A randomized, controlled trial of Panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia.
A randomized, controlled trial of Panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia.
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DOI：
10.1016/j.suponc.2011.10.005
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发表时间：
2012-09
期刊：
影响因子：
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通讯作者：
Shaw, Edward G
中科院分区：
文献类型：
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作者：
High, Kevin P;Case, Doug;Hurd, David;Powell, Bayard;Lesser, Glenn;Falsey, Ann R;Siegel, Robert;Metzner-Sadurski, Joanna;Krauss, John C;Chinnasami, Bernard;Sanders, George;Rousey, Steven;Shaw, Edward G
慢性淋巴细胞白血病（CLL）患者是急性呼吸道疾病（ARI）的高危人群。评估西洋参（Panax quinequefolius） CVT-E002 （Afexa Life Sciences）专有提取物减少ARI的安全性/有效性。双盲，安慰剂对照，随机试验：293例早期未治疗的慢性淋巴细胞白血病患者，2009年1月- 3月。在研究期间，大约10%的日子出现ARI。两个先验的主要终点：ARI天数（CVT-E002组为8.5±17.2天，安慰剂组为6.8±13.3天）或严重ARI天数（CVT-E002组为2.9±9.5天，安慰剂组为2.6±9.8天）没有显著差异。然而，51%的CVT-E002和56%的安慰剂接受者经历了至少一次ARI（差异-5%，95% ci -16%,7%）；32%的CVT-E002患者发生了更严重的ARI，而安慰剂患者为39%（差异为7%，95% ci为18%，4%），症状特异性评估显示CVT-E002患者的中重度喉咙痛减轻（p = 0.004），≥3级毒性发生率较低（p = 0.02）。CVT-E002受体血清转化（抗体滴度增加4倍）高于9种常见病毒病原体（16%对7%；p = 0.04）。抗体滴度的血清学评估与特定疾病无关，但在整个研究期间进行评估。CVT-E002耐受性良好。CVT-E002并没有减少ARI天数或抗生素的使用；然而，有降低中重度ARI发生率和明显减少喉咙痛的趋势，表明血清转化率的增加很可能反映了cvt - e002增强的抗体反应。
Chronic Lymphocytic Leukemia (CLL) patients are at high risk for acute respiratory illness (ARI). Evaluate safety/efficacy of a proprietary extract of Panax quinequefolius, CVT-E002 (Afexa Life Sciences) to reduce ARI. Double-blind, placebo-controlled, randomized trial:293 subjects with early-stage, untreated CLL January-March, 2009. ARI days were common occurring on about 10% of days during the study period. There were no significant differences of the two a priori primary endpoints: ARI days (8.5 ± 17.2 for CVT-E002 vs. 6.8 ± 13.3 for placebo) or severe ARI days (2.9 ± 9.5 for CVT-E002 vs. 2.6 ± 9.8 for placebo). However, 51% percent of CVT-E002 vs. 56% of placebo recipients experienced at least one ARI (diff -5%, 95% C.I. -16%,7%); more intense ARI occurred in 32% of CVT-E002 vs. 39% of placebo recipients (diff -7%, 95% C.I. -18%, 4%), and symptom-specific evaluation showed reduced moderate-severe sore throat (p = 0.004) and a lower rate of grade ≥3 toxicities (p = 0.02) in CVT-E002 recipients. Greater seroconversion (4-fold increases in antibody titer) vs. 9 common viral pathogens was documented in CVT-E002 recipients (16% vs. 7%; p = 0.04). Serologic evaluation of antibody titers were not tied to a specific illness, but evaluated over the entire study period. CVT-E002 was well tolerated.CVT-E002 did not reduce the number of ARI days or antibiotic use; however, there was a trend toward reduced rates of moderate-severe ARI and significantly less sore throat, suggesting the increased rate of seroconversion most likely reflects CVT-E002-enhanced antibody responses.