Background/Aims: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy. Methods: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset. Conclusions Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

Objective To select the effective parts of blood nourishing and to investigate the utilization of fuzzy matter-element model in evaluating the effect of blood nourishing of Angelica's different extracted parts.Methods KM mice half males and half females were randomly divided into 10 groups,including blank control group,model group (blood-deficiency),positive control group (Complex Prescription Glue Mucilage:0.02 mL· g-1),experimental group consisted by 7 different extracted parts of Angelica (3.4 g kg-1 Angelica herbs) Acetylphenyhydrazine (APH) and cyclophosphamide (CTX) were used to copy the blood-deficiency model mice by administration APH at the second day (20 mg · kg-1) and the fifth day (40 mg · kg-1) respectively,since the fifth day,ip CTX 40 mg · kg-1 everyday,once a day for four days.Periphera hemogram and organ index,including thymus index (TI),spleen index (SI),were detected at the 10th day.Then using Fuzzy Matter-element model on variation coefficient weight.Results The TI,SI,red blood cell (RBC),platelet count(PLT),hematokrit (HCT),hemoglobin (HGB),white blood cell (WBC) were (7.70 ± 1.81) × 10-2,(56.90 ± 12.23) × 10-2,8.44 ± 1.59,1453.10 ± 102.50,56.54 ± 6.69,170.00 ± 26.39,2.10 ± 0.49,respectively in model group.The 70％ ethanol impregnation part (part 2) for TI,SI,RBC,PLT,HCT,HGB,WBC were 0.10 ± 2.66 ×10-2,(33.83 ±8.97) × 10-2,11.94 ±2.07,1749.60 ±211.50,55.53 ±9.42,55.53 ±9.42,2.60 ± 0.47,respectively.The part 2 can increase TI,RBC,PLT,HCT,WBC and reduce SI,HGB.Compared with model group,the difference was statistically significant in SI,RBC,PLT,HCT,WBC (P ＜ 0.05 or P ＜ 0.001).There were no significant differences between part 1 and part 2 (P ＞ 0.05).Combining with the result of the value of Euclid approach degree,in part 1-7,the maximum is 0.50 (part 2),is greater than 0.40 (part 1).Conclusion The 70％ alcohol impregnation part is the effective part of blood nourishing.The method and model can be used to objectively evaluate the comprehensive effect of blood nourishing of Angelica's different extracted parts.

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
Clinical Trials as Topic ; methods ; standards ; Humans ; Moxibustion ; methods ; standards ; Randomized Controlled Trials as Topic ; Research Design ; standards

OBJECTIVETo investigate the clinical characteristics, diagnosis and treatment of digestive tract leakage after orthotopic liver transplantation (OLT).

METHODSSixty-one recipients had digestive tract leakage in early stage after OLT among 1173 cases from January 2000 to December 2010. There were 55 male and 6 female patients, aging from 36 to 61 years, with a median of 45 years. Digestive tract leakage included bile leakage (46 cases), gastric leakage (5 cases), duodenal leakage (1 case), jejunal leakage (4 cases), ileal leakage (1 case) and colon transversum leakage (4 cases). Ten of recipients with gastrointestinal leakage had 1 to 3 times of abdominal surgery before OLT. Abdominal drainage was used in 28 cases with bile leakage, and additionally, endoscopic retrograde cholangiopancreatography, endoscopic nasobiliary drainage and stenting were performed for 8 of them, and surgical neoplasty for another 18 patients with bile leakage. Simple surgical neoplasty of perforation was performed for 13 patients with gastrointestinal leakage, and diverticulectomy and neoplasty for 1 case with duodenal leakage, and partial jejunostomy for one severe jejunal leakage. Nutritional support was administered for all of cases.

RESULTSThe incidence rate of digestive tract leakage in early stage after OLT was 5.20% (61/1173). Intra-operative iatrogenic injury of gastrointestinal tract was occurred in 6 cases with gastrointestinal leakage. After treatment, 11 cases died of multiple organ failure resulted from severe infection, with mortality of 18.0% (11/61), including 4 cases with bile leakage, with the mortality of 8.6% (4/46), and 7 cases with gastrointestinal tract leakage, with the mortality of 46.6% (7/15). The remanent 50 cases through comprehensive treatment with a span of 1 to 3 months recovered and discharged healthily. No digestive tract leakage reoccurred in the follow-up of 6 to 84 months.

