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 evaluate the clinical value of co-observation of the expression of MAGE-A3 gene and MDR1 gene on esti-mating the curative effect in non M3-subtype acute leukemia. Methods Expressions of MAGE-A3 and MDRI were measured in 77 patients with non M3-subtype acute leukemia by RT-PCR method. Clinical observation was done to estimate the relationship between the genes with curative effect in non M3-subtype acute leukemia. Results Expression of MAGE-A3 and MDRI gene were 50. 6% and 23. 3% in non M3-subtype acute leukemia patients. Positive expression of MDRI in MAGE-A3-positive and negative patients were 46. 2% and 13. 2% (P < 0.01). The complete remission rate in MAGE-A3 negative and positive patients were 86. 8% and 64. I% (P <0. 05). Complete remission (CR) rate in MDR1 negative and positive patients was 83.3% and 56. 5% (P <0. 05). Complete remission rate were 87.9% and 55.6% in beth negative and both positive expression of MAGE-A3 and MDR1 (P < 0. 05). Conclusion The patients of positive expression of MAGE-A3 in non M3-subtype AL had higher expression of MDR1. The patients with negative expression of beth MAGE-A3 and MDR1 had higher CR rate than that in both positive patients. These researches indicated that eo-observatian of the expression of MAGE-A3 and MDR1 can predict the curative effect in non M3-subtype AL.

Objective To isolate and cultivate Long-Evans rat bone mesenchymal stem cells (BMSCs) and identify their biological characteristics. Methods BMSCs were obtained from femurs of Long-Evan rats and dealt with 0.85 NH4Cl. The cell growth curve and cell cycle were measured and surface antigens were detected by flow cytometry. Osteoblast differentiation was studied by Alizarin red staining. Results BMSCs had active proliferative ability. The growth velocity of passage 5 cells was slower than that of passage 3 cells. The cell cycle analysis showed that 93.79 of BMSCs was at G0/G1 phase. BMSCs were positive for CD29 and CD44, but negative for CD45. Alizarin red staining of BMSCs after osteoblast induction was positive. Conclusion Highly purified BMSCs obtained from Long-Evan rats by 0.85 NH4Cl show stable biological properties.

ObjectiveTo investigate the changes of non-linear dynamics characteristic of electroencephalogram (EEG) under three states (eyes closed, mental arithmetic with eyes closed and orientation test with eyes closed), and the application of non-linear dynamic analysis for cognitive function research.MethodsEEG was recorded in 30 healthy young volunteers at three stages. The correlation dimension (D2) and approximate entropy (ApEn) were calculated for all subjects.ResultsD2 and ApEn increased significantly during mental tasks as compared to the rest state with eyes closed (P<0.01). In different mental tasks, the complexity of mental functions and the regions involved in the cognitive task were different.ConclusionNon-linear analysis methods are appropriate for the study of cognitive functions and can help to understand the working mechanism of brain during mental activities.

Objective To investigate the effect of α-crystallin on the proliferation of rat retinal microglia after optic nerve injury. Methods The effect of α-crystallin on number and proliferation of microglia were analyzed by MTT assay.After the rat model with optic nerve injury was established,α-crystallin was iniected into vitreous cavity and the microglia cell number were counted and compared by retinal fiat counting and immunofluorescence labeling in different groups. Results The proliferation and activation of microglia cells could be stimulated by LPS at 10-6g/L to 10-2g/L.α-crystallin at 10-4g/L and 10-6g/L could inhibit proliferation and activation of microglia cells.Compared to BSA iniection group,α-crystallin could inhibit more significantly the number of microglia cells 1-3 weeks after injury (P＜0.05). Conclusions α-crystallin can inhibit proliferation and activation of retinal microglia and alleviate overphagocytosis and secondary damage of retinal microglia to retinal ganglion cells(RGCs),which may be another mechanism that α-crystallin contributes to indirect protection of RGCs.

Objective To explore clinical effect of repairing soft tissue defect in forearm, hand and foot with free super-thin anterolateral thigh perforator flaps. Methods At first the site of perforator vessels were determined by Doppler, then the flaps were designed and harvested with the site as center; the fascia lata and subcutaneous fat were removed by sandhill-likely only the 4.0 cm × 3.0 cm - 3.0 cm×2.5 cm disc-like fascia lata and dermis layer were reserved. 15 traumatic soft tissue defects including forearm, hand and foot were repaired with the ree super-thin antemlateral thigh perforator flaps. Results No vascular crisis happened and all skin grafts survived in donor sites. 2.0 cm×1.2 cm of the distal of flap was necrosis in 1 case and it was healed by dress changing. 15 cases were followed up 3 months-2 years and the average is 6 months. The contour and texture of all flaps were good and two point discrimination (2-PD) was about 8-10 mm of. Conclusions The contour and texture of free super-thin anterolateral thigh perforator flap are good, the feeling of recipient site recovered well, it's less injury for donor site and there is no reshaping for flap. It is a fineness donor site for repairing soft tissue defects in hand and foot.

