Application of LEARNS model based on Triangle stratified model on the management of out-patients with type 2 diabetes mellitus / 中国实用护理杂志

Objective:To analyze the effects of stratified follow-up intervention combined with LEARNS model on self-management, glucose metabolism, compliance and satisfaction in patients with type 2 diabetes mellitus (T2DM).Methods:This study was a quasi-experimental study. A total of 212 patients with T2DM who visited the DM nursing clinic of Beijing Tiantan Hospital, Capital Medical University from June 2020 to May 2021 were selected and divided into control group (102 cases) and intervention group (110 cases) according to the treatment time. All the patients received the conventional medical treatment and health education guidance for 6 months, at the same time, the intervention group received management of the triangle stratified model combined with LEARNS mode. The glucose metabolism, self-management behavior, satisfaction and compliance were compared before and after the intervention.Results:Before the intervention, the baseline data of the 2 groups had no significant difference(all P>0.05) and were comparable. Three and six months after the intervention, the HbA1c values of the intervention group were (6.18 ± 0.57)% and (6.40 ± 0.47)%, which were significant better than those in the control group, (6.74 ± 0.90)% and (6.99 ± 0.91)%, the differences were significant ( t=8.05 and 9.12, both P<0.01). Three and six months after the intervention, the SDASC values in the intervention group were (46.51 ± 5.80) and (44.41 ± 5.61), which were higher than those in the control group, (43.45 ± 4.20) and (42.08 ± 3.67), the difference were significant ( t=6.56 and 5.32, both P<0.01). Three and six months after the intervention, the compliance and patient satisfaction of intervention group were better than those in the control group ( χ2=5.52 and 7.26, t=7.02 and 15.75, all P<0.05). Conclusions:Triangle hierarchical management combined with LEARNS model can effectively improve the blood glucose levels of T2DM patients as well as their self-management levels, satisfaction and compliance, which can help nurses reasonably allocate follow-up time.

Status and associated factors of pre-exposure prophylaxis use among men who have sex with men in 24 cities in China / 中华流行病学杂志

Objective: To understand the cognition and medication use of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China and its associated factors. Method: From August 25 to September 5, 2021, 2 447 MSM were recruited in 24 cities to complete the online questionnaire through a male social interaction platform, Blued 7.5 software. The survey contents included demographic information of the respondents, PrEP awareness and usage, and risk behaviors. Descriptive analysis and multi-level logistic regression were performed for data analysis. SPSS 24.0 and SAS 9.4 software were used for statistical analysis. Results: Among the 2 447 respondents of MSM, 1 712 (69.96%) had heard of PrEP, 437 (17.86%) ever used PrEP, 274 (11.20%) were on PrEP, and 163 (6.66%) had discontinued PrEP; among the 437 cases (whoever used PrEP), more than 61.88% (388/627) adopted emtricitabine/tenofovir disoproxil fumarate regimen, and most of them adopted on-demand regimen. The average PrEP dosage reported in the past year is 1.12 tabletsper person per week. PrEP purchase was primarily via an online channel, and the most concerned factor was the PrEP effectiveness on HIV prevention. The most common reasons for discontinuing PrEP, reported by 163 cases, were the lack of HIV risk perception, the use of a condom to prevent HIV, and the economic burden of PrEP use. The logistic regression analysis showed that PrEP use among MSM in 24 cities was statistically associated with age, monthly income, ever having unprotected anal sex in the past year, used sexual drugs and sexually transmitted disease (STD) diagnosis in the past year. Compared with MSM aged 18-24, the proportion of MSM was relatively lower among those aged 25-44, who discontinued the PrEP (aOR=0.54,95%CI:0.34-0.87) or never used PrEP (aOR=0.62,95%CI:0.44-0.87). The proportion of unprotected anal sex among MSM currently on PrEP use was higher than those who have stopped PrEP and never used PrEP (all P<0.05). Those MSM group, with monthly income higher than 5 000 Yuan, used sexual drugs and STD diagnosis in the past year were more likely to have a higher rate for PrEP usage (all P<0.05). Conclusions: Currently, pre-exposure prophylaxis in the MSM group is primarily obtained via the online channel and adopted in an on-demand mode. Although the PrEP users have reached a certain proportion, it is still necessary to strengthen health education on the PrEP effects and side effects of MSM and to improve the awareness and use rate, especially for young MSM group, which can be combined with the advantages of the internet targeting its needs and use barriers.

