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一种新型不可输注的植物源药物PG2用于治疗癌症相关疲劳:一项II期双盲、随机、安慰剂对照研究。

A novel infusible botanically-derived drug, PG2, for cancer-related fatigue: a phase II double-blind, randomized placebo-controlled study.

作者信息

Chen Hong-Wen, Lin I-Hsin, Chen Yu-Jen, Chang Kao-Hwa, Wu Meng-Hao, Su Wen-Hao, Huang Gwo-Che, Lai Yuen-Liang

机构信息

Department of Radiation Oncology and Hospice Center, Mackay Memorial Hospital, Taipei, Taiwan.

出版信息

Clin Invest Med. 2012 Feb 1;35(1):E1-11. doi: 10.25011/cim.v35i1.16100.

DOI:10.25011/cim.v35i1.16100
PMID:22309959
Abstract

PURPOSE

This study investigated the efficacy of the botanical-derived drug, PG2, a partially purified extract of Astragalus membranaceus, as a complementary and palliative medicine for managing cancer-related fatigue (CRF).

METHODS

Patients with advanced cancer and moderate to severe CRF were randomized to receive either PG2 or a placebo (normal saline, NS) in the first treatment cycle (four weeks) in a double-blind manner; thereafter, on the next cycle (four weeks), all patients received open-label treatment with PG2.

RESULTS

PG2 significantly improved CRF in the NS-primed group. In the first four week cycle, PG2 administration resulted in a greater fatigue-improvement response rate than seen with NS alone. In addition, approximately 82% of patients who reported an improvement of fatigue symptoms following the first cycle of PG2 experienced sustained benefits after administration of the second treatment cycle. Among patients treated with PG2 who did not report an improvement in symptoms throughout the first treatment cycle, approximately 71% showed significant improvement after the second treatment cycle. No major or irreversible toxicities were observed with PG2 treatment.

CONCLUSION

PG2 might be an effective and safe treatment for relieving CRF among advanced cancer patients.

摘要

目的

本研究调查了植物源药物PG2(一种黄芪的部分纯化提取物)作为治疗癌症相关疲劳(CRF)的补充和姑息药物的疗效。

方法

晚期癌症且伴有中度至重度CRF的患者在第一个治疗周期(四周)以双盲方式随机接受PG2或安慰剂(生理盐水,NS)治疗;此后,在下一个周期(四周),所有患者接受PG2的开放标签治疗。

结果

PG2在NS起始组中显著改善了CRF。在第一个四周周期中,给予PG2导致的疲劳改善反应率高于单独使用NS。此外,在第一个PG2治疗周期后报告疲劳症状改善的患者中,约82%在第二个治疗周期给药后持续受益。在第一个治疗周期中未报告症状改善的接受PG2治疗的患者中,约71%在第二个治疗周期后显示出显著改善。PG2治疗未观察到重大或不可逆毒性。

结论

PG2可能是缓解晚期癌症患者CRF的一种有效且安全的治疗方法。

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