Clinical efficacy of da Vinci Xi surgical system assisted programmed six-hole method anterior resection of rectal cancer / 中华消化外科杂志

Objective:To investigate the clinical efficacy of da Vinci Xi surgical system assisted programmed six-hole method anterior resection of rectal cancer.Methods:The retrospec-tive cohort study was conducted. The clinicopathological data of 102 patients with middle and low rectal cancer who were admitted to the Affiliated Hospital of Xuzhou Medical University from August 2020 to June 2021 were collected. There were 62 males and 40 females, aged (53±12)years. Of the 102 patients, 51 cases undergoing da Vinci Xi surgical system assisted programmed six-hole method anterior resection of rectal cancer were divided into the robotic group and 51 cases undergoing laparoscopic anterior resection of rectal cancer were divided into the laparoscopic group. Observa-tion indicators: (1) treatment; (2) postoperative pathological examination; (3) follow-up. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Repeated measurement data were analyzed using the repeated ANOVA. Results:(1) Treatment. All patients of the two groups under-went radical resection of rectal cancer successfully, and none of patient with intraoperative blood transfusion, conversion to open surgery, and death within 30 days after surgery. The operation time, volume of intraoperative blood loss, number of lymph nodes dissected, time to postoperative first flatus, time to postoperative first liquid food intake, time to postoperative catheter removal, cases with postoperative pain grading as grade 1, grade 2, grade 3, grade 4, cost of treatment were (170±12)minutes, (73±50)mL, 23±6, (35.1±9.4)hours, (2.1±0.8)days, (2.9±2.7)days, 13, 15, 17, 6, (7.1±4.5) ten thousand yuan in patients of the robotic group, versus (153±22)minutes, (119±66) mL, 15±4, (40.7±1.9)hours, (2.9±0.4)days, (5.3±2.1)days, 6, 7, 26, 12, (6.7±1.6) ten thousand yuan in patients of the laparoscopic group, showing significant differences in the above indicators between the two groups ( t=6.79, -4.46,20.09, -3.01, -5.54, -16.69, Z=-2.87, t=4.22, P<0.05). (2) Postoperative patho-logical examination. The tumor diameter, length of specimen resected, distance of upper resection margin to tumor, distance of lower resection margin to tumor, cases with mesorectal specimens as integrity and mostly integrity, cases with tumor differentiation as high differentiation, moderate differentiation, low differentiation, cases with postoperative TNM staging as stage Ⅰ, stage Ⅱ, stage Ⅲ were (3.8±1.1)cm, (18.7±3.2)cm, (11.8±3.6)cm, (2.7±0.8)cm, 48, 3, 4, 41, 6, 6, 17, 28 in patients of the robotic group, versus (3.7±1.0)cm, (18.3±2.8)cm, (10.2±2.7)cm, (2.5±0.6)cm, 46, 5, 6, 39, 6, 5,20, 26 in patients of the laparoscopic group, showing no significant difference in the above indicators between the two groups ( t=1.72, 1.29, 1.64, 1.11, χ2=0.14, Z=-0.42, -0.26, P>0.05). Cases with positive circumferential margin and cases with destruction of mesentery was 0 and 0 in patients of the robotic group, versus 1 and 1 in patients of the laparoscopic group, showing no significant difference in the above indicators between the two groups ( P>0.05). (3) Follow-up. All patients in the two groups were followed up for 12 months after surgery and none of patient had postoperative local recurrence and distant metastasis of tumors. The anal incontinence score, low anterior resection syndrome score, international prostate symptom score, night urination score, international index of erectile score, female sexual function index score in patients of the robotic group were 0, 12.25±1.08, 4.43±0.33, 0.49±0.09, 24.07±2.75, 65.84±1.79 before surgery and 1.34±0.11, 18.11±3.54, 4.03±0.26, 1.08±0.28, 22.63±2.03, 38.57±6.13 at postoperative 12 months, respectively. The above indicators in patients of the laparoscopic group were 0, 12.60±1.11, 4.56±0.36, 0.46±0.07, 23.11±2.77, 66.31±1.73 before surgery and 1.99±1.33,20.85±6.19, 6.43±1.78, 2.27±0.23, 21.00±2.73, 27.62±8.20 at postoperative 12 months, respectively. There were significant differences in the above indicators between the two groups ( P<0.05). Conclusions:The oncological effects of da Vinci Xi surgical system assisted programmed six-hole method anterior resection of rectal cancer and lapa-roscopic anterior resection of rectal cancer are comparable. However, robotic surgery is superior to laparoscopic surgery in terms of intraoperative bleeding, lymph node dissection, gastrointestinal function recovery, and pelvic autonomic nerve protection.