CONCLUSIONSThe morbidity of digestive tract leakage in early stage after OLT is low, but its mortality is high, especially for gastrointestinal tract leakage. High dose corticosteroids therapy, history of abdominal operation and intra-operative iatrogenic injury may be high risk factor. Comprehensive treatment is crucial for improving prognosis.

Adult ; Digestive System Fistula ; diagnosis ; etiology ; therapy ; Drainage ; Female ; Humans ; Liver Transplantation ; adverse effects ; Male ; Middle Aged ; Postoperative Complications ; diagnosis ; therapy

OBJECTIVETo summarize the treatment outcomes after combined en bloc liver and pancreas transplantation.

METHODSFive patients with end-stage liver disease and type 2 diabetes mellitus received combined en bloc liver and pancreas transplantation after hepatectomy.

RESULTSFive operations were performed successfully. The operative time ranged from 9 to 16 hours and blood loss from 1600 to 3000 ml. Postoperatively, one patients developed pulmonary infection, one died of graft-versus-host disease(GVHD), and one experienced acute renal failure. No intestinal fistula, anastomotic leakage, biliary complications, chronic and acute rejection and pancreatitis were seen. Liver function index including alanine aminotransferase, aspartate aminotransferase and total bilirubin returned to normal levels a week after surgery, while levels of C peptide and blood glucose resumed within 1 to 2 weeks. Apart from 1 case died of GVHD, the other 4 maintained normal liver function during the follow up ranging from 2 to 23 months and no insulin was required for the diabetes.

CONCLUSIONCombined en bloc liver and pancreas transplantation is technically feasible and an effective treatment for multi-organ diseases.

Adult ; Diabetes Mellitus, Type 2 ; complications ; surgery ; Female ; Humans ; Liver Failure ; complications ; surgery ; Liver Transplantation ; Male ; Middle Aged ; Pancreas Transplantation ; Retrospective Studies

OBJECTIVETo investigate the effect of Campath-1H induction on immunosuppression in small intestine transplantation.

METHODSClinical data of a patient who underwent small intestine transplantation were retrospectively summarized.

RESULTSIntraoperative Campath-1H induction by intravenous injection was administered. Triple immunosuppression(FK506, MMF and methylprednisolone) was used postoperatively. The lymphocyte and leukocyte decreased significantly following Campath-1H induction, and returned to normal after adjusting the dose of immunosuppressant and use of colony stimulating factor. There were no acute rejection, graft versus host disease, or severe infection during the immediate postoperative period. The patient recovered and discharged.

CONCLUSIONIntraoperative Campath-1H induction and postoperative triple immunosuppression using FK506, MMF, and methylprednisolone may prevent rejection and graft versus host disease in the early stage after small intestine transplantation.

Adult ; Alemtuzumab ; Antibodies, Monoclonal, Humanized ; therapeutic use ; Graft Rejection ; prevention & control ; Humans ; Immunosuppression ; Immunosuppressive Agents ; therapeutic use ; Intestine, Small ; transplantation ; Male ; Retrospective Studies

OBJECTIVETo evaluate the influence of simultaneous pancreas-kidney (SPK) transplantation on the quality of life of diabetic recipients with end-stage renal disease.

METHODSWe performed a retrospective analysis of the data of diabetic patients with end-stage renal disease and evaluated the quality of life of the recipients using SF-36 health survey.

RESULTSOne patient died of cerebrovascular accident, and 7 patients recovered smoothly. During the follow-up lasting for a mean of 23.3 months, the blood glucose, C-peptide and creatine levels of the patients remained stable. The score of 8 domains of SF-36 of the diabetic recipient at 2 years after SPK transplantation showed a significant improvement compared with that before the operation, similar to that of Chinese normal population(P > 0.05).

CONCLUSIONSSPK transplantation can achieve a significant improvement of the quality of life of diabetic patients with end-stage renal disease.

Adult ; Diabetic Nephropathies ; surgery ; Female ; Graft Survival ; Humans ; Kidney Failure, Chronic ; surgery ; Kidney Transplantation ; methods ; Male ; Middle Aged ; Pancreas Transplantation ; methods ; Postoperative Period ; Quality of Life ; Retrospective Studies ; Surveys and Questionnaires

OBJECTIVETo investigate the safety and feasibility of steroids minimization immunosuppressive regimen in liver transplantation.

METHODSOne hundred and sixteen patients in line with the selecting criteria from January 2005 to June 2008 were divided into three groups according to the withdrawal of steroids: 40 cases in 3 months withdrawal group, 40 cases in 7 d withdrawal group and the other 36 cases in 24 h withdrawal group. The difference of recipients' survival, infection, acute rejection and steroids resistant acute rejection, wound healing, recurrence of HBV and hepatocellular cell (HCC), new on-set of diabetes, hyperlipidemia and hypertension between the three groups were compared.

