文献

J-GLOBAL ID：202202273743644052   整理番号：22A1170097

HBeAg陰性慢性B型肝炎の治療のためのエンテカビルと併用したBushen Jianpi公式: 多施設無作為化二重盲検プラセボ対照試験【JST・京大機械翻訳】

Bushen Jianpi Formula Combined with Entecavir for the Treatment of HBeAg-Negative Chronic Hepatitis B: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

著者 (25件)： Zhang Jing-Hao (Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Zhang Xin (Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Zhou Zhen-Hua (Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Zhu Xiao-Jun (Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Zheng Chao (Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Li Man (Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Jin Shu-Gen (Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Mao De-Wen (Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530023, China) ,  Xue Jing-Dong (Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi’an 710003, China) ,  Shi Wei-Bing (Department of Infectious Diseases, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China) ,  Chi Xiao-Ling (Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510006, China) ,  Wang Xian-Bo (Department of Integrated TCM and Western Medicine, Ditan Hospital Affiliated of Capital Medical University, Beijing 100015, China) ,  Li Xiao-Dong (Department of Hepatology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China) ,  Li Yong (Department of Hepatology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250011, China) ,  Wang Hui (Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China) ,  Li Qin (Department of Hepatology, Department of Infectious Disease, Fuzhou Infectious Diseases Hospital, Fuzhou 350000, China) ,  Zhou Da-Qiao (Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen 518033, China) ,  Wang Cheng-Bao (Department of Infectious Diseases, Linyi People’s Hospital, Linyi 276003, China) ,  Shi Chang-He (Qingdao Liver Diseases Institute, Qingdao Hospital of Infectious Diseases, Qingdao 266033, China) ,  Li Cheng-Zhong (Department of Infectious Diseases, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China) ,  Wu Jian-Hua (Department of Hepatopathy, Xiamen Hospital of Traditional Chinese Medicine, Xiamen 361001, China) ,  Kong Xiao-Ni (Central Laboratory, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Sun Xue-Hua (Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Gao Yue-Qiu (Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China) ,  Gao Yue-Qiu (Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China)
資料名： Evidence-Based Complementary and Alternative Medicine (Web)  (Evidence-Based Complementary and Alternative Medicine (Web))
巻： 2022  ページ： Null  発行年： 2022年 
JST資料番号： U7703A  ISSN： 1741-427X  資料種別： 逐次刊行物 (A)
記事区分： 原著論文  発行国： イギリス (GBR)  言語： 英語 (EN)

抄録/ポイント： 背景.Bushen Jianpi処方(BSJPF,Lingmao式としても知られる)は,慢性B型肝炎(CHB)のための漢方薬である。以前の研究は,BSJPFとエンテカビル(ETV)の併用が,B型肝炎e抗原(HBeAg)の有意な損失と,軽度に上昇したアラニンアミノトランスフェラーゼを有するHBeAg陽性CHB患者におけるB型肝炎ウイルス(HBV)DNAの血清レベルの有意な低下を達成できることを示唆した。目的.本研究は,HBeAg陰性CHB患者の治療のためのETVと組み合わせたBSJPFの有効性と安全性を評価することを目的とした。【方法】合計640人の患者を,無作為に治療群(96週間ETVと組み合わせたBSJPFを受信)または対照群(96週間ETVと組み合わせたプラセボを1: 1比)に割り当てた。一次エンドポイントはB型肝炎表面抗原(HBsAg)の損失率である。二次転帰は,HBsAg濃度≧1lg・IU/mL,HBV DNA抑制,肝臓での共有結合閉鎖環状DNA(cccDNA)のレベル低下,組織学的改善,ALT正常化率の低下率を含んだ。結果.治療群におけるHBsAg損失率は,対照群より有意に高かった(5.5%対1.8%,[数式:原文を参照])。HBsAg≧1lg・IU/mLの減少を記録した治療群の患者の11.1%があり,対照群([数式:原文を参照])の患者の5.9%以上だった。HBV DNAクリアランス率,肝内cccDNAの減少およびALT正常化率([数式:原文を参照])に関して,2群間に有意差はなかった。治療群の肝線維症改善率は,対照群のそれより良好であった(35.5%対11.8%,[数式:原文を参照])が,壊死性炎症改善([数式:原文を参照])には差がなかった。有害事象(AEs)は,異常腎機能を除いて,対照群で2.2%,治療群([数式:原文を参照])で0.0%の2群間で類似していた。結論.BSJPFとETVの併用は,CHB患者における重篤な有害事象なしでHBsAg損失率と組織学的線維症改善率を増加させることができる。試験登録。この試験は,2016年11月16日のChiCTR-IOR-16009880で登録され,http://www.chictr.org.cn/showproj.aspx?proj=16836が登録された。Copyright 2022 Jing-Hao Zhang et al. Translated from English into Japanese by JST.【JST・京大機械翻訳】

シソーラス用語： 安全性 ,  DNA【核酸】 ,  アラニンアミノトランスフェラーゼ ,  *偽薬 ,  血清中濃度 ,  *二重盲検法 ,  HBs抗原 ,  B型肝炎ウイルス ,  cDNA ,  線維症 ,  肝線維症 ,  漢方製剤 ,  *B型慢性肝炎
準シソーラス用語： cccDNA ,  有害事象 , 【Automatic Indexing@JST】

分類 (1件)： 消化器疾患の薬物療法  (GH05020G)

物質索引 (1件)： エンテカビル

引用文献 (43件)：

• J. Liu, W. Liang, W. Jing, M. Liu, "Countdown to 2030: eliminating hepatitis B disease, China," Bulletin of the World Health Organization, vol. 97, no. 3, pp. 230-238, 2019.
• World Health Organization, Global Hepatitis Report 2017, World Health Organization, Geneva, Switzerland, 2017.
• F. Cui, L. Shen, L. Li, H. Wang, F. Wang, S. Bi, J. Liu, G. Zhang, F. Wang, H. Zheng, X. Sun, N. Miao, Z. Yin, Z. Feng, X. Liang, Y. Wang, "Prevention of chronic hepatitis B after 3 decades of escalating vaccination policy, China," Emerging Infectious Diseases, vol. 23, no. 5, pp. 765-772, 2017.
• Chinese Society of Infectious Diseases, Chinese Medical Association, Chinese Society of Hepatology, Chinese Medical Association, "Guidelines for the prevention and treatment of chronic hepatitis B," Chinese Journal of Hepatology, vol. 27, no. 12, pp. 938-961, 2019, (in Chinese).
• European Association for the Study of the Liver, "EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection," Journal of Hepatology, vol. 67, no. 2, pp. 370-398, 2017.

タイトルに関連する用語 (7件)： 慢性B型肝炎 ,  治療 ,  エンテカビル ,  併用 ,  施設 ,  二重盲検 ,  プラセボ