Diagnosis and treatment of internal hernia after laparoscopic surgery for gastric cancer / 中华消化外科杂志

With the development of laparoscopic surgery for gastric cancer, more and more surgeons use laparoscopic techniques and even totally laparoscopic techniques in gastric cancer surgery. However, technological progress brings not only smaller trauma, but also new problems and risks. Compared with traditional open surgery, the high incidence of internal hernia after laparoscopic gastric cancer surgery is an urgent problem to be solved. As the incidence of internal hernia often occurs after discharge, patients usually choose the nearest hospital for diagnosis and treatment due to the urgent course of disease. As a result, patients with internal hernia often have serious complications due to delayed treatment because of the difficulty in diagnosis. Sometimes, there are patients even death. The authors review the relevant research on postoperative internal hernia of gastric cancer in recent years and combine with practical experience to discuss the diagnosis and treatment strategy of internal hernia after laparoscopic surgery for gastric cancer, aiming to improve the clinicians′ attention to the disease and provide reference for its diagnosis and treatment.

Application value of short-term prehabilitation in elderly patients undergoing gastrointestinal tumor surgery / 中国实用护理杂志

Objective:To explore the effectiveness of short-term prehabilitation in elderly patients undergoing gastrointestinal tumor surgery.Methods:Elderly patients(139 cases) with gastrointestinal tumors who were admitted to Nanfang Hospital, Southern Medical University for surgery from December 2020 to January 2022 were included through the purposive sampling method, and were divided into the intervention group (69 cases) and the control group (70 cases) according to the patient's wishes using a quasi-experimental research design of non randomized grouped. Routine perioperative nursing was used in the control group, while the short-term prehabilitation was used in the intervention group in addition. The incidence of postoperative complications, the performance indicators, and postoperative functional recovery indicators were analyzed in the two groups.Results:The 6MWD in the intervention group of 1 day and 7 days after the surgery were (460.93 ± 76.36) m and (391.72 ± 72.93) m, which were significant higher than those in the control group, (423.69 ± 72.88) m and (351.13 ± 65.04) m ( t = 8.65, 12.01, both P<0.05). The first exhaust time, first postoperative ambulatory time, the first full fluid intake time and the duration of drainage tube indwelling in the intervention group were (51.28 ± 21.74) h, (33.93 ± 12.50) h, (69.39 ± 29.36) h and (4.30 ± 1.44) d, which were significant lower than those in the control group, (71.51 ± 23.68) h, (47.37 ± 14.58) h, (96.29 ± 38.36) h and (5.35 ± 2.09) d ( t values were -5.83 - -3.44, all P<0.05). Besides, the best critical value of preoperative 6MWD to predict postoperative rehabilitation effect was 477.5 m, with a sensitivity of 68% and specificity of 71%. Conclusions:Short-term prehabilitation improves the perioperative functional reserve and promotes overall functional recovery after surgery to a certain extent, and the postoperative functional recovery effect may be better when the patient′s preoperative 6MWD reaches 477.5 m.

Biomechanical Study on Contiguous Three-Level Cervical Hybrid Surgery and Anterior Cervical Discectomy and Fusion / 医用生物力学

Objective To compare the biomechanical effects of contiguous three-level cervical Hybrid surgery[anterior cervical discectomy and fusion (ACDF) + cervical disc arthroplasty ( CDA)] and three-level ACDF. Methods The finite element model of C1-T1 cervical-thoracic spine was developed based on CT data. Three models were simulated by the implantation of Prestige LP and Zero-P prostheses, including two Hybrid models (AFA, Prestige LP implanted at C3-4 and C5-6 segments and Zero-P implanted at C4-5 segment; FAF, Zero-P implanted at C3-4 and C5-6 segments and Prestige LP implanted at C4-5 segment) and three-level ACDF model(FFF). The changes in range of motion (ROM) of adjacent levels during flexion, extension, lateral bending and axial rotation, the overall ROM, as well as the intradiscal pressure ( IDP) and facet contact force ( FCF) of adjacent levels were compared. Results The ROM in adjacent levels and the overall ROM of the AFA modelwere closer to the intact model, and the maximum increases in the ROM of the adjacent levels for the FAF and FFF models were 15. 0% and 23. 4% , respectively. For AFA, FAF and FFF models, the maximum increases in the maximum IDP of adjacent levels were 19. 0% , 66. 7% , 147. 6% , and the maximum increases in FCF were 17. 4% , 55. 7% , 80. 1% , respectively. Conclusions This study provides biomechanical basis for three-level cervical Hybrid surgery in treating patients with the contiguous three-level cervical degenerative disc disease.

