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ObjectiveTo investigate the efficacy， safety， and cost-effectiveness of endoscopic ultrasound （EUS）-guided coil placement combined with tissue adhesive injection in the treatment of gastric varices with spontaneous shunt. MethodsA retrospective analysis was performed for the patients with acute gastric variceal bleeding and spontaneous portosystemic shunt who were hospitalized and received balloon-occluded retrograde transvenous obliteration （BRTO） combined with endoscopic tissue adhesive injection or EUS-guided coil placement combined with tissue adhesive injection in Xiangyang Central Hospital from March 2019 to September 2022. The two surgical procedures were compared in terms of efficacy （technical success rate， 5-day rebleeding rate， 1-year rebleeding rate， and time to rebleeding）， safety （the incidence rate of ectopic embolism， the amount of tissue adhesive used， and the amount of lauromacrogol used）， and cost-effectiveness （hospital costs and length of hospital stay）. The t-test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. The Kaplan-Meier method was used to estimate the rebleeding. The chi-square test was used for comparison of categorical data between two groups. ResultsA total of 25 patients received successful EUS-guided coil placement and tissue adhesive injection， with a technical success rate of 100%， a median amount of 2.5 mL tissue adhesive used， a median amount of 11.0 mL lauromacrogol used， a mean length of hospital stay of 14.88±3.21 days， a mean hospital cost of 32 660.00±4 602.07 yuan， and a 5-day rebleeding rate of 0%； among these patients， 2 were lost to follow-up， and 23 patients with complete follow-up data had an incidence rate of ectopic embolism of 0% and a median time to rebleeding of 689 days. A total of 14 patients underwent modified BRTO combined with endoscopic tissue adhesive injection， with a technical success rate of 100%； a median amount of 5.0 mL tissue adhesive used during surgery， which was significantly higher than that used in EUS （U=39.000， P<0.001）； a median amount of 10.5 mL lauromacrogol used during surgery； a mean length of hospital stay of 15.38±4.94 days； a mean hospital cost of 57 583.47±18 955.40 yuan， which was significantly higher than that used in EUS （t=-6.310， P<0.001）； a 5-day rebleeding rate of 0%. No patient was lost to follow-up， and all 14 patients had an incidence rate of ectopic embolism of 0% and a median time to rebleeding of 244.50 days， with no significant difference between the two groups （χ2=1.448， P=0.229）. ConclusionEUS-guided coil placement combined with tissue adhesive injection is a relatively safe and effective technique for the treatment of gastric variceal bleeding and has a high technical success rate， a low incidence rate of serious adverse events， and similar efficacy to BRTO， with higher safety and cost-effectiveness.
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Public health emergencies have occurred frequently in recent years, with the characteristics of difficult rescue and a complex environment. Helicopter emergency medical service is an effective way to deal with catastrophic events. The service can effectively shorten the transfer time taken for patient transfer between hospitals, directly send patients to the hospitals that meet requirements for clinical treatment, and avoid the possible delayed treatment caused by a secondary transfer. Helicopter emergency medical service in China is still in its infancy, and there are various problems in the actual operation. Strict whole process quality management is needed to achieve the expected outcome. The paper reviews the current situation of helicopter rescue for critically ill patients in China and suggests a set of quality management schemes (including base construction, rescue equipment allocation, rescue personnel selection, rescue system construction, and on-site rescue procedure standardization). Findings from this paper hope to provide evidence for the development of aviation rescue in China. This study is innovative and scientific.
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OBJECTIVE：To study the current situation of pharmacovigilance work in large ，medium and small-scale pharmaceutical manufacturers in Jiangsu Province ，and to provide reference for the pharmacovigilance development of drug manufacturers with different scales. METHODS ：The situation of pharmacovigilance work in 108 manufacturers in Jiangsu province was investigated through a questionnaire survey and related websites. The pharmacovigilance work （organization，personnel and training，document，computer system ），drug safety monitoring （case report ，regular safety update report ，post-marketing safety research） and drug risk management （signal management ， risk management plan ， risk control measures ， drug safety communication）of different manufacturers were investigated to put forward the suggestions. RESULTS & CONCLUSIONS ：There was no significant difference in the organizational structure （independently established specialized agencies ）among manufacturers of different scales （P＝0.60）. Most of the manufacturers had less than 50％ of the proportion in the independent establishment of specialized institutions for pharmacovigilance. There was significant difference in personnel and training （situation and number of full-time staff in charge ，medical and clinical pharmacy personnel number ），document（formulating training management system ， entrusted management and key monitoring procedures ），computer system （P＜0.05）. There was no difference in the main collection ways of case reports among manufacturers of different scales ；however，the number of independent reports in 2019（P＜ 0.01），the proportion of quality control process for regular safety update reports （P＝0.01），and the proportion of carrying out post-marketing safety research in recent five years （P＜0.01）in large-scale manufacturers were all significantly higher than small- and medium-scale manufacturers. The proportions of large-scale manufacturers （70.00％） and medium-scale manufacturers （84.38％），which considered “lack of technical guidelines ”as an important factor affecting signal management ，were higher than that of small-scale manufacturers （53.57％）（P＝0.01）；the proportions of large-scale manufacturers （60.00％）and medium-scale manufacturers（50.00％），which had carried out risk management plans in the past five years ，were higher than that of small-scale manufacturers（30.36％）（P＝0.04）；the proportion of large-scale manufacturers （50.00％），which adopted the measures in recent 5 year，was higher than medium-scale manufacturers （37.50％）and small-scale manufacturers （25.00％）；the proportions of large-scale manufacturers （70.00％ ） and medium-scale manufacturers （59.38％ ）， which carried out communication for pharmacists，were higher than small-scale manufacturers （32.14％）（P＜0.01）. Large-scale manufacturers outperformed small- and medium-scale manufacturers in terms of pharmacovigilance system ，drug safety monitoring and drug risk management. Large-scale manufacturers had a certain degree of lack of initiative on performing risk management plans ，medium-scale manufacturers on full-time staffs in charge ，and small-scale manufacturers on pharmacovigilance system. So ，it is recommended that large-scale manufacturers take effective control of variety risk as the goal and actively risk management ；medium-scale manufacturers should continuously enhance the awareness of responsibility and improve the investment of resources on pharmacovigilance work ； small-scale manufacturers should pay more attention to improving the pharmacovigilance system and the compliance of specific work.
