This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.

Objective To observe the clinical efficacy using curette and stripping wire method in treating diabetic foot. Methods 36 hospitalized patients diagnosed as diabetic foot were enrolled, and 18 of them were chosen as the experimental group according to random digital table method who was treated with medical therapy plus curette and stripping wire method in treating diabetic foot. The other 18 patients were named as the control group who were treated by medical treatment and routine treatment. The granulation tissue maturity, wound healing, and the differences on curative effect were compared. Results 10 cases′wound granulation tissue maturity in the experimental group got++and+++on the 10th day while 4 cases in control group. Wound healing rate of the experimental group at the 10th and 14th day were (78.6±10.5)%and (82.7±8.4)%while the control group were (43.2±8.7)%and (66.2±10.1)%. Cure rate of the experimental group was 14/18 four weeks after treatment, the inefficiency was 0, while the control group was 6/18 and 3/18. Conclusions Curette and stripping wire method is a good method to promote the dressing diabetic foot wound healing. It is superior to traditional methods, worthy of clinical application.

BACKGROUND: Al ogeneic hematopoietic stem cel transplantation is the main method to cure leukemia, but the patients receiving al ogeneic hematopoietic stem cel transplantation stil have to face the risk of recurrence. Myeloid sarcoma is a rare extramedul ary relapse mode with worse clinical outcomes, so it is necessary to understand the characteristics of myeloid sarcoma and relative treatment methods. OBJECTIVE: To analyze the clinical characteristics and treatment methods of myeliod sarcomas in cardio-phrenic angle after al ogeneic peripheral blood stem cel transplantation. METHODS: One case was diagnosed as single myeloid sacoma in the cardio-phrenic angle after al ogeneic peripheral blood stem cel transplantation. The patient underwent surgical resection of the mass, chemotherapy and radiotherapy. The clinical effect, complications and survival situation were observed. RESULTS AND CONCLUSION: The patient suffered from bacteremia, fungal pneumonia and even life-threatening sepsis shock during two courses chemotherapies. Then, the patient received radiotherapy for mediastinum and the myeloid sacoma never relapsed. However, the patient suffered central nervous system leukemia after free of the disease for 25 months. Myeliod sarcoma after al ogeneic hematopoietic stem cel transplantation is rare and its manifestation is changeful. The diagnosis mainly depends on histopathology and immunohistochemistry. Surgery, chemotherapy, radiotherapy, second transplantation and molecular targeted drugs are the choices of treatment strategy. However, the optimal treatment strategy for individual patients remains to be determined.

Based on a retrospective study design, this article was aimed to discuss the transformation path and method of hospital medical records information into analyzable data, in order to solve the problem of text-based information digitalization, and improve the credibility of statistical results. The hospital medical records information of traditional Chinese medicine (TCM) treatment for infantile cerebral palsy was taken as example. After the identification of research purpose, the study contained 8 steps, which were index identification, index definition, coding and assignment, database design, data entry, quality control, and database locking. The database contained research-related indicators was received. The results showed that a set of path and method based on indicator extraction and conversion of hospital medical records information into data. It was concluded that in the retrospective study design, the conversion of text information into analyzable data was the key step. Extraction and digitalization of indicators should be based on the research plan. Key elements such as the crowd, treatment plan, evaluation indicator, should be paid attention to for the systematic analysis, in order to ensure the system integrity of research indicators.

Objective To discuss the methods and the effects of percutaneous kyphoplasty(PKP)in the treatment of thoracolumbar osteoporotic vertebral compression fractures ( OVCFs).Methods Retrospective analysis was made on 110 vertebrae in 96 thoracolumbar OVCFs patients undergoing transpedicular unilateral PKP or PKP combined with percutaneous vertebroplasty(PVP) from Jan.2004 to Nov.2011.We analyzed the change of the anterior heights of the vertebra,the clinical outcomes using VAS and Oswcstry bcforc and after the treatment,and the rate of cement leakage.Results 85 vertebrae were treated with the PKP sucessfully,and 25 vertebraewere treated with both PKP and PVP sucessfu]ly.All patients were satisfied with the diffusion of the cement.Theoperation time of each vertebra was about 20-40 minutes for one side.The injection volume of of each vertebrawas about 5.4 ml.According to VAS and Oswestry,the pain was alleviated obviously after the operation ( P ＜0.01) and the anterior heights of the vertebrae changed ( P ＜ 0.01).The leakage of the cement was the only complication in these patients and most of the leakage happened at the anterior of the vertebrae and the vein nearby.The overall rate of the leakage was 56.3％.For the 40 vertebrae of the 36 patients that were followed up,1patient had fracture in a neighbor vertebra and 1patient had subsidence in the upper anterior edge of the treated vertebra where there was no cement filled in,but the patient had no discomfort.Conclusion PKP or PKP combined with PVP are safe,convenient and effective methods in treating OVCFs.

