In September 2023， the Measures for Scientific and Technological Ethics Review （Trial Implementation） was issued， revising the provisions related to the simplified procedure for ethical review in Chapter 3， Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work， ensuring that ethical review procedure is well-regulated， and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead， based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations， improving the efficiency of ethical review and subsequent research work， and promoting the development of life sciences and medical research involving humans. In practical work， it introduces numerous new opportunities and challenges for the improvement of ethics review ability， such as new tests on the judgment and decision-making power of ethics committees， how to ensure the reliability and controllability of the conditions related to the simplified review procedure， and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore， to actively respond to the challenges and possible risks brought by the simplified procedure review， efforts should be made to achieve three “unifications”， including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments； the unification of the standard formulation of the simplified procedure review and the review work in practice； and the unification of ethical responsibility and legal responsibility.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

A retrospective analysis was conducted on data of 13 patients with rectal or anal canal lesions involving the dentate line who underwent endoscopic submucosal dissection (ESD) at the Digestive Endoscopy Center of Jiangsu Province Hospital of Chinese Medicine from January 2022 to July 2023. The efficacy and safety of ESD were evaluated. ESD was performed on 14 lesions in 13 patients. The lesions had a length of 1.4 to 12.5 cm and 5.4 cm in average, which were removed entirely in a single session, with an R0 resection rate of 92.31% (12/13). The ESD procedure duration ranged from 35 to 225 minutes, with an average of 88.3 minutes. Anal canal stenosis occurred in 1 case after ESD, which was improved after treatment with anal dilatation. No delayed bleeding, perforation, or other complications occurred. Pathological examination after ESD revealed 6 tubulovillous adenoma, 2 tubular adenoma, 3 tubular adenocarcinoma, and 2 squamous epithelial intraepithelial neoplasia (both 2 lesions were combined with human papillomavirus infection). In one case of tubular adenocarcinoma, the local resection margin showed focal tubulovillous adenoma, while the other cases were negative on lateral margins around and basal margins. The median follow-up period was 7.0 months (range 2 to 13 months), with no local residue, recurrence or metastasis observed. ESD is safe and effective for early rectal or anal canal lesions involving the dentate line, and is worthy of clinical promotion and application.

Background/Aims: Low educational attainment is a well-established risk factor for nonalcoholic fatty liver disease (NAFLD) in developed areas. However, the association between educational attainment and the risk of NAFLD is less clear in China. Methods: A cross-sectional study including over 200,000 Chinese adults across mainland China was conducted. Information on education level and lifestyle factors were obtained through standard questionnaires, while NAFLD and advanced fibrosis were diagnosed using validated formulas. Outcomes included the risk of NAFLD in the general population and high probability of fibrosis among patients with NAFLD. Logistic regression analysis was employed to estimate the risk of NAFLD and fibrosis across education levels. A causal mediation model was used to explore the potential mediators. Results: Comparing with those receiving primary school education, the multi-adjusted odds ratios (95% confidence intervals) for NAFLD were 1.28 (1.16 to 1.41) for men and 0.94 (0.89 to 0.99) for women with college education after accounting for body mass index. When considering waist circumference, the odds ratios (95% CIs) were 0.94 (0.86 to 1.04) for men and 0.88 (0.80 to 0.97) for women, respectively. The proportions mediated by general and central obesity were 51.00% and 68.04% for men, while for women the proportions were 48.58% and 32.58%, respectively. Furthermore, NAFLD patients with lower educational attainment showed an incremental increased risk of advanced fibrosis in both genders. Conclusions In China, a low education level was associated with a higher risk of prevalent NAFLD in women, as well as high probability of fibrosis in both genders.

ObjectiveTo investigate the current status and high-risk factors of chromosomal aberrations in peripheral blood lymphocytes （PBL） of radiation workers in Hainan Province. MethodsA total of 200 radiological workers who underwent occupational health examination in Hainan Provincial Hospital of Traditional Chinese Medicine from January 2021 to December 2021 were selected to collect the occupational health examination data and the rate of PBL chromosomal aberrations. The influencing factors of PBL chromosomal aberrations were analyzed by logistic regression model. The predictive value of logistic regression prediction model on PBL chromosomal aberrations were determined by using the reciver operator characteristic （ROC） curve. ResultsA total of 20 000 cells （100 cells/person） were tested. The chromosomal aberration rate was 0.37% （74/20 000） and the PBL chromosomal aberration rate in the subjects was 6.00% （12/200）. Univariate analysis showed that PBL chromosomal aberrations in radiological workers were related to age， length of service， type of work and education （all P<0.05）， but not to gender （P>0.05）. The logistic regression prediction model was constructed based on the influencing factors， with χ²=9.413， df=9， P=0.852， suggesting a good model fit. The logistic regression prediction model predicted the area under the curve （AUC） for the occurrence of PBL chromosomal aberrations in radiation workers was 0.914 （95%CI： 0.866‒0.949）， with a cut-off value of 3.05， corresponding to a prediction sensitivity and specificity of 100.00% and 75.98%， respectively. ConclusionThe incidence of PBL chromosomal aberrations in radiological workers in Hainan Province was 6.00%， with age， working age and job type as high-risk factors and education level as a protective factor. The prediction model constructed by the above factors can provide a reliable basis for clinical prediction of PBL chromosomal aberrations in radiological workers.

