Objective:To investigate the survival of rabbits receiving autologous left auricle cardiomyocytes transplantation into the infarcted myocardium and to assess the effect of transplantation on the peripheral blood supply, heart rate, and cardiac function. Methods: Healthy adult rabbits were randomly divided into transplantation group (n=8) and control group (n=8). The myocardial infarction (MI) models were established by ligating the left anterior descending arteries in all rabbits. Four weeks later the left auricles were harvested and the auricle cardiomyocytes were isolated and labelled with DAPI ex vivo. Rabbits in the transplantation group were injected with DAPI-labelled cell suspension into the infarcted areas and those in control group received culture medium. All the rabbits were examined by electrocardiogram (ECG) and 2-D ultrasonic cardiogram (UCG) 4 weeks after transplantation. Specimens were harvested from the transplanted areas and observed histologically. Results: All rabbits survived 4 weeks after transplantation. ECG showed that the heart rate in transplantation group was faster than that in control group (P

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control

Objective　To establish animal model for hypertrophic scar and study the characters of its morphology and collagen metabolism. Methods　A total of 64 round wounds (diameter of 6 mm each) with total skin loss were made on the ventral side of rabbit ear using a trephine. Morphology and collagen metabolism of scar wounds were studied at 14,21,35,70 and 98 days after operation, respectively. Results　There were 76% elevated scars developed (45/59 wounds) on the ventral side of rabbit ear at 21 days and 46% elevated scars disappeared (11/24) at 98 days after operation. There were numerous fibroblast proliferation and whorl-arranged collagen fibers at 21 and 35 days. The number of fibroblast decreased, but irregular-arranged fibers still presented in the elevated scars at 70 and 98 days after operation. Hydroxyproline content in elevated scars at 21 days was higher than that in normal skin (P<0.05), and at 35 days was 3 times as that in normal skin and at 98 days was also markedly higher than that in normal skin (P<0.05). Conclusion　Excessive deposition of collagen is a characteristic of hypertrophic scar in rabbits. The conversion of normal scarring to hypertrophic scarring in rabbits occurs at 14～21 days after operation. Both development and regression of hypertrophic scar in rabbit are quicker than that in human.

Objective　To establish animal model for hypertrophic scar and study the characters of its morphology and collagen metabolism. Methods　A total of 64 round wounds (diameter of 6 mm each) with total skin loss were made on the ventral side of rabbit ear using a trephine. Morphology and collagen metabolism of scar wounds were studied at 14,21,35,70 and 98 days after operation, respectively. Results　There were 76% elevated scars developed (45/59 wounds) on the ventral side of rabbit ear at 21 days and 46% elevated scars disappeared (11/24) at 98 days after operation. There were numerous fibroblast proliferation and whorl-arranged collagen fibers at 21 and 35 days. The number of fibroblast decreased, but irregular-arranged fibers still presented in the elevated scars at 70 and 98 days after operation. Hydroxyproline content in elevated scars at 21 days was higher than that in normal skin (P<0.05), and at 35 days was 3 times as that in normal skin and at 98 days was also markedly higher than that in normal skin (P<0.05). Conclusion　Excessive deposition of collagen is a characteristic of hypertrophic scar in rabbits. The conversion of normal scarring to hypertrophic scarring in rabbits occurs at 14～21 days after operation. Both development and regression of hypertrophic scar in rabbit are quicker than that in human.

