We found that the number of institutions made use of the undocumented in vitro diagnostic reagent in the survey. The phenomenon poses some risks and problems. In use this paper, we analyzed the situation and the reasons for the use of the undocumented in vitro diagnostic reagents, and put forward the corresponding measures.
Humans ; Indicators and Reagents ; standards

Based on the characteristics of oncology clinical teaching and the defects of current teaching methods,we launched teaching reform including the combination of basic and clinical medical curriculum,the practice of clinical problem-based learning (CPBL) method and the introduction of some guidance for medical practice.The teaching reform was effective,but there were drawbacks for improvement.

Two villages including a pilot village and a control village in Xuaneheng City were selected.An integrated measure including replacing bovine with tractors for farming,renovating of latrines and water supply,egarRination and treatment of schistosomiasis in humans,snail survey and control,health education wag implemented in the pilot village,while the sarIIe integrated measure except replacing bovine with tractors was implemented in the control village.From 2005 to 2007.the infection rate of snails in the pilot Villge reduced from 0.0630% to 0.but that increased from 0 to 0.000 2% in the control village.Theinfection rates of schistosome in humans in the pilot and control villages reduced by 71.10% and 74.20%.respectively.It is indicatedthat replacing bovine with tlactors for farming Pan decrease the infection rate of schistosome in humans and snails effectively.

Preoperative biliary drainage (PBD) has become an essential part of perioperative management for perihilar cholangiocarcinoma. However, it is controversial about the indication of PBD. There are three main PBD methods, including percutaneous transhepatic biliary drainage, endoscopic nasobiliary drainage and endoscopic biliary stenting. At present, different centers have different preferences on PBD, and the controversies mainly focus on the followings: the relationship between percutaneous transhepatic biliary drainage and seeding metastasis; the success rate, tolerance and pancreatitis risk of endoscopic nasobiliary drainage; as an internal drainage, the merits and demerits of endoscopic biliary stenting. Additionally, whether PBD could increase the incidence of postoperative infections is still ambiguous. This review summarizes the recent scenario about the above-mentioned controversies to provide references for clinical decision-making.

Objective: To investigate the impact of minimal residual disease (MRD) by multiparameter flow cytometry (MPFC) during aplasia on efficacy and prognosis of de novo acute myeloid leukemia (AML) (non M₃) patients. Methods: The MRD data by 8-color MPFC during aplasia (day 14-15 of induction therapy) in 85 de novo AML (non M₃) patients and the MRD impact on efficacy and prognosis were retrospectively analyzed. Results: Data of 85 patients, including 42 males (49.4%) and 43 females (50.6%) , were collected, with a median age of 35 (15-54) years. The median MRD by MPFC during aplasia was 0.58% (0-81.11%) , and 70 (82.4%) patients achieved complete remission (CR) after first induction chemotherapy. The cutoff of MRD by receiver operating characteristic (ROC) analysis was 2.305% (Se= 0.867, Sp=0.800) . The CR rate after one course was significantly higher in patients with MRD<2.305% [96.6% (56/58) ]than in patients with MRD≥2.305%[51.9% (14/27) ] (χ²=22.348, P<0.001) ; no significant difference with respect to relapse-free survival rate (χ²=1.08, P=0.299) or overall survival rate (χ²=0.42, P=0.516) could be demonstrated for the comparison of the two groups. Multivariates analysis showed MRD divided by 2.305% was the only independent prognostic factor for CR after one course (OR= 21.560, 95% CI 4.129-112.579, P<0.001) . Conclusion Flow cytometric MRD divided by 2.305% during aplasia could be a predictor of efficacy after first induction therapy in AML patients.

Objective To investigate the characteristics of NPM-MLF1 fusion gene in acute myeloid leukemia (AML). Methods The data of one AML patient with NPM-MLF1 fusion gene was analyzed,and literatures were reviewed. Results A female patient was diagnosed as AML M6. In the course of the disease, 2 hematologic relapsed, and 2 recurrences were associated with NPM-MLF1 fusion gene positive. After inductive treatment, hematologic complete remission was achieved, and NPM-MLF1 fusion genes were all negative. Survival time surpassed 6 years when the chemotherapy was performed alone. Conclusion The incidence of NPM-MLF1 fusion gene in AML is low. It is necessary to collect more clinical data to judge whether an independent disease type or not.

