Two-stage estimation on adjustment for cross-over in oncology trials / 中国临床药理学与治疗学

AIM: To investigate the application of two-stage estimation (TSE) on adjustment for treatment switch in oncology trials. METHODS: The theory and implementation of TSE method was described, and was applied to adjust the data from a two-arm randomized controlled trial of anti-tumor drugs. The changes of survival curves and hazard ratio of two groups after adjustment for cross-over were evaluated. In addition, the results of two-stage estimation and rank preserving structural failure time model (RPSFT) were compared. RESULTS: After adjustment for cross-over using TSE methods, the results showed that the median survival time of control group was shorter than the original one, and the hazard ratio was lower than the observed value. Moreover, TSE method showed similar results to rank preserving structural failure time model. CONCLUSION: The TSE method is relatively simple to use, reliable and has a good practice property in cross-over analysis of oncology trials. At the same time, it is necessary to pay attention to its application scopes.

Risk factors of mortality in painful chronic pancreatitis / 中华胰腺病杂志

Objective To investigate the survival of patients with painful chronic panereatitis and evaluate the risk factors for mortality in these patients.Methods This was a historical cohort study,subjects ≥18 yr with painful chronic pancreatitis who were treated in our center from Feb.1997 to July 2007 were enrolled.A life-table method was used to estimate the probability of the cumulative survival rate.COX proportional-hazards model was used for multivariate analysis.Results Follow-up data were obtained from 346 patients (87.2%) with the ratio of male/female was 2.4:1.The age of first admission and first symptom onset was (47±14)years and (43±15 ) years.The mean follow-up period was ( 34.3±27.1 ) months.Alcoholic origin accounted for 22.2% of all the patients,while biliary origin was 26.0%.The overall mortality rate was 9.8% (34/346),which happened (62.5±61.1 ) months after abdominal pain was present.The causes of mortality included pancreatic cancer and cancers of other sites.The cumulative survival rate estimated at 2 years was 96.3%,at 5 years 93.6% and at 10 years 86.4%.COX proportional-hazards model suggested age at onset (≥51 years),no improvement of abdominal pain or increased frequency of pain,active smoking,and no diarrhea were associated with increased mortality,and the corresponding hazard rates (HR) were 3.4,3.5,4.2,2.8 and 17.7,respectively.Conclusions The mortality rate of painful chronic panereatitis in China was lower than those reported outside China.The main cause of mortality was pancreatic cancer.Great caution shall be placed on patients with age at onset ≥51 yr,no improvement of abdominal pain,increased frequency of pain,active smoking and no diarrhea.

Safety evaluation of edaravone in clinical application / 中华神经科杂志

Objective To analyze the adverse drug reactions(ADRs)of edaravone in treatment of patients with acute cerebral infarction(ACI)by reviewing Chinese medical literature and to evaluate safety of edaravone treatment in ACI.Methods Publications from Pubmed and Chinese Biomedical Literature Datababe(CBMdisc)were reviewed and the ADR of edaravone was analyzed among the published 8645 cases.Literatures about randomed-control clinical trails(RCTs)on security of edaravone for treating ACI Was analyzed by meta-analysis.Results Abnormal hepatic function,especially mild elevation of aminotransferase,renal dysfunction and skin rash induced by edaravone were tIle most common ADRs.Among 8645 patients,ADRs were reported in 283(3.27 % ).The meta-analysis in RCTs showed that between the group treated with a combination of edaravone and routine and the group treated with routine treatment only,there was no significant difference in the occurrence rate of ADRs(OR=1.18,95 % CI0.70-2.00,P=0.536),elevation of aminotransferase(OR=1.23,95 % CI 0.57-2.68,P=0.595)or renal dysfunction including albuminutia,increased level of serum ereatinine and nitrogen(OR=1.65.95 % CI0.57- 4.79.P=0.353).Conclusion Edaravone has a low ADRs OCCurrence rate and iS safely used in cerebral infarction treatment.

