【Objective】 To explore the effectiveness and safety of polyglycolic acid (PGA) and hydroxypropyl methylcellulose (HPMC) composite materials in distal pancreatectomy postoperative suturing. 【Methods】 We selected 36 healthy adult beagles and divided them randomly into observation group and control group, with 18 distal pancreatectomy surgeries in each group. The observation group used PGA+HPMC composite materials for incision reinforcement while the control group used NEOVEIL for incision reinforcement. 3 days before surgery, 3 days after surgery, and before dissection, blood routine tests were performed on each group of experimental dogs. Observation periods of 2-week, 4-week and 8-week were set, and six animals at each observation point were evaluated for histological examination of heart, liver, spleen, lung, and kidney tissues, hard tissue slice pathological diagnosis, and safety evaluation. 【Results】 There was no significant difference between the observation group and the control group in the preoperative blood routine test. Repeated measures ANOVA results showed differences in the mean values of white blood cell count (WBC) ( F=14.875, P=0.001), mean corpuscular hemoglobin concentration (MCHC) (F=5.049,P=0.009), neutrophil percentage (Neu%) (F=4.794, P=0.011), red blood cell count (RBC) (F=6.591, P=0.002), hemoglobin (HGB) (F=8.154, P=0.001), hematocrit (HCT) (F=5.281, P=0.007), platelet count (PLT) (F=6.560, P=0.014), red blood cell distribution width coefficient of variation (RDW-CV) (F=33.950, P=0.039), or lymphocyte percentage (Lym%) (F=3.299, P=0.043) at different time points. However, the observation group and the control group did not differ, and the interaction between time and group had no significant effect on the above indicators, suggesting that both groups of dogs had inflammatory response or surgical stress. For the 8-week postoperative hard tissue pathological section score, there was no significant difference between the observation group and the control group in the inflammation and necrosis related score, fibrosis, repair or other related scores and total score (P>0.05). In the dissection at 8 weeks after surgery, no obvious damage to the heart, liver, spleen, lung, kidney, or other organs was found in both groups, nor was there any residual suture material, pancreatic fistula, or pancreatitis, indicating that the suture materials in both groups had been completely absorbed and metabolized, and the incision healed well without causing adverse effects on the visceral organs. 【Conclusion】 PGA and HPMC are effective and safe postoperative suture materials, with good biodegradability, biocompatibility, suture strength, and wound healing quality. They can be comparable to traditional absorbable reinforcement materials in distal pancreatectomy postoperative suturing, thus providing scientific basis for their clinical application.

