Objective To explore the association between interleukin 28B (IL-28B),equilibrative nucleoside transporters 1 (ENT1) gene polymorphisms and spontaneous clearance of HCV in HIV/HCV co-infectors in Hunan province.Methods Genotypes of IL-28B and ENT1 (rs12980275,rs12979860,rs8099917 and rs760370) were analyzed in 107 HIV/HCV co-infectors in Hunan province and the distributions of gene polymorphisms were compared between chronic hepatitis and spontaneous clearance groups.Results The major genotypes in rs12980275,rs12979860 and rs8099917 of IL-28B were AA,CC and TT in HIV/HCV co-infectors,which accounted for 84.1％ of each.The three single nucleotide polymorphisms were highly linkage disequilibrium (r2＞0.94) and the differences of genotype distribution were statistically significant between chronic hepatitis and the spontaneous clearance groups (P＜0.05).Infectors which carrying the major genotypes were more susceptible to spontaneous clearance of HCV.Differences of the genotype distributions in rs760370 of ENT1 were not statistically significant between the two groups.Conclusion Genotypes AA,CC and TT of IL-28B were related to spontaneous clearance of HCV in HIV/HCV co-infectors.

Human epidermal growth factor receptor-2 (HER-2) tyrosine kinase inhibitors (TKI) is the targeted drug of HER-2-positive breast cancer. Lapatinib, pyrotinib and neratinib, as ErbB family TKIs, have been approved by National Medical Products Administration and applied in the treatment of HER-2 positive breast cancer in China. The most common adverse effects (AEs) of TKI agents include diarrhea, drug-induced liver injury (DILI), nausea, vomiting, skin toxicity, cardiotoxicity and oral mucositis. The Breast Cancer Expert Group of Chinese Society of Clinical Oncology (CSCO) summarized the incidence and characteristics of AEs of TKI, evaluated the manifestations and severity of AEs, and formulated the consensus of the management of common AEs based on the clinical experiences and updated advances from domestic and abroad studies. This consensus aims to provide the practical strategy for clinicians in the management of ErbB-family TKI-related AEs in China, and eventually enhance the patients′ compliance and improve the therapeutic efficacy.

Human epidermal growth factor receptor-2 (HER-2) tyrosine kinase inhibitors (TKI) is the targeted drug of HER-2-positive breast cancer. Lapatinib, pyrotinib and neratinib, as ErbB family TKIs, have been approved by National Medical Products Administration and applied in the treatment of HER-2 positive breast cancer in China. The most common adverse effects (AEs) of TKI agents include diarrhea, drug-induced liver injury (DILI), nausea, vomiting, skin toxicity, cardiotoxicity and oral mucositis. The Breast Cancer Expert Group of Chinese Society of Clinical Oncology (CSCO) summarized the incidence and characteristics of AEs of TKI, evaluated the manifestations and severity of AEs, and formulated the consensus of the management of common AEs based on the clinical experiences and updated advances from domestic and abroad studies. This consensus aims to provide the practical strategy for clinicians in the management of ErbB-family TKI-related AEs in China, and eventually enhance the patients′ compliance and improve the therapeutic efficacy.

Objective To observe curative effect of rhubarb acupoint sticking with nasal feeding therapy among severe acute pancreatitis (SAP) patients complicated with the paralytic ileus. Methods During July 2012 to April 2014 in Gastroenterology Department in Zhejiang Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Zhejiang University, a total of 40 SAP inpatients were divided into experimental group and control group by random number table. All patients in the two groups received routine anti-infection, fluid infusion treatment, but the patients of experimental group underwent rhubarb acupoint sticking of Shenque Point with nasal feeding therapy while patients were taken placebo of Shenque point and nasal feeding therapy in the control group. We observed patient′s recovery time of bowl sound, time of first self defecation, recovery time of hemodlastase, local complication and mortality in two groups. Results The recovery time of bowl sound, time of first self defecation, recovery time of hemodlastase were (2. 85 ± 1. 04), (3. 55 ± 1. 32) and (8. 85 ± 2. 30) d in the experimental group lower than these of the control group ( t =2. 226,2. 332,2. 067, respectively;P < 0. 05). There were one case of local complication in the experimental group compared with 7 cases in the control group (χ2 = 5. 625,P < 0. 05). The difference was no statistic for mortality between two groups (P > 0. 05). Conclusions Rhubarb acupoint sticking with nasal feeding therapy can minimize the lasting time of paralytic ileus, reduce complication, enhance peristalsis function and clinical effect and operation, and is worth of clinical promotion.

Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Objective:To investigate the influence of maternal autoimmune diseases and anticoagulants, including low-molecular-weight heparin (LMWH) and aspirin, on the fetal fraction of maternal plasma cell-free DNA of non-invasive prenatal testing (NIPT).Methods:A prospective cohort study was conducted on women with singleton pregnancies receiving NIPT in the Nanjing Drum Tower Hospital from March 2021 to July 2022. NIPT was carried out using a polymerase chain reaction (PCR)-free amplification platform. In this study, four types of maternal autoimmune diseases, which were antiphospholipid syndrome, undifferentiated connective tissue disease, Sj?gren's syndrome, and systemic lupus erythematosus (SLE), and two anticoagulants, LMWH and aspirin, were studied. Univariate and multivariate linear regression models were used to analyze the factors influencing fetal fraction of maternal plasma cell-free DNA.Results:A total of 4 102 singleton pregnant women were enrolled in the prospective cohort, and 3 948 were finally included after excluding the cases with unclear dosing time of LMWH or aspirin, other autoimmune diseases, conceiving through ovulation induction alone, and having true positive or failed NIPT result. There were 96 cases with antiphospholipid syndrome, 35 with undifferentiated connective tissue disease, 34 with Sj?gren's syndrome, and 18 with SLE. A total of 108 patients only received LMWH treatment, 121 only received aspirin treatment, and 113 received both LMWH and aspirin treatment. Univariate linear regression analysis showed that maternal body mass index at blood collection ( B=－0.423), conceived by assisted reproductive technology ( B=－0.803), male fetus ( B=－0.458), undifferentiated connective tissue disease ( B=1.774), and SLE ( B=3.467) had influence on the fetal fraction (all P<0.05). Multivariate linear regression analysis showed that maternal body mass index at blood collection ( B=－0.415), conceived by assisted reproductive technology ( B=－0.585), male fetus ( B=－0.322), SLE ( B=3.347) and undifferentiated connective tissue disease ( B=1.336) were factors influencing fetal fraction (all P<0.05). Conclusions:Maternal use of LMWH or aspirin does not affect fetal fraction when performing NIPT on a PCR-free amplification platform, but undifferentiated connective tissue disease and SLE are the influencing factors. Therefore, pregnant women should be informed before the NIPT that the fetal fraction of maternal plasma cell-free DNA may be affected by maternal autoimmune diseases.

Numerous studies on cancers, biopharmaceuticals, and clinical trials have necessitated comprehensive and precise analysis of protein O-glycosylation. However, the lack of updated and convenient databases deters the storage of and reference to emerging O-glycoprotein data. To resolve this issue, an O-glycoprotein repository named OGP was established in this work. It was constructed with a collection of O-glycoprotein data from different sources. OGP contains 9354 O-glycosylation sites and 11,633 site-specific O-glycans mapping to 2133 O-glycoproteins, and it is the largest O-glycoprotein repository thus far. Based on the recorded O-glycosylation sites, an O-glycosylation site prediction tool was developed. Moreover, an OGP-based website is already available (http://www.oglyp.org/). The website comprises four specially designed and user-friendly modules:statistical analysis, database search, site prediction, and data submission. The first version of OGP repository and the website allow users to obtain various O-glycoprotein-related information, such as protein accession Nos., O-glycosylation sites, O-glycopeptide sequences, site-specific O-glycan structures, experimental methods, and potential O-glycosylation sites. O-glycosylation data mining can be performed efficiently on this website, which will greatly facilitate related studies. In addition, the database is accessible from OGP website (http://www.oglyp.org/download.php).