Effects of cadmium chloride on testicular autophagy and blood-testis barrier integrity in prepubertal male rats / 中华劳动卫生职业病杂志

Objective: To study the effects of cadmium chloride (CdCl(2)) exposure on testicular autophagy levels and blood-testis barrier integrity in prepubertal male SD rats and testicular sertoli (TM4) cells. Methods: In July 2021, 9 4-week-old male SD rats were randomly divided into 3 groups: control group (normal saline), low dose group (1 mg/kg·bw CdCl(2)) and high dose group (2 mg/kg·bw CdCl(2)), and were exposed with CdCl(2) by intrabitoneal injection. 24 h later, HE staining was used to observe the morphological changes of testis of rats, biological tracer was used to observe the integrity of blood-testis barrier, and the expression levels of microtubule-associated protein light chain 3 (LC3) -Ⅰ and LC3-Ⅱ in testicular tissue were detected. TM4 cells were treated with 0, 2.5, 5.0 and 10.0 μmol/L CdCl(2) for 24 h to detect the toxic effect of cadmium. The cells were divided into blank group (no exposure), exposure group (10.0 μmol/L CdCl(2)), experimental group[10.0 μmol/L CdCl(2)+60.0 μmol/L 3-methyladenine (3-MA) ] and inhibitor group (60.0 μmol/L 3-MA). After 24 h of treatment, Western blot analysis was used to detect the expression levels of LC3-Ⅱ, ubiquitin binding protein p62, tight junction protein ZO-1 and adhesion junction protein N-cadherin. Results: The morphology and structure of testicular tissue in the high dose group were obvious changed, including uneven distribution of seminiferous tubules, irregular shape, thinning of seminiferous epithelium, loose structure, disordered arrangement of cells, abnormal deep staining of nuclei and vacuoles of Sertoli cells. The results of biological tracer method showed that the integrity of blood-testis barrier was damaged in the low and high dose group. Western blot results showed that compared with control group, the expression levels of LC3-Ⅱ in testicular tissue of rats in low and high dose groups were increased, the differences were statistically significant (P<0.05). Compared with the 0 μmol/L, after exposure to 5.0, 10.0 μmol/L CdCl(2), the expression levels of ZO-1 and N-cadherin in TM4 cells were significantly decreased, and the expression level of p62 and LC3-Ⅱ/LC3-Ⅰ were significantly increased, the differences were statistically significant (P<0.05). Compared with the exposure group, the relative expression level of p62 and LC3-Ⅱ/LC3-Ⅰ in TM4 cells of the experimental group were significantly decreased, while the relative expression levels of ZO-1 and N-cadherin were significantly increased, the differences were statistically significant (P<0.05) . Conclusion: The mechanism of the toxic effect of cadmium on the reproductive system of male SD rats may be related to the effect of the autophagy level of testicular tissue and the destruction of the blood-testis barrier integrity.

Ambient dose equivalent in 99mTcO4- single photon emission computed tomography of the thyroid among patients with hyperthyroidism / 预防医学

