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【Objective:】 To analyze the emotional status and follow-up status of the participants in the drug clinical trials in a hospital during the epidemic prevention and control, with a view to maximizing the protection of participants’ rights and interests under special circumstances. 【Methods:】 The general information, depression screening scale (PHQ-9), anxiety screening scale (GAD-7) and subject compliance assessment scale were completed online by participants with gold data questionnaire. At the same time, the status of drug clinical trials under study and the follow-up status of participants under study were collected from November 1, 2021 to December 8, 2021 and from December 9, 2021 to January 24, 2022. Excel software and SPSS18.0 software were used for data statistics and analysis. 【Results:】 During the epidemic prevention and control, there were 20 drug clinical trial projects under way in the hospital. From December 9, 2021 to January 24, 2022, the planned number of visits was 161, and the actual number of visits to the hospital was 84 (52.2%). Plus 24 participants who mailed drugs, the overall visit rate was 67.1%, among which the visit rates of oral drugs, non-oral drugs, and oral drugs combined with non-oral drugs were 79.3%, 71.9%, and 41.0% respectively. From November 1, 2021 to December 8, 2021, the planned number of visits was 166, the actual number of visits to the hospital was 157 (94.6%), and the number of telephone visits accounted for 1.8% of the total planned number of visits. The number of participants who did not take the drug and those who delayed taking the drug were both 0. The total compliance of participants was as high as 80.0%. A total of 40 valid questionnaires were retrieved, and the detection rates of depression and anxiety were 42.5% and 30.0% respectively. 【Conclusion:】 The epidemic prevention and control has a large short-term impact on the follow-up of the participants under study. The formulation of relevant follow-up measures and the conduction of classification management can not only improve the emotions of the participants to a certain extent, but also protect the rights and interests of participants, providing suggestions for the follow-up of participants under emergencies in the future.
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Objective:To investigate the therapeutic effect of percutaneous transhepatic one-step biliary fistulation (PTOBF) combined with rigid choledochoscopy in the treatment of benign hepatic bile duct strictures.Methods:The clinical data of 46 patients with hepatic ductal stenosis and stones undergoing PTOBF combined with rigid choledochoscopy at the First Hospital of Guangzhou Medical University between September 2016 and September 2022 were retrospectively analyzed, including 20 males and 26 females, aged (48.5±17.6) years. The location of stones and strictures, stone retrieval rate, postoperative complications, stricture release rate, stone recurrence rate, and reoperation rate were analyzed to access the safety and effectiveness of this procedure.Results:A total of 58 sites of stenoses were found in 46 patients, and PTOBF lithotripsy combined with rigid choledochoscopy were performed for 77 times. The early postoperative complication rate was 19.6% (9/46), and the stenosis release rate was 93.5% (43/46). The mean follow-up time was (28.1±19.6) months, the complete stone retrieval rate was 91.3% (42/46), the stone recurrence rate was 19.6% (9/46), the reoperation rate was 8.7% (4/46), and the long-term postoperative complication rate was 6.5% (3/46).Conclusion:PTOBF combined with rigid choledochoscopic stenoplasty for benign hepatic duct strictures is a safe and feasible procedure to reduce the stone recurrence and long-term postoperative complications.
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Objective:To study the correlation between biliary angle and hepatolithiasis in liver segment Ⅵ.Methods:A retrospective analysis of the clinical data of 46 patients with liver segment Ⅵ bile duct stones treated at the First Affiliated Hospital of Guangzhou Medical University from January 2017 to January 2021 was carried out. There were 18 males and 28 females, with the age of (55.7±10.5) years. During the study period, 50 patients with cholecystitis were enrolled to form the control group, which consisted of 19 males and 31 females, with the age of (57.4±14.4) years. The angles of the right hepatic duct and the bile duct in segment Ⅵ were measured by the 3D hepatic visualization model. Univariate and multivariate logistic regressions were used to analyze factors correlated with formation of segment Ⅵ bile duct stones.Results:The angles of the segment Ⅵ bile duct (124.5±23.1)° and the right hepatic duct (83.5±14.4)° in the study group were significantly larger than the control group(111.8±27.7)°, (76.9±14.8)°. The difference was significant ( t=2.44, 2.10, P=0.017, 0.039). Analysis showed that the angles of segment Ⅵ bile duct ( OR=1.024, 95% CI: 1.006-1.042, P=0.010) and right hepatic duct ( OR=1.035, 95% CI: 1.005-1.065, P=0.020) correlated with bile duct stones in segment Ⅵ, with greater the angles, greater were the rates of bile duct stones in segment Ⅵ. Receiver operating characteristic curve showed that stones were more commonly formed when the angle of bile duct in segment Ⅵ was over 102.295°. The sensitivity, specificity and area under the curve were 91.3%, 34.0% and 0.631 respectively. Conclusion:The angles of segment Ⅵ bile duct and right hepatic duct were risk factors associated with segment VI bile duct calculi.
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In this double-blind,double-dummy,non-inferiority study,144 cases of newly diagnosed acute gouty arthritis were reassigned to Chuanhu anti-gout mixture group (CH,n =72) and colchicine group (Col,n =72).After treatment for 10 days,the total efficiency rates of CH and Col groups were 93.02％ and 95.35％,respectively,showing no difference between two groups.Three months later,the overall recurrence rates in CH and Col groups were 12.50％ and 13.89％ respectively (P＜0.05).The incidence of adverse reactions in colchicine group was significantly higher than CH group (34.72％ vs 2.78％,P ＜ 0.01).Blood uric acid,alanine aminotransferase,aspartate aminotransferase,and creatinine in CH group were decreased significantly compared with Col group (P＜0.05 or P＜0.01).The results suggest that the clinical efficacy of Chuanhu anti-gout mixture in the treatment of acute gouty arthritis was not inferior to colchicine,but with higher safety.
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OBJECTIVE To study the prevalence,fungal species,therapy and prevention of invasive fungal infections in our Affiliated Hospital.METHODS From Jan 2004 to Dec 2005,all patients with positive results for fungal culture of blood and sterile fluid were reviewed retrospectively.The in vitro activity of antifungal agents against fungal isolates was determined.RESULTS Eighty-eight positive patients were collected in this analysis based on the diagnosis of invasive fungal infection in our hospital for two years,from them the majority were diagnosed as candidal infections(n=72,81.8%),the others were Cryptococcus neoformans(n=8,9.1%),Aspergillus(n=5,5.7%) and other different fungal infections.The most common was C.albicans(n=48,66.7%),C.glabrata(n=12,16.7%),and C.tropicalis(n=8,11.1%),C.parapsilosis and C.krusei were both the same results(n=2,2.8%).CONCLUSIONS Infections caused by Candida are the most common invasive fungal ones in our hospital,and C.albicans is the most common one.Fluconazole remains effective for treament of candidal infections,especially those caused by C.albicans.
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OBJECTIVE:To prepare oceanic lysozyme film and establish a method for its quality control.METHODS:Film agent was prepared with oceanic lysozyme as the principle agent and hydroxy propyl methylcellulose as the film-former.Folin-phenol method and agar plate diffusion method were used respectively to determine the concentration of albumen and enzyme activity of oceanic lysozyme;and the content of lysozyme in the oceanic lysozyme film was determined by ultraviolet spectrophotometry.RESULTS:Both albumen concentration and enzyme activity of oceanic lysozyme were up to the bacte?riostatic requirement.The average recovery rate of sample was101.0%(RSD=0.67%).Storing within6months,each index of the sample experienced no marked change.CONCLUSION:The preparation is simple in production,controllable in quality and it served as a new preparation for the clinical treatment of vaginitis.