, blood glucose variability risk indicators, and MACE. Results:A total of 612 patients were ultimately included in the analysis. The blood glucose variability indicators (FPG-VS, VIM) of the HbA 1c non-compliant group (302 cases) were higher than those of the compliant group (310 cases): [FPG-VS: (0.7±0.3) vs (0.4±0.4), P<0.001, VIM: (0.4±0.2) vs (0.3±0.2), P<0.001], while there was no statistically significant difference in FPG-M between the two groups [(7.9±3.2) vs (8.0±3.9), P=0.221]. In the HbA 1c non-compliant group, the correlation between FPG-VS, VIM, and FPG-M and the risk of MACE within 30 days was 0.89(95% CI: 0.69-1.15), 1.21(95% CI: 0.65-2.25), and 1.06(95% CI: 0.97-1.16), respectively (all P>0.05). In the HbA 1c compliant group, FPG-VS was associated with an increase in MACE risk within 30 days ( P=0.04): for each increase in FPG variation ≥1 mmol/L, after multiple factor adjustment, the risk of MACE increased by 8% within 30 days ( OR=1.08, 95% CI: 0.71-1.65); Compared with FPG-VS<20%, FPG-VS≥80% increased the risk of MACE within 30 days by 33% ( OR=1.33, 95% CI: 0.21-8.25, P<0.01), while the correlation between VIM and FPG-M and the risk of MACE within 30 days was 1.65(95% CI: 0.96-2.83) and 1.15(95% CI: 0.98-1.35), respectively (all P>0.05). Conclusions:High FPG-VS is associated with the recent MACE risk in STEMI patients who do not meet HbA 1c standards. After reaching HbA 1c standards, FPG-VS remains an independent MACE risk factor.

Platelet Removal Efficiency by Leukocyte Filter in Red Blood Cell Units at Different Storage Periods / 中山大学学报(医学科学版)

ObjectiveThe aim of this study is to investigate change of platelet count in red blood cell （RBC） units at different storage periods and explore the efficiency of platelet removal by leukocyte filter. MethodsA total of 58 RBC units were divided into four groups according to different storage periods： 1 week Group （16）， 2 weeks Group （16）， 3 weeks Group （14） and 4 weeks Group （12）. RBC units in the four groups were filtered through leukocyte filter. The RBC samples before and after filtration were obtained. The platelet count was detected by automatic blood cell counter and the efficiency of platelet removal was calculated. RBC samples before filtration were made into blood cell smears. The blood cell smears were dyed with Wright-Giemsa stain， and the morphology of platelets was observed through a microscope. ResultsThe platelet count in RBC units stored for 1， 2， 3 and 4 weeks was （286.5±62.34）×109/L， （238.0±57.37）×109/L， （193.6±56.21）×109/L and （167.8±24.76）×109/L， respectively. Platelet count in blood stored for 3 weeks （P<0.01） and 4 weeks （P <0.000 1） were significantly lower than those stored for 1 weeks. When observed in the blood smears of RBC units at different storage periods， platelets with normal morphology were distributed in clump and scattered style. The platelet removal rates of the four groups were （80.13±9.06） %， （76.41±10.13） %， （77.78±9.30） % and （70.63±9.39） %， respectively， with no significant difference （P >0.05）. ConclusionsPlatelet count in RBC units decreases gradually as the storage period increases， but most platelets still remain in RBC units of late storage periods （3 weeks and 4 weeks）. The leukocyte filter is able to remove most of the platelets， and the removal efficiency is similar among the groups.

Efficacy and Prognostic Factors of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Acute Myeloid Leukemia / 中国实验血液学杂志

