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钾竞争性酸阻断剂替戈拉生治疗酸相关疾病的研究进展
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Abstract:
替戈拉生作为一种新型的钾竞争性酸阻断剂，能够高选择性的通过抑制H+/K+ ATP酶，阻断H+-K+交换，有效减少胃酸分泌，同时能有效地克服质子泵抑制剂的不足，在治疗许多酸相关疾病中显示出良好的效果。本文对其药理学、临床应用研究进展及安全性加以总结。
As a novel potassium-competitive acid blocker, tegoprazan can highly selectively block H+-K+ exchange by inhibiting H+/K+ ATPase, effectively reduce gastric acid secretion, and at the same time can effectively overcome the deficiencies of proton pump inhibitors, showing good results in the treatment of many acid-related diseases. This paper summarises the progress of its pharmacology, clinical application research and safety.
| [1] | Domingues, G., Chinzon, D., Moraes-Filho, J., Senra, J., Perrotti, M. and Zaterka, S. (2023) Potassium-Competitive Acid Blockers, a New Therapeutic Class, and Their Role in Acid-Related Diseases: A Narrative Review. Gastroenterology Review, 18, 47-55. https://doi.org/10.5114/pg.2022.116673 |
| [2] | Shim, Y.K. and Kim, N. (2017) The Effect of H2 Receptor Antagonist in Acid Inhibition and Its Clinical Efficacy. The Korean Journal of Gastroenterology, 70, 4-12. https://doi.org/10.4166/kjg.2017.70.1.4 |
| [3] | Sachs, G., Shin, J.M. and Howden, C.W. (2006) Review Article: The Clinical Pharmacology of Proton Pump Inhibitors. Alimentary Pharmacology & Therapeutics, 23, 2-8. https://doi.org/10.1111/j.1365-2036.2006.02943.x |
| [4] | Leowattana, W. and Leowattana, T. (2022) Potassium-Competitive Acid Blockers and Gastroesophageal Reflux Disease. World Journal of Gastroenterology, 28, 3608-3619. https://doi.org/10.3748/wjg.v28.i28.3608 |
| [5] | Piche, T. and Galmiche, J.P. (2005) Pharmacological Targets in Gastro‐Oesophageal Reflux Disease. Basic & Clinical Pharmacology & Toxicology, 97, 333-341. https://doi.org/10.1111/j.1742-7843.2005.pto_273.x |
| [6] | He, J., Cao, G., Yu, J., Wang, J., Cheng, N., Wu, J., et al. (2020) Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Oral Doses of Tegoprazan in Healthy Chinese Subjects. Clinical Drug Investigation, 41, 89-97. https://doi.org/10.1007/s40261-020-00986-4 |
| [7] | 梁笑楠, 战蓉蓉, 张晓岚. 《2020年中国胃食管反流病专家共识》解读[J]. 河北医科大学学报, 2021, 42(8): 869-871. |
| [8] | Inatomi, N., Matsukawa, J., Sakurai, Y. and Otake, K. (2016) Potassium-Competitive Acid Blockers: Advanced Therapeutic Option for Acid-Related Diseases. Pharmacology & Therapeutics, 168, 12-22. https://doi.org/10.1016/j.pharmthera.2016.08.001 |
| [9] | Takahashi, N. and Take, Y. (2017) Tegoprazan, a Novel Potassium-Competitive Acid Blocker to Control Gastric Acid Secretion and Motility. Journal of Pharmacology and Experimental Therapeutics, 364, 275-286. https://doi.org/10.1124/jpet.117.244202 |
| [10] | Yang, E., Kim, S., Kim, B., Kim, B., Kim, Y., Park, S.S., et al. (2022) Night‐Time Gastric Acid Suppression by Tegoprazan Compared to Vonoprazan or Esomeprazole. British Journal of Clinical Pharmacology, 88, 3288-3296. https://doi.org/10.1111/bcp.15268 |
| [11] | Fujimori, S. (2020) Gastric Acid Level of Humans Must Decrease in the Future. World Journal of Gastroenterology, 26, 6706-6709. https://doi.org/10.3748/wjg.v26.i43.6706 |
| [12] | Han, S., Choi, H.Y., Kim, Y.H., Nam, J.Y., Kim, B., Song, G.S., et al. (2021) Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan. Clinical Therapeutics, 43, 1371-1380. https://doi.org/10.1016/j.clinthera.2021.06.007 |
| [13] | Ghim, J., Chin, M.C., Jung, J., Lee, J., Kim, S., Kim, B., et al. (2021) Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered with Amoxicillin and Clarithromycin in Healthy Subjects. The Journal of Clinical Pharmacology, 61, 913-922. https://doi.org/10.1002/jcph.1805 |
| [14] | Nirwan, J.S., Hasan, S.S., Babar, Z., Conway, B.R. and Ghori, M.U. (2020) Global Prevalence and Risk Factors of Gastro-Oesophageal Reflux Disease (GORD): Systematic Review with Meta-Analysis. Scientific Reports, 10, Article No. 5814. https://doi.org/10.1038/s41598-020-62795-1 |
| [15] | Lu, T., Li, S., Zhang, J. and Chen, C. (2022) Meta-Analysis on the Epidemiology of Gastroesophageal Reflux Disease in China. World Journal of Gastroenterology, 28, 6410-6420. https://doi.org/10.3748/wjg.v28.i45.6410 |
| [16] | Kim, S.H., Cho, K.B., Chun, H.J., Lee, S.W., Kwon, J.G., Lee, D.H., et al. (2021) Randomised Clinical Trial: Comparison of Tegoprazan and Placebo in Non‐Erosive Reflux Disease. Alimentary Pharmacology & Therapeutics, 54, 402-411. https://doi.org/10.1111/apt.16477 |
