華蟾素是一種中藥,，由干蟾皮提取而來,，其抗癌作用在于干蟾皮中的蟾蜍精和蟾蜍甙元,。研究發(fā)現其在癌癥治療中具有良好的毒性耐受水平，甚至可以是正常劑量的8倍之多,，可能延緩一些癌癥患者病情的發(fā)展,。
該結果來源于華蟾素的一期臨床試驗，這是德克薩斯大學Anderson博士和復旦大學腫瘤醫(yī)院的一個合作項目,。在Cancer早期的在線版本上就有關于這項研究結果的相關報道,。這項研究是首次探索華蟾素劑量和毒性的關系。
華蟾素在中國廣泛用于治療肝癌,，肺癌,，結腸癌和胰腺癌。中國的臨床試驗是從20世紀70年代開始的,，在晚期肝細胞型肝癌和肺癌中華蟾素的抗癌總響應率分別是10%和16%,。
研究人員介紹說，對于美國研究機構來說,，對華蟾素的研究是全新的,，他們希望能夠通過這項研究，將其結合到西藥開發(fā)中,，并希望能夠產生更好的癌癥治療效果,，而且沒有毒性和副作用。
在中國,，華蟾素臨床試驗的劑量大約是15 mL/m2,。這項試驗中，研究人員對15位參與者在不同的周期內使用不同的劑量進行治療,。當劑量上升到傳統用量的8倍后,，研究人員發(fā)現也只是表現出很低的毒性或副作用。在患者中也沒有觀察到顯著的心臟毒性,，癌癥相關的癥狀也沒有顯著變化,。在接受完全治療的15位病人中，6位肝細胞癌患者在治療過程中病情保持穩(wěn)定,，而其中的一位出現了腫瘤減小的情況,。
這項研究盡管沒有看到完全的治療效果，但令人鼓舞的是,，在大部分的干細胞癌患者中沒有出現癌癥病情的惡化,。（生物谷Bioon.com）
生物谷推薦原始出處：
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.
