Objective To investigate the prognostic factors of low-and undifferentiated gastric cancer with negative metastasis of lymph nodes.Methods The clinicopathological data of 270 patients with low-and undifferentiated gastric cancer and negative metastasis of lymph nodes who were admitted to the Tianjin Cancer Hospital from January 2002 to December 2007 were retrospectively analyzed.All the patients received radical gastrectomy.One hundred and sixty-one patients had the number of lymph nodes dissected under 15,53 patients had 15-20 lymph nodes dissected,33 had 21-30 lymph nodes dissected and 23 patients with the number of lymph nodes dissected more than 30.Patients were followed up via out-patient examination,phone call and mail till October 2013.The prognosis analysis was done by COX step-wise regression.The survival curve was drawn by KaplanMeier method,and the survival was analyzed using the Log-rank test.Results All the patients were followed up for a median time of 63 months (range,2-103 months).The median survival time was 63 months (range,2-103 months),and the 1-,3-,5-year overall survival rates were 93.0％,69.5％ and 58.5％,respectively.The median survival time of the 161 patients with the number of lymph nodes dissected under 15 was 58 months (range,2-103 months),and the 1-,3-,5-year survival rates were 91.4％,59.3％ and 48.8％,respectively.The median survival time of the 53 patients with the number of lymph nodes dissected between 15 and 20 was 68 months (range,4-95 months),and the 1-,3-,5-year survival rates were 94.3％,84.9％ and 71.7％,respectively.The median survival time of the 33 patients with the number of lymph nodes dissected between 21 and 30 was 68 months (range,34-94 months),and the 1-,3-,5-year survival rates were 100.0％,97.0％ and 87.9％,respectively.The median survival time of the 23 patients with the number of lymph nodes dissected more than 30 was 60 months (range,2-84 months),and the 1-,3-,5-year survival rates were 87.5％,62.5％ and 54.2％,respectively.There was significant difference in the prognosis between the 4 groups (x2 =25.077,P ＜ 0.05).There was significant difference in the prognosis between patients who had 21-30 lymph nodes resected and those had 15-20 lymph nodes resected (x2=3.924,P ＜0.05).Significant difference was also observed in the prognosis between patients who had 15-20 lymph nodes resected and those had more than 30 lymph nodes resected (x2=4.454,P ＜ 0.05),while no significant difference was observed in the prognosis between patients who had lymph nodes resected more than 30 and those had lymph nodes resected less than 15 (x2=0.450,P ＞0.05).The results of univariate analysis showed that gender,age,location and diameter of the tumor,serosal invasion,Borrmann classification,range of gastric resection and the number of lymph nodes dissected were factors influencing the prognosis of patients with low-and undifferentiated gastric cancer and with negative metastasis of lymph nodes (x2 =4.143,12.607,23.665,11.549,26.350,8.059,5.222,25.077,P ＜0.05).The results of multivariate analysis showed that the tumor diameter longer than 5 cm and serosal invasion were the independent factors influencing the prognosis of patients with low-and undifferentiated gastric cancer and with negative metastasis of lymph nodes (HR =1.842,3.084,95％ confidence interval:1.286-2.638,1.956-4.861,P ＜ 0.05).Lymph nodes dissected for 21-30 was the protective factor of prognosis (HR =1.533,95％ confidence interval:1.229-2.248,P ＜ 0.05).Conclusions Lymph nodes dissected for 21-30 during radical gastrectomy may improve the long-term survival of patients.The tumor diameter longer than 5 cm,serosal invasion and the number of lymph nodes dissected (less than 15,15-20 and more than 30) were the independent factors influencing the prognosis of patients with low-and undifferentiated gastric cancer and with negative metastasis of lymph nodes.

Objective To explore gene polymorphism of the C/T genotype of rs1143627 in the promoter of IL-1β gene in male population living in the coastal area of Shandong, and thus to investigate the relationship between the gene polymorphism of IL-1β and gout. Methods A total of 208 gout patients and 210 healthy controls were enrolled. The possible association between the polymorphism of IL-1 β -3 1C/T and gout in Chinese were investigated and genotype frequencies and allelic frequencies was calculated by polymerase chain reaction (PCR)-restriction fragment length polymorphism (RFLP) method. Hardy-Weinberg was used to verify the representativeness of the sample. Comparisons between the groups were performed with χ2 test and t-test. Results The frequencies of CC, CT, and TT genotypes were 32.7%, 43.3% and 24.0%,respectively among gout patients, while they were 31.9%,46.2% and 21.9%, respectively among the controls.There was no statistically difference in IL-1β -31C/T genotype frequencies between gout patients and controls (χ2=0.427, P>0.05). The allele frequencies of C and T in gout cases were different from those in the controls (54.3%, 55.0%; 45.7%, 45.0%; χ2=0.038, P>0.05). Moreover, no association between IL- I β-31 C/T genotypes and risk factors for gout were observed in gout cases by χ2 test. Conclusion Results of the present study suggest that the C/T genotype of rs1143627 in the promoter of IL-1β gene is not associated with gout in male population living in the coastal area of Shandong.

