Objective To evaluate the short-term curative effect and the safety of transcatheter arterial chemoembolization (TACE) therapy by using microspheres and lipiodol for hepatocellular carcinoma (HCC).Methods A total of 87 patients with pathologically proved HCC were randomly divided into the study group (n=44,using embospheres of 100-300 μm in diameter together with lipiodol) and the control group (n=43,using gelfoam particles of 350-560 μm in diameter together with lipiodol).Postopertaive biochemical (liver function and AFP) findings and imaging (CT and/or MRI) manifestations were recorded,and the clinical efficacy and adverse reactions were analyzed.Results TACE was performed in all 87 patients.After the treatment,both the disease benefit rate and the postoperative reduction in AFP level in the study group were remarkably better than those in the control group (P＜0.05),but postoperative liver function indexes were not significantly different from the preoperative ones (P＞0.05).The average number of interventional therapy within the follow-up period of 6 months in the study group was smaller than that in the control group (P＜0.05).No statistically significant differences in 6-,12-and 18-month survival rates existed between the two groups (P＞0.05).Conclusion In treating HCC,TACE by combination use of microspheres and lipiodol is safe,its short-term curative effect is more obvious than TACE by combination use of gelfoam particles and lipiodol,and it can reduce the times of interventional procedure.Before TACE,careful planning of the pre-treatment of hepatic artery-portal vein fistula and the superselective catheterization with micro catheter should be taken into consideration.

Objective To describe the characteristics and registration status of clinical trials of new drugs for nonalcoholic steatohepatitis (NASH), and to provide a reference for the design and implementation of clinical trials of new drugs for NASH. Methods The U.S. Clinical Trials Database, China Clinical Trial Registry, and Center for Drug Evaluation, National Medical Products Administration, were searched for clinical trials of new drug registration and interventional studies with NASH as the indication published up to August 6, 2021, using NASH in English and Chinese characters as the keywords, and liver cirrhosis was excluded. Two researchers independently searched and screened the articles to extract relevant information. Results A total of 196 clinical trials of new drug registration or interventional studies for NASH were included, among which there were 174 trials registered abroad and 22 trials registered in China, and the number of registrations tended to increase year by year. The numbers of phase Ⅰ, phase Ⅰ/Ⅱ(including Ⅰb/Ⅱa), phase Ⅱ, phase Ⅱ/Ⅲ, and phase Ⅲ clinical trials were 45(23.0%), 8(4.1%), 112(57.1%), 4(2.0%), and 19(9.7%), respectively. The main drug types included farnesoid X receptors, fibroblast growth factors, peroxisome proliferator-activated receptor agonists, and glucagon-like peptide-1, with numbers of 16(8.16%), 14(7.14%), 11(5.61%), and 13(6.63%), respectively. The clinical trials of innovative drugs for NASH initiated by the sponsors in European and American regions accounted for the highest proportion, and there was a gradual increase in the number of clinical trials of innovative drugs in China in recent years, with a similar distribution of single-center and multicenter clinical trials. As for the trials with NASH patients as subjects, the numbers of trials with pathology, imaging, and clinical diagnosis as the main inclusion criteria were 125, 66, and 42, respectively. Phase Ⅰ clinical trials used safety, tolerability, and pharmacokinetic parameters as the main assessment indices, while phase Ⅱ and phase Ⅲ clinical trials often used safety and efficacy as the main assessment indices. The number of clinical trials for the registration of innovative drugs for NASH was relatively low but kept increasing in China, and there were fewer clinical trials of innovative traditional Chinese medicine drugs compared with innovative chemical drugs. Conclusion There is a significant increase in the registration of international clinical trials of innovative drugs for NASH, and most of these trials are in the early phases, with large differences in inclusion criteria and assessment indices, a lack of unified evaluation indices, and relatively few trials with new designs. There are fewer clinical trials of innovative drugs for NASH in China than in European and American countries, and the number of such trials is gradually increasing in China.