The method of placing an implant immediately into the fresh extraction socket at the same time as tooth extraction has the advantages of reducing the number of operations and the overall treatment time, making full use of the existing bone mass, and resulting in ideal aesthetic effects. However, immediate implant placement also has its own inherent shortcomings. Due to the existence of the extraction socket, it is difficult to close the wound; because the size of the implant does not match the size of the extraction socket, it is difficult to achieve good initial stability, and there is a risk of soft tissue recession. This article reviews the success rate, indications and expansion of immediate implant placement, surgical requirements, complications and the prevention and treatment of anterior teeth in the aesthetic area. A literature review showed that the 5-year success rate of immediate implant placement was over 95%. The indications included intact socket walls, a facial bone wall at least 1 mm in thickness, the presence of thick, soft tissue, the absence of acute infection at the site, and the availability of bone apically and lingually to the socket to provide primary stability. In addition, in recent years, with the improvement of surgical implantation technology and the improvement of bone substitute material performance, immediate implant placement can be used as one of the conventional methods for oral implantation treatment, and its indications have shown a trend toward expansion. Immediate implant placement also has complications, including poor placement of implants and gingival receding that results in poor aesthetic outcomes. In addition, immediate restoration and conventional loading protocols after immediate implant appear to have similar outcomes and result in better aesthetic effects. However, the long-term stability and patient satisfaction after immediate implant placement in terms of soft tissue aesthetics require more research.