OBJECTIVE@#To retrospectively analyze the efficacy and complications of our institution's modified nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) in treating intermediate-risk acute myeloid leukemia (AML) - first complete remission (CR1) and prognostic factors.@*METHODS@#Clinical data of 50 intermediate-risk AML-CR1 patients who underwent matched related NST at the Fifth Medical Center of Chinese People's Liberation Army General Hospital from August 2004 to April 2021 were collected, the hematopoietic recovery, donor engraftment and complications were observed, and overall survival (OS) rate, leukemia-free survival (LFS) rate, treatment-related mortality (TRM), and cumulative relapse rate were calculated. Statistical analysis of factors affecting prognosis was also preformed.@*RESULTS@#The median times for neutrophil and platelet recovery after transplantation were 10 (6-16) and 13 (6-33) days, respectively. One month after transplantation, 22 patients (44%) achieved full donor chimerism (FDC), and 22 patients (44%) achieved mixed chimerism (MC), among whom 18 cases gradually transited to FDC during 1-11 months, 4 cases maintained MC status. The overall incidence of acute graft-versus-host disease (aGVHD) was 36%, with a rate of 18% for grade II-IV aGVHD and a median onset time of 45 (20-70) days after transplantation. The overall incidence of chronic GVHD (cGVHD) was 34%, with 20% and 14% of patients having limited or extensive cGVHD, respectively. The incidence rates of infections, interstitial pneumonia, and hemorrhagic cystitis were 30%, 10%, and 16%, respectively. The 5-year OS rate, LFS rate, TRM, and cumulative relapse rate were 68%, 64%, 16%, and 20%, respectively. The increase of the number of CD34+ cells infused had shortened the recovery time for neutrophils and platelets (r =0.563, r =0.350). The number of CD34+ cells infused significantly influenced the occurrence of extensive cGVHD (OR =1.36, 95%CI : 1.06-1.84, P =0.024).@*CONCLUSION@#Modified NST is effective in treating intermediate-risk AML-CR1 patients, however, further expansion of sample size is needed to study prognostic factors.

Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula / 中华医学杂志(英文版)

BACKGROUND@#Colorectal carcinogenesis and progression are related to the gut microbiota and the tumor immune microenvironment. Our previous clinical trial demonstrated that berberine (BBR) hydrochloride might reduce the recurrence and canceration of colorectal adenoma (CRA). The present study aimed to further explore the mechanism of BBR in preventing colorectal cancer (CRC).@*METHODS@#We performed metagenomics sequencing on fecal specimens obtained from the BBR intervention trial, and the differential bacteria before and after medication were validated using quantitative polymerase chain reaction. We further performed ApcMin/+ animal intervention tests, RNA sequencing, flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assays.@*RESULTS@#The abundance of fecal Veillonella parvula ( V . parvula ) decreased significantly after BBR administration ( P = 0.0016) and increased through the development from CRA to CRC. Patients with CRC with a higher V. parvula abundance had worse tumor staging and a higher lymph node metastasis rate. The intestinal immune pathway of Immunoglobulin A production was activated, and the expression of TNFSF13B (Tumor necrosis factor superfamily 13b, encoding B lymphocyte stimulator [BLyS]), the representative gene of this pathway, and the genes encoding its receptors (interleukin-10 and transforming growth factor beta) were significantly upregulated. Animal experiments revealed that V. parvula promoted colorectal carcinogenesis and increased BLyS levels, while BBR reversed this effect.@*CONCLUSION@#BBR might inhibit V. parvula and further weaken the immunomodulatory effect of B cells induced by V. parvula , thereby blocking the development of colorectal tumors.@*TRIAL REGISTRAION@#ClinicalTrials.gov, No. NCT02226185.

Distribution and health risk of residual trihalomethane in regional drinking water / 上海预防医学

ObjectiveTo explore the variation rules and health risks of trihalomethane in regional drinking water， and to provide evidence for the innovative water processing technology and the optimization of drinking water quality. MethodsBased on regional drinking water sanitation monitoring， non-parametric rank sum test was used to analyze the effects of residual trihalomethane production in different periods and with disinfection methods. The United States environmental protection agency （USEPA） classic "four-step" health risk assessment model was used to evaluate the carcinogenic risk and non-carcinogenic risk of trihalomethane through drinking water exposure. ResultsThe yield of trichloromethane in wet season was 6.3 μg·L-1， which was higher than that in dry season. Compared with chlorination pretreatment， ozone pretreatment reduced the content of bromomethane dichloromethane. Compared to liquid chlorine disinfection， sodium hypochlorite treatment incresed the levels of trichloromethane and bromomethane chloride. Although the total carcinogenic and non-carcinogenic risks of trihalomethane in drinking water in the region were at safe levels， they were above the acceptable limits occasionally. The highest carcinogenic risk of trihalomethane were dichlorobromomethane and chlorodibromomethane，and the highest non-carcinogenic risk was trichloromethane. The health risk of children was 1.2 times higher than that for adults. ConclusionThe production of residual trihalomethane in drinking water in this area is relatively low， which is less harmful to the health of adults and children. Monitoring， including other disinfection byproducts， should continue and appropriate disinfection techniques for drinking water should be explored.