Objective:To investigate the clinicopathological characteristics and prognostic factors of gastrointestinal stromal tumor (GIST) with initial surgical resection.Methods:The retro-spective cohort study was conducted. The clinicopathological data of 847 GIST patients who under-went initial surgical resection in Tianjin Medical University Cancer Institute & Hospital from January 2011 to December 2020 were collected. There were 405 males and 442 females, aged (60±10)years. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data was conducted using the nonparameter rank sum test. The Kaplan-Meier method was used to calculate survival rates. Univariate analysis was conducted using the Log-rank test. Multivariate analysis was conducted using the COX regression model. Results:(1) Clinicopatholo-gical characteristics. Of 847 patients, the tumor primary location was stomach in 585 cases, jejunum and ileum in 142 cases, duodenum in 76 cases, colorectum in 10 cases, esophagus in 3 cases, and extra-gastrointestinal in 31 cases. There were 13 cases with liver metastasis and 22 cases with abdominal metastasis. The tumor maximum diameter was (7±5)cm, and the number of nuclear divisions was 4(range, 0-60) cells/50 high-power field or 5 mm 2. According to risk classification of National Institutes of Health (NIH), 31 cases were of extremely low risk, 238 cases were of low risk, 213 cases were of moderate risk, 365 cases were of high risk. There were 839 of 847 patients positive for CD117, 788 cases positive for Dog-1, 710 cases positive for CD34, respectively. There were 272 cases with Ki-67 <5%, 214 cases with Ki-67 of 5%- 9%, 198 cases with Ki-67 ≥10%, 163 cases with missing data. R 0 resection was in 814 cases and non-R 0 resection was in 33 cases. (2) Gene testing and postoperative adjuvant therapy of GIST patients. ① Gene testing. Of 847 patients, 424 underwent genetic testing. The proportion of genetic testing was 1.89%(1/53) in 2011, 9.76%(8/82) in 2012, 8.45%(6/71) in 2013, 15.66%(13/83) in 2014, 50.00%(40/80) in 2015, 55.26%(42/76) in 2016, 73.86%(65/88) in 2017, 68.27%(71/104) in 2018, 80.65%(75/93) in 2019, 88.03%(103/117) in 2020, respectively. Of 424 with genetic testing, 338 cases had KIT mutation, 31 cases had PDGFRA mutation, 55 cases were wild type. ② Adjuvant therapy. Of 847 patients, 253 patients underwent postoperative adjuvant therapy. The proportions of postoperative adjuvant therapy were 8.82%(21/238), 41.78%(89/213), 39.18%(143/365) in patients of low risk, moderate risk, high risk. Of 578 patients with moderate to high risk, the proportion of postoperative adjuvant therapy was 15.15%(5/33) in 2011, 14.71%(10/68)in 2012, 22.45%(11/49) in 2013, 29.09%(16/55) in 2014, 41.38%(24/58) in 2015, 46.15%(24/52) in 2016, 32.81%(21/64)in 2017, 60.00%(45/75) in 2018, 60.42%(29/48) in 2019, 61.84%(47/76) in 2020, respectively. Of 253 patients underwent postoperative adjuvant therapy, 247 cases received imatinib had 6 cases received sunitinib. (3) Comparison of clinicopathological characteristics of GIST with non-gastric origin and gastric origin. Of 847 patients, 262 cases had non-gastric origin and 585 cases had gastric origin. There were significant differences in gender, the number of tumor, tumor maximum diameter, Ki-67 index, risk classification of NIH, and R 0 resection between the two groups ( χ2=8.62, 8.40, 12.97, 6.57, Z=-6.15, χ2=17.19, P<0.05). (4) Analysis of influencing factors for recurrence-free survival rate in GIST patients. Results of multivariate analysis showed that the year of initial diagnosis, primary site, tumor maximum diameter, mitotic image, risk classification of NIH, R 0 resection, genetic testing and postoperative adjuvant therapy were independent factors influencing recurrence-free survival rate in GIST patients with initial surgical resection ( hazard ratio=0.58, 0.61, 2.00, 1.71, 5.81, 2.56, 0.65, 0.38, 95% confidence interval as 0.39-0.85, 0.45-0.83, 1.46-2.74, 1.24-2.35, 3.16-10.69, 1.63-4.02, 0.46-0.94, 0.25-0.56, P<0.05). Conclusions:GIST with initial surgical resection is common located in stomach, with high positive rate in CD117 and Dog-1. The number of people undergoing genetic testing and targeted therapy for GIST is increasing year by year. There are significant differ-ences in clinicopathological characteristics between GIST with non-gastric origin and gastric origin. The year of initial diagnosis, primary site, tumor maximum diameter, mitotic image, risk classifica-tion of NIH, R 0 resection, genetic testing and postoperative adjuvant therapy are independent factors influencing recurrence-free survival rate in GIST patients with initial surgical resection.

Objective:To analyze the expression levels and clinical significance of interferon (IFN)-α/β in the renal cortex and serum of children with lupus nephritis (LN).Methods:A total of 32 children with LN diagnosed in the pediatric nephrology department of the Second Xiangya Hospital of Central South University from December 2017 to September 2020 were selected as the study subjects (LN group). The normal kidney control group consisted of 3 normal kidney transplant volunteers who underwent biopsy of kidney tissue (normal kidney control group), while 14 healthy children who underwent physical examination were collected as the normal control group. According to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), LN patients were divided into mild activity group ( n=8), moderate activity group ( n=9), and severe activity group ( n=15). According to the International Society of Nephrology/Society of Nephrology (ISN/RPS) 2003 LN classification criteria, pathological classification was performed (3 cases in the mild pathological damage group, 8 cases in the moderate pathological damage group, and 11 cases in the severe pathological damage group); Immunohistochemistry was used to detect the expression and distribution of IFN-α/β in glomeruli and renal interstitium; Enzyme linked immunosorbent assay (ELISA) was used to detect the concentration of IFN-α/β in serum samples and analyze its correlation with the pathological classification and disease activity of LN patients. Results:The serum and renal cortex IFN-α/β levels in the LN group were higher than those in the normal control group and normal kidney control group, respectively (all P<0.05). The average level of serum IFN-α/β in the heavy activity group was higher than that in the light and moderate activity groups (all P<0.05). The serum and renal cortex IFN-α/β levels in the severe pathological damage group were significantly higher than those in the mild and moderate pathological damage groups (all P<0.05). Conclusions:IFN-α/β in the renal cortex is closely related to renal injury in LN; Serum IFN-α/β can assist in evaluating the disease activity level of LN to a certain extent.