Patent application of intelligent quality control technology in traditional Chinese medicine production process: a review / 中国中药杂志

In the new stage for intelligent manufacturing of traditional Chinese medicine(TCM) from pilot demonstration to in-depth application and comprehensive promotion, how to raise the degree of intelligence for the process quality control system has become the bottleneck of the development of TCM production process control technology. This article has sorted out 226 TCM intelligent manufacturing projects that have been approved by the national and provincial governments since the implementation of the "Made in China 2025" plan and 145 related pharmaceutical enterprises. Then, the patents applied by these pharmaceutical enterprises were thoroughly retrieved, and 135 patents in terms of intelligent quality control technology in the production process were found. The technical details about intelligent quality control at both the unit levels such as cultivation, processing of crude herbs, preparation pretreatment, pharmaceutical preparations, and the production workshop level were reviewed from three aspects, i.e., intelligent quality sensing, intelligent process cognition, and intelligent process control. The results showed that intelligent quality control technologies have been preliminarily applied to the whole process of TCM production. The intelligence control of the extraction and concentration processes and the intelligent sensing of critical quality attributes are currently the focus of pharmaceutical enterprises. However, there is a lack of process cognitive patent technology for the TCM manufacturing process, which fails to meet the requirements of closed-loop integration of intelligent sensing and intelligent control technologies. It is suggested that in the future, with the help of artificial intelligence and machine learning methods, the process cognitive bottleneck of TCM production can be overcome, and the holistic quality formation mechanisms of TCM products can be elucidated. Moreover, key technologies for system integration and intelligent equipment are expected to be innovated and accelerated to enhance the quality uniformity and manufacturing reliability of TCM.

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines (Ⅱ): classification of tablets disintegration behavior / 中国中药杂志

In this paper, 50 batches of representative traditional Chinese medicine tablets were selected and the disintegration time was examined with the method in Chinese Pharmacopoeia. The disintegration time and disintegration phenomenon were recorded, and the dissolution behaviors of water-soluble and ultraviolet-absorbent components during the disintegration process of tablets were characterized by self-control method. The results revealed that coating type and raw material type influenced the disintegration time of tablets. It was found that only 4% of traditional Chinese medicine tablets had obvious fragmentation during the disintegration process, while 96% of traditional Chinese medicine tablets showed gradual dissolution or dispersion. Furthermore, according to the disintegration speed, disintegration phenomenon, and whether the cumulative dissolution of measured components was > 90% at complete disintegration, a disintegration behavior classification system(DBCS) was created for the regular-release traditional Chinese medicine tablets. As a result, the disintegration behaviors of 50 batches of traditional Chinese medicine tablets were classified into four categories, i.e. ⅠA_2, ⅠB_1, ⅡB_1, and ⅡB_2. traditional Chinese medicine tablets(Class I) with disintegration time ≤ 30 min were defined to be rapid in disintegration, which can be the objective of optimization or improvement of Chinese herbal extract(semi extract) tablets. Different drug release models were used to fit the dissolution curve of traditional Chinese medicine tablets with gradual dissolution or dispersion phenomenon(i.e. Type B tablets). The results showed that the dissolution curves of water-soluble components in the disintegration process conformed to the zero order kinetics and the Ritger-Peppas model. It could be inferred that the disintegration mechanisms of type B tablets were a combination of dissolution controlled and swelling controlled mechanisms. This study contributes to understanding the disintegration behavior of traditional Chinese medicine tablets, and provides a reference for the design and improvement of disintegration performance of traditional Chinese medicine tablets.

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ): classification of processing routes / 中国中药杂志

Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for the research and development of traditional Chinese medicine OSDs. On the basis of prescriptions and preparation methods of 1 308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia, we summarized the patterns of processing routes of both modern dosage forms(tablets, granules, and capsules) and traditional dosage forms(pills and powder) and constructed a manufacturing classification system(MCS) based on the processing routes. Based on the MCS, statistical analyses were conducted respectively on medicinal materials, pharmaceutical excipients, extraction solvents in the pretreatment process, crushed medicinal materials, methods of concentration and purification, and methods of drying and granulation, aiming to uncover the process features. The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation. The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract, semi-extract, and total crushed powder, which accounted for different proportions. The raw materials for traditional dosage forms are mainly decoction pieces powder. Semi-extracts are the main raw materials for tablets and capsules, which account for 64.8% and 56.3%, respectively. Total extracts are the main raw materials for granules, with a proportion of 77.8%. Compared with tablets and capsules, traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process, a higher proportion of refining process(34.7%), and a lower proportion of crushed medicinal mate-rials in semi-extract granules. There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine. In addition, some new technologies and processes have been used in concentration, filtration, and granulation processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.