Objective:To investigate the expression of long non-coding RNA (Lnc RNA) RP5-919F19 in gastric cancer tissues and its correlation with gastric cancer invasion and metastasis.Methods:Non-tumor gastric mucosa (more than 3cm away from the cancer tissue) and gastric adenocarcinoma tissues were collected from Jan. 2020 to Jan. 2022 in our hospital. TRIzol kit was used to extract total RNA from cells and tissues, and reverse transcription kit was used to reverse transcribed RNA into cDNA. Quantitative real-time PCR kit was used for quantitative analysis. SGC-7901 and AGS human gastric cancer cells were used to construct RP5-919F19 knockdown and overexpression models. CCK-8 assay was used to confirm cell proliferation, and Transwell invasion assay was used to confirm the invasion ability of gastric cancer cells.Results:The expression of RP5-919F19 was detected in 79 cases of gastric cancer tissues and adjacent normal tissues, and it was found that the relative expression of RP5-919F19 in gastric cancer tissues was 1.51±0.05 significantly higher than that of 0.82±0.04 in adjacent normal tissues ( P<0.05) . The levels of RP5-919F19 in patients with different pathological conditions were compared and analyzed. The results showed that there were statistically significant differences in RP5-919F19 expression in patients with different TNM stages, distant metastasis, lymph node metastasis and different depth of invasion ( P<0.05) . There was no significant difference in RP5-919F19 expression among patients with different tumor sizes, ages and genders ( P>0.05) . AGS gastric cancer cells were transfected with RP5-919F19 overexpression plasmid and control plasmid, and the efficiency of RP5-919F19 was detected. The results showed that the expression level of RP5-919F19 in the overexpression group was 1.83±0.14 higher than that of 0.82±0.05 in the control group ( P<0.05) . SGC-7901 gastric cancer cells were transfected with RP5-919F19 knockout vector and control vector, and the efficiency of RP5-919F19 was detected. The results showed that the expression level of RP5-919F19 in the knockout group was 0.42±0.07 lower than that of 0.89±0.08 in the control group ( P<0.05) . CCK-8 was used to detect the proliferation ability of gastric cancer cells. The results showed that the proliferation ability of AGS cells in RP5-919F19 overexpression group was significantly increased compared with that of the control group at 24 and 48h after culture ( P<0.05) . However, the proliferation ability of SGC-7901 cells in RP5-919F19 knockdown group was lower than that in the control group at 24 h and 48 h ( P<0.05) . Transwell invasion assay showed that the invasion and migration abilities of AGS cells in RP5-919F19 overexpression group were higher than those in the control group ( P<0.05) , and the invasion and migration abilities of SGC-7901 cells in RP5-919F19 knockout group were lower than those in the control group ( P<0.05) . Western blot showed that compared with control cells, the expression of MMP-2 and MMP-9COPS7A proteins in down-regulated Lnc RNA RP5-919F19 SGC-7901 cells was decreased. Conclusion:The expression of LncRNA RP5-919F19 is abnormally increased in gastric cancer tissues, and the increased expression of RP5-919F19 can promote the proliferation and metastasis of gastric cancer cells.

OBJECTIVETo test and analyze chemical composition of Paeoniae Radix Alba decoction at molecular level.

METHODRaman spectra of decoctions prepared from seven batches of Paeoniae Radix Alba pieces, five batches of Paeoniae Radix Alba medicinal material and five batches of Paeoniae Radix Rubra pieces were measured respectively, and the characteristic Raman bands were tentatively assigned. Raman spectra of decoctions were compared and analysed between Paeoniae Radix Alba pieces and Paeoniae Radix Alba medicinal material, Paeoniae Radix Alba pieces and Paeoniae Radix Rubra pieces.

RESULTNine Raman bands (637, 783, 847, 981, 1 091, 1 128, 1 336, 1 458 and 1 636 cm(-1)) were observed in the Paeoniae Radix Alba pieces decoction. Compared with the decoction of Paeoniae Radix Alba pieces, the Raman bands of 783, 981, 1 128, 1 336 and 1 458 cm(-1) were also exists in Paeoniae Radix Alba medicinal material decoction, meanwhile, the Raman bands of 633 cm(-1) and 1 633 cm(-1) occurs slight frequency shift, however, the bands of 716, 737, 835, 916, 1 072, 1 271 and 1 600 cm(-1) were disappear. In addition, the Raman spectra are quite different between the decoctions of Paeoniae Radix Alba pieces and Paeoniae Radix Rubra pieces.

CONCLUSIONThe results showed that Raman spectroscopy might provide a novel method for the fast component detection of the Radix Paeoniae Alba decoction or other traditional Chinese medicine.

Drugs, Chinese Herbal ; chemistry ; Paeonia ; chemistry ; Plant Roots ; chemistry ; Spectrum Analysis, Raman ; methods

OBJECTIVETo investigate the safety and feasibility of laparoscopy-assisted combined radical resection for synchronous rectal and gastric cancer in elderly patients.

METHODSClinical data of two elderly patients undergoing laparoscopy-assisted combined radical resection for synchronous rectal and gastric cancer were analyzed retrospectively.

RESULTSThe two cases were 78 and 75 years old respectively. Both were complicated with many medical conditions. One case suffered from stage II cancer in the gastric body and stage IB rectal cancer, and the other suffered from stage IIIA gastric cancer and stage IB rectal cancer. Both cases had received laparoscopy-assisted combined radical resection for synchronous rectal and gastric cancer, with 5 cm of incision. The operative time was 260 and 255 min and the intraoperative bleeding was 60 and 80 ml respectively. No complication occurred intraoperatively. Time to resume oral intake was 4 and 5 days and length of postoperative hospital stay was 13 and 14 days respectively. No postoperative complication occurred. The patients were followed up for 13 and 12 months and no postoperative recurrence or metastasis was noticed.