Objective:To assess the risk of venous thromboembolism (VTE) and anticoagulation-related bleeding of acute critical emergency patients staying in the emergency department at least 72 h, so as to improve the ability of emergency physicians to identify risk factors of VTE and their awareness of safety prevention in these patients.Methods:Multicenter emergency internal medicine patients meeting the inclusion criteria at the same time were collected. Padua and Caprini scores were used to evaluate the risk of VTE and the HAS-BLED score was used to assess the risk of anticoagulation-related bleeding.Results:A total of 930 emergency patients from 7 medical centers were enrolled in our study from January 15, 2021 to March 15, 2021. The proportion of high-risk population with VTE was 50.22% with Padua score and 78.49% with Caprini score, respectively. The proportion of high-risk bleeding (HAS-BLED score) was 40.43%.Conclusions:More than half of the acute critical ill patients who stay in emergency department for more than 72 h are at high risk of VTE. This group of patients have a relatively low risk of anticoagulation-related bleeding.

Melanoma is the most malignant skin tumor, which is characterized by early metastasis and poor prognosis. In recent years, adoptive immunotherapy, as a new immunotherapy, has made great breakthrough in treatment of solid tumors. Represented by tumor-infiltrating lymphocyte, adoptive immunotherapy exhibits remarkable effects in melanoma. Its combination with immunotherapy or targeted therapy will be a certain trend for future development, while the large-scale clinical study on adoptive immunotherapy remains to be carried out. This article reviews the research progress of adoptive immunotherapy on melanoma.

Melanoma is the most malignant skin tumor, which is characterized by early metastasis and poor prognosis. In recent years, adoptive immunotherapy, as a new immunotherapy, has made great breakthrough in treatment of solid tumors. Represented by tumor-infiltrating lymphocyte, adoptive immunotherapy exhibits remarkable effects in melanoma. Its combination with immunotherapy or targeted therapy will be a certain trend for future development, while the large-scale clinical study on adoptive immunotherapy remains to be carried out. This article reviews the research progress of adoptive immunotherapy on melanoma.

Objective:To compare the predictive value of Oxford acute severity of illness score (OASIS) and simplified acute physiology score Ⅱ (SAPSⅡ) for in-hospital mortality in intensive care unit (ICU) patients with sepsis.Methods:A retrospective cohort study was conducted using the data in the Medical Information Mart for Intensive Care-Ⅳ0.4 (MIMIC-Ⅳ 0.4). Based on Sepsis-3 diagnostic criteria, the basic information of ICU adult sepsis patients with infection and sequential organ failure assessment (SOFA) score ≥ 2 within 24 hours of ICU admission admitted for the first time in the database was extracted, including gender, age, vasopressor drugs, sedative drugs, mechanical ventilation, renal replacement therapy, length of ICU stay, OASIS, SAPSⅡ scores, etc. The primary outcome was in-hospital mortality. A receiver operator characteristic curve (ROC curve) was drawn, and the area under the ROC curve (AUC) was calculated to compare the prognostic value of OASIS score and SAPSⅡ score.Results:A total of 11 098 adult ICU sepsis patients were enrolled in the final analysis, of which 2 320 died and 8 778 survived in hospital, with a mortality of 20.90%. Compared with the survivors, the non-survivors were older [years old: 71 (60, 81) vs. 67 (56, 78)], had longer length of ICU stay [days: 6.95 (3.39, 13.07) vs. 4.23 (2.19, 9.73)] and higher proportions of using vasopressor drugs, sedative drugs, mechanical ventilation and renal replacement therapy [vasopressor drugs: 50.65% (1 175/2 320) vs. 33.05% (2 901/8 778), sedative drugs: 58.53% (1 358/2 320) vs. 48.41% (4 249/8 778), mechanical ventilation: 89.57% (2 078/2 320) vs. 81.66% (7 168/8 778), renal replacement therapy: 11.98% (278/2 320) vs. 6.57% (577/8 778), all P < 0.01]. Moreover, the non-survivors had higher OASIS score [43 (36, 49) vs. 35 (29, 41), P < 0.01] and SAPSⅡ score [49 (40, 60) vs. 38 (31, 47), P < 0.01] as compared with the survivors. ROC curve analysis showed that the AUC of OASIS score and SAPSⅡ score for predicting in-hospital death of ICU patients with sepsis was 0.713 [95% confidence interval (95% CI) was 0.701-0.725] and 0.716 (95% CI was 0.704-0.728), respectively, and the Delong test showed no significant difference in AUC between the two scoring systems ( P > 0.05). Conclusions:OASIS score has a good predictive value for in-hospital mortality in sepsis patients, which is similar to SAPSⅡ score. OASIS score is simpler and has a broader clinical application prospect than SAPSⅡ score.