CRP is an important factor affecting the timing of surgical drainage of ureteral calculi with upper urinary tract infection / 现代泌尿外科杂志

【Objective】 To explore the timing of surgical drainage for ureteral calculi with upper urinary tract infection. 【Methods】 Clinical data of 117 cases of ureteral calculi with upper urinary tract infection treated in our hospital during Jan.2018 and Jan.2020 were retrospectively analyzed. According to different treatment methods, the patients were divided into surgical drainage group and non-surgical drainage group. The patients’ age, gender, side of calculi, peak body temperature, time of onset, white blood cell (WBC) count, C-reactive protein (CRP) and other clinical indicators were compared between the two groups. The cutoff value of surgical drainage was determined with receiver operator characteristic (ROC) curve. 【Results】 The patients’ age, peak body temperature, WBC count and CRP level were the influencing factors of surgical drainage (P<0.05). Regression analysis showed that CRP (P<0.001), age (P=0.003) and WBC count (P=0.014) were independent risk factors for surgical drainage. The area under the ROC curve (AUC) of CRP, age, and WBC count were 0.923, 0.601, and 0.796, respectively. The cutoff value of CRP was 29.87 mg/L (sensitivity 79.4%, specificity 90.0%). Logistic regression model showed CRP was a significant clinical predictor. 【Conclusion】 Ureteral calculi with upper urinary tract infection need to be diagnosed and treated in time. Positive anti-infection should be performed during emergency treatment, and surgical drainage could be selected according to the value of CRP.

Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans / 中国医学伦理学

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Guidelines for Ethical Review Project Entrustment of Life Science and Medical Research Involving Humans / 中国医学伦理学

The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.

Reflection on the Changes in the Scope of Ethical Review / 中国医学伦理学

At the end of February 2023, the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine. It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans , and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review. Based on the Ethical Review Measures for Biomedical Research Involving Humans, the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review. Different experts in the field have discussed in detail the changes in the scope of review, and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers’ reference.

Construction of blood transfusion prediction model for patients with severe traumatic brain injury / 中国输血杂志

【Objective】 To construct a blood transfusion prediction model for patients with severe traumatic brain injury (TBI), in order to predict the risk of blood transfusion and guide blood transfusion decision-making. 【Methods】 The clinical data of 756 patients with severe TBI admitted to the hospital from January 1, 2015 to June 30, 2021 were retrospectively analyzed. According to whether the patients were transfused with red blood cells after admission, the patients were divided into blood transfusion group (n=354) and non-blood transfusion group (n=402). The basic clinical data and prognostic indicators of the two groups were compared. Logistic regression algorithm was used to screen the risk factors related to blood transfusion in hospital to establish a nomogram prediction model, and the performance of the model was evaluated. 【Results】 No significant differences were noticed in gender, age, body temperature, cause of injury, ABO blood group, Rh blood group, serum Na and K concentrations between the two groups (P>0.05). Significant differences were found in Glasgow coma score (GCS), heart rate (HR), systolic blood pressure (SP), diastolic blood pressure (DP), shock index (SI), respiratory rate (RR), clinical diagnosis, treatment, hemoglobin concentration (Hb), hematocrit (Hct), platelet count (Plt) and coagulation function between the two groups (P0.05). Multivariate logistic regression analysis showed that surgical treatment, skull fracture, hemorrhagic shock, decreased Plt, decreased Hct and increased INR were independent risk factors for blood transfusion. A nomogram prediction model was constructed and the area under the ROC curve of the training set and the test set was 0.819(95% CI: 0.784-0.854) and 0.866(95% CI: 0.818-0.910), respectively, which had good predictive performance. 【Conclusion】 Surgical treatment, skull fracture, hemorrhagic shock, decreased Plt, decreased Hct and increased INR are independent risk factors for blood transfusion in adult patients with severe traumatic brain injury. The nomogram prediction model can better predict the blood transfusion demand of TBI patients and has high application value.

