Objective:To analyze the clinical application value of a novel magnetic navigation ultrasound (MNU) combined with digital subtraction angiography (DSA) dual-guided percutaneous transhepatic biliary drainage (PTCD) through the right hepatic duct for the treatment of malignant obstructive jaundice.Methods:Randomized controlled trial. The clinical data of 64 patients with malignant obstructive jaundice requiring PTCD through the right hepatic duct at the Hepatobiliary Center of the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People′s Hospital) from December 2018 to December 2021 were retrospectively analyzed. The MNU group ( n=32) underwent puncture guided by a novel domestic MNU combined with DSA, and the control group ( n=32) underwent puncture guided by traditional DSA. The operation time, number of punctures, X-ray dose after biliary stenting as shown by DSA, patients' tolerance of the operation, success rate of the operation, pre- and post-operative total bilirubin, and incidence of postoperative complications were compared between the two groups. Results:The operation time of the MNU group was significantly shorter than that of the control group [(17.8±7.3) vs. (31.6±9.9) min, t=-6.35, P=0.001]; the number of punctures in the MNU group was significantly lower [(1.7±0.6) vs. (6.3±3.9) times, t=-6.59, P=0.001]; and the X-ray dose after biliary stenting as shown by DSA in the MNU group was lower than that in the control group [(132±88) vs. (746±187) mGy, t=-16.81, P<0.001]; Five patients in the control group were unable to tolerate the operation, and two stopped the operation, however all patients in the MNU group could tolerate the operation, and all completed the operation, with a success rate of 100% (32/32) in the MNU group compared to 93.8%(30/32) in the control group; the common complications of PTCD were biliary bleeding and infection, and the incidence of biliary bleeding (25.0%, 8/32) and infection (18.8%, 6/32) in the MNU group was significantly lower than that in the control group, 53.1% (17/32) and 28.1% (9/32), respectively. Conclusion:Magnetic navigation ultrasound combined with DSA dual-guided PTCD through the right biliary system for the treatment of malignant obstructive jaundice is safe and feasible.

Objective To evaluate the efficacy and safety of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local - advanced non - small cell lung cancer with sensitive EGFR mutations. Methods From June 2015 to December 2016,fifty-six eligible patients in Chongqing Three Gorges Central Hospital were randomly assigned into two groups by one to one ratio,with 28 cases in each group.A group received treatment of gefitinib combined with concurrent thoracic radiotherapy, and B group adopted concurrent chemoradiotherapy. The toxic effects were recorded and all patients were followed up as defined by the study protocol.Primary study endpoints included:severe toxic effects,objective response rate and disease control rate,progression free survival and overall survival.Results Twenty-six patients in A group completed the study,and the severe toxic effects were as followed:interstitial pneumonia(3/26),radiation esophagitis(4/26),myelosuppression,skin rashes and gastrointestinal disruption. Twenty- eight patients in B group completed the study, and the severe toxicity included: interstitial pneumonia (4/26),radiation esophagitis(3/26),myelosuppression,skin rashes and gastrointestinal disruption.No toxicity higher than gradeⅢdeveloped in both two groups,and there were no statistically significant differences in incidence rates of interstitial pneumonia and radiation esophagitis between the two groups ( all P >0. 05 ). Moreover, there were no statistically significant differences in ORR and DCR between the two groups( ORR:61.5% vs.39.3% ,P=0.102;DCR:84. 6% vs. 71. 4% , P =0. 505 ). A group showed the benefit over B group in PFS ( 12. 45 months vs. 10.35 months,P=0.036).However,OS didn＇t reach and needed further follow-up.Conclusion The modality of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local -advanced non -small cell lung cancer with sensitive EGFR mutations is safe and effective,and it yet needs further follow-up.

To detect the levels of miR-146a and miR-155 in different samples from chronic hepatitis B (CHB), reveal whether there is a correlation between the 2 miRNAs in different samples, and to provide a theoretical basis for sample choice of miRNA research in liver.
 Methods: Real-time PCR was conducted to examine the expression of miR-146a and miR-155 in the plasma, peripheral blood mononuclear cell (PBMC), and liver tissues from 41 CHB patients who underwent nucleoside analogues antiviral therapy for 104 weeks. Correlations between the levels of miR-146a and miR-155 among the 3 samples were analyzed.
 Results: The expressions of miR-146a and miR-155 in the plasma, PBMC and liver tissues were significantly down-regulated at the 104th week than those at the baseline (all P<0.05). There was a correlation in the expression of miR-146a between plasma and liver tissues (r=0.560, P=0.007), PBMC and liver tissues (r=0.428, P=0.047) at baseline. There was a correlation in the expression of miR-155 between plasma and liver tissue (r=0.587, P=0.004), PBMC and liver tissue (r=0.483, P=0.023) at baseline. The expressions of miR-146a and miR-155 between the plasma and PBMC were not correlated (P>0.05).
 Conclusion: Compared with PBMC, miR-146a and miR-155 from plasma can better reflect the expression in the liver tissues, suggesting that plasma can be applied in the mechanism research on miR-146a and miR-155 in the liver diseases instead of liver tissues.
Hepatitis B, Chronic ; genetics ; Humans ; Leukocytes, Mononuclear ; MicroRNAs ; genetics ; Real-Time Polymerase Chain Reaction

