Hisashi Hidaka1, Shigehiro Kokubu2, Takahiro Sato3, Shinji Katsushima4, Namiki Izumi5, Takumi Igura6, Shingo Asahara7, Kazuo Notsumata8, Yukio Osaki9, Keiji Tsuji10, Hirofumi Kawanaka11, Tomohiko Akahoshi11, Shozo Hirota12, Shoichi Matsutani13,14. 1. Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan. 2. Institute for Liver Disease Minimal Invasive Treatment, Shinyurigaoka General Hospital, Kawasaki, Japan. 3. Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo, Japan. 4. Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 5. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan. 6. Department of Gastroenterology, Ikeda Municipal Hospital, Osaka, Japan. 7. Department of Internal Medicine, Chiba Tokushukai Hospital, Chiba, Japan. 8. Department of Internal Medicine, Fukui-ken Saiseikai Hospital, Fukui, Japan. 9. Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan. 10. Department of Gastroenterology/Liver Center, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan. 11. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 12. Department of Radiology, Hyogo College of Medicine, Hyogo, Japan. 13. Chiba Prefectural University of Health Science, Chiba, Japan. 14. Funabashi Municipal Medical Center, Chiba, Japan.
Abstract
AIM: Portal vein thrombosis (PVT) is one of the most critical disorders in liver disease patients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver disease patients with those who received no treatment. METHODS:Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50% of the cross-sectional lumen of the portal vein. Patients with 70% or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. RESULTS: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6%; 20/36 patients; 95% confidence interval, 38.1-72.1) than in the placebo group (19.4%; 7/36 patients, 95% confidence interval, 8.2-36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. CONCLUSION:Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.
RCT Entities:
AIM: Portal vein thrombosis (PVT) is one of the most critical disorders in liver diseasepatients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver diseasepatients with those who received no treatment. METHODS: Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50% of the cross-sectional lumen of the portal vein. Patients with 70% or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. RESULTS: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6%; 20/36 patients; 95% confidence interval, 38.1-72.1) than in the placebo group (19.4%; 7/36 patients, 95% confidence interval, 8.2-36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. CONCLUSION:Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.
Authors: Cheng Han Ng; Darren Jun Hao Tan; Kameswara Rishi Yeshayahu Nistala; Nicholas Syn; Jieling Xiao; Eunice Xiang Xuan Tan; Felicia Zuying Woo; Nicholas W S Chew; Daniel Q Huang; Yock Young Dan; Arun J Sanyal; Mark D Muthiah Journal: Hepatol Int Date: 2021-08-21 Impact factor: 9.029
Authors: Xingshun Qi; Xiaozhong Guo; Eric M Yoshida; Nahum Méndez-Sánchez; Valerio De Stefano; Frank Tacke; Andrea Mancuso; Yasuhiko Sugawara; Sien-Sing Yang; Rolf Teschke; Ankur Arora; Dominique-Charles Valla Journal: BMC Med Date: 2018-06-05 Impact factor: 8.775