Mok T S K, Yeo W, Johnson P J, Hui P, Ho W M, Lam K C, Xu M, Chak K, Chan A, Wong H, Mo F, Zee B
Department of Clinical Oncology, Prince of Wales Hospital, Institute of Chinese Medicine, Hong Kong Cancer Institute, Chinese University of Hong Kong, Hong Kong Special Administrative Region (HKSAR), China.
Ann Oncol. 2007 Apr;18(4):768-74. doi: 10.1093/annonc/mdl465. Epub 2007 Jan 17.
Chinese herbal medicine (CHM) is a common complementary therapy used by patients with cancer for reduction of chemotherapy-induced toxic effects. This study applied the highest standard of clinical trial methodology to examine the role of CHM in reducing chemotherapy-induced toxicity, while maintaining a tailored approach to therapy.
Patients with early-stage breast or colon cancer who required postoperative adjuvant chemotherapy were eligible for the study. Enrolled patients were randomly assigned to one of three Chinese herbalists who evaluated and prescribed a combination of single-item packaged herbal extract granules. Patients received either CHM or placebo packages with a corresponding serial number. The placebo package contained nontherapeutic herbs with an artificial smell and taste similar to a typical herbal tea. The primary end points were hematologic and non-hematologic toxicity according to the National Cancer Institute Common Toxicity Criteria Version 2.
One hundred and twenty patients were accrued at the time of premature study termination. Patient characteristics of the two groups were similar. The incidence of grade 3/4 anemia, leukopenia, neutropenia, and thrombocytopenia for the CHM and placebo groups were 5.4%, 47.3%, 52.7%, and 1.8% and 1.8%, 32.2%, 44.7%, and 3.6%, respectively (P = 0.27, 0.37, 0.63, and 0.13, respectively). Incidence of grade 2 nausea was the only non-hematologic toxicity that was significantly reduced in the CHM group (14.6% versus 35.7%, P = 0.04).
Traditional CHM does not reduce the hematologic toxicity associated with chemotherapy. CHM, however, does have a significant impact on control of nausea.
中药是癌症患者常用的辅助疗法，用于减轻化疗引起的毒性作用。本研究采用最高标准的临床试验方法，以检验中药在减轻化疗毒性方面的作用，同时保持个性化治疗方法。
需要术后辅助化疗的早期乳腺癌或结肠癌患者符合本研究条件。入选患者被随机分配给三位中医师之一，由其评估并开出单项包装草药提取物颗粒的组合药方。患者接受带有相应序列号的中药或安慰剂包。安慰剂包包含无治疗作用的草药，其气味和味道与典型的草药茶相似。主要终点是根据美国国立癌症研究所通用毒性标准第2版确定的血液学和非血液学毒性。
在研究提前终止时，共招募了120名患者。两组患者的特征相似。中药组和安慰剂组3/4级贫血、白细胞减少、中性粒细胞减少和血小板减少的发生率分别为5.4%、47.3%、52.7%和1.8%，以及1.8%、32.2%、44.7%和3.6%（P值分别为0.27、0.37、0.63和0.13）。2级恶心的发生率是中药组中唯一显著降低的非血液学毒性（14.6%对35.7%，P = 0.04）。
传统中药不能减轻与化疗相关的血液学毒性。然而，中药对恶心的控制有显著影响。
