Weber Lisa A, Delarocque Julien, Feige Karsten, Kietzmann Manfred, Kalbitz Jutta, Meißner Jessica, Paschke Reinhard, Cavalleri Jessika-M V
Clinic for Horses, University of Veterinary Medicine Hannover, Foundation, Bünteweg 9, 30559 Hannover, Germany.
Department of Pharmacology, Toxicology and Pharmacy, University of Veterinary Medicine Hannover, Foundation, Bünteweg 17, 30559 Hannover, Germany.
Animals (Basel). 2021 Nov 13;11(11):3250. doi: 10.3390/ani11113250.
The naturally occurring betulinic acid (BA) and its derivative NVX-207 induce apoptosis in equine melanoma cells in vitro. After topical application, high concentrations of the substances can be reached in healthy equine skin. With the aim to investigate the effect and safety of topically applied BA and NVX-207 in horses with melanocytic tumors, the longitudinal, prospective, randomized, double-blind, placebo-controlled study protocol included eighteen Lipizzaner mares with early-stage cutaneous melanoma assigned to three groups. Melanocytic lesions were topically treated either with a placebo, 1% BA or 1% NVX-207 twice a day for 91 days. Caliper measurements, clinical examinations and blood tests were performed to assess the effects and safety of the medication. The topical treatment was convenient and safe. The volumes of tumors treated with BA were significantly reduced over time as compared to tumors treated with the placebo from day 80 of the study. Although treatment with NVX-207 seemed to decrease tumor volume, these results did not reach statistical significance. The findings must be regarded as preliminary due to the limited group size and need to be replicated in a larger cohort with modified pharmaceutical test formulations. Accordingly, the treatment protocol cannot yet be recommended in its current form.
天然存在的桦木酸（BA）及其衍生物NVX - 207在体外可诱导马黑色素瘤细胞凋亡。局部应用后，在健康马的皮肤中可达到高浓度的这些物质。为了研究局部应用BA和NVX - 207对患有黑素细胞瘤的马匹的疗效和安全性，这项纵向、前瞻性、随机、双盲、安慰剂对照研究方案纳入了18匹患有早期皮肤黑色素瘤的利皮扎马母马，分为三组。对黑素细胞病变局部给予安慰剂、1% BA或1% NVX - 207治疗，每天两次，共91天。进行卡尺测量、临床检查和血液检查以评估药物的疗效和安全性。局部治疗方便且安全。与从研究第80天起用安慰剂治疗的肿瘤相比，用BA治疗的肿瘤体积随时间显著减小。虽然用NVX - 207治疗似乎可减小肿瘤体积，但这些结果未达到统计学显著性。由于样本量有限，这些发现必须被视为初步结果，需要在更大的队列中使用改良的药物测试制剂进行重复验证。因此，目前形式的治疗方案尚不能被推荐。