Objective To compare the clinical outcomes of endoscopic nasobiliary drainage (ENBD) versus percutaneous transhepatic biliary drainage (PTBD) in patients with perihilar cholangiocarcinoma.Methods This retrospective case-control study was conducted on 55 patients with perihilar cholangiocarcinoma who were treated by of hepatobiliary and pancreatic surgeons at the Nanjing Drum Tower Hospital between December 2010 and August 2017.Results There was no significant difference in the effectiveness of the two drainage methods (P＞0.05).Morbidity after drainage was significantly higher in the ENBD group than the PTBD group (86.7％ vs 28.0％,P＜0.05).24 patients in the ENBD group developed postERCP pancreatic complications which included hyperamylasemia (n =20) and pancreatitis (n =4).All these patients responded well to conservative treatment.A patient in the PTBD group developed catheter tract tumor implantation.There were no significant differences in the surgical outcomes and in the different Clavien-Dindo grades of complications (P＞0.05).Abdominal infection after surgery was more common in the PTBD group than the ENBD group (64.3％ vs 26.3％,P＜0.05).Conclusion As PTBD caused catheter tract tumor implantation and increased the incidence of abdominal infection after surgery,ENBD was recommended for patients with perihilar cholangiocarcinoma treated in a tertiary medical center.

Objective:To investigate the influencing factors for pancreatic endocrine and exocrine insufficiency after pancreaticoduodenectomy.Methods:The retrospective case-control study was conducted. The clinicopathological data of 168 patients who underwent pancreaticoduodenectomy in the Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from January 2016 to December 2017 were collected. There were 96 males and 72 females, aged (64±13)years, with a range from 38 to 75 years. Of the 168 patients, 36 had pancreatic endocrine insufficiency while 8 had pancreatic exocrine insufficiency preoperatively. All patients underwent pancreaticoduodenectomy. Observation indications: (1) surgical situations and follow-up; (2) analysis of influencing factors for pancreatic endocrine insufficiency after pancreaticoduodenectomy; (3) analysis of influencing factors for pancreatic exocrine insufficiency after pancreaticoduodenectomy. Follow-up using out-patient examination and telephone interview was performed to detect postoperative condition of blood glucose control, diet and nutrition, tumor recurrence and metastasis up to June 2018. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the independent sample t test. Measurement data with skewed distribution were described as M (range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were expressed as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test. Univariate analysis was conducted using the chi-square test. Multivariate analysis was conducted using the Logistic regression model. Results:(1) Surgical situations and follow-up: all the 168 patients underwent pancreaticoduodenectomy successfully and recovered well after operation. All patients were followed up for 6 months. The level of fasting and postprandial blood glucose of the 168 patients after surgery were 7 mmol/L(range, 5-9 mmol/L) and 10 mmol/L(range, 7-14 mmol/L), respectively. The defecation frequency was (2.4±1.2)times per day. No tumor recurrence or metastasis occurred in either patient. One hundred and thirty-two of the 168 patients were included in the study excepting patients with pancreatic endocrine insufficiency before operation. At postoperative 6 months, 47 patients developed pancreatic endocrine insufficiency, with an incidence of 35.61%(47/132). One hundred and sixty of the 168 patients were included in the study excepting patients with pancreatic exocrine insufficiency before operation. At postoperative 6 months, 68 patients had pancreatic exocrine insufficiency, with an incidence rate of 42.50%(68/160). (2) Analysis of influencing factors for pancreatic endocrine insufficiency after pancreaticoduodenectomy. Results of univariate analysis showed that gender, metabolic syndrome, chronic pancreatitis, excision point, and postoperative chemotherapy were the related factors for pancreatic endocrine insufficiency after pancreaticoduodenectomy ( χ2=5.300, 6.270, 4.473, 4.392, 5.397, P<0.05). Results of multivariate analysis revealed that male and metabolic syndrome were independent risk factors for pancreatic endocrine insufficiency after pancreaticoduodenectomy [ hazard ratio ( HR)=5.252, 5.364, 95% confidence interval ( CI): 1.362-6.382, 1.891-12.592, P<0.05)]. (3) Analysis of risk factors for pancreatic exocrine insufficiency after pancreaticoduodenectomy. Results of univariate analysis showed that body mass index (BMI), chronic pancreatitis, total bilirubin, excision point, postoperative pancreatic fistula as grade B or C, and pancreatic fibrosis were related factors for pancreatic exocrine insufficiency after pancreaticoduodenectomy ( χ2=1.691, 4.910, 7.763, 5.605, 4.663, 7.700, P<0.05). Results of multivariate analysis showed that BMI<18.5 kg/m 2, chronic pancreatitis, total bilirubin ≥171 μmol/L were independent risk factors for pancreatic exocrine insufficiency after pancreaticoduodenectomy ( HR=3.695, 5.231, 7.623, 95% CI: 1.232-7.324, 2.161-6.893, 1.562-5.235, P<0.05). Conclusions:Male and metabolic syndrome are risk factors for pancreatic endocrine insufficiency after pancreaticoduodenectomy. BMI<18.5 kg/m 2, chronic pancreatitis, and total bilirubin ≥171 μmol/L are risk factors for pancreatic exocrine insufficiency after pancreaticoduodenectomy.