Risk factors of failure in pain resolution in chronic pancreatitis after endoscopic treatment / 中华消化内镜杂志

Objective To evaluate the risk factors of failure in pain resolution in chronic pancreatitis(CP)after endoscopic treatment.Methods We undertook a retrospective cohoa study of subjects with pain caused by CP,who underwent endoscopic treatment from January 1997 to December 2006.Cox proportional-hazards model was used for multivariate analysis of the variables that were possibly related to failure of treatment.Results Follow-up data were obtained from 172 patients(114 males and 58 females,mean age 39.4 yr.Pain resolution after endoscopic treatment was achieved in 148(86.0%).Cox proportional-hazards model showed risk factors of failure in pain resolution after endoscopic treatment were onset age(＞36 years,hazard rate(HR)=3.5),mild and moderate abdominal pain before endoscopy(HR=2.4),no decrease in amount alcohol consume(＜50%,HR=1.9)and inappropriate diet(HR=2.8).Conclusion Patients with CP should abstain from alcohol and have low-fat diet,especially for those with pain onset at older ages (＞36 years)and with mild and moderate abdominal pain before endoscopic treatment.

The incidence and risk factors of pancreactic cancer in adult patients with chronic pancreatitis / 中华消化杂志

Objective To investigate the incidence and risk factors of pancreatic cancer in patients with painful chronic pancreatitis (CP). Methods Three hundred and ninty-seven patients with painful CP were recruited between Jan. 1997 to July 2007. A life-table method was used to estimate the cumulative probability of the incidence of pancreatic cancer. Cox proportional-hazards model was used for multivariate analysis of the variables including age, sex, drinking and smoking habits, etiological factor, presence of pancreatic masses, pancreatic calcifications, measure of intervention, diabetes mellitus, diarrhea, weight loss and degree of pain. Results Of 397 patients,346 (87.2%) were follow-up for (34.3±27.1)months with 244 males and 102 females(2.4 :1). The mean age of the patients were (47.7 ±13. 7) years and alcoholic origin accounted for 22. 2%. The incidence of the pancreatic cancer was 8.1 % (28/346). There was a high incidence of cancers during the 4 years after the episodes of abdominal pain. The cumulative risks of pancreatic cancer 1, 5 and 10 years after the episodes of pain were 5 %, 5.6% and 11.6% respectively. Cox proportional-hazards model selected age at onset (≥51 years) [hazard rate(HR) = 3. 1], pancreatic calcifications ( HR = 4.1) ,pancreatic masses ( HR = 7. 1 )], no improvement of abdominal pain ( HR = 3. 8), increased frequency of pain (HR= 6.8), no diarrhea (HR= 15.3) as variables identified with pancreatic cancer in painful CP patients. Conclusions Pancreatic cancer should be suspected in patients with CP. The risk factors of pancreatic cancer are age at onset (≥ 51 years), pancreatic calcifications, pancreatic masses, no improvement of abdominal pain, increased frequency of pain and no diarrhea.

Risk factors for diabetes mellitus in patients with chronic pancreatitis / 中华消化杂志

Objective To investigate the incidence of diabetes mellitus and risk factors for the disease in chronic pancreatitis (CP) patients.Methods A historical cohort study on subjects with painful CP who were admitted to hospital from Jan.1997 to July 2007 were conducted.A life-table method was used to estimate the cumulative probability of the development of diabetes mellitus once clinical onset of abdominal pain.Cox proportional-hazards model was used for multivariate analysis of the variables including age,sex,drinking and smoking habits,etiological factor,presence of pancreatic masses,pancreatic calcifications,measure of intervention,diarrhea,weight loss and degree of pain.Results Data were obtained from 354 patients (239 males,mean age at onset of pain (38.1±17.6) years;alcoholic origin 18.1%) with painful CP.The mean follow-up period was (45.2±32.9)months.The rate of diabetes mellitus in CP patients was 16.1%.There was a high incidence (29.8%)of diabetes mellitus 1 year before the episodes of abdominal pain.The cumulative risk of diabetes mellitus in subjects 5 and 10 years after the episodes of pain was 9.3% and 20.7%,respectively.Cox proportional-hazards model selected smoking (＞10 pack years) (hazard rate (HR)= 3.3),mild abdominal pain (HR=5.2),weight loss (HR = 2.6) and pancreatic calcifications (HR = 2.2) as variables identifying subjects with diabetes mellitus in patients with painful CP before they were performed therapeutic endoscopy or surgical intervention.Smoking (＞10 pack years) (HR = 3.0),weight loss (HR= 2.8) and distal pancreatectomy (HR =7.3) were identified with an increased risk of diabetes mellitus in these cases after they received therapeutic endoscopy or surgical intervention.Conclusion The risk factors of diabetes mellitus for CP appears to be independent of smoking (＞10 pack years),mild abdominal pain,weight loss,pancreatic calcifications and distal pancreatectomy.