Expert Opin Drug Saf. 2010 Jan;9(1):1-8. doi: 10.1517/14740330903460317.
Hepatocellular carcinoma (HCC) is increasing in numbers worldwide, and no effective systemic treatment existed for advanced HCC until SHARP (Sorafenib in HCC Assessment Randomized Protocol) study proved sorafenib (Nexavar((R)), Bayer Pharmaceuticals, Wayne, NJ, USA) prolonged survival versus placebo. Child-Pugh class A liver function and a platelet count of > or = 60,000/mm(3) were among the inclusion criteria for SHARP. No safety data in patients with < 60,000/mm(3) of platelets are present. Thrombocytopenia is one of the most frequent challenges faced in patients with chronic liver diseases. We report a series of three patients with HCC and platelet count < 60,000/mm(3) who were successfully treated with sorafenib with no complications. We describe the current data on sorafenib and challenges faced in patients with HCC. In addition, we emphasize the need for informed consent when facing factors that predispose to bleeding (esophageal varices, coagulopathy and thrombocytopenia), possible band ligation before the start of sorafenib, careful clinical monitoring and discontinuation of sorafenib when major bleeding occurs.
肝细胞癌 (HCC) 在全球范围内的发病率正在增加，直到 SHARP（索拉非尼治疗 HCC 的随机评估协议）研究证明索拉非尼（多吉美（R），拜耳制药，美国新泽西州韦恩）可延长晚期 HCC 患者的生存期，才为晚期 HCC 患者提供了有效的系统治疗方法。SHARP 的纳入标准包括肝功能 Child-Pugh 分级为 A 和血小板计数 > 或 = 60,000/mm(3)。目前尚无血小板 < 60,000/mm(3) 的患者的安全性数据。血小板减少症是慢性肝病患者最常见的挑战之一。我们报告了三例 HCC 且血小板计数 < 60,000/mm(3) 的患者，他们成功地接受了索拉非尼治疗，没有出现并发症。我们描述了目前关于索拉非尼的数据以及 HCC 患者面临的挑战。此外，我们强调在面临易出血因素（食管静脉曲张、凝血障碍和血小板减少症）时需要获得知情同意，在开始使用索拉非尼之前可能需要进行带结扎，以及在发生大出血时需要进行仔细的临床监测和停止使用索拉非尼。