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

OBJECTIVE:To offer the literature basis for clinical safe drug use by literature research about ADR induced by Yishen juanbi pill. METHODS:Using“Yishen juanbi pill”as searching word,related literatures about ADR induced by Yishen juanbi pill were collected from CNKI,and then the occurrence of ADR was summarized and analyzed. RESULTS:A total of 15 literatures were included,involving 58 patients. Primary disease were mainly rheumatoid arthritis (28 cases,48.28%);organs/systems involved in ADR were digestive system (77 cases, 76.24%). Main clinical manifestations were epigastric discomfort, pernicious vomiting,diarrhea,etc. No obvious ADR was found. ADR-inducing dose was mainly 8 g,tid(47 cases,92.16%);ADR-inducing drug combination were two-drug combination (33 cases,56.90%). Fifty-eighe cases of ADR were recovered after treatment,and main treatment was drug withdrawal or symptomatic treatment. CONCLUSIONS:Although Yishen juanbi pill may induce ADR,those ADR can disappear spontaneously after drug withdrawal or the symptoms are recovered after symptomatic treatment. Yishen juanbi pill is a relatively safe Chinese patent medicine of anti-inflammatory,but ADR monitoring should be strengthened during application.

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.

Objective To explore the therapeutic effects and mechanism of bone marrow mesenchymal stem cells (MSC) transplantation in mice autoimmune hepatitis (AIH).Methods AIH model was established in 44 C57BL/6 mice,which were induced by homologous series liver-specific antigen S-100 and Freund's complete adjuvant.After modeling,six mice were collected for AIH model confirming.The other 38 mice were divided into three groups.Fourteen mice of MSC transplantation group (group A) were treated by MSC tail vein injection,12 mice of dexamethasone (DXM) group (group B) were treated by DXM intraperitoneal injection,and 12 mice of PBS control group (group C) received phosphate buffer saline (PBS) intraperitoneal injection.Eighteen mice of healthy control group (group D) weren't modeled and received no treatment.At the 5th and 9th week,the mice weights and serum alanine aminotransferase (ALT) level were tested,mice liver tissues of each group were estimated by pathological examination and Knodell scoring,and spleen T lymphocytes of mice were isolated for proliferation-inhibition examination.The data were analyzed by rank sum test,ANOVA and t test.Results After treatment,mice weights of both group A and B showed upward trend (F=15.678,P＜0.01; F=3.730,P=0.037).Before and after treatment,there was no significant difference in group C (P＞0.05).At the 5th and 9th week,the ALT level of group A and B gradually decreased,there was statistical significance between the time points (F=20.267,P＜0.01; F=4.277,P=0.034).Before and after treatment,there was no significant difference in ALT level of group C (P＞0.05).At the 5th and 9th week,the degree of mice serum ALT reduction of group A was larger than that of group B,and the difference was statistically significant (t=3.566 and 3.218,both P＜0.05).At the 5th and 9th week,the Kondell scores of group A and B gradually decreased,there was statistical significance between the time points (F=8.070,P=0.003; F=6.547,P=0.009).Before and after treatment,there was no significant difference in Kondell scores of group C (P＞0.05).At the 9th week,there was statistical significance in Kondell scores among group A,group B and group C (F =4.477,P =0.029).The in vitro spleen lymphocytes proliferation-inhibition experiment demonstrated that the supernatant of MSC could significantly inhibit the proliferation of T lymphocytes stimulated by S-100 antigen and concanavalin A,the absorbance values were0.267±0.167 vs.0.217±0.128 and0.165±0.187 vs.0.082±0.051 respectively,the differences were statistically significant (t =7.187 and 4.602,both P＜ 0.01).Conclusion MSC transplantation may play a therapeutic role in mice AIH through inhibiting T lymphocyte proliferation.