In vitro transcribed (IVT) mRNA drugs: technical progress and application prospect / 药学学报

The in vitro transcribed (IVT) mRNA technology has progressed rapidly and the application of mRNA vaccines in the COVID-19 pandemic made it become the most talked-about topic. Compared with protein drugs, IVT mRNA has a lower cost; it can be modular produced and its sequence can be modified easily, so it has a broad application prospect. However, due to its short history, mRNA drugs face the problem of lacking sufficient clinical data, and there is no quality control standard for mRNA drugs except mRNA vaccines. We overview the sequence design, delivery vectors, administration, application prospect and safety considerations of mRNA drugs. We also discussed the quality control of mRNA drugs briefly.

Efficacy of the enhanced recovery after surgery approach in endometrial cancer patients treated with surgical staging and its influence on the oxidative stress response / 中华老年医学杂志

Objective:To analyze the efficacy of the enhanced recovery after surgery(ERAS)approach in endometrial cancer patients treated with surgical staging and its beneficial effects on the oxidative stress response.Methods:Eight-two endometrial cancer patients treated with surgical staging at our hospital between March 2020 and March 2022 were recruited and divided into different groups using a computer-generated random number table, with 41 in the control group who were given routine intervention and 41 in the observation group receiving ERAS.Results:About perioperative performances, the oxidative stress response, inflammatory factor levels and complications were compared between the two groups.Results in the observation group, the intraoperative body surface temperature was higher than in the control group[(36.71±0.22)℃ vs.(36.20±0.21)℃, t=10.737, P=0.000], and the time from the end of surgery to first water intake[(4.41±1.30)h vs.(6.79±1.28)h, t=8.353, P=0.000], to first food intake[(7.86±1.35)h vs.(12.88±2.57)h, t=11.073, P=0.000], to first ambulation[(12.92±3.11)h vs.(24.24±5.06)h, t=12.204, P=0.000], to first flatus[(24.11±4.96)h vs.(35.13±6.20)h, t=8.887, P=0.000], to first bowel movement[(2.67±0.63)d vs.(4.03±1.15)d, t=6.641, P=0.000]and the length of hospitalization[(3.31±1.25)d vs.(5.77±1.59)d, t=7.788, P=0.000]were shorter than in the control group.On the third day after surgery, the levels of malondialdehyde[(77.96±7.62)μmol/L vs.(90.16±7.88)μmol/L, t=7.126, P=0.000], advanced oxidation protein products[(33.16±4.75)μmol/L vs.(43.55±5.37)μmol/L, t=9.280, P=0.000], CAT[(22.59±3.01)U/ml vs.(25.12±3.3)U/ml, t=3.609, P=0.000]and reactive oxygen species[(74.13±5.02)pmol/L vs.(90.33±5.89)pmol/L, t=13.404, P=0.000]in the two groups were higher than those on the day before surgery, but were lower in the observation group than in the control group at the same time points after surgery.On the 3rd day after surgery, the levels of Tumor Necrosis Factor-α, C-reactive protein and interleukin 6 in the two groups were higher than those on the day before surgery, but were lower in the observation group than in the control group at the same points after surgery(all P<0.05). In the observation group, the incidence of complications was 14.63%, lower than 39.02% in the control group( χ2=6.212, P=0.013). Conclusions:The ERAS approach can achieve significant results in endometrial cancer patients treated with surgical staging.It can not only improve perioperative performance, relieve oxidative stress and lower inflammatory factor levels, but also effectively prevent complications.

Exploring risk factors for combined coronary microvascular dysfunction in patients with ischemia and non-obstructive coronary artery disease / 中华核医学与分子影像杂志

