ObjectiveTo investigate the protective effect of N-(2R,3R,4R,5R,6R-pentahydroxyhexyl)-(N-disubstituted sodium formate)-L-methylthio-glutamate sodium (GMDTC) against cisplatin-induced acute kidney injury (AKI) in rats. Methods Specific pathogen free male adult SD rats were randomly divided into the control group, model group, low-dose group and high-dose group, with eight rats in each group. The rats in the latter three groups were injected with cisplatin at a dose of 4 mg/kg body mass through the tail vein to establish an AKI model, while the control group was not treated. Rats in the low-dose and high-dose groups were injected with injectable GMDTC at doses of 108 and 433 mg/kg body mass through the tail vein, respectively, in two hours after intoxication, while the rats in the model group were injected with an equal volume of 0.9% sodium chloride solution, once per day for five consecutive days. The 24-hours urine platinum level at day 1, 3, 5 and the level of whole blood platinum, serum platinum, urinary platinum and renal platinum at day 6 were determined using the inductively coupled plasma-mass spectrometry after GMDTC administration. Serum renal functional indicators and electrolyte level were detected, and renal histopathology was observed at day 6 after GMDTC administration. Results The levels of serum urea, serum creatinine, serum calcium ion, whole blood platinum, serum platinum and renal platinum, and the score of renal tubular injury in the model group were higher than those in the control group (all P<0.05). The 24-hours urinary platinum level at day 1, 3 and 5 after GMDTC administration in the model group was also higher than those in the control group (all P<0.05), and AKI changes were observed in histopathology. The levels of serum urea, serum creatinine, serum calcium ion, whole blood platinum, serum platinum, renal platinum, and renal tubular injury scores of rats in the low- and high-dose groups decreased compared with that in the model group (all P<0.05). The 24-hour urinary platinum levels on the first day after GMDTC administration of rats in the low- and high-dose groups increased compared with that in the model group (all P<0.05), as well as the renal histopathological changes of AKI were improved. However, there was no significant difference in the above-mentioned indicators between the low- and high-dose groups (all P>0.05). Conclusion GMDTC can promote the elimination of platinum in urine, effectively reduce the platinum level in blood and renal tissues, alleviate the pathological damage of renal tubules in rats, and improve the cisplatin-induced AKI.

Humans ; SARS-CoV-2 ; COVID-19 ; Antibodies ; Antibodies, Viral/therapeutic use* ; Antibodies, Neutralizing/therapeutic use*

Objective:To investigate the factors for serious complications within 30 days after surgery in elderly patients with advanced epithelial ovarian cancer(EOC)who undertook primary debulking surgery(PDS).Methods:The clinical data of International Federation of Gynecology and Obstetrics(FIGO)stage ⅢC/Ⅳ EOC patients aged≥60 years who received PDS in gynecological department of National Cancer Center and National Center of Gerontology between January 2014 and December 2018 were retrospectively analyzed.Clavien-Dindo scoring system was applied to grade the complications within 30 days after surgery.The serious early postoperative complications were those of grade Ⅲ or above occurred within 30 days after surgery.Multivariate Logistic regression analysis was used to screen the independent risk factors of serious complications within 30 days after surgery.Results:A total of 133 patients were included in this study and serious complications rated 11.3%(15/133). The mean age of patients in severe complication group was significantly higher than that in the control group[(69.80±6.56) vs.(65.87±5.14), t=2.699, P=0.008]. The proportion of patients with preoperative ECOG score≥2 was significantly higher in the severe complication group than that in the control group[26.7%(4/15) vs.5.9%(7/118), χ2=4.985, P=0.026], and the proportion of preoperative hypoalbuminemia(<35 g/L)was significantly higher in the severe complication group[20.0%(3/15) vs.3.4%(4/118), χ2=4.897, P=0.027]. However, there was no significant difference in intraoperative bleeding, R0 resection rate as well as surgical complexity( χ2=1.964, 0.330, 4.637, all P>0.05)between the two groups.Multivariate Logistic regression analysis showed that the independent factors for serious early postoperative complications were age≥70 years( OR=4.345, P=0.028), ECOG score≥2( OR=25.619, P=0.008)and preoperative albumin <35 g/L( OR=6.733, P=0.040). Conclusions:In the elderly ovarian cancer patients, individualized perioperative management should be strengthened for the patients with factors associated with serious early postoperative complications, in order to reduce severe complications and improve the prognosis.