Objective:To investigate expression profiles of the plasma exosomal miRNAs of the chronic hepatitis B (CHB) patients with persistently normal alamine aminotransferase (PNALT) for the first time and try to find exosomal miRNAs which could reflect liver inflammation better.Methods:Five CHB patients with liver tissue inflammation grade ≥A2 of PNALT and 5 CHB patients with liver tissue inflammation grade ＜A2 of PNALT were enrolled and their blood samples were collected.The exosomes were extracted from these blood samples and measured by electron microscope to determine the extraction effect.The exosomal miRNAs were extracted and sent for high throughput sequencing,and the expression of exosomal miRNAs in the 2 groups of patients was analyzed.Results:Under the electron microscope,exosomes were small membranous vesicles with 30-100 nm in diameter.The peak value of particle size ranged from 10 to 100 nm.High throughput sequencing showed that there were 591 differentially expressed exosomal miRNAs between the 2 groups.Compared with the control group,18 exosomal miRNAs were up-regulated and 6 exosomal miRNAs were down-regulated in PNALT patients with the liver tissue inflammation grade ≥ A2.Conclusion:Exosomal miRNAs in the CHB patients with PNALT who have the different grades of liver inflammation are differently expressed.Some of the differently expressed exosomal miRNAs are expected to be sensitive biomarkers for timely assessment of liver inflammation in the CHB patients with PNALT.

Objective To evaluate the accuracy and feasibility of time-resolved immunofluorometric assay (TRI FA) for detection of HBsAg based on Abbott automated chemiluminescence immunoassay(CMIA),so as to carry out this project in primary hospitals,and provide reference for individual antiviral strategy and prediction of therapeutic effect.Methods Serum of 157 patients infected with hepatitis B virus were detected with CMIA and TRIFA,specimens with HBsAg titers exceeding the detection limit were firstly diluted,then performed quantitative analysis.HBsAg levels were divided into 4 groups:≤100 IU/mL,101-1 000 IU/mL,1 001-20 000 IU/mL,and ＞ 20 000 IU/mL,quantitative correlation between two methods was analyzed.Results The linear regression equation of two methods was Y=2.323X-896.3,correlation coefficent r=0.943,P＜0.001.CMIA was as a reference,4 groups were divided for analysis,results showed that when detected specimens was at low concentration of HBsAg,TRIFA value was low compared with CMIA method,while detected specimens was at high concentration of HB sAg,CMIA value was high,two reagents had good consistency in the detection of different concentrations of HBsAg(both P＜0.05),when concentration was at 1 001-20 000 IU/mL,consistency was the best.Conclusion The accuracy of two reagents in the quantitative detection of HBsAg is similar,and the best correlation of detection value is 1 000-20 000 IU/mL.TRIFA assay has wide application for its low-cost and easy to be operated,which is especially suitable for primary hospitals.

Objective:To observe the sensitivity of transcription mediated amplification (TMA),and to compare its performance with real-time reverse transcription polymerase chain reaction (real-time RT-PCR) in detecting human immunodeficiency virus RNA (HIV RNA).Methods:TMA system was established with TaqMan probes,specific primers,moloney murine leukemia virus (MMLV) reverse transcriptase,T7 RNA polymerase,and reaction substrates.The sensitivity of TMA was evaluated by amplifying a group of 10-fold diluted HIV RNA standards which were transcribed in vitro.A total of 60 plasma of HIV infected patients were measured by TMA and Cobas Amplicor HIV-1 Monitor test to observe the positive rate.The correlation and concordance of the above two technologies were investigated by linear regression and BlandAltman analysis.Results:TMA system was established successfully and HIV RNA transcribed standards at concentration of equal or more than 10 copies/mL could be detected by TMA technology.Among 60 samples of plasma from HIV infected patients,46 were positively detected and 12 were negatively amplified by both TMA and Cobas reagents;2 samples were positively tested by Cobas reagent but negatively tested by TMA system.The concordance rate of the two methods was 97.1％ and the difference of positive detection rate between the two methods was not statistically significant (P＞0.05).Linear regression was used for 46 samples which were positively detected by both TMA and Cobas reagents and showed an excellent correlation between the two reagents (r=0.997,P＜0.001).Bland-Altma analysis revealed that the mean different value ofHIV RNA levels for denary logarithm was 0.02.Forty-four samples were included in 95％ of credibility interval of concordance.Conclusion:TMA system has the potential of high sensitivity.TMA and real-time RT-PCR keep an excellent correlation and consistency in detecting HIV RNA.

