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
A multi center randomized clinical trial was adopted in the present study. 1705 eligible women with identical demographic and gynecological characteristics were divided into two groups: 871 using phenol atabrine pas...A multi center randomized clinical trial was adopted in the present study. 1705 eligible women with identical demographic and gynecological characteristics were divided into two groups: 871 using phenol atabrine paste (PAP) and 834 using phenol mucilage (PM). The five year follow up rates for the two groups were 97.5% and 98.1%, respectively. The multiple decrement life table analysis showed that there was a significant difference in the gross cumulative failure rates between the two groups. The 60th month gross cumulative failure rates for PAP group and PM group were 4.61% and 11.87%, respectively, thus indicating the efficacy of PAP to be significantly higher than that of PM. 97.7% users had cervical smear examinations, but no suspected cancer cells or cancer cells were found. Meanwhile, there was no known diseases related to the chemical reagent. This follow up study indicates that tubal sterilization by chemical instillation is a simple,safe and efficient female method. It suggested that this method would be introduced to a wider use on the basis of modification in the composition of chemical agents, standardized operational procedure, and improved administrative regulation in the use of this technology.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A multi center randomized clinical trial was adopted in the present study. 1705 eligible women with identical demographic and gynecological characteristics were divided into two groups: 871 using phenol atabrine paste (PAP) and 834 using phenol mucilage (PM). The five year follow up rates for the two groups were 97.5% and 98.1%, respectively. The multiple decrement life table analysis showed that there was a significant difference in the gross cumulative failure rates between the two groups. The 60th month gross cumulative failure rates for PAP group and PM group were 4.61% and 11.87%, respectively, thus indicating the efficacy of PAP to be significantly higher than that of PM. 97.7% users had cervical smear examinations, but no suspected cancer cells or cancer cells were found. Meanwhile, there was no known diseases related to the chemical reagent. This follow up study indicates that tubal sterilization by chemical instillation is a simple,safe and efficient female method. It suggested that this method would be introduced to a wider use on the basis of modification in the composition of chemical agents, standardized operational procedure, and improved administrative regulation in the use of this technology.