Objective@#To investigate the changes of ambient dose equivalent rate in 99mTcO4- single photon emission computed tomography (SPECT) of the thyroid among patients with hyperthyroidism, so as to provide insights into radiation protection guidance.@*Methods@#Patients with hyperthyroidism who underwent 99mTcO4- SPECT of the thyroid in a tertiary hospital were enrolled. The ambient dose equivalent rate was measured at different time points following 99mTcO4- infection and at sites with different distances from patients' neck, and the effects of time post-injection, distance from patients' neck, 24-hour thyroidal radioiodine uptake and thyroid weight on the ambient dose equivalent rate were examined using a generalized linear mixed model.@*Results@#Totally 100 patients with hyperthyroidism were enrolled, including 24 men and 76 women and with a mean age of (38.5±14.0) years. The generalized linear mixed model was statistically significant (F=6 610.165, P<0.001), and patients' thyroid weight, time post-injection and distance from patients' neck significantly affected the ambient dose equivalent rate (F=57.967, 15 988.574, 11 200.645, all P<0.001), and the ambient dose equivalent rate positively correlated with patients' thyroid weight and negatively correlated with time post-injection and distance from patients' neck.@*Conclusions@#The ambient dose equivalent rate is affected by patients' thyroid weight, time post-injection and distance from patients' neck among patients with hyperthyroidism undergoing 99mTcO4- SPECT of the thyroid. Delay in contact with patients or keeping distance from patients may be effective for radiation protection.

Association Between Ferroptosis and Central Nervous System Diseases and A Review of Traditional Chinese Medicine Intervention / 中国实验方剂学杂志

Central nervous system （CNS） is a sophisticated system subject to complex regulation， which dominates the high-level neural activities of the human body. Due to its complex physiological structure and refined regulatory mechanism covering a variety of diseases， CNS is the place where many chronic， refractory and rare diseases occur. Nerve cell is the basic unit of CNS， and its dysfunction and death is the root cause of CNS diseases. Ferroptosis is a new form of programmed cell death proposed in recent years， and has been proved to be closely related to the production and development of multiple CNS diseases. Traditional Chinese medicine （TCM）， including Chinese herbs， acupuncture and moxibustion， and massage， has shown unique advantages in the treatment of CNS diseases for a long time. A large number of studies have demonstrated that TCM participates in the regulation of CNS diseases via regulating ferroptosis and shows a good research prospect. This paper summarized the characteristics of ferroptosis and discussed the association between ferroptosis and CNS diseases in pathological mechanism. We also reviewed the regulation of various CNS diseases by different TCM interventions through ferroptosis， providing references for TCM to participate in the treatment of CNS diseases properly in the future.

Platelet RNA enables accurate detection of ovarian cancer: an intercontinental, biomarker identification study

Platelets are reprogrammed by cancer via a process called education, which favors cancer development. The transcriptional profile of tumor-educated platelets (TEPs) is skewed and therefore practicable for cancer detection. This intercontinental, hospital-based, diagnostic study included 761 treatment-naïve inpatients with histologically confirmed adnexal masses and 167 healthy controls from nine medical centers (China, n = 3; Netherlands, n = 5; Poland, n = 1) between September 2016 and May 2019. The main outcomes were the performance of TEPs and their combination with CA125 in two Chinese (VC1 and VC2) and the European (VC3) validation cohorts collectively and independently. Exploratory outcome was the value of TEPs in public pan-cancer platelet transcriptome datasets. The AUCs for TEPs in the combined validation cohort, VC1, VC2, and VC3 were 0.918 (95% CI 0.889-0.948), 0.923 (0.855-0.990), 0.918 (0.872-0.963), and 0.887 (0.813-0.960), respectively. Combination of TEPs and CA125 demonstrated an AUC of 0.922 (0.889-0.955) in the combined validation cohort; 0.955 (0.912-0.997) in VC1; 0.939 (0.901-0.977) in VC2; 0.917 (0.824-1.000) in VC3. For subgroup analysis, TEPs exhibited an AUC of 0.858, 0.859, and 0.920 to detect early-stage, borderline, non-epithelial diseases and 0.899 to discriminate ovarian cancer from endometriosis. TEPs had robustness, compatibility, and universality for preoperative diagnosis of ovarian cancer since it withstood validations in populations of different ethnicities, heterogeneous histological subtypes, and early-stage ovarian cancer. However, these observations warrant prospective validations in a larger population before clinical utilities.

Advances in stem cell transplantation for traumatic spinal cord injury at different stages / 中国修复重建外科杂志

OBJECTIVE@#To summarize the research progress of stem cell transplantation in treating spinal cord injury (SCI) at different stages based on the pathophysiological mechanism of SCI.@*METHODS@#The relevant research literature at home and abroad was extensively reviewed to explore the impact of transplantation timing on the effectiveness of stem cell transplantation in treating SCI.@*RESULTS@#Researchers performed different types of stem cell transplantation for subjects at different stages of SCI through different transplantation approaches. Clinical trials have proved the safety and feasibility of stem cell transplantation at acute, subacute, and chronic stages, which can alleviate inflammation at the injured site and restore the function of the damaged nerve cells. But the reliable clinical trials comparing the effectiveness of stem cell transplantation at different stages of SCI are still lacking.@*CONCLUSION@#Stem cell transplantation has a good prospect in treating SCI. In the future, the multi-center, large sample randomized controlled clinical trials are needed, with a focus on the long-term effectiveness of stem cell transplantation.

