2007年5月，世界卫生组织国际临床试验注册平台（World Health Organization International Clinical Trial Registration Platform，WHO ICTRP）正式运行，澳大利亚-新西兰临床试验注册中心（Australian and New Zealand Clinical Tria...2007年5月，世界卫生组织国际临床试验注册平台（World Health Organization International Clinical Trial Registration Platform，WHO ICTRP）正式运行，澳大利亚-新西兰临床试验注册中心（Australian and New Zealand Clinical Trials Registry，ACTR），展开更多
目的:观察新三期中药外治方案治疗急性外踝韧带损伤的临床疗效。方法:将2023年7月至2023年12月期间招募的64例急性外踝韧带损伤患者,按照治疗方法不同分为观察组和对照组,每组32例。观察组男17例,女15例;年龄25~36(30.59±3.10)岁;...目的:观察新三期中药外治方案治疗急性外踝韧带损伤的临床疗效。方法:将2023年7月至2023年12月期间招募的64例急性外踝韧带损伤患者,按照治疗方法不同分为观察组和对照组,每组32例。观察组男17例,女15例;年龄25~36(30.59±3.10)岁;采用新三期中药外治方案联合“POLICE”治疗方案即保护(protect)、适当负重(optimal loading)、冰敷(ice)、加压包扎(compression)和抬高患肢(elevation)。对照组男14例,女18例;年龄24~37(30.03±3.19)岁;采用“POLICE”治疗方案。分别在初次入组和治疗第1、6周后采用视觉模拟评分(visual analogue scale,VAS)评估和Figure of 8测量法评估受试者踝关节疼痛和肿胀程度。同时采用美国足踝外科踝功能评分(American Orthopaedic Foot and Ankle Society,AOFAS)和Karlsson踝关节功能评分系统评价各阶段患者踝关节功能改善情况。通过MRI特定图像观察距腓前韧带生物愈合程度,通过计算信噪比(signal to noise ratio,SNR)评估,信噪比越低代表韧带含水量越低,愈合越好。结果:所有患者获得6周随访。治疗前两组VAS、AOFAS和Karlsson评分差异无统计学意义(P>0.05),治疗1周和6周后,两组VAS、AOFAS评分和Karlsson评分均较治疗前显著改善(P<0.05)。治疗1周后,观察组VAS(3.21±0.87)分,低于对照组(4.21±1.50)分(P<0.05)。治疗1周后,观察组AOFAS和Karlsson评分[(50.84±4.70)分,(49.97±4.00)分],高于对照组[(46.91±5.56)分,(46.66±5.36)分],P<0.05。MRI图像显示,治疗6周后,观察组SNR值75.25±16.59,低于对照组的85.81±15.55(P<0.05)。结论:与对照组相比,新三期中药外治方案早期临床疗效显著,能够明显减轻急性外踝韧带损伤患者踝关节的疼痛和肿胀程度,提高韧带修复质量,促进患者踝关节功能的恢复。展开更多
The number of clinical trials conducted in China's Mainland,including investigator‐initiated trials(IITs),has increased rapidly in recent years.However,there are few data on the characteristics of cancer‐related...The number of clinical trials conducted in China's Mainland,including investigator‐initiated trials(IITs),has increased rapidly in recent years.However,there are few data on the characteristics of cancer‐related IITs.We performed a comprehensive analysis of the landscape of cancer‐related IITs in China's Mainland in the past decade.All cancer‐related IITs registered on two clinical trial registries in the United States(www.clinicaltrials.gov,CT.gov)and China's Mainland(www.chictr.org.cn,ChiCTR)from 2010 to 2019 were identified.IITs were reviewed manually to validate classification,subcategorized by cancer type,and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.A total of 8199 cancer‐related IITs were identified.The number of trials registered annually increased over time,especially in the last 5 years.Although interventional studies were predominant,randomized double‐blind studies accounted for only 8%of IITs.In the past decade,the trend for interventional studies conducted with different drugs increased year on year,although the increase in hormonal therapy IITs was not significant.Additionally,cancerrelated IITs were unevenly geographically distributed,with half concentrated in the economically developed cities Shanghai,Beijing,and Guangdong.We also found an increase in registration before participant enrollment(64.9%for trials in conducted in 2015–2019 vs.40.2%in 2010–2014,p<0.001)and data monitoring committee use(44.5%vs.40.0%,p=0.001)and a decrease in randomization(51.5%vs.62.7%,p<0.001)and funding(36.4%vs.56.3%,p<0.001)between these periods.We also observed changes in intervention type(decrease in cytotoxic drug therapy[34.8%vs.48.9%,p<0.001];increase in targeted therapy[17.8%vs.14.2%,p=0.004],immune checkpoint inhibitor therapy[6.6%vs.0.0%,p<0.001],and immune cell therapy[9.6%vs.4.5%,p<0.001]).Details of cancer‐related IITs conducted during the past decade illustrate the merits of oncology research in China's Mainland.Although 展开更多
