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
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
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.
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。