Objective:To investigate the influencing factors for the number of lymph node harvested after Da Vinci robotic and laparoscopic radical gastrectomy for gastric cancer.Methods:The retrospective case-control study was conducted. The clinicopathological data of 1 396 patients who underwent Da Vinci robotic or laparoscopic radical gastrectomy for gastric cancer in the First Affiliated Hospital of Nanchang University from December 2014 to July 2019 were collected. There were 991 males and 405 females, aged (60±11) years. Surgery using Da Vinci robotic system or laparoscopic system was completed according to patients' wishes. Cases with early gastric cancer underwent D 1+ lymphadenectomy and cases with advanced gastric cancer underwent standard D 2 lymphadenectomy. Observation indicators: (1) intraoperative situations; (2) postoperative situations; (3) influencing factors for the number of lymph node harvested after radical gastrectomy for gastric cancer; (4) follow-up and survival. Follow-up using outpatient examination or telephone interview was performed to detect survival of patients up to October 2020. Measurement data with normal distribution were represented as Mean± SD. Univariate analysis was done using the chi-square test or Fisher exact probability. Multivariate analysis was performed using Logistic regression model. The survival rate was calculated by Kaplan-Meier method. Results:(1) Intraoperative situations: all the 1 396 patients underwent radical gastrectomy, including 415 cases undergoing Da Vinci robotic radical gastrectomy and 981 cases undergoing laparoscopic radical gastrectomy. Thirty-five of the 1 396 patients were converted to open surgery, including 5 cases undergoing Da Vinci robotic radical gastrectomy and 30 cases undergoing laparoscopic radical gastrectomy. Of the 1 396 patients, 983 cases underwent distal gastrectomy, 400 cases underwent total gastrectomy and 13 cases underwent proximal gastrectomy, among which 597 cases underwent Billroth Ⅰ anastomosis, 385 cases underwent Billroth Ⅱ anastomosis, 401 cases underwent Roux-en-Y anastomosis and 13 cases underwent residual stomach-esophagus anastomosis. The operation time, volume of intraoperative blood loss and cases with intraoperative blood transfusion were (221±51)minutes, (201±81)mL, 24 of 415 cases undergoing Da Vinci robotic radical gastrectomy, and (196±42)minutes, (232±76)mL, 75 of 981 cases undergoing laparoscopic radical gastrectomy, respectively. (2) Postoperative situations: the time to postoperative first flatus, time to postoperative initial liquid food intake and duration of postoperative hospital stay of the 1 396 patients were (3.0±1.0) days, (4.2±1.5) days and (9.0±3.8) days, respectively. Two hundred and ten of the 1 396 patients had postoperative complications including 170 cases with grade Ⅰ-Ⅱ complications and 40 cases with grade Ⅲ-Ⅴ complications. Eight of the 210 patients with postoperative complications died of serious complica-tions and the other 202 cases were cured after symptomatic treatment. Results of postoperative histopathological examination showed that there were 958 cases of adenocarcinoma, 220 cases of mucinous adenocarcinoma, and 218 cases of signet ring cell carcinoma. The number of lymph node harvested and the number of positive lymph node of the 1 396 patients were 26.0±8.3 and 3.6±0.9, respectively, and cases with the number of lymph node harvested ≥16 or <16 were 1 312 and 84. (3) Influencing factors for the number of lymph node harvested after radical gastrectomy for gastric cancer: results of univariate analysis showed that the operating surgeon, operation method, range of gastric resection, nerve invasion, degree of tumor invasion and tumor pathological N stage were related factors influencing the number of lymph node harvested after Da Vinci robotic and laparoscopic radical gastrectomy for gastric cancer ( χ2=13.167, 6.029, 15.686, 5.573, 9.402, 17.139, P<0.05). Results of multivariate analysis showed that the operating surgeon, operation method, range of gastric resection and tumor pathological N stage were independent factors influencing the number of lymph node harvested after Da Vinci robotic and laparoscopic radical gastrectomy for gastric cancer ( odds ratio=1.589, 2.018, 1.787, 0.267, 95% confidence interval as 1.221?2.068, 1.140?3.570, 1.066?2.994, 0.103?0.689, P<0.05). (4) Follow-up and survival: of the 1 396 patients, 1 256 cases were followed up for 2 to 70 months, with a median follow-up time of 27 months. The 3-year cumulative survival rate of the 1 256 cases was 70.2%. Conclusion:The operating surgeon, operation method, range of gastric resection and tumor pathological N stage are independent factors influencing the number of lymph node harvested after Da Vinci robotic and laparoscopic radical gastrectomy for gastric cancer.

OBJECTIVE: To systematically evaluate therapeutic efficacy and safety of Compound muni ziqi granules in the adjuvant treatment of chloasma, and to provide evidence-based reference for clinical treatment. METHODS; Retrieved from Chinese Journal Full-text Database (CJFD), China Scientific Journal Database (CSJD), Wanfang database, Medline and Embase, randomized controlled trials (RCTs) about therapeutic efficacy (total response rate, cure rate, the decrease level of E2, FSH and LH in serum) and safety of Compound muni ziqi granules alone or combined with routine drug (trial group) vs. routine drug (control group) in the treatment of chloasma were collected. Meta-analysis was conducted by using Rev Man 5. 3 statistical software after data extraction of clinical studies meeting inclusion criteria and quality evaluation with Cochrane systematic evaluator manual 5. 1. 0. RESULTS: Totally 12 RCTs were enrolled, involving 1 100 patients. Results of Meta-analysis showed that total response rate [OR=2. 84, 95％CI(2. 20, 3. 67), P<0. 001], cure rate [OR=2. 11, 95％CI(1. 59, 2. 79),P<0. 001],decrease level of Ez [OR=-98. 64, 95％ CI (-110. 84, -86. 44), P <0. 001], decrease level of FSH [OR=-1. 85, 95％CI(-2. 58,-1. 11),P<0. 001] and decrease level of LH [OR= - 5. 85, 95％ CI (-6. 83, -4. 87), P<0. 001] in trial group were significantly better than control group, with statistical significance. In trial group, a few patients suffered from the increase of menstruation, the decrease of menstruation, temporary pigmentation and transient burnout; but all symptoms did not affect the treatment. CONCLUSIONS: Compound muni ziqi granules show definite clinical efficacy and good response rate in the adjuvant treatment of chloasma with mild ADR.