Objective:To investigate the risk factors for combined coronary microvascular dysfunction (CMD) in patients with ischemia and non-obstructive coronary artery disease (INOCA).Methods:From October 2020 to May 2022, 100 INOCA patients with myocardial ischemic symptoms who underwent coronary angiography (CAG) suggestive of <50% stenosis in all three coronary arteries at the Tenth People′s Hospital of Tongji University were prospectively recruited. Myocardial perfusion imaging (MPI), transthoracic echocardiography and cadmium-zinc-telluride (CZT) SPECT coronary flow quantification were performed in the same month, and 93 INOCA patients (36 males and 57 females, age (63.0±10.9) years) were finally included. CMD was defined as coronary flow reserve (CFR)<2.5. Independent-sample t test, Mann-Whitney U test and χ2 test were used to compare MPI results and left ventricular volume parameters between CMD and non-CMD groups. ROC curve analysis was used to analyze the efficacy of each index in predicting CMD, and independent risk factors for CMD were screened by multivariate logistic regression analysis. Results:Among 93 INOCA patients, 29 were in the CMD group and 64 were in the non-CMD group. The age, proportion of hypertension, left ventricular mass index (LVMI), summed stress score (SSS), summed difference score (SDS), left ventricular internal diameter systolic (LVIDS), interventricular septum thickness (IVST), and left ventricular posterior wall thickness (LVPWT) in the CMD group were higher than those in the non-CMD group ( t values: 2.42-3.76, χ2=8.94, z values: -3.31, -3.41, all P<0.05). ROC curve analysis showed that LVMI, SSS, SDS, LVPWT, IVST and age were significant in predicting CMD (AUCs: 0.67-0.72). Multivariate logistic regression analysis showed that LVMI (odds ratio ( OR)=1.08, 95% CI: 1.01-1.17), SDS ( OR=5.37, 95% CI: 1.95-14.78), hypertension ( OR=5.68, 95% CI: 1.34-24.18) and age ( OR=1.10, 95% CI: 1.03-1.18) were risk factors for CMD. Conclusion:LVMI, SDS, hypertension and age are strongly associated with combined CMD in INOCA patients, which can be used for early risk stratification of INOCA patients.

Analysis of HIV-1 genetic subtype and pretreatment drug resistance among men who have sex with men infected with HIV-1 from 19 cities of 6 provinces in China / 中华流行病学杂志

Objective: To investigate the distribution of HIV-1 genetic subtypes and pretreatment drug resistance (PDR) among men who have sex with men (MSM) from 19 cities of 6 provinces in China. Methods: From April to November 2019, 574 plasma samples of ART-naive HIV-1 infected MSM were collected from 19 cities in Hebei, Shandong, Jiangsu, Zhejiang, Fujian, and Guangdong provinces, total ribonucleic acid (RNA) was extracted and amplified the HIV-1 pol gene region by nested polymerase chain reaction (PCR) after reverse transcription. Then sequences were used to construct a phylogenetic tree to determine genetic subtypes and submitted to the Stanford drug resistance database for drug resistance analysis. Results: A total of 479 samples were successfully amplified by PCR. The HIV-1 genetic subtypes included CRF01_AE, CRF07_BC, B, CRF55_01B, CRF59_01B, CRF65_cpx, CRF103_01B, CRF67_01B, CRF68_01B and unrecognized subtype, which accounted for 43.4%, 36.3%, 6.3%, 5.9%, 0.8%, 0.8%, 0.4%, 0.4%, 0.2% and 5.5%, respectively. The distribution of genetic subtypes among provinces is statistically different (χ2=44.141, P<0.001). The overall PDR rate was 4.6% (22/479), the drug resistance rate of non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, and protease inhibitors were 3.5% (17/479), 0.8% (4/479) and 0.2% (1/479), respectively. The PDR rate of recent infections was significantly higher than that of long-term infections (χ2=4.634, P=0.031). Conclusions: The HIV-1 genetic subtypes among MSM infected with HIV-1 from 19 cities of 6 provinces in China are diverse, and the distribution of subtypes is different among provinces. The overall PDR rate is low, while the PDR rate of recent infections was significantly higher than that of long-term infections, suggesting the surveillance of PDR in recent infections should be strengthened.

Application of limiting antigen avidity enzyme immunoassay for estimating HIV-1 incidence in men who have sex with men / 中华流行病学杂志

