Clinical data management,a critical part of clinical trials,plays a decisive role in assuring the accuracy and reliability of the trail results.This article discusses the quality standards of clinical data,introduces the important rules and principles for standardized clinical data management,and reviews the development and current status of clinical data management home and abroad.It is proposed that we should learn the advanced clinical data management modes from international partners and introduce standardized clinical management software from abroad,so as to improve the clinical data management in China.

Objective To study the effect and mechanism of taspine on wound healing and fibroblast proliferation. Methods The effect of taspine on skin wound was observed in vivo. The different concentration of taspine hydrochloride was added to L929 fibroblast cultivated in vitro, and lactate dehydrogenase was detected and MTT method was applied to observe effect of taspine on fibroblast proliferation. Results The local application of taspine 3 mg/Ml and 1.5 mg/mL accelerated the healing of skin wounded. In vitro, 0.01～0.5 μg/mL of taspine hydrochloride showed no effect on the change of lactate dehydrogenase activity and fibroblast proliferation. Conclusion Taspine is a kind of active alkaloid from leontice robustum which can enhance wound healing, its mechanism on wound healing is not by means of accelerating the proliferation of fibroblast, other mechanisms are necessary for being further studied.

Objective To explore the clinical and MSCT manifestations of nontuberculous mycobacteria (NTM) lung diseases.Methods Totally 102 patients with proved NTM lung diseases (NTM group) and 102 patients with pulmonary tuberculosis (TB group) were included in the study.MSCT image and clinical data of patients were retrospectively analyzed.The t/x2 test were used to analyze the differences of clinical and imaging findings between two groups.Results The main clinical symptoms of NTM group were cough,expectoration,hemoptysis and shortness of breath after activity,which had no significant differences between two groups (all P＞ 0.05).NTM lung diseases patients often associated with chronic lung diseases such as pulmonary tuberculosis,chronic obstructive pulmonary disease,pulmonary heart disease.The differences were significant between two groups (all P＜0.05).The main CT manifestations of NTM lung diseases included centrilobular nodules (89/102,87.25％),bronchiectasis (67/102,65.69％) and patchy consolidation (64/102,62.75％).Secondly,fiber cable disease,thin-wall cavities and pleural incrassation were common found.The detection rate of centrilobular nodules,bronchiectasis and thin-wall cavities in NTM group were significantly higher than those in TB group (x2 =3.995,22.675,12.823,respectively,all P＜0.05).Bronchiectasis were often found in the right middle lobe and/or left lingula lobe.Conclusion NTM lung diseases patients often associate with chronic lung disease.The CT manifestations of NTM lung diseases have certain characteristics.Especially when the bronchiectasis occurred in the right middle lobe and/or left lingular lobe and accompany by the centrilobular nodules,thin-wall cavity and antituberculous therapy being invalid,NTM lung diseases should be considered.

OBJECTIVE: To study the effect of taspine hydrochloride (TA/HCl) on skin wound healing in rats and its mechanism. METHODS: Bilateral round wounds were made on the backs of SD rats. The effect of TA/HCl on the skin wound was evaluated through determining closure time and contracting ability of the skin wound, observing histopathological characteristics and measuring contents of hydroxyproline (Hyp) and protein in the wound tissue. RESULTS: The closure time of the skin wounds was significantly shorter in the TA/HCl-treated groups than that in the model group. The percentages of wound contraction were higher in the TA/HCl-treated groups than that in the dimethyl sulfoxide (DMSO) control group of the same group (P<0.05 or P<0.01) on the 3rd to 14th days after wounding. The content of the protein in the wound tissue in the TA/HCl-treated group (2 mg/ml) was higher than that in the model group (P<0.05) on the 3rd to 7th days after wounding, and it arrived at the peak on the 7th day and gradually decreased to the normal level in skin tissue on the 14th to 21st days after wounding. The contents of Hyp in the wound tissues in the TA/HCl-treated groups were higher than that in the model group (P<0.05 or P<0.015) on the 3rd to 21st days after wounding, and they arrived at the peak on the 14th day and at the normal level in skin tissue on the 21st day. Histopathological test results showed that TA/HCl could promote the formation of newly born capillaries in the early period of the wound healing. CONCLUSION: TA/HCl has the ability of promoting skin wound healing in rats, and it can also accelerate the growth of newly born capillaries and raise the production of protein and collagen in wound tissue.

In order to improve the scientific research capability of medical graduates,help them cultivate scientific statistical mind and the ability to resolve actual medical scientific research issues,we made a teaching reform on the teaching objectives,curriculum system,teaching material and informational teaching of Medical Statistics teaching,established a diversified teaching pattern and improved the teaching quality.

