A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis

被引：14

作者：

Yagi, Minami ^{[1
]}

Matsumoto, Kosuke ^{[1
]}

Komori, Atsumasa ^{[2
]}

Abe, Masanori ^{[3
]}

Hashimoto, Naoaki ^{[4
]}

Inao, Mie ^{[5
]}

Namisaki, Tadashi ^{[6
]}

Kawata, Kazuhito ^{[7
]}

Ninomiya, Masashi ^{[8
]}

Fujii, Hideki ^{[9
]}

Takahashi, Atsushi ^{[10
]}

Kang, Jong-Hon ^{[11
]}

Takamura, Masaaki ^{[12
]}

Arakawa, Mie ^{[13
]}

Joshita, Satoru ^{[14
]}

Sato, Ken ^{[15
]}

Itakura, Jun ^{[16
]}

Nomura, Takako ^{[17
]}

Kakisaka, Keisuke ^{[18
]}

Kaneko, Akira ^{[19
]}

Tamura, Yamato ^{[1
]}

Miura, Ryo ^{[1
]}

Aiso, Mitsuhiko ^{[1
]}

Arizumi, Toshihiko ^{[1
]}

Asaoka, Yoshinari ^{[1
]}

Kikuchi, Kentaro ^{[20
]}

Takikawa, Yasuhiro ^{[18
]}

Masaki, Tsutomu ^{[17
]}

Umemura, Takeji ^{[14
]}

Honda, Akira ^{[21
]}

Ohira, Hiromasa ^{[10
]}

Kawada, Norifumi ^{[9
]}

Yoshiji, Hitoshi ^{[6
]}

Mochida, Satoshi ^{[5
]}

Takikawa, Hajime ^{[22
]}

Tanaka, Atsushi ^{[1
]}

机构：

[1] Teikyo Univ, Dept Med, Sch Med, Tokyo, Japan

[2] Natl Hosp Org NHO Nagasaki Med Ctr, Clin Res Ctr, Nagasaki, Japan

[3] Ehime Univ, Dept Gastroenterol & Metabol, Grad Sch Med, Matsuyama, Ehime, Japan

[4] Tokyo Teishin Hosp, Dept Gastroenterol, Tokyo, Japan

[5] Saitama Med Univ, Fac Med, Dept Gastroenterol & Hepatol, Saitama, Japan

[6] Nara Med Univ, Dept Internal Med 3, Nara, Japan

[7] Hamamatsu Univ, Dept Internal Med, Hepatol Div, Sch Med, Hamamatsu, Shizuoka, Japan

[8] Tohoku Univ, Div Gastroenterol, Grad Sch Med, Sendai, Miyagi, Japan

[9] Osaka City Univ, Grad Sch Med, Dept Hepatol, Osaka, Japan

[10] Fukushima Med Univ, Dept Gastroenterol, Sch Med, Fukushima, Japan

[11] Teine Keijinkai Hosp, Ctr Gastroenterol, Sapporo, Hokkaido, Japan

[12] Niigata Univ, Dept Gastroenterol & Hepatol, Grad Sch Med & Dent Sci, Niigata, Japan

[13] Oita Univ, Fac Med, Dept Gastroenterol, Yufu City, Japan

[14] Shinshu Univ, Dept Med, Div Hepatol & Gastroenterol, Sch Med, Matsumoto, Nagano, Japan

[15] Gunma Univ, Dept Gastroenterol & Hepatol, Grad Sch Med, Maebashi, Gumma, Japan

[16] Musashino Red Cross Hosp, Dept Gastroenterol & Hepatol, Tokyo, Japan

[17] Kagawa Univ, Dept Gastroenterol & Neurol, Sch Med, Takamatsu, Kagawa, Japan

[18] Iwate Med Univ, Dept Internal Med, Div Hepatol, Morioka, Iwate, Japan

[19] Minoh City Hosp, Dept Gastroenterol, Osaka, Japan

[20] Teikyo Univ, Mizonokuchi Hosp, Dept Internal Med 4, Tokyo, Japan

[21] Tokyo Med Univ, Dept Internal Med, Ibaraki Med Ctr, Div Gastroenterol & Hepatol, Ibaraki, Japan

[22] Teikyo Univ, Fac Med Technol, Tokyo, Japan

来源：

LIVER INTERNATIONAL | 2020年 / 40卷 / 08期

关键词：

alkaline phosphatase; bezafibrate; cohort study; endpoint; treatment response; validation; PLACEBO-CONTROLLED TRIAL; BIOCHEMICAL RESPONSE; CIRRHOSIS; PROGNOSIS;

D O I：

10.1111/liv.14534

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background/Purpose Although ursodeoxycholic acid (UDCA) is a first-line treatment for primary biliary cholangitis (PBC), 20%-30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC. Methods Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase All parameters were available in 804 patients (male/female = 120/684, age 58.9 [interquartile range 51.1-66.9] years). Bezafibrate was commenced within 12 months of UDCA in 78 patients (9.7%) because of the lack of an early response. We found that the endpoint was not reached in these 78 patients, and the area under the receiver operating characteristic curve (AUROC) of the score was 0.74 (95% confidence interval [CI] 0.70-0.79). The AUROC was 0.77 (95% CI 0.70-0.83) in patients undergoing UDCA monotherapy (n = 726). Finally, the AUROC of the modified UDCA Response Score using only data from the treatment start date was 0.80 (95% CI 0.70-0.90) in patients receiving a combination therapy of UDCA and bezafibrate (n = 160). Conclusion The validity of the UDCA Response Score was acceptable in Japanese patients; this score will be informative in patients treated with a combination therapy of UDCA and bezafibrate.

引用

页码：1926 / 1933

页数：8

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