Objective:To effectively express the receptor binding domain (RBD) of SARS-CoV-2 spike protein in Pichia pastoris and to evaluate its immunogenicity. Methods:The gene encoding the RBD protein was synthesized and cloned into the pPICZαA plasmid. After linearization, the plasmid was transferred and integrated into the genome of Pichia pastoris. The expressed RBD protein in culture supernatant was analyzed by Western blot and Biolayer interferometry. After screening, a single clone expressing the RBD protein was selected. The high-level expression of RBD protein was achieved by optimizing the fermentation process, including the salt concentration adjusting of the medium and induction condition optimization (pH, temperature and duration). The immunogenicity of the expressed RBD protein was evaluated in a mouse model. Results:A single clone with a high expression level of RBD protein was obtained and named RBD-X33. The expression level of RBD protein in the fermentation supernatant reached up to 240 mg/L after optimization of the induction condition (HBSM medium, pH=6.5±0.3, 22℃ and 120 h). In the mouse experiment, the recombinant RBD protein was formulated with Alum+ CpG dual adjuvant and injected into mice. The binding IgG antibody levels were up to 2.7×10 6 tested by ELISA and the neutralizing antibody levels were up to 726.8 tested by live virus neutralizing antibody assay (prototype). Conclusions:The RBD protein could be efficiently expressed in Pichia pastoris and induce stronger immune response in animals. This study suggested that the recombinant SARS-CoV-2 RBD protein expressed in Pichia pastoris could serve as a candidate antigen in the development of SARS-CoV-2 vaccine.

Objective:To compare the effect of temporal external fixator and digital guide plate in the immediate reconstruction of mandibular defect after segmental mandibulectomy.Methods:The clinical data of all patients who received segmental mandibulectomy and immediate mandibular reconstruction with free vascularized bone graft by a single surgical team in the Department of Oral & Maxillofacial-Head & Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine from August 2016 to December 2017 were retrospectively analyzed. According to different auxiliary methods, the patients were divided into temporal external fixator (TEF) group and computer aided design-manufacture (CAD-CAM) group. The width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were measured by CT before and one month after surgery, and the difference before and after surgery was calculated to evaluate the surgical effect. SPSS 19.0 was used for statistical analysis, and the data were expressed as Mean ± SD. Independent sample t-test was used for comparison of indexes of surgical time and surgical effect evaluation between the two groups, and P<0.05 indicated statistically significant differences. Results:A total of 29 patients were enrolled, including 13 patients in TEF group, 4 males and 9 females, aged (47.7±14.5) years, including 7 ameloblastomas, 2 squamous cell carcinomas, 2 abnormal proliferation of bone fibers, 1 rhabdomyosarcoma and 1 osteosarcoma. In the CAD-CAM group, there were 16 cases, including 11 males and 5 females, aged (42.4±19.7) years, including 10 ameloblastomas, 3 squamous cell carcinomas, 1 osteoblastoma, 1 otogenic fibromyxoma and 1 osteosarcoma. The bone grafts in 29 patients were all alive, the wounds healed primarily, and the occlusal relationship and facial contour of the patients were fine. After 3 years follow-up, there were no postoperative complications and tumor recurrence. The function of the supply area was not affected. The operative time was (7.12±1.40) h in the TEF group and (4.72±1.10) h in the CAD-CAM group, and the difference between the two groups was statistically significant ( P<0.01). In the TEF group, the difference of the width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were (1.08±1.12) mm, (2.08±1.61) mm, (1.77±3.15) mm, respectively; CAD-CAM group were (0.88±1.15) mm, (0.94±1.34) mm, (0.87±1.47) mm, respectively, and there was no statistical significance between the two groups ( P>0.05). Conclusions:It took significantly longer to perform immediate mandibular reconstruction assisted by TEF than that assisted by CAD-CAM in surgery, but both groups achieved better surgical results. It is simpler and more effective to use TEF when time is urgent or technology is too limited to carry out preoperative digital design.