Objective To determine the effects of curcumin microemulsion on proliferation and apoptosis of the human leukemia cell line K562 cells.Methods The curcumin microemulsion was prepared with the routine procedure.MTT assay was used to determine cell proliferation in cultured K562 cells,flow cytometry analysis was applied to examine cell apoptosis,and WT1 mRNA was determined with RT-PCR.The results about curcumin microemulsion were compared with these on curcumin.Results The prepared curcumin microemulsion was a stable clear solution with diameter of 10-100 nm.Curcumin microemulsion inhibited K562 cell proliferation by 24％,46％,68％with a 24 h incubation at dose of 2.5 μg/ml,5.0 μg/ml,and 10.0 μg/ml respectively,whereas curcumin reduced the proliferation by 6％,14％,25％at equal concentrations.WT1 mRNA level of curcumin microemulsion group(0.190±0.036)was reduced stronger than that of curcusin group(0.456±0.047).Conclusions Microemulsion is a great carrier for curcumin.Curcumin microemulsion is more effective in inhibiting proliferation,pro-apoptosis,and reducing WT1 gene expression than curcumin.A strong basis of medical value for the use of curcumin microemulsion to treat tumors is provided.

Objective To evaluate the efficacy and safety of the damage-controlling surgery for the elderly patients with obstructive biliary diseases. Methods 278 elderly patients with obstructive biliary diseases were divided into the damage-controlling surgery group and definite surgery group.The obstructive biliary diseases were divided into the benign obstructive group and the malignant obstructive group. The complication rate and mortality between the 2 groups were analyzed and compared. Results One hundred and eighteen elderly patients were treated by damage-contolling surgery, its complication rate was 9.32 % and the mortality was 0 %. One hundred and sixty elderly patients,were treated by definite surgery, its complication rate was 24.38%, the mortality was 6.88%. There were significant differences in complication rate and mortality between the damage-controlling surgery group and the definite surgery group (all P＜0.01). The complication rate of the benign obstructive diseases group treated by damage-controlling surgery was 17.3%, the mortality was 0%. The complication rate of the benign obstructive diseases group treated by definite surgery was 16.3%, the mortality was 4.34%. There was no significant difference in the complication rate and mortality between the 2 groups (all P＞0.05). The complication rate and mortality of the malignant obstructive biliary diseases group treated by damage-controlling surgery were 4.45% and 0% respectively, and were 35.29% and 10.29% by definite surgery, there were significant differences in the complication rate and mortality between the 2 groups (P＜0.01 and P＜0.05). Conclusions Damage-controlling surgery may decrease the complication rate and mortality of the elderly patients with obstructive biliary diseases, and improve the operation safety of the elderly patients.

Objective To investigate the effects of human IL-18 gene combined with diterpenoid alkaloids in inhibiting the proliferation and inducing the apoptosis of tongue squamous carcinoma cells Tscca.Methods We constructed recombinant plasmid pEGFPN3-IL-18 and tranfected it into tongue squamous carcinoma cells Tscca.The transduction efficiency of the target cells was detected by fluorescent microscopy,cytotoxic effect of IL-18 gene with diterpenoid alkaloids on Tscca was detected by MTT assay,and apoptosis was detected by flow cytometry. Western blot was employed to examine the expression level of cellular signal-regulated kinase Akt/p-Akt.Results The tongue squamous cells Tscca which transfected pEGFPN3-IL-18 had significantly increased apoptosis compared with non-transfected cells (P<0 .05 ).Tongue carcinoma squamous cells cultured with diterpenoid alkaloids at the concentrations of 0 .2 ,0 .4 and 0 .6 mg/mL had significantly increased apoptosis in a dose-dependent manner (P<0.05).Human IL-18 gene combined with diterpenoid alkaloids for 48 hours inhibited significantly Tscca in a concentration-dependent manner compared with diterpenoid alkaloids alone (P<0 .05 ).The two in combination could also decrease the protein level of p-Akt dose-dependently.Conclusion The combination of pEGFPN3-IL-18 and diterpenoid alkaloids has a synergistic effect in inhibiting the growth of tongue squamous carcinoma cells Tscca.

Objective: To investigate the cinlical features and therapeutic methods of unex-pected gallbladder carcinoma. Methods: A retrospective analysis was performed in 19 cases of unexpected gallbladder carcinoma treated in our hospital from April 2002 to April 2008. Results: Ten cases in early stage were perfomed gallbaldder resection and local lymph node removal, and the average survival time was 18.7 months; 4 cases were perfomed extend radical resection, and the average survival time was 12.3 months; 5 cases were performed palliative resection, and the survival time was less than 6 months. Conclusions: Frozen section examination during opera-tion is key to diagnose unexpected gallbladder carcinoma. Radical resection is the first option once the diagnosis is confirmed, and the method can be decided according to Nevin classification and B ultrosound scaning during opreation.

Objective:To investigate the surgical indication and effect of surgical treatment for giant cavernous hemangioma of the liver(LHG).Methods:The clinical data,including selection of operations,management for severe operative bleeding and postoperative supplementary treatment,of 15 patients with giant LHG treated by surgical measures from 2003 in our hospital were summarized and assessed.Results:Nine cases accepted decollement of LHG,and the recovery courses were all right,6 cases accepted embolization of hepatic artery,in which 2 cases accepted operation afterward.Conclusions:Decollement or embolization of hepatic artery were effective in the treatment of giant cavernous hemangioma.