Research progress on new antiplatelet therapeutic targets for the treatment of acute coronary syndrome / 中国临床药理学与治疗学

Acute coronary syndrome (ACS) is a cardiac acute ischemic syndrome caused by the rupture or erosion of unstable atherosclerotic plaques within the coronary artery, leading to thrombus formation. Antiplatelet therapy is a key strategy in treating ACS, and although some success has been achieved, there are still limitations, such as thrombus recurrence and bleeding side effects, which limit the long-term use of drugs. Future antiplatelet therapies may achieve more effective or safer treatment methods by targeting novel targets involved in platelet function. This article focuses on potential target inhibitors, including GPVI, protease -activated receptor (PAR) - 4, GPIb, 5-hy-droxytryptamine receptor subtype 2A (5-HT2A), protein disulfide isomerase, P-selectin, and phosphatidylinositol 3-kinase β inhibitors.

Bendamustine combined with pomalidomide and dexamethasone in relapsed multiple myeloma with extramedullary disease: a multicenter study / 中华血液学杂志

Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment of relapsed multiple myeloma (MM) with extramedullary disease. Methods: This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen. Results: The median age of the 30 patients was 62 (47-72) years, of which 18 (60% ) had first-time recurrence. The overall response rate (ORR) of the 18 patients with first-time recurrence was 100%, of which three (16.7% ) achieved complete remission, 10 (55.5% ) achieved very good partial remission (VGPR), and five (27.8% ) achieved partial remission (PR). The ORR of 12 patients with recurrence after second-line or above treatment was 50%, including zero patients with ≥VGPR and six patients (50% ) with PR. Three cases (25% ) had stable disease, and three cases (25% ) had disease progression. The one-year progression free survival rate of all patients was 65.2% (95% CI 37.2% -83.1% ), and the 1-year overall survival rate was 90.0% (95% CI 76.2% -95.4% ). The common grade 3-4 hematology adverse reactions included two cases (6.7% ) of neutropenia and one case (3.3% ) of thrombocytopenia. The overall adverse reactions are controllable. Conclusions: The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.

Correlation between postoperative visual acuity and macular morphological structure and blood flow density in patients with idiopathic macular epiretinal membrane / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To observe the postoperative changes in macular morphological structure and blood flow density of patients with idiopathic macular epiretinal membrane(IMEM)by optical coherence tomography angiography(OCTA), and explore their correlation with visual acuity.METHOD: Prospective study. A total of 45 cases(45 eyes)with IMEM admitted to our hospital from January 2020 to July 2021 were included. The best corrected visual acuity(BCVA), central macular area thickness(CMT), foveal avascular zone(FAZ)area and changes in blood flow density of superficial capillary plexus(SCP)were observed at 1mo, 1, 3 and 6mo before and after operation.RESULT: The BCVA at 1wk after operation had no significant change compared with preoperative data(P>0.05), while it was improved at other time points(P<0.05). The CMT measured at 1wk after operation was thickened significantly(P<0.05), while it was significantly decreased at 1mo, 3mo and 6mo after operation(P<0.05). The FAZ area measured at 1wk and 1mo after operation had no significant change(P>0.05), while it was significantly enlarged at 3 and 6mo after operation(P<0.05). The SCP measured at 1wk, 1 and 3mo after operation had no significant change(P>0.05), while it was significantly decreased at 6mo after operation(P<0.05). BCVA measured at 3 and 6mo after operation was positively correlated with CMT(r=0.457, 0.615, P=0.032, 0.012).CONCLUSION: The visual acuity of patients with IMEM recovered quickly within 1mo after operation, and then it tended to be stable. However, the recovery of macular foveal morphology and blood flow distribution was slower than that of visual acuity, and there was no obvious correlation with visual acuity.