RESULTSThe difference of recipients' survival, acute rejection including steroids resistant acute rejection, recurrence of HBV and HCC, hyperlipidemia between the three groups were not significant (P > 0.05), the incidence of wound un-healing and hypertension in 24 h withdrawal group was significantly lower than that in the other 2 groups (P < 0.05), the incidence of infection and new on-set diabetes in 24 h withdrawal group and 7 d withdrawal group was significantly lower than that in 3 months withdrawal group (P < 0.05).

CONCLUSIONSteroids minimization immunosuppressive strategy is safe and feasible in liver transplantation field, it will significantly reduce the steroids related complications without increasing the risk of rejection.

Adult ; Female ; Follow-Up Studies ; Graft Survival ; Humans ; Immunosuppression ; methods ; Immunosuppressive Agents ; administration & dosage ; therapeutic use ; Liver Transplantation ; Male ; Middle Aged ; Postoperative Care ; Prognosis ; Retrospective Studies ; Steroids ; administration & dosage ; therapeutic use ; Young Adult

OBJECTIVETo investigate the causes and treatment of postoperative gastrointestinal bleeding after orthotopic liver transplantation (OLT).

METHODSClinical data of 776 patients after OLT between January 2000 and December 2006 were analyzed retrospectively.The experiences in diagnosis and treatment of postoperative gastrointestinal bleeding after OLT were reviewed.

RESULTSGastrointestinal bleeding occurred in 18 patients (2.3%) after OLT, among whom 8 (44.5%) were from peptic ulcer, 3 (16.7%) from gastric and esophageal varices, 3 (16.7%) from gastroduodenitis, 3 (16.7%) from hemobilia, and 1 (5.6%) had diverticular bleeding in the jejunum. These 18 patients with gastrointestinal bleeding were managed with conservative treatment, endoscopic treatment, radiological interventional embolism,or exploratory laparotomy. Five patients died of gastrointestinal bleeding and the gastrointestinal bleeding-related mortality rate was 27.8%. After a mean follow up of 3.5 years, only 1 patient died of recurrence of hepatic cellular carcinoma while others survived disease-free.

CONCLUSIONSGastrointestinal bleeding may occur from different sites after OLT and the mortality is high. Prompt identification of the source of bleeding and correct management are required to improve the prognosis.

Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Female ; Gastrointestinal Hemorrhage ; etiology ; prevention & control ; Humans ; Liver Transplantation ; adverse effects ; Male ; Middle Aged ; Postoperative Hemorrhage ; prevention & control ; Retrospective Studies ; Young Adult

OBJECTIVETo assess the indication, surgical and post-operative complications of the multivisceral transplantation.

METHODSThe post-transplant complications of 8 patients who underwent multivisceral transplantation between May 2004 and May 2010 were analyzed. There were 7 male and 1 female, aged from 28 to 65 years. Five patients who suffered from non-resectable advanced upper abdominal malignancy experienced the liver, stomach, spleen, pancreas, duodenum, omentum and variable amounts of the colon resection, and then underwent standard multivisceral transplantation (included liver, stomach, pancreaticoduodenal and small bowel). After underwent hepatectomy while retaining the native pancreas and entire gastrointestinal, three recipients with end-stage liver cirrhosis and type 2 insulin-dependent diabetes mellitus (IDDM) was performed combined en bloc liver/pancreaticoduodenal transplantation.

RESULTSSince the third day post-operation, all recipients no longer needed exogenous insulin and had normal blood glucose concentrations. Two weeks after transplantation, their liver function almost became normal. For the 5 recipients who suffered abdominal malignancy, the longest survival period was 326 days. Cause of death are recurrent tumor (n = 2), multiple organ failure (n = 3). All the 5 patients experienced infection. For 3 patients suffered cirrhosis and IDDM, the longest survival was over 18 month. Excepting the case 8 died of graft versus host disease, all were still living without apparently post-transplant complication.

CONCLUSIONSMultivisceral transplantation is an alternative in the treatment of the patients with benign massive abdominal pathologies. Careful patient selection and technical modification are crucial to improve the outcome of these patients.

Abdomen ; surgery ; Adult ; Aged ; Duodenum ; transplantation ; Female ; Follow-Up Studies ; Humans ; Liver Transplantation ; Male ; Middle Aged ; Organ Transplantation ; Pancreas Transplantation ; Retrospective Studies