Background:Cancerous ascites is a common and severe complication that occurs in patients with late-stage malignant tumors.The prognosis of cancerous ascites is poor,clinical treatment is difficult and therapeutic outc...Background:Cancerous ascites is a common and severe complication that occurs in patients with late-stage malignant tumors.The prognosis of cancerous ascites is poor,clinical treatment is difficult and therapeutic outcome is disappointing.In the present study,tumor cell-derived vesicles were used as drug delivery vehicles that encapsulated a chemotherapeutic agent and were perfused into a patients’abdominal cavity to effectively kill the cancer cells in cancerous ascites.Pre-clinical data has demonstrated that tumor vesicles that carry low-dose chemotherapeutics can efficiently eliminate metastatic tumor cells in the abdominal cavity with minimal toxic or adverse effects.When combined,tumor cell-derived vesicles can sensitize tumor cells,which facilitates the entry of chemotherapeutics into tumor cells,thereby enhancing killing of tumor cells and limiting the risk of drug resistance.In this study,we designed a clinical trial to evaluate the safety and efficacy of intraperitoneal perfusion with tumor vesicle-encapsulated methotrexate for the treatment of cancerous ascites.Methods:Sixty patients with cancerous ascites were enrolled in this open,randomized and controlled clinical trial.Participants were randomly assigned a visit number and,according to their visiting order for which a random numerical table was used,were assigned to the trial group or the control group in a 1:1 ratio.The change in ascetic volume was used as the study outcome and adverse events were monitored during the entire length of the study.Conclusion:In this clinical trial,randomization and electronic case report forms were implemented.The trial indicated that tumor vesicle-encapsulated methotrexate was proposed to be a safe and effective method for treating malignant ascites.Our study may provide at the first time evidence for the clinical application of tumor vesicles in tumor therapy.展开更多
文摘2007年5月，世界卫生组织国际临床试验注册平台（World Health Organization International Clinical Trial Registration Platform，WHO ICTRP）正式运行，澳大利亚-新西兰临床试验注册中心（Australian and New Zealand Clinical Trials Registry，ACTR），
文摘目的:观察新三期中药外治方案治疗急性外踝韧带损伤的临床疗效。方法:将2023年7月至2023年12月期间招募的64例急性外踝韧带损伤患者,按照治疗方法不同分为观察组和对照组,每组32例。观察组男17例,女15例;年龄25~36(30.59±3.10)岁;采用新三期中药外治方案联合“POLICE”治疗方案即保护(protect)、适当负重(optimal loading)、冰敷(ice)、加压包扎(compression)和抬高患肢(elevation)。对照组男14例,女18例;年龄24~37(30.03±3.19)岁;采用“POLICE”治疗方案。分别在初次入组和治疗第1、6周后采用视觉模拟评分(visual analogue scale,VAS)评估和Figure of 8测量法评估受试者踝关节疼痛和肿胀程度。同时采用美国足踝外科踝功能评分(American Orthopaedic Foot and Ankle Society,AOFAS)和Karlsson踝关节功能评分系统评价各阶段患者踝关节功能改善情况。通过MRI特定图像观察距腓前韧带生物愈合程度,通过计算信噪比(signal to noise ratio,SNR)评估,信噪比越低代表韧带含水量越低,愈合越好。结果:所有患者获得6周随访。治疗前两组VAS、AOFAS和Karlsson评分差异无统计学意义(P>0.05),治疗1周和6周后,两组VAS、AOFAS评分和Karlsson评分均较治疗前显著改善(P<0.05)。治疗1周后,观察组VAS(3.21±0.87)分,低于对照组(4.21±1.50)分(P<0.05)。治疗1周后,观察组AOFAS和Karlsson评分[(50.84±4.70)分,(49.97±4.00)分],高于对照组[(46.91±5.56)分,(46.66±5.36)分],P<0.05。MRI图像显示,治疗6周后,观察组SNR值75.25±16.59,低于对照组的85.81±15.55(P<0.05)。结论:与对照组相比,新三期中药外治方案早期临床疗效显著,能够明显减轻急性外踝韧带损伤患者踝关节的疼痛和肿胀程度,提高韧带修复质量,促进患者踝关节功能的恢复。
