Procedures for application of the extended dosing after antitumor drug clinical trials / 中南大学学报(医学版)

New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors, and the extended dosing is a special way for patients' withdrawal from antitumor clinical trials to obtain investigational new drugs. However, neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present, expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions, and a complete management system has not been established to meet patients' urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital, this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review, it is recommended that all parties fully consider the risks and benefits of extended dosing for patients, and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.

Pharmacologic Therapy for Nonalcoholic Fatty Liver Disease / 대한내과학회지

Weight loss via lifestyle modification remains the most efficient treatment for NAFLD. Weight loss and exercise are the cornerstones of therapy, but achieving long-term lifestyle modification is not free from difficulties. Pharmacologic therapy should be considered for patients with NAFLD unable to achieve or maintain lifestyle-induced weight loss. Unfortunately, there is no approved drug for NAFLD currently. Current treatment methods for NAFLD can be divided roughly into those methods that target components of metabolic syndrome using weight reduction and insulin sensitizers (pioglitazone) and those that use antioxidants (Vitamin E) to benefit the liver. Pioglitazone has been shown to improve steatosis, hepatocellular ballooning, and inflammation and also to reduce the risk of fibrosis progression in several randomized-controlled trials (RCTs). In a large RCT, large doses of vitamin E improved all histological lesions except for fibrosis. Compared with a placebo, Metformin lowered ALT, but did not improve liver histology. Recently, novel anti-diabetic agents (GLP-1 analogues, DPP IV inhibitors) and probiotics that alter the gut microbiome were shown to mildly benefit ALT and liver histology. In this report, we systemically review current pharmacologic therapies and other promising agents that were not considered in the most recent guidelines for the treatment of NAFLD.