ObjectiveTo investigate the changes of non-linear dynamics characteristic of EEG in patient with acute cerebral stroke under eyes closed state. MethodsEEG were recorded in 31 patients with acute cerebral infarction and 22 healthy volunteers under eyes closed state. Correlation dimension (D2) and Approximate Entropy (ApEn) were calculated for all subjects. ResultsD2 and ApEn of uninjured forehead cortex (FP1,FP2)reduced significantly in the group of cerebral infarction as compared with the group of normal control at eyes closed state. ConclusionDynamic analysis based on D2 and ApEn topographic maps might be helpful in understand the changes of mental functions after stroke, that can be used in the study of mental function.

OBJECTIVE:To optimize the ultrasonic extraction technology for Tianshu capsules. METHODS:Using the transfer rate of active ingredient ferulic acid in Ligusticum chuanxiong and gastrodin in Gastrodia elata of Tianshu capsules as investigation indexes,L9(34)orthogonal design test was adopted to investigate the effects of ethanol volume fraction,ethanol amount,extraction time and ultrasonic power on the extraction rate. Ultrasonic extraction technology for Tianshu capsules was optimized,and verifica-tion test was carried out. RESULTS:The optimized extraction technology for Tianshu capsules was as follow as 8-fold 70% etha-nol,extracting twice under 350 W,extracting 1.5 h every time. Results of verification test showed the average transfer rate was 94.06% for ferulic acid(RSD=0.18%,n=3)and 95.02% for gastrodin(0.47%,n=3). CONCLUSIONS:The optimized tech-nology is rapid,simple,stable and feasible,and can be used for extracting the active ingredients in Tianshu capsules.

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 explore the effects of various forms of prostatic apex on positive apical margin rate (PAM) and biochemical recurrence (BCR) after laparoscopic radical prostatectomy. Methods: A retrospective analysis of 309 patients (aging (65±6) years) who were experienced laparoscopic radical prostatectomy from January 2010 to December 2016 at the Department of Urology, First Affiliated Hospital of Fujian Medical University. According to the relationship between prostate apex and membrane urethra at the mid-sagittal plane of preoperative MRI, all patients were classified into 4 categories. There were 31 patients for type 1, apex covering both anterior and posterior aspects of membranous urethra, 139 patients for type 2, apex covering anterior side of membranous urethra, 63 patients for type 3, apex covering posterior aspect of membranous urethra, 76 patients for type 4, apex not covering membranous urethra. PAM and BCR after operation were compared between this four groups respectively. The χ² test was used to compare PAM among the 4 types. Logistic regression analysis were undertaken to analyze the factors affecting PAM. Cox′s proportional hazards regression model was undertaken to identify the variables influencing BCR. Results: There was no significant difference in the 4 groups concerning age, body mass index, prostate volume, preoperative prostate-specific antigen (PSA) value, postoperative Gleason score and pathological stage (P>0.05).The median follow-up time was 32 months (ranged from 12 to 60 months).The data showed that the apical type 3 patients has the highest PAM. There was statistical difference among the 4 groups in PAM (χ²=15.592, P=0.001). Preoperative level of PSA (OR=20.356, 95% CI: 2.440 to 169.810, P=0.005), postoperative Gleason score (OR=4.113, 95% CI: 1.911 to 8.849, P=0.001), pathological stage (OR=3.422, 95% CI: 1.600 to 7.319, P=0.002) and apical type 3 (OR=6.134, 95% CI: 2.196 to 17.132, P=0.001) were independent relactive factors of PAM. Preoperative level of PSA (HR=1.362, 95% CI: 1.006 to 1.843, P=0.045), postoperative Gleason score (HR=1.920, 95% CI: 1.384 to 2.665, P=0.001), pathological stage (HR=1.476, 95% CI: 1.098 to 1.983, P=0.010), PAM (HR=3.497, 95% CI: 2.407 to 5.081, P=0.001)and apical type 3 (HR=1.828, 95% CI: 1.266 to 2.639, P=0.001) were independent prognosis factors of BCR. Conclusion Prostate apical type 3 could be a significant independent predictor of PAM, and an independent prognosis factor for BCR.