目的探讨佛山市某三甲医院药物临床试验质量现状调查及影响因素分析。方法选取2022年1月—2024年1月期间佛山市某医院进行的61项药物临床试验项目进行分析,根据问题发生频次及严重性综合评估试验项目质量,并分别采用单、多因素Logistic...目的探讨佛山市某三甲医院药物临床试验质量现状调查及影响因素分析。方法选取2022年1月—2024年1月期间佛山市某医院进行的61项药物临床试验项目进行分析,根据问题发生频次及严重性综合评估试验项目质量,并分别采用单、多因素Logistic回归分析临床试验质量的影响因素。结果61项药物临床试验共涉及262条质量问题。低风险项目与中高风险项目在药物注册分类、临床监查员(clinical research associate,CRA)来源、受试者依从性、CRA的资质经验、临床研究协调员(clinical research coordinator,CRC)更换次数方面比较,差异有统计学意义(P均<0.05)。受试者依从性差、CRC更换次数>3次、CRA资质经验不足均为影响临床试验质量的独立危险因素(OR=1.980、2.056、1.470,P均<0.05)。结论受试者依从性差、CRC更换次数>3次、CRA的资质经验不足均为影响本院近年来临床试验质量独立危险因素,可通过对以上方面进行针对性加强管理,以提高临床试验质量。展开更多
DNAzymes with RNA-cleaving activity have been widely used as biosensing and bioimaging tools for detection of metal ions.Despite the achievements,DNAzyme-based biosensors sometime suffer from false positive signals an...DNAzymes with RNA-cleaving activity have been widely used as biosensing and bioimaging tools for detection of metal ions.Despite the achievements,DNAzyme-based biosensors sometime suffer from false positive signals and unexpected off-target turn-on in biological environments,which are likely due to the unstable nature of the RNA site.Ways to control DNAzyme activity in order to improve the sensing performance remain a significant challenge.To meet the challenge,there is growing interest to develop synthetic strategies that can cage native DNAzyme under undesired conditions and reactivate it in target environment in order to function in a controlled manner.A variety of caging-decaging strategies have been developed to realize spatiotemporal control of the DNAzyme activity,improving its specificity and sensitivity as well as extending its application regimes.In this review,we focus on strategies to regulate the catalytic activity of DNAzyme,highlight the nucleic acid modification chemistries,and summarize three strategies to cage DNAzyme functions.Examples of using caged DNAzyme for bio-applications have also been reviewed in detail.Finally,we provide our perspectives on the potential challenges and opportunities of this emerging research topic that could advance the DNAzyme field.展开更多
文摘目的探讨佛山市某三甲医院药物临床试验质量现状调查及影响因素分析。方法选取2022年1月—2024年1月期间佛山市某医院进行的61项药物临床试验项目进行分析,根据问题发生频次及严重性综合评估试验项目质量,并分别采用单、多因素Logistic回归分析临床试验质量的影响因素。结果61项药物临床试验共涉及262条质量问题。低风险项目与中高风险项目在药物注册分类、临床监查员(clinical research associate,CRA)来源、受试者依从性、CRA的资质经验、临床研究协调员(clinical research coordinator,CRC)更换次数方面比较,差异有统计学意义(P均<0.05)。受试者依从性差、CRC更换次数>3次、CRA资质经验不足均为影响临床试验质量的独立危险因素(OR=1.980、2.056、1.470,P均<0.05)。结论受试者依从性差、CRC更换次数>3次、CRA的资质经验不足均为影响本院近年来临床试验质量独立危险因素,可通过对以上方面进行针对性加强管理,以提高临床试验质量。
基金supported by the National Natural Science Foundation of China(No.21877032)the Hunan Province Talented Young Scientists Program,China(Nos.2019RS2021,2019RS2023)+2 种基金the Open Research Fund Program of the State Key Laboratory of Analytical Chemistry for Life Sciences,China(No.SKLACLS2102)the Scientific Research Program of Shenzhen Institute of Synthetic Biology,China(No.DWKF20210005)the Fundamental Research Funds for the Central Universities,China.
文摘DNAzymes with RNA-cleaving activity have been widely used as biosensing and bioimaging tools for detection of metal ions.Despite the achievements,DNAzyme-based biosensors sometime suffer from false positive signals and unexpected off-target turn-on in biological environments,which are likely due to the unstable nature of the RNA site.Ways to control DNAzyme activity in order to improve the sensing performance remain a significant challenge.To meet the challenge,there is growing interest to develop synthetic strategies that can cage native DNAzyme under undesired conditions and reactivate it in target environment in order to function in a controlled manner.A variety of caging-decaging strategies have been developed to realize spatiotemporal control of the DNAzyme activity,improving its specificity and sensitivity as well as extending its application regimes.In this review,we focus on strategies to regulate the catalytic activity of DNAzyme,highlight the nucleic acid modification chemistries,and summarize three strategies to cage DNAzyme functions.Examples of using caged DNAzyme for bio-applications have also been reviewed in detail.Finally,we provide our perspectives on the potential challenges and opportunities of this emerging research topic that could advance the DNAzyme field.