Mode establishment and preliminary clinical application of anterior cervical surgery in outpatient setting / 中国修复重建外科杂志

OBJECTIVE@#To establish the mode of anterior cervical surgery in outpatient setting, and evaluate its preliminary effectiveness.@*METHODS@#A clinical data of patients who underwent anterior cervical surgery between January 2022 and September 2022 and met the selection criteria was retrospectively analyzed. The surgeries were performed in outpatient setting ( n=35, outpatient setting group) or in inpatient setting ( n=35, inpatient setting group). There was no significant difference between the two groups ( P>0.05) in age, gender, body mass index, smoking, history of alcohol drinking, disease type, the number of surgical levels, operation mode, as well as preoperative Japanese Orthopaedic Association (JOA) score, visual analogue scale score of neck pain (VAS-neck), and visual analogue scale score of upper limb pain (VAS-arm). The operation time, intraoperative blood loss, total hospital stay, postoperative hospital stay, and hospital expenses of the two groups were recorded; JOA score, VAS-neck score, and VAS-arm score were recorded before and immediately after operation, and the differences of the above indexes between pre- and post-operation were calculated. Before discharge, the patient was asked to score satisfaction with a score of 1-10.@*RESULTS@#The total hospital stay, postoperative hospital stay, and hospital expenses were significantly lower in the outpatient setting group than in the inpatient setting group ( P<0.05). The satisfaction of patients was significantly higher in the outpatient setting group than in the inpatient setting group ( P<0.05). There was no significant difference between the two groups in operation time and intraoperative blood loss ( P>0.05). The JOA score, VAS-neck score, and VAS-arm score of the two groups significantly improved at immediate after operation when compared with those before operation ( P<0.05). There was no significant difference in the improvement of the above scores between the two groups ( P>0.05). The patients were followed up (6.67±1.04) months in the outpatient setting group and (5.95±1.90) months in the inpatient setting group, with no significant difference ( t=0.089, P=0.929). No surgical complications, such as delayed hematoma, delayed infection, delayed neurological damage, and esophageal fistula, occurred in the two groups.@*CONCLUSION@#The safety and efficiency of anterior cervical surgery performed in outpatient setting were comparable to that performed in inpatient setting. Outpatient surgery mode can significantly shorten the postoperative hospital stay, reduce hospital expenses, and improve the patients' medical experience. The key points of the outpatient mode of anterior cervical surgery are minimizing damage, complete hemostasis, no drainage placement, and fine perioperative management.

Effectiveness validation of a novel comprehensive classification for intertrochanteric fractures / 中国修复重建外科杂志

OBJECTIVE@#To validate the effectiveness of a novel comprehensive classification for intertrochanteric fracture (ITF).@*METHODS@#The study included 616 patients with ITF, including 279 males (45.29%) and 337 females (54.71%); the age ranged from 23 to 100 years, with an average of 72.5 years. Two orthopaedic residents (observers Ⅰ and Ⅱ) and two senior orthopaedic surgeons (observers Ⅲ and Ⅳ) were selected to classify the CT imaging data of 616 patients in a random order by using the AO/Orthopaedic Trauma Association (AO/OTA) classification of 1996/2007 edition, the AO/OTA classification of 2018 edition, and the novel comprehensive classification method at an interval of 1 month. Kappa consistency test was used to evaluate the intra-observer and inter-observer consistency of the three ITF classification systems.@*RESULTS@#The inter-observer consistency of the three classification systems evaluated by 4 observers twice showed that the 3 classification systems had strong inter-observer consistency. Among them, the κ value of the novel comprehensive classification was higher than that of the AO/OTA classification of 1996/2007 edition and 2018 edition, and the experience of observers had a certain impact on the classification results, and the inter-observer consistency of orthopaedic residents was slightly better than that of senior orthopaedic surgeons. The intra-observer consistency of two evaluations of three classification systems by 4 observers showed that the consistency of the novel comprehensive classification was better for the other 3 observers, except that the consistency of observer Ⅳ in the AO/OTA classification of 2018 version was slightly higher than that of the novel comprehensive classification. The results showed that the novel comprehensive classification has higher repeatability, and the intra-observer consistency of senior orthopaedic surgeons was better than that of orthopaedic residents.@*CONCLUSION@#The novel comprehensive classification system has good intra- and inter-observer consistency, and has high validity in the classification of CT images of ITF patients; the experience of observers has a certain impact on the results of the three classification systems, and those with more experiences have higher intra-observer consistency.

