华蟾素是一种中药，由干蟾皮提取而来，其抗癌作用在于干蟾皮中的蟾蜍精和蟾蜍甙元。研究发现其在癌症治疗中具有良好的毒性耐受水平，甚至可以是正常剂量的8倍之多，可能延缓一些癌症患者病情的发展。
该结果来源于华蟾素的一期临床试验，这是德克萨斯大学Anderson博士和复旦大学肿瘤医院的一个合作项目。在Cancer早期的在线版本上就有关于这项研究结果的相关报道。这项研究是首次探索华蟾素剂量和毒性的关系。
华蟾素在中国广泛用于治疗肝癌，肺癌，结肠癌和胰腺癌。中国的临床试验是从20世纪70年代开始的，在晚期肝细胞型肝癌和肺癌中华蟾素的抗癌总响应率分别是10%和16%。
研究人员介绍说，对于美国研究机构来说，对华蟾素的研究是全新的，他们希望能够通过这项研究，将其结合到西药开发中，并希望能够产生更好的癌症治疗效果，而且没有毒性和副作用。
在中国，华蟾素临床试验的剂量大约是15 mL/m2。这项试验中，研究人员对15位参与者在不同的周期内使用不同的剂量进行治疗。当剂量上升到传统用量的8倍后，研究人员发现也只是表现出很低的毒性或副作用。在患者中也没有观察到显著的心脏毒性，癌症相关的症状也没有显著变化。在接受完全治疗的15位病人中，6位肝细胞癌患者在治疗过程中病情保持稳定，而其中的一位出现了肿瘤减小的情况。
这项研究尽管没有看到完全的治疗效果，但令人鼓舞的是，在大部分的干细胞癌患者中没有出现癌症病情的恶化。（生物谷Bioon.com）
生物谷推荐原始出处：
Cancer Aug 21 2009 9:17AM DOI: 10.1002/cncr.24602
Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer
Zhiqiang Meng, MD, PhD 1, Peiying Yang, PhD 2, Yehua Shen, MD 1, Wenying Bei, RN 1, Ying Zhang, RN 1, Yongqian Ge, MD 1, Robert A. Newman, PhD 3 a, Lorenzo Cohen, PhD 2 4 *, Luming Liu, MD, PhD 1 *, Bob Thornton, MPH 2 b, David Z. Chang, PhD 5, Zongxing Liao, MD 6, Razelle Kurzrock, MD 7
1International Center of Integrative Oncology, Fudan University Cancer Hospital, Shanghai, China
2The Integrative Medicine Program, Department of General Oncology, The University of Texas M. D. Anderson Cancer, Houston, Texas
3Department of Experimental Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
4Department of Behavioral Science, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
5Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
6Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
7Department of Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
BACKGROUND:
Huachansu, a Chinese medicine that comes from dried toad venom from the skin glands of Bufo gargarizans or B. melanostictus, has been used in the treatment of various cancers in China. The authors conducted a pilot study, using a phase 1 trial design, of huachansu in patients with advanced cancer.
METHODS:
Huachansu was administered intravenously for 14 days followed by 7 days off (1 cycle). Without significant adverse events or progressive disease, treatment continued beyond 2 cycles. The dose of huachansu was escalated as follows with 3 patients per cohort: 10 (level 1), 20 (level 2), 40 (level 3), 60 (level 4), and 90 (level 5) mL/m2.
RESULTS:
Fifteen patients (hepatocellular cancer, n = 11; nonsmall cell lung cancer, n = 2; pancreatic cancer, n = 2) were enrolled in the trial, and no dose-limiting toxicities (DLTs) were found. Eleven patients had no drug-related toxicity greater than grade 1. Six (40%) had stable disease (median duration, 6.0 months; range, 3.5-11.1 months). One of these patients (with hepatocellular cancer) had 20% regression (duration, 11 months) (dose level 1). Quality of life improved for patients with stable disease. Plasma bufalin concentration reached maximal levels at the end of the 2-hour infusion and was proportional to the amount of drug being administered (0.81-3.38 ng/mL).
CONCLUSIONS:
No DLT was observed with the use of huachansu at doses up to 8× higher than typically used in China. Six patients had prolonged stable disease or minor tumor shrinkage.