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

Objective To study the clinical effects and immunological rejection of allogenic bone as autologous bone graft substitute materials in the treatment of developmental dislocation of the hip.Methods Selected 36 chlidren 40 hip joint undergoing Salter innominate osteotomy,shortening and derotational of the femur bone cutting,Allogeneic bone implantation.Results According to the clinical evaluation criteria of Mckay,excellent 32,good 6,satisfaction 87.5％.All 40 cases of hip bone graft healing,complications such as postoperative incisional drainage response,and no obvious immune rejection.Conclusions Allogeneic bone implantion in the treatment of developmental dislocation of the hip is safe.

OBJECTIVETo evaluate the effect of different immune status on the incidence of hepatic lesions in patients with hepatitis B virus (HBV) infection undergoing anti-tuberculosis therapy.

METHODSThe PubMed (1966-2013), Embase (1966-2013), Wanfang (1998-2013), Chinese National Knowledge Infrastructure (CNKI; 1997-2013), and Chinese Biomedical (CBMdisc; 1860-2013) literature databases were searched for case-control studies of hepatic lesions in patients undergoing anti-tuberculosis therapy with or without concomitant HBV infection. The HBV patients were divided into subgroups according to hepatitis B e antigen (HBeAg) positivity or negativity, all members of the control group were HBsAg⁻. The data from all 7 studies included in the meta-analysis were extracted and analysed using RevMan5.2 soft-ware.

RESULTSPatients with HBV infection who were undergoing anti-tuberculosis therapy had a higher risk factor than the control patients (OR =5.81, 95% CI =[4.26, 7.39]). The HBV patients with HBeAg positivity who were undergoing anti-tuberculosis therapy had a high risk factor than the HBV patients with HBeAg negativity (OR =2.56, 95% CI=[1.90, 3.44]).

CONCLUSIONHBV infection is a risk factor for hepatic lesions when undergoing anti-tuberculosis therapy, and HBeAg-positive status may put a patient at higher risk.

Antitubercular Agents ; adverse effects ; therapeutic use ; Hepatitis B ; complications ; pathology ; Hepatitis B e Antigens ; blood ; Humans ; Liver ; drug effects ; pathology ; Tuberculosis ; complications ; drug therapy ; pathology

Objective:To observe the stability and sensitivity of transcription mediated ampliifcation (TMA) system, and to compare it with real-time reverse transcription polymerase chain reaction (RT-PCR) in amplifying serum HCV RNA in HCV infected patients. Methods: TMA system was established by moloney murine leukemia virus (MMLV) reverse transcriptase, T7 RNA polymerase and 2 speciifc primers ifrstly,and then its stability and repeatability were compared at different storage temperatures by the correlation change of HCV RNA amplification curve. The sensitivity difference between TMA and RT-PCR was evaluated by amplifying a group of 10-fold diluted HCV RNA samples which were transcribed in vitro. A total of 101 serums of chronic HCV infected patients were measured by TMA system and RT-PCR to observe the positive rate and their correlation. Linear correlation and linear regression were used to observe the correlation of the two methods. Results:TMA system was successfully established. TMA system was not stable when stored at 20℃ (placed for 24 hours only), but it was stable for 6 days when stored at 4℃ or within 6 months when stored at-20 ℃. Compared with RT-PCR whose reagent was made by Hunan Sansure Biotechology Corporation, TMA system showed 20 positive samples and 11 negative samples in a total of 31 samples. So was the RT-PCR kit of the Sansure Biotechology Corporation, and the concordance rate of the two methods was 100%. Advanced quantitative study of the 20 positive samples found that the two methods had good correlation and consistency (r=0.91,P<0.01). Compared with the results of RT-PCR whose reagent was made by Shanghai Kehua Bio-engineering Corporation, TMA system had 34 positive samples and 36 negative samples, while the RT-PCR technology had 32 positive samples and 38 negative samples out of 70 samples. hTe concordance rate of the two methods was 97.1%, with no statistical difference in the positive rate of the two methods (P>0.05). Advanced quantitative study of 29 positive samples found that the two methods had good correlation and consistency (r=0.96,P<0.01). Conclusion:The stability and repeatability of TMA system are good within 6 months when stored at-20 ℃ storage temperature. Both TMA and RT-PCR HCV RNA can detect serum HCV RNA well, and the two methods have good correlation and consistency.