Empirical analysis on lumbar disc herniation treated with "sinew-bone three needling technique" of Chinese medicine / 中国针灸

The paper presents professor WU Han-qing's experience in treatment of lumbar disc herniation (LDH) with "sinew-bone three needling technique" of Chinese medicine. Based on the theory of meridian sinew, the points are located by "three-pass method" in terms of the distribution of meridian sinew and syndrome/pattern differentiation. The cord-like muscles and adhesion are relieved by relaxing technique to work directly on the affected sites and alleviate the local compression to the nerve root. The needle technique is operated flexibly according to the affected regions involved, due to which, the needling sensation is increased while the safety ensured. As a result, the meridian qi is enhanced, the mind and qi circulation is regulated; and the clinical effect is improved.

Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

BACKGROUND@#LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.@*METHODS@#We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.@*RESULTS@#On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).@*CONCLUSION@#LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT04563936.

Factors influencing mechanical properties of clear aligners and research progress / 口腔医学

@#In recent years, clear aligner technology has been maturing and is rapidly gaining popularity in the orthodontic market for its aesthetic and removable properties. However, despite the background of its large-scale clinical application, mechanical properties of clear aligners need to be studied in depth. This paper reviews the factors influencing mechanical properties of clear aligners and the current status of research to provide evidence-based guidance for clinical application.

The PK bioanalysis method study of c-Met antibody-drug conjugate (RC108) in cynomolgus monkey / 药学学报

Antibody-drug conjugate (ADC) has the characteristics of low toxicity and high efficiency, and plays an important role in cancer treatment. However, due to the complexity of its structure, it brings difficulties in pharmacokinetic (PK) bioanalysis. This study established an analytical method for the detection of ADC (RC108) in cynomolgus monkey plasma by ligand-binding assay (LBA) and liquid chromatography tandem mass spectrometry (LC-MS/MS), which was used to analyze and quantify the total antibody, bound antibody and free drug in cynomolgus monkey plasma. Based on the LBA method, rabbit anti-RC108 Fab and mouse anti-MMAE (monomethyl auristatin E) mAb were pre-coated in 96-well plates as the total antibody and antibody binding reagents, respectively. The samples to be tested were added, and then the detection reagents were added in turn. Goat anti-human IgG (H+L)-HRP, chromogenic solution tetramethylbenzidine (TMB), H2SO4 terminate the reaction, read data at 450 nm/630 nm wavelength of microplate reader; LC-MS/MS analysis method quantifies MMAE concentration, and refer to relevant regulations for methodological validation. The analytical method for quantifying total antibody, bound antibody and free drug of RC108 drug obtained good accuracy and precision, and the selectivity, dilution linearity, hook effect, parallelism and stability were verified. Meet the requirements of biological analysis. Finally, a bioanalytical method for the determination of the concentration of the test substance RC108 (total antibody, conjugated antibody, free MMAE) in cynomolgus monkey plasma with high sensitivity and high throughput was established by LBA and LC-MS/MS method. Subsequent non-clinical research on PK research in cynomolgus monkeys will provide technical support.

