Objective To investigate the preventive effect of oral ulcer using two methods in radio-therapeutic patients after tongue squamous cell carcinoma operation. Methods Thirty-six radiotherapeutic patients after tongue squamous cell carcinoma operation were collected from May 2012 to May 2014 and divided into control group and treatment group according to the random number table method. Regular oral nursing was administered to control group, treatment group were received regular therapy plus orally vitamin B and cetylpyridinium chloride gargle for gargling, and then evaluated the efficacy according related standards. Results Less oral ulcer (1/18 vs.7/18,χ2=-2.372,P<0.05), better oral lustration (Z=-2.093,P<0.05) and overall oral nursing effect (Z=-2.166,P<0.05) were observed in treatment group compared to control group after 7 days of therapy, however, treatment group presented no significantly better comfort level at the same time (Z=-1.708,P>0.05). Conclusions Regular therapy plus orally vitamin B and cetylpyridinium chloride gargle for gargling are effective for the prevention of oral ulcer in radiotherapeutic patients after tongue squamous cell carcinoma operation.

Objective To optimize ethonal extraction technology for no sugar runfei granules.Methods Ethanol was used as a solvent to extract the ethanol dissolvable ingredients in 9 kinds of medicinal materials.The formula L9 (34 ) table was used to examine the effects of 4 factors and 3 levels.The weighted sum of baicalin content and the dried extract quantity was used as quantitative index.Results The maximize optimize condition for extraction of ethanol dissolvable ingredients was as follows:9 kinds of medicinal materials, add of 10-fold 70% ethanol solution, soaked for 45 min, and extracted by heating reflux for 3 times,1.5 h each time.Conclusion The method can maximize extraction of ethanol dissolvable effective ingredents in 9 kinds of medicinal materials and can be used as ethonal extraction technologgary of no sugar runfei granules.

Recently, microRNAs (miRNAs) have been shown to be involved in multiple biological pathways that can influence tumor progression and metastasis and they can serve as prognostic biomarkers in many cancers. The present study examined the prognostic significance of miR-215 in cervical cancer. The paraffin-embedded paired cervical scrape samples and tumor tissue samples from 302 patients with stage II cervical cancer were detected for the expression of miR-215 by using qRT-PCR. A miR-215-based classifier was established by using the Cox regression model. The prognostic and predictive accuracy of this classifier was determined in both the internal testing group of 138 patients, and the external independent group of 280 patients. Moreover, cervical cancer HeLa cells overexpressing miR-215 (HeLa-miR-215) were constructed and subcutaneously injected into the nude mice to examine the effect of miR-215 on tumor growth and metastasis in vivo. The results showed that the expression level of miR-215 was significantly higher in cervical cancer tissues than in paired normal tissues (P<0.0001). When patients were classified into high- and low-risk cancer progression groups according to miR-215 level, the 5-year disease-free survival in high- and low-risk groups were 43% (95% CI: 32.1-51.6) and 67% (95% CI: 48.6-77.3) (hazard ratio [HR] 2.02, 95% CI: 1.16-3.52; P=0.013) respectively. Moreover, the expression level of miR-215 was negatively associated with survival rate in patients at TNM stage T3 (HR: 3.317; 95% CI: 1.18-5.14, P=0.017) and TNM stage T4 (HR: 3.48; 95% CI: 1.49-4.45, P=0.008). Tumor volume in nude mice injected with HeLa-miR-215 cells was significantly larger than that in mice injected with control HeLa cells. It was concluded that the expression level of miR-215 is associated with cervical tumor progression and worse survival rate, suggesting that it may serve as a potential prognostic marker to identify patients at higher risk of recurrence.

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.

Aged ; Aged, 80 and over ; Blood Platelets ; chemistry ; Humans ; Receptor, PAR-1 ; blood ; Receptors, Thrombin ; blood ; Renal Dialysis ; Uremia ; blood ; therapy

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.
Clinical Trials as Topic ; Data Collection ; standards ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards

MP-Rep fusion gene which size is about 1000bp was constructed by recombinant PCR technique.In order to construct fusion gene,Tobacco mosaic virus(TMV) partial movement protein gene(MP) and Cucumber mosaic virus(CMV) partial replicase gene(rep) were ligated.Two copies of MP-Rep fusion gene were ligated with soybean intron in inverted repeat manner,the recombinant fragments were then inserted into binary vector pBIN438 under the control of 35S promoter.Recombinant clone pBIN438-MP-Rep(i/r) which contained two different virus derived genes was constructed.Recombinant clone pBIN438-MP-Rep(i/r) in accord with expected design was certified by restriction endonuclease enzymes digestion and PCR analysis.This approach provides a basis for Broad-spectrum plant virus resistance mediated by RNA Silencing.