Objective:To translate the Pressure Ulcer Quality of Life Questionnaire (PU-QOL) into Chinese and test its reliability and validity.Methods:The PU-QOL was translated, back translated, cross-cultural debugged and pre-investigated to form the Chinese version of PU-QOL. From August 2020 to November 2021, 405 patients with PU in wound clinics of two third-class hospitals in north and south regions of China were conveniently selected as the research objects.Results:The Chinese version of PU-QOL had 74 items. The content validity of the items was 0.80 to 1.00 and the content validity of the scale level was 0.95. Exploratory factor analysis extracted 7 common factors and the cumulative variance contribution rate was 60.79%. Each problem area is moderately correlated with the 12-Item Short Form Survey (SF-12), and the correlation coefficient between each dimension (0.13-0.28) was less than the correlation coefficient between each dimension and the total score of the scale and the difference was statistically significant( P<0.01). The Cronbach′s α coefficient was 0.84 and the retest reliability was 0.92. Conclusions:The Chinese version of PU-QOL questionnaire was proved to be a good instrument with acceptable reliability and validity, which can be used as a tool for evaluating quality of life of patients with PU in China.

Objective:To study the morphologic features of the fusion site of proximal tibial epiphysis in normal adults and analyze its potential clinical value based on Mimics three-dimensional (3D) reconstruction.Methods:CT images of knee joint of 68 patients without obvious abnormalities of lower limbs were retrospectively analyzed in electronic database of our hospital from June 2020 to June 2021, including 41 males and 27 females. The mean age of the patients was 38.7±8.4 years (range, 25-55 years), and the mean body mass index (BMI) was 25.3±4.0 kg/m 2 (range, 18.75-41.8 kg/m 2). Mimics 3D reconstruction technique was used to reconstruct the 3D model of the proximal tibia and epiphyseal fusion site. The relationship between the surface area of epiphyseal fusion site and age and BMI was studied, and the changes of cortical thickness and density at epiphyseal fusion site were also explored. Results:The fusion site of adult epiphyseal reconstructed by Mimics 3D reconstruction is a complex wavy surface structure in 3D space. The surface area of the epiphyseal fusion site was 2,994.7±645.3 mm 2 (range, 1,704.0-4,650.0 mm 2) obtained by 3-Matic Research 12.0. The fusing area of male epiphysis was 3 269.3±533.9 mm 2 than that of female 2,577.6±578.7 mm 2, the difference was statistically significant ( t=5.06, P<0.001). However, there was no significant correlation between the epiphyseal fusion site surface area and age ( R2=0.02, P=0.268) and BMI ( R2=0.04, P=0.125). Mimics software was used to obtain the CT values of bone cortex at the epiphysis line and the distal end of the epiphysis line at 10 mm and 20 mm levels as 451.059±74.953 Hu, 1,018.412±125.732 Hu and 1,414.162±107.848 Hu, respectively. The thickness of bone cortex was 1.814±0.090 mm, 2.511±0.089 mm and 3.189±0.185 mm at 10 mm and 20 mm layers of epiphysis line and distal epiphysis line, respectively. Conclusion:In this study, Mimics 3D reconstruction technique was used to visualize the fusion site of the proximal tibial epiphysis in normal adults. The epiphyseal fusion site of adult is a undulating plate-like structure, and the cortical bone density of epiphyseal fusion site is low and thin, theoretically, it is easy to fracture under indirect violence.

Objective:To compare the effect of temporal external fixator and digital guide plate in the immediate reconstruction of mandibular defect after segmental mandibulectomy.Methods:The clinical data of all patients who received segmental mandibulectomy and immediate mandibular reconstruction with free vascularized bone graft by a single surgical team in the Department of Oral & Maxillofacial-Head & Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine from August 2016 to December 2017 were retrospectively analyzed. According to different auxiliary methods, the patients were divided into temporal external fixator (TEF) group and computer aided design-manufacture (CAD-CAM) group. The width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were measured by CT before and one month after surgery, and the difference before and after surgery was calculated to evaluate the surgical effect. SPSS 19.0 was used for statistical analysis, and the data were expressed as Mean ± SD. Independent sample t-test was used for comparison of indexes of surgical time and surgical effect evaluation between the two groups, and P<0.05 indicated statistically significant differences. Results:A total of 29 patients were enrolled, including 13 patients in TEF group, 4 males and 9 females, aged (47.7±14.5) years, including 7 ameloblastomas, 2 squamous cell carcinomas, 2 abnormal proliferation of bone fibers, 1 rhabdomyosarcoma and 1 osteosarcoma. In the CAD-CAM group, there were 16 cases, including 11 males and 5 females, aged (42.4±19.7) years, including 10 ameloblastomas, 3 squamous cell carcinomas, 1 osteoblastoma, 1 otogenic fibromyxoma and 1 osteosarcoma. The bone grafts in 29 patients were all alive, the wounds healed primarily, and the occlusal relationship and facial contour of the patients were fine. After 3 years follow-up, there were no postoperative complications and tumor recurrence. The function of the supply area was not affected. The operative time was (7.12±1.40) h in the TEF group and (4.72±1.10) h in the CAD-CAM group, and the difference between the two groups was statistically significant ( P<0.01). In the TEF group, the difference of the width of mandible, length of mandibular body and vertical dimension of inferior 1/3 face were (1.08±1.12) mm, (2.08±1.61) mm, (1.77±3.15) mm, respectively; CAD-CAM group were (0.88±1.15) mm, (0.94±1.34) mm, (0.87±1.47) mm, respectively, and there was no statistical significance between the two groups ( P>0.05). Conclusions:It took significantly longer to perform immediate mandibular reconstruction assisted by TEF than that assisted by CAD-CAM in surgery, but both groups achieved better surgical results. It is simpler and more effective to use TEF when time is urgent or technology is too limited to carry out preoperative digital design.

