精氨酸营养补充剂对女性癌症幸存者性功能及生活质量的影响：WFU CCOP研究基地方案97106的结果
Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106.
作者信息
Greven Kathryn M, Case L Douglas, Nycum Lawrence R, Zekan Patricia J, Hurd David D, Balcueva Ernie P, Mills Glenn M, Zon Robin, Flynn Patrick J, Biggs David, Shaw Edward G, Lesser Glenn, Naughton Michelle J
机构信息
Comprehensive Cancer Center of Wake Forest University CCOP Research Base, Winston-Salem, North Carolina, USA.
出版信息
J Community Support Oncol. 2015 Mar;13(3):87-94. doi: 10.12788/jcso.0114.
BACKGROUND
Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.
OBJECTIVE
To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.
METHODS
This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of Arginmax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.
RESULTS
186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm,satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.
LIMITATIONS
Study results are limited by a lack of data on the participants' psychological and physical symptoms and sexual partner variables.
CONCLUSIONS
ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.
背景
乳腺癌和妇科癌症治疗后性功能问题很常见，尽管有效治疗方法很少。
目的
评估一种名为ArginMax的营养补充剂对女性癌症幸存者性功能和生活质量的影响，该补充剂由L-精氨酸、人参、银杏和达米阿那提取物以及多种维生素和矿物质组成。
方法
这是一项为期12周的随机、安慰剂对照试验，研究对象为符合条件的患者，这些患者在积极治疗后6个月或更长时间，且报告有治疗后性兴趣、满意度和性功能方面的问题。参与者每天服用3粒Arginmax胶囊或安慰剂，分两次服用。结局指标为女性性功能指数（FSFI）和癌症治疗功能评估通用量表（FACT-G）。在基线、第4周、第8周和第12周进行评估。
结果
2007年5月10日至2010年3月24日期间招募了186名年龄中位数为50岁的患者。76%的患者为非西班牙裔白人。大多数患者患有乳腺癌或妇科癌症（分别为78%和12%）。在12周时，ArginMax组（n = 96）和安慰剂组（n = 92）在性欲、性唤起、润滑、性高潮、满意度或疼痛方面没有差异。然而，与服用安慰剂的参与者相比，服用ArginMax的参与者FACT-G总分显著更高（最小二乘法[LS]均值分别为87.5和82.9；P = 0.009）。受影响最大的FACT-G子量表是身体状况（25.37对23.51，P = 0.001）和功能幸福感（22.46对20.72，P = 0.007）。两组的毒性反应相似。
局限性
研究结果受到参与者心理和身体症状以及性伴侣变量数据缺乏的限制。
结论
ArginMax对性功能没有显著影响，但接受ArginMax的参与者在12周时生活质量显著更好。
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