Heparin-induced extracorporeal LDL- precipitation(HELP): Mode of action, safety and clinical experience(2)

Rheological effects of acute and chronic HELP - treatment The acute reduction of rheologically relevant plasma constituents such as fibrinogen and largesized lipoproteins significantly improves whole blood and plasma viscosity by a decrease of approximately 15%, erythrocyte aggregability decreases by 53% whereas erythrocyte filtrability improves by 10% (figure 3).……

Heparin-induced extracorporeal LDL-precipitation(HELP):Mode of action, safety and clinical experience(3)

Safety and practicability of the HELP procedure Compared to standard plasma exchange, HELP-apheresis is much better tolerated, primarily be-cause heparin rather than citrate is used for anti-coagulation and therefore problems due to hypercalce-mia do not play a role.……

Safety and efficacy of intraperitoneal perfusion with tumor vesicle-encapsulated methotrexate for the treatment of cancerous ascites - an open, randomized and controlled clinical trial

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.

Status and Development Trend of Evaluation of Post-Marketing Traditional Chinese Medicines in China

Evaluation of traditional Chinese medicines after the market has achieved fruitful results after years of development.The real-world research concept has been first proposed by Chief Researcher Xie Yanming in 2010 and to 2020 with the approval of the National Medical Products Administration to use real-world evidence to support drug development and review in 2020.Real-world data application and transformation continue to cause heated discussions in the industry.Real-world research concepts have been added new motivation into the evaluation of Chinese medicines after they are marketed.The development of the Chinese patent medicine industry is facing unprecedented opportunities and challenges.

Risk Assessment and Refined Management of Blood Collection and Supply during the COVID-19 Epidemic

Since the end of 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continued to spread worldwide and has become a major global public health threat. SARS-CoV-2 has the characteristics of a long incubation period and asymptomatic infection, which are undoubtedly major challenges to blood transfusion safety. Although no research has suggested that there is a risk of SARS-CoV-2 transmission through blood transfusion, the safe use of clinical blood during the epidemic is a serious problem faced by blood collection and supply institutions. Herein, we elaborate on the management of blood collection and supply during the coronavirus disease 2019 (COVID-19) pandemic from aspects such as blood inventory management, clinical blood use, and reducing the risk of transmission of SARS-CoV-2 via blood transfusion. Blood service departments should adopt flexible policies to ensure that blood collection networks can meet clinical needs, while at the same time protecting staff and blood donors, maintaining blood safety, and reducing blood risks during the epidemic.

A multi-center clinical observation on safety and efficacy of a plasma derived coagulator factor Ⅷ for treatment of patients with hemophilia A

Objective To evaluate the efficacy and safety of home-made plasma derived coagulation factorⅧin patients with hemophilia A.Methods Patients with congenital hemophilia A who met the inclusive and exclusive criteria were enrolled in the study after informed consent.