Objective: To estimate the incidence of HIV-1 infection in men who have sex with men (MSM) in key areas of China through HIV-1 limiting antigen avidity enzyme immunoassay (LAg-Avidity EIA), analyze the deviation from the actual results and identify influencing factors, and provided reference for improving the accuracy of estimation results. Methods: Based on the principle of the cohort randomized study design, 20 cities were selected in China based on population size and the number of HIV-positive MSM. The sample size was estimated to be 700 according to the HIV-1 infection rate in MSM. MSM mobile phone app. was used to establish a detection appointment and questionnaire system, and the baseline cross-sectional survey was conducted from April to November 2019. LAg-Avidity EIA was used to identify the recent infected samples. The incidence of HIV-1 infection was calculated and then adjusted based on the estimation formula designed by WHO. The influencing factors were identified by analyzing the sample collection and detection processes. Results: Among the 10 650 blood samples from the participants, 799 were HIV-positive in initial screening, in which 198 samples (24.78%) missed during confirmation test. Only 621 samples were received by the laboratory. After excluding misreported samples, 520 samples were qualified for testing. A total of 155 samples were eventually determined as recent infection through LAg-Avidity EIA; Based on the estimation formula , the incidence of HIV-1 infection in MSM in 20 cities was 4.06% (95%CI:3.27%-4.85%), it increased to 5.53% (95%CI: 4.45%-6.60%)after the adjusting for sample missing rate. When the sample missing rate and misreporting rate were both adjusted, the incidence of HIV-1 infection in the MSM increased to 5.66% (95%CI:4.67%-6.65%). The actual incidence of HIV-1 infection in MSM in the 20 cities might be between 4.06% and 5.66%. Conclusions: Sample missing and misreporting might cause the deviation of the estimation of HIV-1 infection incidence. It is important to ensure the sample source and the quality of sample collection and detection to reduce the deviation in the estimation of HIV-1 infection incidence.

Relationship between preoperative inflammatory indexes and prognosis of patients with rectal cancer and establishment of prognostic nomogram prediction model / 中华肿瘤杂志

Objective: To compare the prognostic evaluation value of preoperative neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII) in rectal cancer patients. Nomogram survival prediction model based on inflammatory markers was constructed. Methods: The clinical and survival data of 585 patients with rectal cancer who underwent radical resection in the First Affiliated Hospital of Xi'an Jiao tong University from January 2013 to December 2016 were retrospectively analyzed. The optimal cut-off values of NLR, PLR, LMR, and SII were determined by the receiver operating characteristic (ROC) curve. The relationship between different NLR, PLR, LMR and SII levels and the clinic pathological characteristics of the rectal cancer patients were compared. Cox proportional risk model was used for univariate and multivariate regression analysis. Nomogram prediction models of overall survival (OS) and disease-free survival (DFS) of patients with rectal cancer were established by the R Language software. The internal validation and accuracy of the nomograms were determined by the calculation of concordance index (C-index). Calibration curve was used to evaluate nomograms' efficiency. Results: The optimal cut-off values of preoperative NLR, PLR, LMR and SII of OS for rectal cancer patients were 2.44, 134.88, 4.70 and 354.18, respectively. There was statistically significant difference in tumor differentiation degree between the low NLR group and the high NLR group (P<0.05), and there were statistically significant differences in T stage, N stage, TNM stage, tumor differentiation degree and preoperative carcinoembryonic antigen (CEA) level between the low PLR group and the high PLR group (P<0.05). There was statistically significant difference in tumor differentiation degree between the low LMR group and the high LMR group (P<0.05), and there were statistically significant differences in T stage, N stage, TNM stage, tumor differentiation degree and preoperative CEA level between the low SII group and the high SII group (P<0.05). The multivariate Cox regression analysis showed that the age (HR=2.221, 95%CI: 1.526-3.231), TNM stage (Ⅲ grade: HR=4.425, 95%CI: 1.848-10.596), grade of differentiation (HR=1.630, 95%CI: 1.074-2.474), SII level (HR=2.949, 95%CI: 1.799-4.835), and postoperative chemoradiotherapy (HR=2.123, 95%CI: 1.506-2.992) were independent risk factors for the OS of patients with rectal cancer. The age (HR=2.107, 95%CI: 1.535-2.893), TNM stage (Ⅲ grade, HR=2.850, 95%CI: 1.430-5.680), grade of differentiation (HR=1.681, 95%CI: 1.150-2.457), SII level (HR=2.309, 95%CI: 1.546-3.447), and postoperative chemoradiotherapy (HR=1.837, 95%CI: 1.369-2.464) were independent risk factors of the DFS of patients with rectal cancer. According to the OS and DFS nomograms predict models of rectal cancer patients established by multivariate COX regression analysis, the C-index were 0.786 and 0.746, respectively. The calibration curve of the nomograms showed high consistence of predict and actual curves. Conclusions: Preoperative NLR, PLR, LMR and SII levels are all correlated with the prognosis of rectal cancer patients, and the SII level is an independent prognostic risk factor for patients with rectal cancer. Preoperative SII level can complement with the age, TNM stage, differentiation degree and postoperative adjuvant chemoradiotherapy to accurately predict the prognosis of rectal cancer patients, which can provide reference and help for clinical decision.

