高トリグリセリド血症誘発性急性膵炎に対する従来の脂質低下療法へのエボロクマブ追加
従来の脂質低下療法にエボロクマブを追加した高トリグリセリド血症誘発性急性膵炎：パイロット無作為化比較試験
The severity of hypertriglyceridemia induced acute pancreatitis (HTG-AP) is closely related to the serum triglyceride (TG) levels. The higher the TG levels, the greater the risk of developing severe acute pancreatitis (SAP). Previous expert consensus has pointed out that the key to treating HTG-AP is to rapidly lower serum TG levels to below 5.65 mmol/L. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which is often used to treat familial hypercholesterolemia, mixed dyslipidemia and atherosclerotic cardiovascular disease. At the same time, evolocumab also has the effect of reducing TG and may provide a feasible option for the management of HTG-AP. However, its efficacy and safety in reducing TG in patients with HTG-AP remain controversial. This study is a multicenter randomized controlled trial to evaluate the efficacy and safety of adding evolocumab to conventional lipid-lowering therapy in patients with HTG-AP.
調査の概要
状態
詳細な説明
Overall, 60 patients with HTG-AP will be included. These patients will be randomly assigned in a 1:1 ratio to the conventional lipid-lowering therapy group and the conventional lipid-lowering therapy + evolocumab group. The primary endpoints are the TG levels at days 3 and 7 after treatment, and the rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L at the same time points. Secondary endpoints include blood levels of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and lipoprotein(a) at days 3 and 7; the incidence of recurrent acute pancreatitis (RAP), SAP, and other complications; as well as the length of hospital stay and total hospitalization costs.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xingshun Qi
- 電話番号：18909881019
- メール：xingshunqi@126.com
研究連絡先のバックアップ
- 名前：Yifan Guo
- 電話番号：18341833373
- メール：guoyifan202402@163.com
研究場所
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Liaoning
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Shenyang、Liaoning、中国、110840
- 募集
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
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コンタクト：
- Xingshun Qi
- 電話番号：18909881019
- メール：xingshunqi@126.com
-
コンタクト：
- Yifan Guo
- 電話番号：18341833373
- メール：guoyifan202402@163.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18~75 years
- Patients with HTG-AP
- Mixed hyperlipidemia
- Sign the informed consent form
Exclusion Criteria:
- Patients who have received lipid-lowering drugs or blood purification treatment within one week before enrollment
- Patients who have used evolocumab within one month before enrollment
- Patients who are accompanied by diseases that can seriously affect the survival
- Patients who have participated in the clinical research of other drugs within one month
- Patients who are pregnant or breastfeeding
- Patients with allergic asthma, allergic urticaria, eczema, and those who have a clear history of multiple drug and food allergies
- Other circumstances that researchers consider not suitable for participation in this study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：従来の脂質低下療法 + エボロクマブ群
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The clinicians strictly follow the treatment strategy for HTG-AP as stipulated in the 2021 "Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis" to provide conventional lipid-lowering treatment for the patients, including dietary adjustments, fibrates, low-molecular-weight heparin, and insulin, etc. On the basis of conventional lipid-lowering treatment, 140mg of evolocumab is added by slow subcutaneous injection every two weeks, and the patients' responses are observed during this period.
他の名前：
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アクティブコンパレータ：従来の脂質低下療法群
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This group only receives conventional lipid-lowering treatment without adding evolocumab.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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治療後3日目および7日目のTGレベル
時間枠：3日間と7日間
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3日間と7日間
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治療開始後3日目および7日目におけるTG値5.65 mmol/L未満および1.7 mmol/L未満の達成率
時間枠：3日間と7日間
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3日間と7日間
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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治療後3日目と7日目のTC、HDL、LDL、およびリポ蛋白(a)の血清レベル
時間枠：3日と7日
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3日と7日
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RAP、SAP、およびその他の合併症の発生率
時間枠：6ヶ月
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6ヶ月
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. Epub 2014 Mar 29.
- Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Wu BU, Johannes RS, Sun X, Tabak Y, Conwell DL, Banks PA. The early prediction of mortality in acute pancreatitis: a large population-based study. Gut. 2008 Dec;57(12):1698-703. doi: 10.1136/gut.2008.152702. Epub 2008 Jun 2.
- Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.
- Zengwu Wang, Jing Liu, Jianjun Li, et al. Chinese Guidelines for Lipid Management (2023). Chinese Journal of Circulation. 2023; 38 (03) : 237-271.
- Ong Y, Shelat VG. Ranson score to stratify severity in Acute Pancreatitis remains valid - Old is gold. Expert Rev Gastroenterol Hepatol. 2021 Aug;15(8):865-877. doi: 10.1080/17474124.2021.1924058. Epub 2021 May 13.
- Qi R, Liu H, Li X, Chen M. Successful use of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Hypertriglyceridemia-induced Acute Pancreatitis: A Case Report. Curr Cardiol Rev. 2025;21(3):e1573403X343784. doi: 10.2174/011573403X343784241115055037.
- Chen H, Li X, Chen J, Zhao Y, Zhang W, Li H, Qi X. Lipid-lowering effect of evolocumab in hypertriglyceridemia-induced acute pancreatitis. Eur J Pharmacol. 2025 Nov 5;1006:178148. doi: 10.1016/j.ejphar.2025.178148. Epub 2025 Sep 16.
- Lu W, Wang L, Du C, Qin L, Li J, Wang H. PCSK9 Inhibitors in Multi-Branch Lesions in Coronary Artery Disease with Substandard Lipid-Lowering Effects. Altern Ther Health Med. 2024 Aug;30(8):356-360.
- Tan H, Li W, Huang Z, Han Y, Huang X, Li D, Xing X, Monsalvo ML, Wu Y, Mao J, Xin L, Chen J; HUA TUO study investigators. Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial. Cardiol Ther. 2023 Jun;12(2):341-359. doi: 10.1007/s40119-023-00304-x. Epub 2023 Feb 21.
- Wiggins BS, Senfield J, Kassahun H, Lira A, Somaratne R. Evolocumab: Considerations for the Management of Hyperlipidemia. Curr Atheroscler Rep. 2018 Mar 6;20(4):17. doi: 10.1007/s11883-018-0720-3.
- Lu Z, Zhang G, Guo F, Li M, Ding Y, Zheng H, Wang D. Elevated triglycerides on admission positively correlate with the severity of hypertriglyceridaemic pancreatitis. Int J Clin Pract. 2020 Mar;74(3):e13458. doi: 10.1111/ijcp.13458. Epub 2019 Dec 14.
- Xin Hong, Liming Wang, Zhengliang Zhang, et al. Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis [J]. Chinese General Practice, 2021, 24(30): 3781-93
- Na Zhang, Haiyan Zhang, Xiaohong Guo, et al. Meta-analysis of etiological changes of acute pancreatitis in China in the past Decade [J]. Chinese Journal of Gastroenterology and Imaging (Electronic Edition), 2016, 6(02): 71-5
- Pancreatic Surgery Group, Surgical Branch of the Chinese Medical Association Chinese Guidelines for Diagnosis and Treatment of Acute Pancreatitis (2021) [J]. Chinese Journal of Digestive Surgery, 2021, 20(07): 730-9.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- XHNKKY-HTGAP
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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