[Progress on clinical trials of common gastrointestinal cancer drugs in China from 2012 to 2021].

Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.

[Correlation analysis of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio and central cervical lymph node metastasis of papillary thyroid microcarcinoma].

Objective: To investigate the correlation between neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and central lymph node metastasis (CLNM) in patients with cN0 papillary thyroid microcarcinoma (PTMC). Methods: The clinicopathological data of PTMC patients confirmed by surgery and pathology in the 81st Military Hospital of People's Liberation Army from 2016 to 2019 were collected, and the relationship between preoperative NLR, PLR levels and postoperative PTMC CLNM were analyzed. Logistic regression analysis was used for multivariate analysis. Receiver operating characteristic (ROC) curve was used to determine the cutoff value of NLR and PLR. The interaction relative excess risk was used to analyze the relationship between NLR, PLR and CLNM. Results: Among 220 patients with cN0 stage PTMC, 92 were CLNM. The ROC curve showed that when the cutoff value of NLR was 2.5 and the cutoff value of PLR was 175, the highest Youden index was 0.318 and 0.264, respectively. NLR and PLR were both related to CLNM (P<0.05). The tumor long diameter, multifocality, NLR≥2.5 and PLR≥175 were independent impact factors of CLNM (P<0.05). The results of the interaction showed that the relative excess risk of the interaction was 5.531 (95%CI: 0.160, 10.901, P=0.016), the attribution ratio was 0.512 (95%CI: 0.230, 0.794, P=0.009), and the synergy index was 2.294 (95%CI: 1.492, 4.579, P=0.022), suggested that NLR and PLR had an interactive effect, and these two synergistically promoted CLNM. Conclusions: NLR and PLR are independent risk factors for cN0 stage PTMC CLNM. When NLR≥2.5 and PLR≥175, preventive central lymph node dissection should be routinely performed.

Histological characteristics of induced membranes in subcutaneous, intramuscular sites and bone defect.

BACKGROUND: The induced membrane technique was proposed as a treatment of large segmental bone defects. The influence of the surrounding tissues on its characteristics remains unknown. It is therefore not known which kind of plastic surgery procedure (muscular or facio-cutaneous flap) would optimize bone osteointegration within a bone defect reconstructed using the induced-membrane technique. HYPOTHESIS: We hypothesized that membrane characteristics could be influenced by the soft-tissue environment either subcutaneous or muscular. OBJECTIVE: To evaluate the histological characteristics of poly-methylmethacrylate (PMMA) induced membranes in intramuscular, subcutaneous and bony environment (radius defects) at 2 steps: spacer implantation; secondary bone graft and its subsequent osteintegration after spacer removal. METHODS: PMMA-induced membranes were obtained in the three sites of 15 rabbits. Subsequent new bone formation was studied in the same environments in 24 other rabbits. Six weeks after the initial implantation, PMMA spacers were replaced with iliac autografts. Animals were euthanized at 2, 4, and 8 weeks postoperatively. Tissue samples were harvested and stained with hematoxylin and eosin. The histological characteristics of the membrane (thickness and microvessel density) and the newly-formed bone (cortical thickness) were quantitatively analyzed. RESULTS: The membranes in the subcutaneous sites developed quicker, were thicker and had the lowest microvessel density (P<0.01). The membranes in the intramuscular sites developed later and were thinner (P<0.01). The membranes in the osseous defects had the greatest microvessel density (P<0.01). After bone grafting, induced membranes became thinner and their microvessel density decreased substantially, but maintained better in osseous site. The newly-formed bone that developed in the radius defects, had the thickest cortices (P<0.01). CONCLUSIONS: The evolution of membranes induced in the intramuscular and subcutaneous environments was close to that of the bone defect model, although bone formation appeared weaker.

Sural nerve grafting in robotic laparoscopic radical prostatectomy: interim report.