A method for measuring the ADCP potency of anti-CD38 monoclonal antibody / 药学学报

A method to measure the antibody-dependent cell-mediated phagocytosis (ADCP) potency of anti-CD38 mAb was developed based on design of experiment (DoE) with a Jurkat/NFAT/CD32a-FcεRIγ transgenic cell line as the effector cell, the Daudi cell line as the target cells, and luciferase as the detection system. The DoE method was used for optimization of experimental parameters and methodological validation. The results show that anti-CD38 mAb exhibits a dose-response relationship with the following four-parameter equation: y = (A - D) / [1 + (x / C)B] + D. Several experimental parameters were optimized by statistical experimental design and determined as follows: the working concentration of anti-CD38 mAb was 800-20.81 ng·mL-1, the density of the target cells was 7.5×104 per well, and the density of effector cells was 2.5×104 per well, with an induction time of 6 h. The method showed good specificity. The recovery rate for samples from 5 different groups showed that the relative potencies of anti-CD38 mAb were (59.97 ± 4.74) %, (82.44 ± 5.15) %, (110.69 ± 11.71) %, (129.23 ± 5.22)% and (162.15 ± 3.66) %. The recoveries ranged from 103% to 120% and the RSDs of the above results were all less than 11%. The linear detection range was 50%-150%. Based on DoE design, this method for measuring ADCP potency of anti-CD38 mAb was optimized and validated with good specificity, repeatability and accuracy. This method can be used for evaluation of ADCP biological activity of anti-CD38 mAbs.

Receiving Human Immunodeficiency Virus Serostatus Disclosure from Male Sexual Partners and Related Factors among Men Who Have Sex with Men Aged 50 and Above / 中国医学科学院学报

Objective To investigate the rate and correlates of receiving human immunodeficiency virus(HIV) serostatus disclosure from their most recent male sexual partners among men who have sex with men(MSM) aged 50 and above. Methods With a geosocial networking application,we recruited participants through online convenience sampling to collect the demographic variables,behavioral information,receiving HIV serostatus disclosure,etc.Univariate and multivariate analyses were performed to interpret the associated factors of receiving HIV serostatus disclosure. Results Overall,38.4%(398/1037) of participants received HIV serostatus disclosure from their most recent male sexual partners.The multivariable analysis demonstrated that the following populations were less likely to receive HIV serostatus disclosure from their most recent male sexual partners:participants with junior high school degree or below(OR=0.660,95%CI=0.473-0.922, P=0.015) compared to those with senior high school degree or above;participants unemployed(OR=0.537,95%CI=0.322-0.896, P=0.017) and employed(OR=0.663,95%CI=0.466-0.944, P=0.022) compared to those retired;participants without knowledge about HIV or acquired immune deficiency syndrome(AIDS) compared to those with knowledge about HIV/AIDS(OR=0.636,95%CI=0.466-0.868, P=0.004);participants having ≥2 male sexual partners in the last year(OR=0.433,95%CI=0.320-0.586, P<0.001) compared to those having none or one male sexual partner;participants never been tested for HIV(OR=0.544,95%CI=0.403-0.734, P<0.001) compared to those ever been tested for HIV;participants ever been diagnosed to have sexually transmitted infection(STI)(OR=0.472,95%CI=0.349-0.637, P<0.001) compared to those never diagnosed to have STI;and participants with higher level of HIV stigma(OR=0.742,95%CI=0.604-0.912, P=0.005). Conclusions Our findings indicated that the MSM aged 50 and above had low possibility of receiving HIV serostatus disclosure from the most recent male sexual partners.Education,employment status,number of sexual partners,HIV/AIDS-related knowledge,HIV testing behaviors,STI infection history,and HIV stigma contributed to this result.

Multicenter post-marketing clinical evaluation on the clinical performance of the five domestic fast nucleic acid detection reagents for 2019-nCoV / 中华检验医学杂志

Objective:This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV.Methods:Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020.Results:The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55); and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15); and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits.Conclusion:The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.