Inducing durable and effective immunity against severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) via vaccination is essential to combat the current pandemic of coronavirus disease 2019 (COVID-19). It has been noticed that the strength of anti-COVID-19 vaccination-induced immunity fades over time, which calls for an additional vaccination regime, as known as booster immunization, to restore immunity among previously vaccinated populations. Here we report a pilot open-label trial of a third dose of BBIBP-CorV, an inactivated SARS-CoV-2 vaccine (Vero cell), on 136 participants aged between 18 to 63 years. Safety and immunogenicity in terms of neutralizing antibody titers and cytokine/chemokine responses were analyzed as the main endpoint until day 28. While systemic reactogenicity was either absent or mild, SARS-CoV-2-specific neutralizing antibody titers rapidly arose in all participants within 4 weeks, surpassing the peak antibody titers elicited by the initial two-dose immunization regime. Broad increases of cellular immunity-associated cytokines and chemokines were also detected in the majority of participants after the third vaccination. Furthermore, in an exploratory study, a newly developed recombinant protein vaccine, NVSI-06-08 (CHO Cells), was found to be safe and even more effective than BBIBP-CorV in eliciting humoral immune responses in BBIBP-CorV-primed individuals. Together, these results indicate that a third immunization schedule with either homologous or heterologous vaccine showed favorable safety profiles and restored potent SARS-CoV-2-specific immunity, providing support for further trials of booster vaccination in larger populations.
Adolescent ; Adult ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; China ; Humans ; Immunogenicity, Vaccine ; Middle Aged ; SARS-CoV-2 ; Vaccination ; Young Adult

Objective:To investigate the clinical efficacy of radical proximal gastrectomy with esophagogastrostomy and double-tract anastomosis for upper gastric cancer.Methods:The retrospective cohort study was conducted. The clinicopathological data of 172 patients who underwent radical proximal gastrectomy for upper gastric cancer in Tianjin Medical University Cancer Institute and Hospital from January 2018 to December 2020 were collected. There were 147 males and 25 females, aged from 25 to 81 years, with a median age of 62 years. All the 172 patients underwent digestive reconstruction. Of the 172 patients, 83 cases undergoing esophagogastrostomy were allocated into esophagogastrostomy group, 89 cases undergoing double-tract anastomosis were allocated into double-tract anastomosis group. Patients were performed radical proximal gastrectomy combined with D 1+ lymph node dissection by attending surgeons from department of gastric cancer. The operator decided to adopt esophagogastrostomy or double-tract anastomosis for digestive reconstruction. Observation indicators: (1) surgical situations; (2) follow-up. Follow-up using outpatient examination, telephone interview, and online APP was conducted at postoperative 1 month, once three months within postoperative 2 years, and once six months within postoperative 2-5 years. The questionnaires of reflux esophagitis, gastroscopy and upper gastrointestinal angio-graphy were conducted to evaluate gastroesophageal reflux and anastomotic stenosis up to February 1, 2021. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M (range), and comparison between groups was analyzed using the Mann-Whitney U test. Comparison of ordinal data was analyzed using the non-parameter rank sum test. Count data were represented as absolute numbers, and comparison between groups was analyzed using the chi-square test. Results:(1) Surgical situations: cases with open, laparoscopic or Da Vinci robotic surgery (surgical method), the number of metastatic lymph node, duration of postoperative hospital stay were 74, 9, 0, 2(range, 0-15), (12±4)days for the esophagogastrostomy group, versus 65, 15, 9, 3(range, 0-28), (11±3)days for the double-tract anastomosis group, respectively, showing significant differences in the above indicators between the two groups ( χ2=10.887, Z=-1.058, t=3.284, P<0.05). (2) Follow-up: 172 patients were followed up for 2-38 months, with a median follow-up time of 13 months. Cases with gastroesophageal reflux and anastomotic stenosis were 58 and 10 for the esophagogastrostomy group, versus 14 and 1 for the double-tract anastomosis group, respectively, showing significant differences in the above indicators between the two groups ( χ2=51.743, 7.219, P<0.05). Conclusions:For upper gastric cancer patients undergoing proximal radical gastrectomy, double-tract anastomosis is more suitable for Siewert type Ⅱ adenocarcinoma of esophagogastric junction in large curvature or lower located tumor. Compared with esophago-gastrostomy, double-tract anastomosis has lower incidence of postoperative gastroesophageal reflux and anastomotic stenosis, without increasing complications.