Objective:To assess the therapeutic efficacy and safety of the gemcitabine combined with nedaplatin (GN) chemotherapy for metastatic human epidermal growth factor receptor-2 (HER-2) negative breast cancer patients.Methods:Forty-five patients with HER-2 negative recurrent metastatic breast cancer who had received prior adjuvant or neoadjuvant therapy with anthracycline and/or taxanes were enrolled. All the patients received GN regime from January 2014 to February 2019. The therapeutic efficacy was evaluated according to response evaluation criteria in solid tumors (RECIST) 1.1. The adverse response was evaluated and monitored according to common terminology criteria for adverse events (CTCAE). The progression-free survival (PFS) and overall survival (OS) and prognostic factors were also analyzed.Results:All of the 45 patients received 4 course GN, 1 of them achieved complete response, 21 achieved partial response. The objective response rate was 48.9 (95% CI: 33.7%-64.1%). Grade 3-4 hematological toxicities include leukopenia occurred in 10 (22.2%) of patients, neutropenia in 13 (28.9%) patients, and thrombocytopenia in 8 (17.6%) patients. The grade 3-4 hematological toxicities mainly manifested as nausea and vomiting, and the incidence was 4.4% (2/45). Among the 45 patients, 34 died, the median PFS was 5.1 (95% CI: 3.9-6.1) months and the median OS was 17.6 (95% CI: 13.1-20.9) months. Conclusion:The combination of gemcitabine and nedaplatin is an effective and tolerable treatment for metastatic breast cancer patients previously treated with anthracyclines and/or taxanes.

Objective:To assess the therapeutic efficacy and safety of the gemcitabine combined with nedaplatin (GN) chemotherapy for metastatic human epidermal growth factor receptor-2 (HER-2) negative breast cancer patients.Methods:Forty-five patients with HER-2 negative recurrent metastatic breast cancer who had received prior adjuvant or neoadjuvant therapy with anthracycline and/or taxanes were enrolled. All the patients received GN regime from January 2014 to February 2019. The therapeutic efficacy was evaluated according to response evaluation criteria in solid tumors (RECIST) 1.1. The adverse response was evaluated and monitored according to common terminology criteria for adverse events (CTCAE). The progression-free survival (PFS) and overall survival (OS) and prognostic factors were also analyzed.Results:All of the 45 patients received 4 course GN, 1 of them achieved complete response, 21 achieved partial response. The objective response rate was 48.9 (95% CI: 33.7%-64.1%). Grade 3-4 hematological toxicities include leukopenia occurred in 10 (22.2%) of patients, neutropenia in 13 (28.9%) patients, and thrombocytopenia in 8 (17.6%) patients. The grade 3-4 hematological toxicities mainly manifested as nausea and vomiting, and the incidence was 4.4% (2/45). Among the 45 patients, 34 died, the median PFS was 5.1 (95% CI: 3.9-6.1) months and the median OS was 17.6 (95% CI: 13.1-20.9) months. Conclusion:The combination of gemcitabine and nedaplatin is an effective and tolerable treatment for metastatic breast cancer patients previously treated with anthracyclines and/or taxanes.