Comparison of preparation for 177Lu-labeled radiopharmaceutical and its preliminary clinical application / 中华核医学与分子影像杂志

Objective:To investigate the preparation methods and quality control of 177Lu-labeled radiopharmaceuticals, and conduct preliminary clinical application research. Methods:177Lu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid (DOTA)- D-Phe1-Tyr3-octreotide (TOC) and 177Lu-prostate specific membrane antigen (PSMA)-I&T were labeled by manual labeling and automatic labeling, respectively. Factors such as the amount of precursor and nuclide, reaction temperature, pH value, reaction time, labeling yield and specific activity were investigated. Quality control of the products were carried out, such as clarity, pH value, sterility, bacterial endotoxin and stability in vitro. 177Lu-PSMA-I&T was applied to the treatment of prostate cancer patients, and the efficacy was evaluated by SPECT/CT imaging. Paired t test was used to analyze the data. Results:The amount of precursor and nuclide, reaction temperature, pH value and reaction time of the two methods were basically the same, both with high yield and specific activity. The yield of 177Lu-DOTA-TOC automatic labeling was significantly higher than that of manual labeling (99.2±0.4)% vs (95.3±1.5)% ( t=7.17, P<0.001), and the specific activity were (91.6±13.7) vs (89.1±13.2) GBq/μmol. The yield of 177Lu-PSMA-I&T automatic labeling was also significantly higher than that of manual labeling (99.6±0.3)% vs (95.7±1.3)% ( t=8.24, P<0.001), and the specific activity were (96.1±14.3) vs (93.2±13.8) GBq/μmol. The labeled products were colorless clear solution with pH value of 6.5-7.0. The sterility and bacterial endotoxin met the requirements. The radiochemical purity of the labeled products was more than 95% after 48 h, which showed good stability. The clinical application of 177Lu-PSMA-I&T in patients with prostate cancer showed that both primary and metastatic lesions had good uptake. Conclusions:The labeling of 177Lu radiopharmaceuticals is simple and has high yield and stability. The application of automatic labeling can simplify the process, improve the yield and reduce irradiation.

Automatic synthesis of 18F-AlF-NOTA-octreotide and PET/CT imaging in neuroendocrine tumor / 中华核医学与分子影像杂志

Objective:To explore the automatic synthesis method of 18F-AlF-1, 4, 7-triazacyclononane-1, 4, 7-triacetic acid (NOTA)-octreotide and the imaging in neuroendocrine tumor (NET). Methods:Using the Trasis AllinOne synthesis module, 18F-AlF-NOTA-octreotide was automatically synthesized by chelating 18F-AlF and NOTA-octreotide at 100 ℃, and the quality of the product was analyzed. 18F-AlF-NOTA-octreotide and 18F-FDG PET/CT imaging were performed and compared in one patient with NET (male, 35 years old). Results:The total synthesis time of 18F-AlF-NOTA-octreotide was 35 min with a radiochemical yield of (55.8±1.8%)% (non-decay corrected, n=6), radiochemical purity more than 95% and good stability. The sterility and pyrogen-free of the product met the requirements. Compared with 18F-FDG (the lesion SUV max=3.8, target-to-background (T/B) ratio=1.03), 18F-AlF-NOTA-octreotide could be clearly imaged in the patient with NET with SUV max of 21.7 and T/B ratio of 4.09. Conclusions:The preparation of 18F-AlF-NOTA-octreotide with Trasis Allinone synthesis module is simple, rapid and stable. The product has high radiochemical purity and can meet the needs of clinical application. In vivo18F-ALF-NOTA-octreotide PET/CT imaging in the patient with NET shows higher T/B ratio, which has obvious advantages compared with 18F-FDG.

Mechanism and research progress of cancer treatment by α-therapy combined with immunotherapy / 中华核医学与分子影像杂志

Alpha-particles, which have strong cytotoxicity, could reduce radiation damage to surrounding tissues, and stimulate anti-tumor immune response, so they have good development prospect in cancer treatment. The current researches show that α-emitting radionuclides increase the presentation of major histocompatibility complex-I (MHC-Ⅰ) on tumor cells and induce immunogenic cell death (ICD) to activate immune response mediated by CD8 + T cells. As two methods of α-therapy, α radioimmunotherapy and diffusing α-emitters radiation therapy (DART) further enhance the anti-cancer effect when combined with immunotherapy. The methods of immunotherapy include adoptive cell therapy (ACT), immune checkpoint blockade, neutralization of immunosuppressive cells and immunoadjuvant. This article reviews the characteristics of α-particles for cancer treatment, the mechanism of immune response induced by ionizing radiation (including α-radionuclides) and the related research of α-therapy combined with immunotherapy.