Herbal Textual Research on Acanthopanacis Cortex in Famous Classical Formulas / 中国实验方剂学杂志

Through the textual research and analysis of ancient and modern documents of Acanthopanacis Cortex（AC）， this paper combed the variety， origin， harvesting， processing and ancient quality evaluation methods of AC， and clarified the historical context of the mixing of its common counterfeit product（Periplocae Cortex）， in order to provide a basis for the development of famous classical formulas containing AC. AC was first published in Shennong Bencaojing with the name of Wujia， Wujiapi is the name rectification in all dynasties since Leigong Paozhilun. According to the description of inflorescence location and fruit morphology of Wujia in the materia medica， it is judged that the mainstream origin of AC used in previous dynasties was Acanthopanax gracilistylus. Periplocae Cortex was mixed with AC in the period of the Republic of China because it was in line with the "like Lycii Cortex， light， brittle and fragrant". The origin of Wujiapi recorded in past dynasties was concentrated in the middle and lower reaches of the Yangtze River， mainly in Hubei， Henan， Anhui and other places. Since modern times， the traditional quality evaluation of AC has been gradually summarized， with thick skin， white color and fragrant smell as the best. The traditional harvesting and processing of AC involved picking the stems in May and July of the lunar calendar， picking the roots in October， and drying in the shade. In modern times， the roots of AC are harvested， washed， peeled and dried in summer and autumn. In the past dynasties， there were rice wine processing， Euodiae Fructus boiling， ginger juice processing and other methods. In modern times， it is usually cut into thick slices after the cleansing. According to the research results， it is suggested that the root bark of A. gracilistylus should be selected as the origin of AC in famous classical formulas， which should be processed into the medicine according to the specific prescription requirements. In addition， it is suggested to restore the medicinal name of Periplocae Cortex as Yangtao， in order to reduce its chaotic influence on the medicinal use of AC.

Herbal Textual Research on Moslae Herba in Famous Classical Formulas / 中国实验方剂学杂志

Through the textual research and analysis of the variety， origin， processing， quality evaluation and clinical application of Moslae Herba in ancient and modern literature， its origin of materia medica was clarified. Moslae Herba has experienced variety changes in history. Elsholtzia ciliata was the mainstream variety during and before the Song dynasty， however， during the Ming and Qing dynasties， emerging variety of Mosla chinensis rose to the mainstream status due to its remarkable efficacy and the formation of cultivation， and differentiated into two commodities（wild variety of Qingxiangru and cultivated variety of Jiangxiangru）， cultivated products formed an authentic producing area in Jiangxi. The three varieties coexisted during the Ming and Qing dynasties， and the Elsholtzia varieties were gradually eliminated. Variety changes have caused changes in the functions and indications of drugs. E. ciliata had the effect of clearing heat and was mainly used to treat heatstroke and cholera， while M. chinensis was used for exogenous wind cold and dampness in the summer because of its warm and strong sweating properties， but not for cholera. Traditional Moslae Herba is mainly harvested in the summer and autumn （flowering to fruiting stage） and the above-ground parts are dry in the shade and used as medicine. Modern Qingxiangru is mostly harvested before the flowering period， and Jiangxiangru is harvested after flowering and fruiting in late summer and early autumn. In summary， according to the 2020 edition of Chinese Pharmacopoeia， the dried above-ground parts of Moslae Herba should be selected for Xinjia Xiangruyin in the Catalogue of Ancient Famous Classical Formulas（The First Batch）， mainly the cultivated variety of Jiangxiangru， and the raw products is cut into segments and used as medicine. It is suggested that when applying and developing famous classical formulas containing Moslae Herba at different periods of time today， the origin should be established in conjunction with clinical efficacy.

Time-Dependent Changes in the Bladder Muscle Metabolome After Traumatic Spinal Cord Injury in Rats Using Metabolomics / 대한배뇨장애요실금학회지

Purpose@#The main treatment options of neurogenic bladder remains catheterization and long-term oral medications. Metabolic interventions have shown good therapeutic results in many diseases. To date, no studies have characterized the metabolites of the detrusor muscle during neurogenic bladder. Using metabolomics, new muscle metabolomic signatures were identified to reveal the temporal metabolic profile of muscle during disease progression. @*Methods@#We used 42 Sprague-Dawley rats (200±20 g, males) for T10 segmental spinal cord injury modeling and collected detrusor tissue and performed nontargeted metabolomics after sham surgery, 30-minute, 6-hour, 12-hour, 24-hour, 5-day, and 2-week postmodelling, to identify the dysregulated metabolic pathways and key metabolites. @*Results@#By comparing mzCloud, mzVault, MassList, we identified a total of 1,271 metabolites and enriched a total of 12 metabolism-related pathways with significant differences (P<0.05) based on Kyoto Encyclopedia of Genes and Genomes analysis. Metabolites in several differential metabolic pathways such as ascorbate and aldarate metabolism, Steroid hormone biosynthesis, and carbon metabolism are altered in a regular manner before and after ridge shock. @*Conclusions@#Our study is the first time-based metabolomic study of rat forced urinary muscle after traumatic spinal cord injury, and we identified multiple differential metabolic pathways during injury that may improve long-term management strategies for neurogenic bladder and reduce costs in long-term treatment.

