青蒿和青蒿茶制剂与青蒿琥酯-阿莫地喹（ASAQ）治疗大规模、双盲、随机临床试验中的恶性疟原虫疟疾的比较。
Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial.
机构信息
Faculté de Médecine Université de Kolwezi-Lualaba, Congo DRC.
Vice Présidente de La Maison de l'Artemisia(association Loi 1901), 20 rue Pierre Demours, 75017Paris, France.
出版信息
Phytomedicine. 2019 Apr;57:49-56. doi: 10.1016/j.phymed.2018.12.002. Epub 2018 Dec 5.
BACKGROUND AND OBJECTIVE
Prior small-scale clinical trials showed that Artemisia annua and Artemisia afra infusions, decoctions, capsules, or tablets were low cost, easy to use, and efficient in curing malaria infections. In a larger-scale trial in Kalima district, Democratic Republic of Congo, we aimed to show A. annua and/or A. afra infusions were superior or at least equivalent to artesunate-amodiaquine (ASAQ) against malaria.
METHODS
A double blind, randomized clinical trial with 957 malaria-infected patients had two treatment arms: 472 patients for ASAQ and 471 for Artemisia (248 A. annua, 223 A. afra) remained at end of the trial. ASAQ-treated patients were treated per manufacturer posology, and Artemisia-treated patients received 1 l/d of dry leaf/twig infusions for 7 d; both arms had 28 d follow-up. Parasitemia and gametocytes were measured microscopically with results statistically compared among arms for age and gender.
RESULTS
Artemisinin content of A. afra was negligible, but therapeutic responses of patients were similar to A. annua-treated patients; trophozoites cleared after 24 h, but took up to 14 d to clear in ASAQ-treated patients. D28 cure rates defined as absence of parasitemia were for pediatrics 82, 91, and 50% for A. afra, A. annua and ASAQ; while for adults cure rates were 91, 100, and 30%, respectively. Fever clearance took 48 h for ASAQ, but 24 h for Artemisia. From D14-28 no Artemisia-treated patients had microscopically detectable gametocytes, while 10 ASAQ-treated patients remained gametocyte carriers at D28. More females than males were gametocyte carriers in the ASAQ arm but were unaffected in the Artemisia arms. Hemoglobin remained constant at 11 g/dl for A. afra after D1, while for A. annua and ASAQ it decreased to 9-9.5 g/dl. Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
CONCLUSION
A. annua and A. afra infusions are polytherapies with better outcomes than ASAQ against malaria. In contrast to ASAQ, both Artemisias appeared to break the cycle of malaria by eliminating gametocytes. This study merits further investigation for possible inclusion of Artemisia tea infusions as an alternative for fighting and eradicating malaria.
背景和目的
先前的小规模临床试验表明，青蒿和黄花蒿的输注液、煎剂、胶囊或片剂价格低廉、使用方便且对治疗疟疾感染有效。在刚果民主共和国基利马区的一项更大规模试验中，我们旨在证明青蒿和/或黄花蒿输注液在治疗疟疾方面优于（或至少等同于）青蒿琥酯-阿莫地喹（ASAQ）。
方法
一项双盲、随机临床试验纳入了 957 例疟疾感染患者，分为两个治疗组：ASAQ 治疗组 472 例，青蒿治疗组 471 例（青蒿 248 例，黄花蒿 223 例），直至试验结束。ASAQ 治疗组患者按制造商的规定进行治疗，青蒿治疗组患者每天接受 1 升干叶/小枝输注液治疗 7 天；两组均进行 28 天随访。用显微镜测量寄生虫血症和配子体，并对各年龄组和性别组的结果进行统计学比较。
结果
黄花蒿中的青蒿素含量可以忽略不计，但患者的治疗反应与青蒿治疗组相似；滋养体在 24 小时后清除，但在 ASAQ 治疗组需要长达 14 天才能清除。D28 定义为无寄生虫血症的治愈率为儿科患者 82%、91%和 50%，分别为黄花蒿、青蒿和 ASAQ；而对于成年患者，治愈率分别为 91%、100%和 30%。ASAQ 组的退热时间为 48 小时，而青蒿组为 24 小时。从 D14 至 28 天，没有青蒿治疗组患者的显微镜可检测到配子体，而在 ASAQ 治疗组仍有 10 名患者为配子体携带者。在 ASAQ 组中，女性比男性更有可能成为配子体携带者，但在青蒿组中没有影响。青蒿琥酯治疗组的血红蛋白在 D1 后保持在 11g/dl 不变，而青蒿琥酯和 ASAQ 组的血红蛋白则降至 9-9.5g/dl。只有 5.0%的青蒿治疗组患者报告有不良反应，而 ASAQ 组为 42.8%。
结论
青蒿和黄花蒿输注液是一种多疗法，对疟疾的疗效优于 ASAQ。与 ASAQ 相反，青蒿和黄花蒿似乎都通过消除配子体来打破疟疾循环。这项研究值得进一步研究，可能将青蒿茶输注液作为一种替代方案，用于对抗和消除疟疾。
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