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Background: Ulcerative colitis (UC) is characterized by a chronic intestinal inflammatory disease with relapsing-remitting course, therefore the evaluation of inflammatory activity is essential for defining reasonable therapy and predicting prognosis. Aims: To evaluate the diagnostic value of noninvasive biomarkers in assessing endoscopic activity of UC. Methods: A total of 56 patients with UC from August 2016 to March 2018 at Xiangyang Central Hospital were enrolled, and 25 patients with irritable bowel syndrome (IBS) were served as controls. Fecal calprotectin (FC) level was measured by ELISA. Clinical activity index (CAI) was assessed, and C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were determined. Endoscopic activity was determined by Mayo score. Diagnostic value of noninvasive biomarkers in assessing endoscopic activity of UC was analyzed. Results: FC level was significantly higher in UC patients than in IBS patients (P<0.001). FC, CAI, CRP, ESR in active UC patients were significantly higher than those in remissive UC patients (P<0.001). Mayo score was correlated with FC (r=0.814), CAI (r=0.724), CRP (r=0.610), ESR (r=0.657) (P all <0.001). FC with a cutoff value of 200 μg/g had sensitivity of 92.3% and specificity of 94.1% for detecting endoscopic activity. Conclusions: Compared with CAI, CRP and ESR, FC can more effectively evaluate the endoscopic active inflammation in UC patients.
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Objective To investigate the diagnostic efficacy of fecal calprotectin(FC) on assessing endoscopic disease activity in colonic or ileo-colonic Crohn disease (CD) and CD-related surgery patients .Methods Totally 56 colonic or ileo-colonic CD pa-tients ,25 CD-related surgery patients and 25 irritable bowel syndrome (IBS) patients with previously confirmed diagnosis of CD and IBS were enrolled into this study .Fecal samples were collected from 1 to 3 day before bowel preparation and FC was measured by ELISA .Endoscopic activity was determined for colonic or ileo-colonic CD with Simple Endoscopic Score for Crohn′s Disease (SES-CD) and CD-related surgery patients with the Rutgeerts′ score .Results Among colonic or ileo-colonic CD patients ,the levels of FC in endoscopic active patients had significantly higher than that of endoscopic remission patients and IBS patients(P 0 .05) ,FC cutoff level of 250 μg /g gave a sensitivity and specificity of 50 .0% ,66 .7% ,respectively .Conclusion FC is a surrogate marker for the evaluation of colonic or ileo-colonic CD endoscopic disease activity .The FC ,however ,can not distinct remission period and active period after CD surgery .
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Objective To assess the performance of the methylation‐sensitive high‐resolution melting curve analysis (MS‐HRM analysis) on the detection of the methylation in stool DNA for colorectal cancer screening .Methods Eighty‐two qualified stool samples were collected from 27 patients with colorectal cancer patients (CRC group) ,25 patients with advanced adenomas (AA group) ,and 30 healthy people (control group) .The methylation status of vimentin gene in all of the stool samples was detected by the MS‐HRM analysis on the LightCycler 480 platform .The fecal occult blood test (FOBT) was also used for the same samples . Results The positive rates of the MS‐HRM assay in the CRC group ,AA group ,and control group were 81 .5% (22/27) ,80 .0%(20/25) ,and 6 .7% (2/30) respectively .The positive rates of FOBT in the three groups were 37 .0% (10/27) ,12 .0% (3/25) and 3 .3% (1/30) respectively .The diagnostic sensitivity of the MS‐HRM assay for colorectal cancer and advanced adenomas (80 .8% , 42/52) was significantly higher than that of FOBT (25 .0% ,13/52)(P0 .05) .Conclusion MS‐HRM performs better than FOBT and has great application potential in the detection of stool DNA methylation for colorectal cancer screening .
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Objective To study the effect of adeno associated virus hepatocyte growth factor K1(AAV‐HGFK1)on the prolifer‐ation of 4 different colorectal cell lines with or without KRAS or BRAF mutation .Methods The levels of epidermal growth factor receptor (EGFR) mRNA were determined in SW48 without KRAS or BRAF mutation ,Lovo with KRAS mutation ,SW620 with KRAS mutation ,HT29 with BRAF mutation by quantitative real time PCR ,respectively .After the infection of AAV‐HGFK1 ,the expressions of EGFR ,p‐EGFR and β‐actin were detected by Western blot and the proliferation of the cells were assayed using MTT .Results Lovo ,SW48 and HT29 expressed EGFR protein while SW620 did not .EGF promoted the proliferation of Lovo , SW48 and HT29 cells .AAV‐HGFK1 down‐regulated the phosphorylation of EGFR and significantly inhibited their proliferation . But EGF had no effect on proliferation of SW620 stimulated by EGF .Conclusion AAV‐HGFK1 exhibited its antitumor effects through EGF/EGFR signaling irrespective of the KRAS or BRAF mutation and may also act through other signaling pathways .