Ouédraogo Joël, Ilboudo Sylvain, Ouédraogo Geoffroy Gueswindé, Somda Gaétan Donzèo, Bonogo Barthélemy, Dakuyo Virginie, Ouédraogo Salfo, Boly Raïnatou, Nitiéma Mathieu, Magnini Dofini Réné, Semdé Rasmané, Ouédraogo Sylvin
Département de Médecine et Pharmacopée Traditionnelles et Pharmacie, Institut de Recherche en Sciences de la Santé, Ouagadougou, BP, 7047, Burkina Faso.
Laboratoire de Développement du Médicament, Université Joseph KI-ZERBO, Ouagadougou, BP, 7021, Burkina Faso.
BMC Pharmacol Toxicol. 2025 Jul 28;26(1):138. doi: 10.1186/s40360-025-00973-5.
Although considered safe and widely used, some natural remedies are responsible for health ailments to their users that deserve to be investigated. SAYE PLUS is one of the most widely used traditional recipes as antimalaria for decades and recently against Covid-19 in Burkina Faso and beyond, and is commonly regarded as safe to use. In the present study, sub-chronic toxicity tests were performed orally in Wistar rats at daily doses of 250, 500, and 1000 mg/kg for 90 days, following the guidelines of the Organization for Economic Cooperation and Development (OECD). The results revealed neither symptoms of toxicity nor mortality. Depending on the dose, time frame, or animal sex, compared with the control, SAYE PLUS powder caused a statistically significant reduction in the water and food consumption of the treated rats. Significantly increases in serum creatinine, total protein, hydrogen phosphate ion (PO), and potassium ion (K) levels were detected in females at all doses. Compared to control values, the male rats' glucose decreased while its PO increased significantly at the daily dose of 1000 mg/kg of SAYE PLUS. Histopathological analysis revealed that the rat heart, lungs, liver, kidneys, and spleen histostructure were unaffected by sub-chronic exposure to SAYE PLUS up to 1000 mg/kg/d. The Findings provide some scientific information on the toxicological profile of the phytomedicine SAYE PLUS when administered in repeated doses for 90 days. However, they are limited by the absence of analysis of the animals' hematological parameters. Nevertheless, results show that for patient safety, it is not advisable to use SAYE PLUS for more than two consecutive weeks. Furthermore, herbal remedies need careful evaluation before or during their human use, especially when a new form of use other than the traditional one is proposed. Further long-term studies focusing on the hematological parameters and certain kidney and liver functional indicators will add the scientific merit and interest of the present work.
尽管一些天然药物被认为是安全且广泛使用的,但有些天然药物会给使用者带来健康问题,值得进行调查。几十年来,SAYE PLUS一直是布基纳法索及其他地区最广泛使用的传统抗疟疾药方,最近还用于对抗新冠病毒,并且通常被认为使用安全。在本研究中,按照经济合作与发展组织(OECD)的指导方针,以每日250、500和1000毫克/千克的剂量对Wistar大鼠进行了为期90天的口服亚慢性毒性试验。结果显示既没有毒性症状也没有死亡情况。根据剂量、时间范围或动物性别,与对照组相比,SAYE PLUS粉末使受试大鼠的水和食物消耗量出现了具有统计学意义的减少。在所有剂量下,雌性大鼠的血清肌酐、总蛋白、磷酸氢根离子(PO)和钾离子(K)水平均显著升高。与对照值相比,在每日剂量为1000毫克/千克的SAYE PLUS作用下,雄性大鼠的血糖降低,而其PO显著升高。组织病理学分析表明,在高达1000毫克/千克/天的剂量下,大鼠连续90天亚慢性接触SAYE PLUS对其心脏、肺、肝脏、肾脏和脾脏的组织结构没有影响。这些发现为重复给药90天的植物药SAYE PLUS的毒理学特征提供了一些科学信息。然而,由于缺乏对动物血液学参数的分析,这些发现存在局限性。尽管如此,结果表明,为了患者安全,连续使用SAYE PLUS超过两周是不可取的。此外,草药在用于人体之前或期间需要仔细评估,特别是当提出一种不同于传统用法的新用法时。进一步针对血液学参数以及某些肾脏和肝脏功能指标的长期研究将增加本研究的科学价值和意义。