Gastrectomy with D2 lymph node dissection has become the global standard procedure for locally advanced gastric cancer. Based on the evidence of the clinic trials, postadjuvant chemotherapy after D2 gastrectomy is the current standard strategy. Neoadjuvant chemotherapy can increase the R0 resection rate, but the consensus has not been reached. These trials could lead to new evidence for improved treatment of gastric cancer in the near future. This review will summarize recent evidence on the benefits of for locally advanced gastric cancer.

Objective: To evaluate the potential clinical value of standardized procedures of fine lymph node sorting from gastric can-cer samples after curative resection. Methods: Between January 2016 and December 2017, 727 gastric cancer patients who under- went R0 resection in the Tianjin Medical University Cancer Institute and Hospital were retrospectively included and assigned to either the fine lymph node sorting group or regional lymph node sorting group in accordance with the lymph node sorting methods from the tumor samples of all patients. Both the numbers of examined lymph nodes and metastatic lymph nodes were compared between the two groups. Additionally, correlation analyses were performed between the numbers of examined lymph nodes and metastatic lymph nodes in the two groups. Results: There was no significant difference in sex, age, or tumor size between the two groups (P>0.05), indi-cating that there was comparability between the two groups. The number of examined lymph nodes in the fine lymph node sorting group was significantly higher than that in the regional lymph node sorting group (P<0.001). Furthermore, the number of examined lymph nodes in the fine lymph node sorting group was much higher than that in the regional lymph node sorting group with the same pT, pN, or pTNM stage (P<0.001). The number of metastatic lymph nodes in the fine lymph node sorting group was significantly higher than that in the regional lymph node sorting group (P<0.001). There was a significant positive correlation between the numbers of ex-amined lymph nodes and metastatic lymph nodes in both groups (fine lymph node sorting group r=0.181, P=0.023; regional lymph node sorting group r=0.227, P<0.001). Additionally, the correlation coefficient between the numbers of examined lymph nodes and metastatic lymph nodes in the fine lymph node sorting group was weaker than that in the regional lymph node sorting group. Conclu-sions: The standard procedures of fine lymph node sorting from tumor samples of gastric cancer may increase the number of exam-ined lymph nodes, accurately provide the postoperative pN stage, reduce the stage migration, and should be applied in clinical stan-dardization.

Objective: To evaluate the impact of perineural invasion (PNI) on the overall survival (OS) of patients with gastric cancer. Methods: A total of 1,007 patients with gastric cancer who underwent curative resection between January 2011 and December 2012 at the Cancer Institute and Hospital of Tianjin Medical University were enrolled. All the patients were categorized into the following two groups according to the status of PNI: positive group, presence of PNI; and negative group, absence of PNI. Potential prognostic factors and clinical pathological variables correlated with the presence of PNI were analyzed. Results: One hundred and twenty (11.9%) patients had PNI. Multivariate analysis revealed that histology, depth of invasion, and lymphovascular invasion were indepen-dently associated with the presence of PNI. Univariate survival analysis revealed that age, tumor location, Borrmann type, tumor size, curability, TNM stage, type of gastrectomy, tumor deposit, lymphovascular invasion, PNI, preoperative CA19-9 levels, and CEA levels were significant prognostic factors. Gastric cancer patients with PNI had a significantly lower 5-year OS rate than those without PNI (5-year OS: 38.3% versus 66.6%, P<0.001). In the multivariate analysis, age, Borrmann typeⅣ, TNM stage, curability, tumor deposit, and PNI were independent prognostic factors for this population cohort. The strata analysis revealed that PNI merely had a significant im-pact on OS in patients at stagesⅠ,Ⅱ, andⅢa. Conclusions: PNI is an independent prognostic factor in patients with gastric cancer and can be used as a prognostic indicator for gastric cancer patients at stagesⅠ,Ⅱ, andⅢa.

