点评：方玉
肿瘤学专业，北京大学肿瘤医院姑息治疗中心医师。目前主要从事肿瘤姑息治疗领域，多次参加国内学术会议。
关于PG2注射剂被批准用于改善正接受标准姑息治疗的晚期癌症患者癌症相关性疲乏的一项双盲、多中心随机性IV期研究。（ABS：10091）
第一作者:Cheng-Hsu Wang.台湾基隆长庚医院。
癌症相关性疲乏(CRF）存在于60%-90%的晚期癌症患者中，是一种最常见、使人虚弱的症状。患者所经受的这种疲劳不仅会影响其生活质量，还会影响治疗效果和生存率。PC2注射剂是台湾植物健康公司利用黄芪多糖（API）研制经台湾食品药品管理局（TFDA）批准的唯一一种用于缓解晚期癌症患者CRF的药物。为进一步探究PG2注射剂在低剂量下的疗效，我们在当前的研究中入组更多患者以观察PG2在2种剂量下的疗效。
将接受姑息治疗的中、重度CRF（短暂疲劳负荷量表（BFI-T）大于等于4）晚期癌症患者入组，按 1:1比率随机分入2组接受PG2注射两个周期治疗：500mg剂量或250mg剂量（两者均用500ml生理盐水配置、每周注射3次、连续4周）。第一周期结束时分析疲劳改善反应率（FIRR）以确定两种PG2剂量的效果，BFI-T量表改善评分大于10%视为缓解CRF有效。
结果
此研究中入组310名患者，214名入ITT组，包括111名分入高剂量组、103名分入低剂量组。结果显示，与对照组相比，250mg注射组中65.07%、46.60%、34.95%和26.61%的受试者在接受第一周期PG2注射治疗后疲劳量表改善率分别为至少10%、20%、30%和40%；500mg组中65.77%、51.35%、34.23%、18.90的受试者在接受一个PG2治疗周期后疲劳改善评分分别为至少10%、20%、30%、40%。
结论
研究表明同对照组相比，超过60%的受试者在接受250mg和500mg PG2注射治疗后疲劳评分至少改善10%。临床试验信息：NCT01720550
专家点评
北京大学公共卫生硕士，现任北京大学肿瘤医院临床营养科主任，副主任营养师。中国营养学会理事，中国抗癌协会肿瘤营养与支持治疗专业委员会委员，中国医促会营养与代谢管理专业委员会委员，中国临床营养网顾问，北京医学会临床营养专家委员会常务委员，北京临床营养质控中心委员。
疲劳是癌症及其治疗的最常见和最痛苦的副作用之一，并且在治疗完成后可能持续数年。癌症相关的疲劳导致生活质量的各个方面的破坏，还可能降低生存时间。目前认为，炎症可能是癌症相关性疲劳的关键生物学机制。相关危险因素包括遗传、生物学、心理社会和行为。鉴于癌症相关疲劳的多因素性，干预方法也应包括多种，如身体活动、心理社会、精神和药理学治疗。虽然目前没有治疗疲劳的金标准，但这些方法中的几种，如营养和运动管理、糖皮质激素治疗、精神药物及心理治疗已经显示出有益的效果，并且可以推荐给患者。
黄芪是中医常推荐用于补气的良药，常用于体衰日久、言语低弱、脉细无力者。该研究采用中药黄芪提取液进行治疗，显示了较明显的临床治疗效，为我们开发更多的用于治疗CRF的中药提供了较好的借鉴。进一步探索其疗效机制和据此开发更多的中药制剂是将来的研究方向。
附摘要原文：
10091 Poster Session (Board #79), Mon, 1:15 PM-4:45 PM
PG2 injection, a novel botanical drug approved for improving cancer-related fatigue among advanced cancer patients under standard palliative care: A double blind, multi-center, randomized phase IV study. First Author: Cheng-Hsu Wang, Chang Gung Memorial Hospital, Keelung, Taiwan
Background: Cancer-related fatigue (CRF) is one of the most frequent and debilitating symptoms in 60% to 90% of patients with advanced cancer. The fatigue experienced by cancer patients can not only deteriorate patient quality of life, but also affect treatment efficacy and survival rate. PG2 injection developed by PhytoHealth Co., Taiwan with Astragulus Poly- saccharides as API is the only drug approved by Taiwan Food and Drug Administration (TFDA) for relieving CRF in patients with advanced cancer. To further explore the effect of PG2 injection at lower dose, we recruited more patients in the current study and observe the effect of PG2 injection in 2 doses.
Methods: Patients with advanced cancer receiving standard palliative care (SPC) with moderate to severe CRF (Score of the Brief Fatigue Inventory- Taiwan (BFI-T)$4) were enrolled. Patients were randomized at a 1:1 ratio into two arms of PG2 injection treatment: 500mg dose or 250mg dose (both were prepared in 500ml saline and injected 3 times per week for 4 weeks) for two cycles. Fatigue improvement response rates (FIRR) were analyzed at the end of the first cycle to determine the efficacy of the two PG2 doses. Improvement of BFI-T score for more than 10% is considered as effective for relieving CRF. Results: Three hundred and ten patients were enrolled in this study. Two hundred and fourteen patients were included in the ITT population, including 111 subjects in high dose group and 103 subjects in low dose group.
Results： showed that improvement in fatigue scores by at least 10%, 20%, 30%, and 40% was observed in 65.07%, 46.60%, 34.95%, and 26.61% of subjects receiving 250 mg PG2 injection after one treatment cycle when compared to the baseline; in 500 mg group, fatigue score improvement by at least 10%, 20%, 30%, and 40% was observed in 65.77%, 51.35%, 34.23%, and 18.92% of subjects after one PG2 treatment cycle when compared to the baseline.
Conclusions: This study demonstrates that more than 60% of subjects showed at least 10% improvement in fatigue score when compared to baseline after both 250mg and500mg PG2 treatments. Clinical trial in- formation: NCT01720550. Clinical trial information: NCT01720550.
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