| [17] | Lee, K.J., Son, B.K., Kim, G.H., Jung, H., Jung, H., Chung, I., et al. (2019) Randomised Phase 3 Trial: Tegoprazan, a Novel Potassium‐Competitive Acid Blocker, Vs. Esomeprazole in Patients with Erosive Oesophagitis. Alimentary Pharmacology & Therapeutics, 49, 864-872. https://doi.org/10.1111/apt.15185 |
| [18] | Lanas, A. and Chan, F.K.L. (2017) Peptic Ulcer Disease. The Lancet, 390, 613-624. https://doi.org/10.1016/s0140-6736(16)32404-7 |
| [19] | Cho, Y.K., Choi, M., Choi, S.C., Lee, K.M., Kim, T.O., Park, S., et al. (2020) Randomised Clinical Trial: Tegoprazan, a Novel Potassium‐Competitive Acid Blocker, or Lansoprazole in the Treatment of Gastric Ulcer. Alimentary Pharmacology & Therapeutics, 52, 789-797. https://doi.org/10.1111/apt.15865 |
| [20] | Ouyang, M., Zou, S., Cheng, Q., et al. (2024) Comparative Efficacy and Safety of Potassium-Competitive Acid Blockers vs. Proton Pump Inhibitors for Peptic Ulcer with or without Helicobacter pylori Infection: A Systematic Review and Network Meta-Analysis. Pharmaceuticals, 17, 698. https://doi.org/10.3390/ph17060698 |
| [21] | Li, Y., Choi, H., Leung, K., Jiang, F., Graham, D.Y. and Leung, W.K. (2023) Global Prevalence of Helicobacter pylori Infection between 1980 and 2022: A Systematic Review and Meta-Analysis. The Lancet Gastroenterology & Hepatology, 8, 553-564. https://doi.org/10.1016/s2468-1253(23)00070-5 |
| [22] | Choi, Y.J., Lee, Y.C., Kim, J.M., Kim, J.I., Moon, J.S., Lim, Y.J., et al. (2022) Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial. Gut and Liver, 16, 535-546. https://doi.org/10.5009/gnl220055 |
| [23] | Kim, J.Y., Lee, S., Kim, H., Kim, J.H., Sung, I. and Park, H.S. (2021) Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Helicobacter pylori Eradication Therapy Administered with Bismuth. Yonsei Medical Journal, 62, 708-716. https://doi.org/10.3349/ymj.2021.62.8.708 |
| [24] | Kim, J.S., Ko, W., Chung, J. and Kim, T.H. (2023) Efficacy of Tegoprazan‐Based Bismuth Quadruple Therapy Compared with Bismuth Quadruple Therapy for Helicobacter pylori Infection: A Randomized, Double‐Blind, Active‐Controlled Study. Helicobacter, 28, e12977. https://doi.org/10.1111/hel.12977 |
| [25] | Nakase, H., Uchino, M., Shinzaki, S., Matsuura, M., Matsuoka, K., Kobayashi, T., et al. (2021) Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease 2020. Journal of Gastroenterology, 56, 489-526. https://doi.org/10.1007/s00535-021-01784-1 |
| [26] | Son, M., Park, I.S., Kim, S., Ma, H.W., Kim, J.H., Kim, T.I., et al. (2022) Novel Potassium-Competitive Acid Blocker, Tegoprazan, Protects against Colitis by Improving Gut Barrier Function. Frontiers in Immunology, 13, Article ID: 870817. |
| [27] | Mermelstein, J., Mermelstein, A.C., and Chait, M.M., (2020) Tegoprazan to Treat Gastroesophageal Reflux Disease. Drugs of Today, 56, 715-721. https://doi.org/10.1358/dot.2020.56.11.3202811 |
| [28] | Hu, W., Tong, J., Kuang, X., Chen, W. and Liu, Z. (2018) Influence of Proton Pump Inhibitors on Clinical Outcomes in Coronary Heart Disease Patients Receiving Aspirin and Clopidogrel: A Meta-Analysis. Medicine, 97, e9638. https://doi.org/10.1097/md.0000000000009638 |
| [29] | Pang, J., Wu, Q., Zhang, Z., Zheng, T., Xiang, Q., Zhang, P., et al. (2019) Efficacy and Safety of Clopidogrel Only vs. Clopidogrel Added Proton Pump Inhibitors in the Treatment of Patients with Coronary Heart Disease after Percutaneous Coronary Intervention. IJC Heart & Vasculature, 23, Article ID: 100317. https://doi.org/10.1016/j.ijcha.2018.12.016 |
| [30] | Yang, E., Ji, S.C., Jang, I. and Lee, S. (2023) Evaluation of CYP2C19-Mediated Pharmacokinetic Drug Interaction of Tegoprazan, Compared with Vonoprazan or Esomeprazole. Clinical Pharmacokinetics, 62, 599-608. https://doi.org/10.1007/s40262-023-01228-4 |
| [31] | Kim, M., Kim, B., Lee, J., Kim, D., Song, G.S., Williams, S.D., et al. (2023) Carcinogenicity Assessment of Tegoprazan in Sprague-Dawley (crl:cd) Rats and ICR (crl:cd1) Mice. Regulatory Toxicology and Pharmacology, 142, Article ID: 105424. https://doi.org/10.1016/j.yrtph.2023.105424 |
| [32] | Kim, M., Im, Y., Lee, J., Kim, E., Yeom, S.W. and Kim, J.S. (2023) Comparison of Hepatotoxicity of Tegoprazan, a Novel Potassium-Competitive Acid Blocker, with Proton Pump Inhibitors Using Real-World Data: A Nationwide Cohort Study. Frontiers in Medicine, 9, Article ID: 1076356. https://doi.org/10.3389/fmed.2022.1076356 |