CONCLUSIONLaparoscopy-assisted combined radical resection for elderly synchronous rectal and gastric cancer is safe and feasible when performed by surgeons with plentiful experience in laparoscopic technology, and associated with less injury and faster recovery.

Aged ; Female ; Humans ; Laparoscopy ; methods ; Rectal Neoplasms ; complications ; surgery ; Retrospective Studies ; Stomach Neoplasms ; complications ; surgery ; Treatment Outcome

OBJECTIVEThe purpose of this study was to determine the feasibility of transcatheter pulmonary valve replacement in sheep up to 6 months post procedure.

METHODSFresh sheep pericardium treated with a 0.6% glutaraldehyde solution for 36 hours was sutured to a valvular ring and then fixed onto a newly designed nitinol self-expandable stent. Thoracotomy was performed in sheep (23.5 +/- 3.1) kg under general anesthesia and the device was delivered into the native pulmonary valve of the sheep via the anterior wall of right ventricle by catheter and fooled for 6 months.

RESULTSOne sheep died 4 months after the procedure due to in-stent thrombosis. Another 4 animals survived the 6-month observing period. Angiographic and hemodynamic measurements confirmed good positioning and function of the stents with a competent valve immediately post procedure and 6 months post the procedure in surviving animals.

CONCLUSIONImplantation of the nitinol self-expandable stent in the pulmonary valve position by a transcatheter approach is feasible and good function of transcatheter implanted memory nitinol valved stents was shown after 6 months of implantation in sheep.

Animals ; Disease Models, Animal ; Female ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; instrumentation ; methods ; Male ; Pulmonary Valve ; surgery ; Sheep ; Stents

OBJECTIVETo observe the effect of targeted argon-helium cryoablation on portal region of the liver in dogs by observing the pathological changes in the first-order branches of the Glisson ductal system.

METHODSTwelve healthy dogs underwent percutaneous targeted argon-helium cryoablation of the liver and sacrificed at 3 and 28 days after the cryoablation to observe the pathological changes in target area for cryoablation and the first-order branches of the Glisson ductal system.

RESULTSNo obvious damage was not found in the vascular wall of the portal vein by gross or microscopic observation, but the liver tissue in the vicinity of the blood vessels showed total necrosis. In spite of the injuries of different degrees in the first-order bile duct system after argon-helium cryoablation, no severe damages such as perforation or full-thickness necrosis occurred in bile duct wall, and most of the injuries were temporary and reversible. The size of the ablated area on day 28 was significantly reduced as compared with that on day 3 following the cryoablation (P<0.05). In the acute stage after the cryoablation (1-3 days), ALT and AST levels increased significantly in (P<0.05) but recovered 1-4 weeks later (P>0.05). The cryoablated area was basically consistent with the pathological area that underwent necrosis (P>0.05).

CONCLUSIONTargeted argon-helium cryoablation can cause total destruction of the liver tissue around the blood vessel without damaging the vascular walls of the portal vein. Argon-helium cryoablation induces relatively minor injuries to the bile duct of hepatic portal section and does not obviously damage the liver function, and the scope of tissue necrosis can be estimated according to the size of frozen area observed. Argon-helium cryoablation is a safe and minimally invasive operation with reliable therapeutic effect.

Animals ; Argon ; Bile Ducts, Extrahepatic ; pathology ; Cryosurgery ; adverse effects ; methods ; Dogs ; Female ; Helium ; Liver Neoplasms, Experimental ; surgery ; Male ; Portal Vein ; pathology ; Random Allocation

OBJECTIVETo identify zebrafish mutants with myelopoiesis defects by ENU mutagenesis and large-scale forward genetic screening.

METHODSMale zebrafish were mutagenized with N-ethyl N-nitrosourea to induce mutations in the spermatogonial cells to generate the founders, which were outcrossed with AB to raise F1 fish. The F1 fish from different founders were mated to generate the F2 families. The F3 embryos from F2 sibling crosses were screened by Sudan black B staining and neutral red staining.

RESULTSA total of 350 F2 families from F1 sibling crosses were screened, and 1424 F2 crosses were analyzed. Six mutations were identified resulting in abnormal Sudan black B staining and neutral red staining, indicating the involvement of neutrophil deficiency or macrophage abnormalities.

CONCLUSIONIt is simple and cheap to induce and screen myelopoiesis deficiency in zebrafish by ENU chemical mutagenesis and Sudan black B staining and neutral red staining. These mutants shed light on the identification of the genes important to myelopoiesis in zebrafish.

Animals ; Gene Expression Regulation, Developmental ; genetics ; Genetic Testing ; Male ; Mutagenesis ; Mutation ; Myeloid Progenitor Cells ; physiology ; Myelopoiesis ; genetics ; Zebrafish ; genetics