Hepatology Department, Cairo University, Cairo, Egypt.
AMKS Time Release LLC, Montclair, NJ, USA.
J Hepatocell Carcinoma. 2015 Jun 22;2:79-89. doi: 10.2147/JHC.S60864. eCollection 2015.
Hepatocellular carcinoma (HCC) is a global public health problem, based on it being the fifth most common cancer and third leading cause of cancer-related mortality worldwide. The approved conventional treatment methods for HCC have shown life-threatening side effects with limited or negligible success, especially in multifocal HCC. As a consequence, new therapeutic approaches are being explored, including immunoregulatory molecules that may have the potential to treat or delay the progression of HCC. A novel pharmaceutical botanical drug - Ambovex(®), an immune-modulator molecule - was tested to treat or delay the progress of HCC. We conducted a 6-month randomized clinical trial with an additional 3-month washing period (no treatment) to evaluate the safety and efficacy of low-dose Ambovex oral spray in treating patients with HCC. The clinical study involved a total of 40 patients, with 33 in the treatment group and seven in the control group. The α-fetoprotein (AFP) levels were measured every month and ultrasound scans were performed at time zero and every 2 months thereafter. Computed tomography (CT) scans were performed for patients in the treatment group. Ambovex proved to be safe, as there were no significant side effects although some patients found that the drug has unpleasant taste. AFP analysis showed a significant decrease in its level (α=0.05; 95% confidence interval) in the treatment group when compared to the control group at 3 months (P=0.0031) and at 6 months (P=0.007). The ultrasound results showed improvement in the treated group, as evidenced by a significant decrease in the lesion numbers and sizes. The lesions in 38% of treated patients decreased from multiple to single with major improvements; 35% of patients exhibited a decrease from multiple lesions to multiple lesions with minor improvements, whereas 27% had stabilized lesions. CT scans in the treated group showed significant improvement, as there was complete disappearance of the lesions after 6 months of treatment with Ambovex in two patients. This clinical study showed the effective and promising results of Ambovex as an immunological modulator in treating HCC. Further exploration of Ambovex is recommended.
肝细胞癌 (HCC) 是一个全球性的公共卫生问题，它是全球第五大常见癌症，也是癌症相关死亡的第三大主要原因。HCC 的传统治疗方法已显示出危及生命的副作用，而且效果有限或可以忽略不计，尤其是在多灶性 HCC 中。因此，正在探索新的治疗方法，包括可能具有治疗或延缓 HCC 进展潜力的免疫调节分子。一种新型药物草药制剂 Ambovex(®)，一种免疫调节剂分子，已被测试用于治疗或延缓 HCC 的进展。我们进行了一项为期 6 个月的随机临床试验，并增加了 3 个月的洗脱期（无治疗），以评估低剂量 Ambovex 口服喷雾剂治疗 HCC 患者的安全性和疗效。该临床研究共涉及 40 名患者，其中治疗组 33 名，对照组 7 名。每月测量甲胎蛋白 (AFP) 水平，零时间和此后每 2 个月进行超声检查。对治疗组患者进行计算机断层扫描 (CT) 扫描。结果表明，Ambovex 是安全的，虽然有些患者觉得这种药物味道不好，但没有出现明显的副作用。与对照组相比，治疗组在 3 个月（P=0.0031）和 6 个月（P=0.007）时 AFP 分析显示其水平显著下降（α=0.05；95%置信区间）。超声结果显示治疗组有改善，病变数量和大小明显减少。38%的治疗患者的病变从多发性减少到单发性，并有明显改善；35%的患者从多发性病变减少到多发性病变，有轻微改善，而 27%的患者病变稳定。治疗组的 CT 扫描显示出明显的改善，因为有两名患者在接受 Ambovex 治疗 6 个月后，病变完全消失。这项临床研究表明 Ambovex 作为一种免疫调节剂治疗 HCC 的有效和有前途的结果。建议进一步探索 Ambovex。