BACKGROUND AND PURPOSE: Sural nerve grafting for patients undergoing prostatectomy has been previously reported using open and minimally invasive methods. We report our experience with sural nerve grafting during robot-assisted laparoscopic radical prostatectomy (RLRP). MATERIALS AND METHODS: Patients with preoperative potency and a minimum of 6 months follow-up were included in this prospective review. A total of 333 patients were identified between February 2003 and January 2006 who met these criteria including 22 of the 25 patients who underwent sural nerve grafting. Patients were divided into 5 groups to compare unilateral and bilateral sural nerve cohorts with non-nerve-sparing and unilateral and bilateral nerve-sparing groups. Patients were followed prospectively using health-related quality-of-life questionnaires. RESULTS: Twenty-two patients underwent sural nerve grafting that included three bilateral grafts. Mean follow-up was 14 months. There was no statistical difference in patients' ages, body mass index, preoperative prostate-specific antigen level, blood loss, complications, and positive margin rate. Operative time was statistically longer for both sural graft cohorts when compared with unilateral (without graft) and bilateral nerve sparing cohorts. No significant differences in subjective or objective sexual function, sexual bother, or urinary function were seen with 6 and 12 months follow-up, possibly related to smaller sural cohorts. Graft-related complications include leg pain in one patient. CONCLUSION: Sural nerve grafting during RLRP is technically feasible and safe and offers improved dexterity and visualization deep within the pelvis. However, a larger randomized cohort of patients will be required to validate any improved benefits afforded by the robot system.

[Experimental study of bone repair induced by cryopreserved allograft periosteum and fetal bone composition in bone defect].

OBJECTIVE: To investigate the repairing effect of transplantation of allogeneic fetal bone in combination with a covering cryopreserved periosteal allograft to bone defect. METHODS: Twenty Long-eared white male rabbits were chosen as experimental model of bilateral 12 mm combined bony and periosteal radial defect. Cryopreserved allograft periosteum with allogeneic fetal bone were implanted in the left defect as experimental side and fetal bone was simply transplanted in the right defect as control side. Bone repair process in the two groups were compared by macroscopy, microscopy, roentgenograms and the contents of calcium and phosphate in the defect area at 2, 4, 8 and 12 weeks after transplantation. RESULTS: There was significant statistic difference in the contents of calcium and phosphate between the experimental and control sides at 4, 8 and 12 weeks after transplantation (P < 0.05). With time passing by, the contents of calcium and phosphate have the increasing trends. In the experimental group, lamella bone was seen and medullary canal recanalized at 8 weeks postoperatively. The histological section showed the bone lacuna and lamella bone were formed. CONCLUSION: It suggests that allogeneic fetal bone in combination with a covering cryopreserved periosteal allograft can promote bone repair, and allogeneic fetal bone is excellent bone substitute.

Purification and characterization of human hepatic stimulator substance.

Human hepatic stimulator substance (hHSS) was purified from fetal liver with 6,000-fold decrease in protein content and 840-fold increase in specific growth stimulative activity. Purification procedures included the heating of a homogenate in 35% (W/V) Tris-HCL at 95 degrees C for 20 min, high and ultra speed centrifugation, passage over Sephadex G100 gel filtration, DEAE-cellulose ion exchange, TSK G3000 SWG high performance liquid chromatography (HPLC) and YWG C-18 reverse phase HPLC techniques. The most purified material (HP-HSS) revealed cell-specific and dose dependent increase in 3H-TdR incorporation into cellular DNA. As little as 38 ng of the HP-HSS per ml of culture medium produced a 2.5-fold increase in DNA synthesis. Further studies indicate that HP-HSS in combination with insulin and epidermal growth factor stimulate DNA synthesis 16-fold compared with serum and hormone free controls and nearly 3-fold over hepatoma growth with HP-HSS alone. Sodium dedecyl sulfate polyacrylamide gel electrophoresis with silver stain and ultrascan XL laser densitrometer quantitative scanning revealed only one band at 12,800.

Air bronchogram in differential diagnosis of small peripheral lung cancers on CT image.

The computed tomographic (CT) images of 52 patients of small peripheral lung nodule < 3 cm proved pathologically were reviewed. Air bronchogram (AB) was found in 14 nodules on thin-section CT images, in which well or moderately differentiated small adenocarcinomas were only seen with lipidic growth. Squamous-cell, large-cell carcinomas and small benign lung nodules had no AB sign both on CT image and in pathologic specimens.