Objective:To study the risk factors and microbial spectrum for infectious complications for patients with biliary tract cancer after major hepatectomy with cholangiojejunostomy.Methods:Enrolled into this study were 78 consecutive patients (57 patients with perihilar cholangiocarcinoma, 17 with intrahepatic cholangiocarcinoma and 4 with gallbladder cancer), who underwent major hepatectomy with cholangiojejunostomy at Nanjing Drum Tower Hospital between September 2010 and March 2019. The clinical data were reviewed using multivariate analysis to find independent risk factors for postoperative infectious complications. Microorganisms isolated from bile and infected sites were determined to study the microbial spectrum.Results:A total of 45(57.7%) patients suffered from postoperative infectious complications. Male sex ( OR=7.765, 95% CI=1.895-31.815, P<0.05) was the independent risk factor, whereas increased preope-rative red blood cell (RBC) ( OR=0.151, 95% CI=0.038-0.592, optimal cut-off value=3.7×10 12/L) and increased total cholesterol (TC) on postoperative day (POD) 1 ( OR=0.227, 95% CI=0.083-0.626, optimal cut-off value=3.5 mmol/L) were protective factors (both P<0.05). The area under the receiver operating characteristic (ROC) curve was 0.805 (95% CI=0.707-0.902, P<0.05). 205 and 230 microorganisms were cultured respectively from 286 and 681 specimens which were collected from pre-/intraoperative bile and potentially infected sites. Staphylococcus, enterococcus, acinetobacter, klebsiella and pseudomonas were the most common pathogens on bile culture. The first 5 most frequently isolated microorganisms from the infected sites were enterococcus, staphylococcus, klebsiella, candida and xanthomonas. Sixteen (61.5%) of 26 patients had at least one pathogen being isolated from the infected sites with the pathogen being previously isolated in bile culture. Conclusions:Male sex were independent risk factors of infectious complications. Increased preoperative RBC and inreased TC on POD were proteetive factors. For patients without a positive bile culture, a third-generation cephalosporin can be considered as a prophylactic antibiotic. It is important to identify high-risk patients and monitor perioperative pathogens actively to prevent and to cure postoperative infectious complications.

Objective: To evaluate the incidence of invasive fungal infections (IFI) and usage of intravenous antifungal drugs during remission induction chemotherapy in patients with acute myeloid leukemia (AML) under primary antifungal prophylaxis with posaconazole. Methods: Clinical records from newly diagnosed AML patients above 15 years old in one single center from February 2014 to January 2016 were retrospectively reviewed and analyzed, excluding acute promyelocytic leukemia. The incidence of IFI and usage of intravenous antifungal drugs were investigated between control group (not receiving any broad spectrum antifungal prophylaxis) and treatment group (receiving posaconazole as primary prophylaxis). Results: A total of 147 newly diagnosed AML patients were enrolled. Of them, 81 received prophylaxis with posaconazole, and 66 did not receive broad-spectrum antifungal treatment. 7 IFI occurred in posaconazole group, and all were possible cases; 19 IFI occurred in control group (3 proven, 4 probable, 12 possible). The incidence of IFI was significantly lower in treatment group than that in control group (8.6% vs 28.8%, χ²=10.138, P=0.001). Usage of intravenous antifungal drugs was significantly decreased in posaconazole group (18.5% vs 50.0%, χ²=16.390, P<0.001). Conclusion Prophylaxis with posaconazole coulf prevent IFI and reduce usage of intravenous antifungal drugs significantly during remission induction chemotherapy in AML patients.