文摘The number of clinical trials conducted in China's Mainland,including investigator‐initiated trials(IITs),has increased rapidly in recent years.However,there are few data on the characteristics of cancer‐related IITs.We performed a comprehensive analysis of the landscape of cancer‐related IITs in China's Mainland in the past decade.All cancer‐related IITs registered on two clinical trial registries in the United States(www.clinicaltrials.gov,CT.gov)and China's Mainland(www.chictr.org.cn,ChiCTR)from 2010 to 2019 were identified.IITs were reviewed manually to validate classification,subcategorized by cancer type,and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.A total of 8199 cancer‐related IITs were identified.The number of trials registered annually increased over time,especially in the last 5 years.Although interventional studies were predominant,randomized double‐blind studies accounted for only 8%of IITs.In the past decade,the trend for interventional studies conducted with different drugs increased year on year,although the increase in hormonal therapy IITs was not significant.Additionally,cancerrelated IITs were unevenly geographically distributed,with half concentrated in the economically developed cities Shanghai,Beijing,and Guangdong.We also found an increase in registration before participant enrollment(64.9%for trials in conducted in 2015–2019 vs.40.2%in 2010–2014,p<0.001)and data monitoring committee use(44.5%vs.40.0%,p=0.001)and a decrease in randomization(51.5%vs.62.7%,p<0.001)and funding(36.4%vs.56.3%,p<0.001)between these periods.We also observed changes in intervention type(decrease in cytotoxic drug therapy[34.8%vs.48.9%,p<0.001];increase in targeted therapy[17.8%vs.14.2%,p=0.004],immune checkpoint inhibitor therapy[6.6%vs.0.0%,p<0.001],and immune cell therapy[9.6%vs.4.5%,p<0.001]).Details of cancer‐related IITs conducted during the past decade illustrate the merits of oncology research in China's Mainland.Although
文摘Background:Cancerous ascites is a common and severe complication that occurs in patients with late-stage malignant tumors.The prognosis of cancerous ascites is poor,clinical treatment is difficult and therapeutic outcome is disappointing.In the present study,tumor cell-derived vesicles were used as drug delivery vehicles that encapsulated a chemotherapeutic agent and were perfused into a patients’abdominal cavity to effectively kill the cancer cells in cancerous ascites.Pre-clinical data has demonstrated that tumor vesicles that carry low-dose chemotherapeutics can efficiently eliminate metastatic tumor cells in the abdominal cavity with minimal toxic or adverse effects.When combined,tumor cell-derived vesicles can sensitize tumor cells,which facilitates the entry of chemotherapeutics into tumor cells,thereby enhancing killing of tumor cells and limiting the risk of drug resistance.In this study,we designed a clinical trial to evaluate the safety and efficacy of intraperitoneal perfusion with tumor vesicle-encapsulated methotrexate for the treatment of cancerous ascites.Methods:Sixty patients with cancerous ascites were enrolled in this open,randomized and controlled clinical trial.Participants were randomly assigned a visit number and,according to their visiting order for which a random numerical table was used,were assigned to the trial group or the control group in a 1:1 ratio.The change in ascetic volume was used as the study outcome and adverse events were monitored during the entire length of the study.Conclusion:In this clinical trial,randomization and electronic case report forms were implemented.The trial indicated that tumor vesicle-encapsulated methotrexate was proposed to be a safe and effective method for treating malignant ascites.Our study may provide at the first time evidence for the clinical application of tumor vesicles in tumor therapy.