Recent advances in developing small-molecule inhibitors against SARS-CoV-2

The COVID-19 pandemic caused by the novel SARS-CoV-2 virus has caused havoc across the entire world. Even though several COVID-19 vaccines are currently in distribution worldwide, with others in the pipeline, treatment modalities lag behind. Accordingly, researchers have been working hard to understand the nature of the virus, its mutant strains, and the pathogenesis of the disease in order to uncover possible drug targets and effective therapeutic agents. As the research continues, we now know the genome structure, epidemiological and clinical features, and pathogenic mechanism of SARS-CoV-2. Here, we summarized the potential therapeutic targets involved in the life cycle of the virus. On the basis of these targets, small-molecule prophylactic and therapeutic agents have been or are being developed for prevention and treatment of SARS-CoV-2 infection.

Functional outcomes of 100 patients with adenocarcinoma of the esophagogastric junction undergoing Cheng's GIRAFFE(®) reconstruction after proximal gastrectomy / 中华胃肠外科杂志

Objective: To investigate the functional outcomes and postoperative complications of Cheng's GIRAFFE reconstruction after proximal gastrectomy. Methods: A descriptive case series study was conducted. Clinical data of 100 patients with adenocarcinoma of the esophagogastric junction who underwent Cheng's GIRAFFE reconstruction after proximal gastrectomy in Cancer Hospital of University of Chinese Academy of Sciences (64 cases), Zhejiang Provincial Hospital of Chinese Medicine (24 cases), Lishui Central Hospital (10 cases), Huzhou Central Hospital (1 case) and Ningbo Lihuili Hospital (1 case) from September 2017 to June 2021 were retrospectively analyzed. Of 100 patients, 64 were males and 36 were females; the mean age was (61.3 ± 11.1) years and the BMI was (22.7±11.1) kg/m(2). For TNM stage, 68 patients were stage IA, 24 were stage IIA and 8 were stage IIB. Postoperative functional results and postoperative complications of radical gastrectomy with Giraffe reconstruction were analyzed and summarized. Gastroesophageal reflux disease questionnaire (RDQ) score and postoperative endoscopy were used to evaluate the occurrence of reflux esophagitis and its grade (grade N, grade A, grade B, grade C, and grade D from mild to severe reflux). The continuous data conforming to normal distribution were expressed as (mean ± standard deviation), and those with skewed distribution were presented as median (Q1, Q3). Results: All the 100 patients successfully completed R0 resection, including 77 patients undergoing laparoscopic surgery and 23 patients undergoing laparotomy. The Giraffe anastomosis time was (38.6±14.0) min; the blood loss was (73.0±18.4) ml; the postoperative hospital stay was 9.5 (8.2, 13.0) d; the hospitalization cost was (6.0±0.3) ten thousand yuan. Fourteen cases developed perioperative complications (14.0%), including 7 cases of pleural effusion or pneumonia, 3 cases of anastomotic leakage, 2 cases of gastric emptying disorder, 1 case of gastrointestinal hemorrhage and 1 case of anastomotic stenosis, who were all improved and discharged after symptomatic management. Patients were followed up for (33.3±1.6) months. Eight patients were found to have reflux symptoms by RDQ scale six months after surgery, and 11 patients (11/100,11.0%) were found to have reflux esophagitis by gastroscopy, including 6 in grade A, 3 in grade B, and 2 in grade C. All the patients could control their reflux symptoms with behavioral guidance or oral PPIs. Conclusion: Cheng's GIRAFFE reconstruction has good anti-reflux efficacy and gastric emptying function; it can be one of the choices of reconstruction methods after proximal gastrectomy.

Functional evaluation after function-preserving gastrectomy / 中华胃肠外科杂志

With the increase of people's health awareness and the progress of medical diagostic technology in recent years, the diagnosis rate of early gastric cancer is increasing year by year. Although radical surgery has good efficacy, how to maximize the preservation of the normal anatomy and function of the stomach and improve the quality of life of patients in the pursuit of radical surgery has become a more important issue in the treatment of early gastric cancer. Under the condition of ensuring radical lymph node dissection, function-preserving gastrectomy can fully preserve gastric function by reducing the resection extent and preserving the pylorus and the vagus nerve, which has advantage of improving quality of life and has great potential in the treatment of early gastric cancer. However, there is no functional evaluation standard for function-preserving gastrectomy at present. Most of the patients are evaluated by quality of life scale, which is relatively subjective. Even though the evaluation of endoscopy, hematology and other objective means can indicate the benefit degree in quality of life brought by functional reconstruction, the evidence level is limited. Therefore, this paper discusses the research status of function-preserving gastrectomy evaluation, postoperative complications, postoperative nutritional status, auxiliary examination and other items in the evaluation of gastric function, and analyzes the prospects of research direction in this field.