Objective To analyze oncological outcomes of 125I permanent implant brachytherapy (125I-PIB) in clinically localized prostate cancer. Methods Between June 2008 and June 2015, 121 patients with clinically localized prostate cancer were treated with 125I-PIB, and their average age was 72.37 years old. Before treatment, the average prostate-specific antigen (PSA) level was 17.7 ng/ml, prostate volume was (51.4 ±15.0) cm3, the International Prognostic Scoring System (IPSS) score was (21.6 ±2.4) scores. The intermediate-risk and high-risk patients were treated with adjuvant endocrine or supplemental external beam radiotherapy. All patients were followed-up. Biochemical recurrence was defined as the PSA nadir plus 2.0 ng/ml. Results Average follow-up time of the 121 patients was 41.81 months. The prostate volume was (23.1 ± 10.2) cm3, and the IPSS score was (9.7±3.3) scores. Rates of 5-year overall survival, biochemical recurrence-free survival and cancer-specific survival were 86.7 %, 76.7 % and 96.5 %, respectively. 5-year biochemical recurrence-free survival rates were 88.5 %, 67.5 % and 65.2 % in the low-, intermediate-, and high-risk groups, respectively. Biochemical recurrence-free survival did not differ significantly by three risk groups (P=0.103), but the difference between high-risk and low-risk groups was statistically significant (P=0.028). According to multivariate analysis, higher prostate-specific antigen (P=0.021), higher Gleason score (P=0.023) and higher clinical T stage (P=0.037) were the significant covariates associated with biochemical recurrence-free survival. The addition of hormonal therapy or external beam radiation therapy was associated with significantly better outcomes than brachytherapy monotherapy (P=0.036, P=0.027). As for complications, there were 4 cases of surgery (trans-urethral resection of the prostate) and 4 cases of cardiovascular complications. Conclusions The 125I-PIB can bring excellent oncological outcomes and acceptable complications in patients. Adjuvant endocrine or external beam radiotherapy for the intermediate-risk and high-risk patients may improve the outcome. Factors influencing efficacy include the high PSA, Gleason score and clinical T stage.

Objective To detect the protective effect of extracorporeal membrane oxygenation (ECMO) on Maastricht type Ⅱ donation after cardiac death (DCD) liver transplantation in pigs.Methods Twenty mini-pigs were randomized into ECMO group (n =10) and control group (n =10).Then 10 pigs in each group were randomized into donors and recipients.Maastricht type Ⅱ DCD model was induced in all of the 10 donors.Donors of ECMO group received 2-h ECMO after cardiac death,then underwent liver graft procurement.The donors of control group underwent liver procurement directly after cardiac death.Recipients of two groups underwent orthotopic liver transplantation without venovenous bypass.During this procedure,vital signs were monitored continuously,lactate and liver biochemistry were tested,and 5-day survival rate was observed.Results Maastricht type Ⅱ DCD model was successfully built in all of the donors with consequent dark liver.For donors of ECMO group,liver turned sanguinous and soft quickly after treatment of ECMO.There were no significant differences in operation time,anhepatic time and anhepatic hemodynamic changes between these two groups (P ＞ 0.05).As compared with control group,ECMO group had better hemodynamic parameters 30 min after reperfusion,lower lactate,ALT and AST levels 30 min after reperfusion and before closing the abdomen,and higher 5-day survival rate (P ＜ 0.05).Conclusion ECMO may improve the quality of Maastricht type Ⅱ DCD liver graft,and increase the survival rate of DCD liver transplantation.

OBJECTIVESTo research the effects of supracondylar fractures of humerus treated by three different surgical methods.

METHODSThere were 103 patients with supracondylar fractures of humerus including 58 male and 45 female. The age was from 3 to 12 years old with the average of 7.4 years. To divide the cases into three groups by the operative approach in the humerus, the inside approach were in 37 cases (group A), the outside in 35 cases (group B) and the rear in 31 cases (group C). Comparing the reduction of the stretching and bending function of elbow joint and incidence of elbow varus.

RESULTSAll patients were followed-up for 1.5 to 8 years after operation with the average of 32 months. The reduction of stretching and bending function of elbow joint occurrenced in 6 cases in group A, 6 cases in group B and 25 cases in group C, the incidenc of group C were obvious more than group A and B (P < 0.01). The elbow varus occurred in 8 cases in group A, 17 cases in group B and 7 cases in group C, the incidence of group B were obviously more than group A and C (P < 0.05).

CONCLUSIONThere are different effects between three kinds of operative approaches in the humerus. The incidence of outside group is higher on the varus of elbow. The incidence of rear group is higher on the ability of elbow joint stretching and bending. The effect of inside group is sure on the operative approach in the humerus.

Child ; Child, Preschool ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Humeral Fractures ; physiopathology ; surgery ; Humerus ; injuries ; physiopathology ; surgery ; Male