<br>补骨脂的正效益风险比：大鼠的综合安全性评估和成骨作用,Journal of Ethnopharmacology

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补骨脂的正效益风险比：大鼠的综合安全性评估和成骨作用
Journal of Ethnopharmacology ( IF 4.8 ) Pub Date : 2024-02-29 , DOI: 10.1016/j.jep.2024.117967
Zhuo Shi ₁ , Jin-Chao Pan ₂ , Yi Ru ₁ , Ning-Ning Shen ₁ , Yu-Fu Liu ₁ , Cheng Zhang ₁ , Xiang-Jun Wu ₁ , Fang-Yang Li ₁ , Jia-Lu Cui ₁ , Chun-Qi Yang ₁ , Jun-Ling Yang ₃ , Mao-Xing Li ₁ , Cheng-Rong Xiao ₁ , Zeng-Chun Ma ₁ , Chuan Li ₃ , Yu-Guang Wang ₁ , Yue Gao ₁

Affiliation

补骨脂（Psoralee Fructus，PF）为补骨脂属植物补骨脂的干燥果实，是我国数千年来为治疗骨科疾病做出贡献的常用传统药材。然而，最近PF相关肝损伤的报道因其潜在的肝毒性风险而引起了广泛关注。本研究旨在通过大鼠26周给药实验评价PF的长期疗效和慢性毒性，以模拟临床使用情况。每天以0.7、2.0和5.6 g/kg（相当于人类临床剂量的1-8倍）的剂量连续给大鼠施用PF水提取物，持续长达26周。自首次给药后 13、26 和 32 周（停药 6 周）后收集样本。采用常规毒理学方法评价PF的慢性毒性，通过自然生长过程中的成骨作用评价PF的功效。在我们的实验中，只有H组（5.6 g/kg）进行26周PF治疗时出现肝或肾损伤，停药6周后损伤可逆转。值得注意的是，超过 13 周的 PF 治疗显示出对大鼠骨骼生长和发育的显着益处，且雌性大鼠的获益风险比更高。 PF 在治疗和预防骨质疏松症（一种迄今为止缺乏有效药物的疾病）方面显示出有希望的效益风险比。这是首次阐明PF的临床剂量和长期使用相关的获益-风险平衡的研究，从而为PF的临床合理使用和风险控制提供有价值的见解。

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Positive benefit-risk ratio of Psoraleae Fructus: Comprehensive safety assessment and osteogenic effects in rats

Psoraleae Fructus (PF), the dried fruit of L., is a commonly used traditional medicine that has contributed to the treatment of orthopedic diseases for thousands of years in China. However, recent PF-related liver injury reports have drawn widespread attention regarding its potential hepatotoxicity risks. This study was aimed to evaluate the long-term efficacy and chronic toxicity of PF using a 26-week administration experiment on rats in order to simulate the clinical usage situation. The PF aqueous extract was consecutively administrated to rats daily at dosages of 0.7, 2.0, and 5.6 g/kg (equivalent to 1–8 times the clinical doses for humans) for as long as 26 weeks. Samples were collected after 13, 26, and 32 weeks (withdrawal for 6 weeks) since the first administration. The chronic toxicity of PF was evaluated by conventional toxicological methods, and the efficacy of PF was evaluated by osteogenic effects in the natural growth process. In our experiments, only the H group (5.6 g/kg) for 26-week PF treatment demonstrated liver or kidney injury, which the injuries were reversible after 6 weeks of withdrawal. Notably, the PF treatment beyond 13 weeks showed significant benefits for bone growth and development in rats, with a higher benefit-risk ratio in female rats. PF displayed a promising benefit-risk ratio in the treatment and prevention of osteoporosis, a disease that lacks effective medicine so far. This is the first study to elucidate the benefit-risk balance associated with clinical dosage and long-term use of PF, thereby providing valuable insights for rational clinical use and risk control of PF.

更新日期：2024-02-29

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