Objective To compare the clinicopathological features of Borrmann type Ⅳ gastric cancer with other gastric cancer and explore prognostic factors of the patients with Borrmann type Ⅳ cancer.Methods We retrospectively reviewed the clinical data of 671 advanced gastric cancer patients.They were divided into 2 groups:Borrmann type Ⅳ (64 cases) and other macroscopic Borrmann types of cancer (607 cases).Their clinicopathologic characteristics and overall survival data were analyzed.Results Age,sex,tumor size,tumor location,lymph node metastasis,distant metastasis,TNM classification were discrepant between Borrmann type Ⅳ and other macroscopic Borrmann types of cancer.The 5-year survival rate of Borrmann type Ⅳ cancer patients was 20.1％,while it was 40.3％ for other types of cancer (P ＜ 0.05).The 5-year survival rate for Borrmann type Ⅳ gastric cancer and the other type gastric cancer was 50.0％ and 72.0％ at stage Ⅰ,30.0％ and 57.9％ at stage Ⅱ,18.0％ and 28.4％ at stage Ⅲ,and 16.4％ and 20.0％ at stage Ⅳ (all P ＜ 0.05),respectively.Multivariate analyses revealed age,histology differentiation type,tumor size,the Borrmann type carcinoma and tumor stage to be independent prognostic factors for survival.Conclusions Borrmann type carcinoma has unique clinicopathological features compared with other types of gastric carcinoma and is an important independent prognostic factor.

Objective To evaluate negative lymph node count (NLNC) in prediction of prognosis of T3 gastric cancer after radical resection.Method 214 T3 patients of radical gastrectomy with complete clinical and follow-up data between Jan 2003 to Dec 2007 were enrolled.Survival was determined by the Kaplan-Metier method and univariate analysis was done by Log-rank test,Multivariate analysis was performed using the COX proportional hazard regression model.-2loglikelihood value and the hazard ratio (HR) value were used to compared the value of number of lymph node-negative (NLNC) staging and pN staging and lymph node metastasis rate (MLR) in gastric cancer prognosis evaluation.Results Univariate analysis showed that,pN stage (x2 =31.664),MLR stage (x2 =34.123),tumor size (x2 =5.025),type of differentiation (x2 =5.993),Borrmann classification (x2 =5.401),NLNC stage (x2 =37.256) were related to survival (P ＜ 0.05).COX multivariate analysis showed that-2loglikelihood of pN staging is 1 336.761,HR value is 1.464,-2loglikelihood value of MRL staging is 1 335.821,HR value is 1.441.-2loglikelihood value of NLNC staging is 1 326.902,HR value is 1.725.The N0 and N1 staging prognosis in different NLNC staging was significant (P =0.008,P =0.014).Conclusions Sufficient number of negative lymph node prolongs survival and reduces the risk of early recurrence in advanced gastric cancer.

Cinobufacino injection is purified from water extraction of the skin of Bufo bufo gargarizans, which has been widely used for various cancers in clinic with significant anti-tumor effects. Bufadienolides were regarded as the main active constituents of cinobufacino injection in previous reports. In present study, 6 bufadienolides were isolated and purified from Cinobufacino injection. Their structures were identified as 3-epi-ψ-bufarenogin (1), ψ-bufarenogin (2), 3-epi-arenobufagin (3), arenobufagin (4), 3-epi-gamabufotalin (5), and 3-oxo-arenobufagin (6), separately. Among them, 1 and 3 were new compounds, 5 and 6 were new natural products. Compounds 1, 2 and compounds 3, 4 were two pairs configuration isomers at C-3, separately.

Objective To evaluate the postoperative prognosis of the modification of diet in renal disease formula (MDRD) in coronary artery bypass graft surgery (CABG) in hospital or 4 years after hospitalization. Methods Two hundred and seventy-two CABG patients were divided into 3 groups according to the levels of estimated glomerular filtration rate (eGFR) including 35 cases in eGFR < 60 ml/min group, 119 cases in 60 ≤ eGFR < 90 mL/min group and 118 cases in eGFR ≥90 ml/min group. The prognostic factors of CABG patients were analyzed by COX proportional hazards models. Kaplan-Meier survival analysis was used to compare survival curves among the three groups stratified by eGFR levels. The Log-rank statistic was used for comparing between groups. Results By multivariate COX regression adjustment for body mass index, smoking, hypertension, hyperlipaemia, diabetes mellitus, previous MI, perioperative PCI and etc. , the relative risk (RR) of the increasing age for cardiac events was 1.077(95% CI 1.002-1.158,P =0.044). RR of left ventricular ejection fraction (LVEF) was 0.005(95% CI 0.000-0.456,P =0.022). RR of eGFR was 0.968(95% CI 0.948-0.988,P =0.002). The survival rate in the first, second, third and fourth year were same in every group. The survival rate of group with eGFR < 60 ml/min, 60 ≤ eGFR < 90 ml/min and eGFR≥ 90 mL/min was 76.4%, 93.1%, and 96.6%. The survival rates among three groups were statistically significant. In the survival curve of 4 year follow-up after CABG, the survival rate of group with eGFR < 60 mL/min was lower than that of 60 ≤ eGFR < 90 ml/min group and eGFR ≥ 90 ml/min group. Conclusions The preoperative eGFR is an independent risk factor in evaluating cardiac events in hospital and after hospitalization. It has a higher prognosis value in patients undergoing CABG.