Clinical practice guidelines and real-life practice in hepatocellular carcinoma: A Taiwan perspective

Hepatocellular carcinoma (HCC) is the fourth most common cancer and the second leading cause of cancer-related death in Taiwan. The Taiwan Liver Cancer Association and the Gastroenterological Society of Taiwan developed and updated the guidelines for HCC management in 2020. In clinical practice, we follow these guidelines and the reimbursement policy of the government. In Taiwan, abdominal ultrasonography, alpha-fetoprotein, and protein induced by vitamin K absence or antagonist-II (PIVKA-II) tests are performed for HCC surveillance every 6 months or every 3 months for high-risk patients. Dynamic computed tomography, magnetic resonance imaging, and contrast-enhanced ultrasound have been recommended for HCC surveillance in extremely high-risk patients or those with poor ultrasonographic visualization results. HCC is usually diagnosed through dynamic imaging, and pathological diagnosis is recommended. Staging of HCC is based on a modified version of the Barcelona Clinic Liver Cancer (BCLC) system, and the HCC management guidelines in Taiwan actively promote curative treatments including surgery and locoregional therapy for BCLC stage B or C patients. Transarterial chemoembolization (TACE), drug-eluting bead TACE, transarterial radioembolization, and hepatic artery infusion chemotherapy may be administered for patients with BCLC stage B or C HCC. Sorafenib and lenvatinib are reimbursed as systemic therapies, and regorafenib and ramucirumab may be reimbursed in cases of sorafenib failure. First-line atezolizumab with bevacizumab is not yet reimbursed but may be administered in clinical practice. Systemic therapy and external beam radiation therapy may be used in specific patients. Early switching to systemic therapy in TACE-refractory patients is a recent paradigm shift in HCC management.

Effect of transcatheter aortic valve replacement on postoperative left ventricular reverse remodeling in patients with aortic regurgitation / 中国胸心血管外科临床杂志

@#Objective     To investigate the left ventricular reverse remodeling (LVRR) in patients with aortic valve insufficiency with reduced ejection fraction (AIrEF) and aortic valve insufficiency with preserved ejection fraction (AIpEF) after transcatheter aortic valve replacement (TAVR). Methods    The clinical and follow-up data of patients who underwent TAVR in the Department of Cardiothoracic Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from 2018 to 2021 were retrospectively analyzed. According to the guideline, the patients with left ventricular ejection fraction<55% were allocated to an AIrEF group, and the patients with left ventricular ejection fraction≥55% were allocated to an AIpEF group. Results    A total of 50 patients were enrolled. There were 19 patients in the AIrEF group, including 15 males and 4 females with a mean age of 74.5±7.1 years. There were 31 patients in the AIpEF group, including 19 males and 12 females with a mean age of 72.0±4.8 years. All patients underwent TAVR successfully. Echocardiographic results showed that TAVR significantly promoted LVRR in the patients. Significant LVRR occurred in the early postoperative period (the first day after the surgery) in both groups. It remained relatively stable after the LVRR in the early postoperative period (the first day after surgery) in the AIpEF patients, while it continued to occur in the early postoperative period (the first day after surgery) to three months after the surgery in the AIrEF patients, and then remained relatively stable. Compared to preoperative values, AIrEF patients had a reduction in the average left ventricular end-diastolic volume index and left ventricular end-systolic volume index by 16.8 mL/m2 (P=0.003) and 8.6 mL/m2 (P=0.005), respectively, and the average left ventricular end-diastolic diameter index and end-systolic diameter index decreased by 2.5 mm/m2 (P=0.003) and 1.9 mm/m2 (P=0.003), respectively on the first day after the surgery. In comparison to the first day after the surgery, AIrEF patients experienced an average increase of 12.1% in the left ventricular ejection fraction three months after the surgery (P<0.001). Conclusion    TAVR has achieved good therapeutic effects in patients with aortic valve insufficiency, significantly promoting the LVRR in patients, and has better curative effects in AIrEF patients.