Objective To evaluate the diagnostic value of CEA, CA19-9, CA72-4, AFP, and CA125 in gastric stromal tumors. Methods 41 patients with gastric stromal tumors and 11 patients with gastric leiomyoma were recruited in this study from Qilu Hospital of Shandong University during May 2014 to December 2017. The tissue was collected by surgery, and HE staining was done. Immunohistochemistry was employed to detect the expression of CD34, CD117, and DOG-1. Serum of all cases and 41 healthy volunteers in the same hospital were collected. The levels of CEA, CA19-9, CA72-4, AFP and CA125 were examined by electrochemiluminescence assay, and the differences in each group were compared by M-W test or K-W test. Then the relationship between those biomarkers and the clinical parameters of gastric stromal tumors was analyzed. Moreover, AUC (Area Under the curve), cut-off value, sensitivity, specificity, positive predictive value, negative predictive value with drawing ROC curve (receiver operating characteristic curve) were also calculated. Results Spindle cells or epithelioid cells were observed in the tissue of gastric stromal tumors. The expression of CD34, CD117, DOG-1 were positive. The level of the serum CEA 1.53 (1.15, 2.22) ng/ml in patients with gastric stromal tumor patients was higher than that in healthy controls 1.06 (0.62, 1.48) ng/ml and that in patients with gastric leiomyoma 0.79 (0.39, 1.39) ng/ml (the U value was 446.5, and 113.0 respectively, P<0.05). The level of CA19-9 in gastric stromal tumors 9.30 (4.95, 12.70) U/ml was higher than that in healthy controls 6.62 (4.56, 8.82) U/ml (the U value was 615.5, P<0.05). There were no significant differences in AFP, CA125, and CA72-4 of three groups (the H value was 4.348, 1.073, and 3.897, P>0.05). Furthermore, the level of CEA was closely related to TNM stage (the U value was 129.0, P<0.05). The diagnostic value of CEA and CA19-9 was statistically not significant (P>0.05). However, the combination of two markers might increase diagnostic efficiency. The sensitivity, specificity, positive predictive value, negative predictive value and AUC was 92.7％, 48.8％, 64.4％, 87.0％ and 0.752 respectively. Conclusion The combination of CEA and CA19-9 has better sensitivity and negative predictive value in auxiliary diagnosis of gastric stromal tumors.

OBJECTIVE： Te analyze the problems of clinical use in pediatric drug in China， and to put forward related countermeasures and suggestions. METHODS： Using “children” and “pediatrics” as retrieval words， registered drug information were retrieved from the website of China Food and Drug Administration； the data of pediatric drug use prescription was retrieved from hospital prescription system of 9 hospitals； all drug information were retrieved from national drug data management system； off-label drug use investigation and the literatures of pediatric drug use in medical institutions （5 representative third grade general medical institutions） were retrieved from CNKI and Wanfang database. General information and problems of pediatric drug use in China were investigated. RESULTS： A total of 170 009 items of registered drug information were retrieved， including 2 784 drug information items labeled with ”children” or ”pediatrics”， accounting for 1.64％；320 000 drug prescriptions from hospital prescription system of 9 hospitals covered 22 treatment areas involving 1 186 drugs and 51 dosage forms. Only 10％ suitable for children. The retrieval results of database showed that the incidence of children off-label drug use in outpatients prescriptions of 5 hospitals was in high level， mainly manifesting as without the information of pediatric drug use， hyper-indication drug use， hyper-dosage drug use. There were many problems in clinical pediatric drug use in China， such as less variety for children， single dosage form and specification， widespread off-label drug use， lack of scientific reference for drug use， difficulty in developing pediatric drug clinical trials， etc. CONCLUSIONS： Although the policies to protect children’s clinical drug use have been introduced in China， the problems facing children’s clinical drug use in China are still very serious. While further implementing relevant policies， it is necessary to establish a linkage management system led by government departments， with the full participation and mutual cooperation of society， enterprises， medical institutions and patients so as to guaratee the safety of pediatric drug use in clinic.