Objective To observe the clinical features and therapeutic effect of 11p15/NUP98 rearrange-ments in acute leukemia. Methods A total of 598 newly diagnosed acute leukemia patients were detected by con-ventional cytogenetics analysis and fluorescence in situ hybridization(FISH)with the NUP98 double color probe, and the clinical data were analyzed retrospectively in the patients with 11p15/NUP98 abnormality. Results Six cases with 11p15/NUP98 rearrangement were found with a median age of 39 years old,one patient is male,the oth-ers are females. Three patients had acute monocytic leukemia(M5),one patient had acute monocytic leukemia (M2),one patient had acute monocytic leukemia(M4),and one patient had acute lymphoblastic leukemia. 11p15/NUP98 abnormality was detectable in all the patients. The median survival in all the patients was 9 months. Con-clusions Acute leukaemia with 11p15 abnormality frequently involves NUP98 gene and mainly occurrs in women. Patients with lower median age mainly developed in acute monocytic leukemia. The major clinical manifestations are anemia,low platelets and hyperleukocytosis. Acute leukemia with 11p15/NUP98 rearrangement is poorly re-sponsive to routine chemotherapies and to allogeneic hematopoietic stem cell transplantation,and thus has poor prognosis.

Objective:To discuss the effect of apolipoprotein C1(APOC1)expression on the proliferation and apoptosis of the hepatocellular carcinoma cells,and to preliminarily clarify the related molecular mechanism.Methods:The expression level of APOC1 mRNA in hepatocellular carcinoma tissue and its relationship with the prognosis of the patient were analyzed by The Cancer Genome Atlas(TCGA)Database;real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the expression levels of APOC1 mRNA in different hepatocellular carcinoma cells;the human liver cancer HepG2 cells with low APOC1 expression were selected as the subjects.The HepG2 cells were transfected with pcDNA3.1-APOC1 plasmid to over-express APOC1(APOC1 over-expression group),and the HepG2 cells transfected with empty vector pcDNA3.1 were regarded as control group.MTS assay and 5-ethynyl-2'-deoxyuridine(EdU)staining were used to detect the proliferative activities and proliferation rates of the cells in two groups;Transwell chamber assay was used to detect the numbers of migration cells in two groups;flow cytometry and TUNEL assay were used to detect the percentages of the cells at different cell cycles and apoptotic rates in two groups;Western blotting method was used to detect the expression levels of extracellular regulated protein kinase(ERK),phosphorylated ERK(p-ERK),protein kinase B(AKT),phosphorylated AKT(p-AKT),B-cell lymphoma-2(Bcl-2),and cleaved cysteinyl aspartate specific proteinase-3(cleaved caspase-3)proteins in the cells in two groups.Results:The TCGA Database results showed that the expression level of APOC1 mRNA in hepatocellular carcinoma tissue was lower than that in normal liver tissue(P<0.05),and the patients with low expression of APOC1 mRNA had poor prognosis.The RT-qPCR results showed that the expression level of APOC1 mRNA in the HepG2 cells was the lowest,and the HepG2 cells were chosen for the subsequent research.Compared with control group,the proliferative activity and proliferation rate of the cells in APOC1 over-expression group were decreased(P<0.05 or P<0.01),the number of migration cells was decreased(P<0.01),and the percentage of the cells at S phase and the apoptotic rate were significantly increased(P<0.01).Compared with control group,the expression levels of p-ERK,p-AKT,and Bcl-2 proteins in the cells in APOC1 over-expression group were significantly decreased(P<0.05),and the expression level of cleaved caspase-3 protein was increased(P<0.01).Conclusion:High expression of APOC1 can inhibit the proliferation of the human liver cancer HepG2 cells and induce the apoptosis,and its mechanism may be related to inhibition of the expressions of p-ERK,p-AKT,Bcl-2 proteins and promotion of the expression of cleaved caspase-3 protein.