海生素辅助治疗晚期肾细胞癌的随机对照临床研究。

Effect of haishengsu as an adjunct therapy for patients with advanced renal cell cancer: a randomized and placebo-controlled clinical trial.

机构信息

Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University , Liaocheng Shandong, China.

出版信息

J Altern Complement Med. 2009 Oct;15(10):1127-30. doi: 10.1089/acm.2009.0260.

DOI:10.1089/acm.2009.0260

PMID:19821717

Abstract

OBJECTIVE

The purpose of this study was to investigate the effect of Haishengsu, an extract from Tegillarca L. granosa, on the effects and side-effects of immunotherapy in patients with advanced renal cell cancer.

METHODS

Fifty-five (55) patients with renal cell cancer were randomly divided into a Haishengsu group (n = 27, 2.4 mg, intravenously for 15 days) and a control group (n = 28). All patients were also treated with interleukin-2, interferon-alpha, and fluorouracil.

RESULTS

In the Haishengsu group, the prevalence of gastrointestinal reactions to the immunotherapy was lower than in the control group (18.5% versus 64.3%, p < 0.01). In comparison with the control group, more patients from the Haishengsu group had increased food intake (74.1% versus 14.3%, p < 0.01), weight gain (77.8% versus 10.7%, p < 0.01) or an increase in Karnofsky Performance Status score (55.6% versus 17.9%, p < 0.01). The remission rate of cancer in the Haishengsu group was higher than in the control group (51.9% and 21.4%, p < 0.01).

CONCLUSIONS

Addition of Haishengsu to the conventional immunotherapy is associated with an increased remission rate in patients with advanced renal cell cancer. Haishengsu was also associated with a reduced rate of gastrointestinal side-effects from the immunotherapeutic agents, and an improvement in the physical functionality of the patients.

摘要

目的

本研究旨在探讨海生素（来自西施舌的提取物）对晚期肾细胞癌患者免疫治疗效果和副作用的影响。

方法

将 55 例肾细胞癌患者随机分为海生素组（n = 27，2.4 mg，静脉注射 15 天）和对照组（n = 28）。所有患者均接受白细胞介素-2、干扰素-α和氟尿嘧啶治疗。

结果

海生素组免疫治疗胃肠道反应发生率低于对照组（18.5%比 64.3%，p < 0.01）。与对照组相比，更多的海生素组患者增加了食欲（74.1%比 14.3%，p < 0.01）、体重增加（77.8%比 10.7%，p < 0.01）或 Karnofsky 表现状态评分增加（55.6%比 17.9%，p < 0.01）。海生素组的癌症缓解率高于对照组（51.9%比 21.4%，p < 0.01）。