Anak Agung Ayu Putri Laksmidewi, I. Nyoman Bayu Mahendra, Andreas Soejitno, Aurelia Vania
{"title":"通过间歇性剂量递增姜黄素提取物改善化疗所致认知障碍患者的认知功能:随机对照试验","authors":"Anak Agung Ayu Putri Laksmidewi, I. Nyoman Bayu Mahendra, Andreas Soejitno, Aurelia Vania","doi":"10.1007/s13596-023-00737-8","DOIUrl":null,"url":null,"abstract":"<div><p>Chemotherapy-induced cognitive impairment (CICI) is an impairment of memory, learning power, concentration, reasoning, executive function, attention, and visuospatial during and after chemotherapy exposures. No proven safe and effective therapeutic regimen are available to improve cognitive function in CICI patients. To evaluate the safety and effectiveness of curcumin extract to improve cognitive function in CICI patients. This study was a double-blind randomized controlled trial clinical trial in patients with cervical carcinoma who underwent a carboplatin-paclitaxel chemotherapy regimen from March to October 2021 at single center hospital. Subjects divided into two groups that received curcumin and placebo caplets by dose escalation method from 240 to 400 mg intermittently (14 days on and 7 days off) between chemotherapy cycles. Cognitive function was evaluated pre- and post-therapy using the AFI questionnaire, Stroop test, and MoCA-Ina. A total of 78 subjects were equally divided into the treatment and control groups. The percentage of drop-out, mortality, and adverse drug response were relatively comparable between each treatment arm. The group of subjects receiving curcumin extract experienced clinically and statistically significant improvements in cognitive function based on the Stroop test (∆ median 8.57 vs. 2.46; Z − 4.503 vs. − 1.762;<i> p</i> < 0.0001 vs. 0.078) and MoCA- Ina (∆ mean 1.53 vs. 0.72; Z − 2.99 vs. − 2.05; <i>p</i> < 0.003 vs. 0.04) versus placebo in between-group and between-subject analyses, respectively. 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Cognitive function was evaluated pre- and post-therapy using the AFI questionnaire, Stroop test, and MoCA-Ina. A total of 78 subjects were equally divided into the treatment and control groups. The percentage of drop-out, mortality, and adverse drug response were relatively comparable between each treatment arm. The group of subjects receiving curcumin extract experienced clinically and statistically significant improvements in cognitive function based on the Stroop test (∆ median 8.57 vs. 2.46; Z − 4.503 vs. − 1.762;<i> p</i> < 0.0001 vs. 0.078) and MoCA- Ina (∆ mean 1.53 vs. 0.72; Z − 2.99 vs. − 2.05; <i>p</i> < 0.003 vs. 0.04) versus placebo in between-group and between-subject analyses, respectively. 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引用次数: 0
摘要
化疗引起的认知功能障碍(CICI)是指化疗期间和化疗后记忆力、学习能力、注意力、推理能力、执行功能、注意力和视觉空间感受损。目前尚无经证实安全有效的治疗方案来改善 CICI 患者的认知功能。本研究旨在评估姜黄素提取物改善 CICI 患者认知功能的安全性和有效性。本研究是一项双盲随机对照临床试验,对象是2021年3月至10月在单中心医院接受卡铂-紫杉醇化疗方案的宫颈癌患者。受试者分为两组,在化疗周期之间,通过剂量递增法间歇服用姜黄素和安慰剂胶囊,剂量从 240 毫克到 400 毫克不等(服用 14 天,停药 7 天)。在治疗前后使用 AFI 问卷、Stroop 测试和 MoCA-Ina 评估认知功能。共有 78 名受试者被平均分为治疗组和对照组。各治疗组的辍学率、死亡率和药物不良反应相对相当。根据 Stroop 测试结果,接受姜黄素提取物治疗的一组受试者的认知功能在临床和统计学上都有显著改善(∆ 中位数 8.57 vs. 2.46;Z - 4.503 vs. 1.762;p &l)。- 在组间分析和受试者间分析中,姜黄素提取物与安慰剂相比(∆ 中位数 1.53 vs. 0.72; Z - 2.99 vs. - 2.05; p < 0.003 vs. 0.04),认知功能分别有明显改善(p < 0.0001 vs. 0.078)和改善(∆ 中位数 1.53 vs. 0.72; Z - 2.99 vs. - 2.05; p < 0.003 vs. 0.04)。采用间歇性剂量递增方案服用姜黄素提取物被证明是安全的,并能在临床和统计学上显著改善CICI患者的认知功能。
Improving cognitive function with intermittent dose escalation of curcumin extract in chemotherapy-induced cognitive impairment patients: a randomized controlled trial
Chemotherapy-induced cognitive impairment (CICI) is an impairment of memory, learning power, concentration, reasoning, executive function, attention, and visuospatial during and after chemotherapy exposures. No proven safe and effective therapeutic regimen are available to improve cognitive function in CICI patients. To evaluate the safety and effectiveness of curcumin extract to improve cognitive function in CICI patients. This study was a double-blind randomized controlled trial clinical trial in patients with cervical carcinoma who underwent a carboplatin-paclitaxel chemotherapy regimen from March to October 2021 at single center hospital. Subjects divided into two groups that received curcumin and placebo caplets by dose escalation method from 240 to 400 mg intermittently (14 days on and 7 days off) between chemotherapy cycles. Cognitive function was evaluated pre- and post-therapy using the AFI questionnaire, Stroop test, and MoCA-Ina. A total of 78 subjects were equally divided into the treatment and control groups. The percentage of drop-out, mortality, and adverse drug response were relatively comparable between each treatment arm. The group of subjects receiving curcumin extract experienced clinically and statistically significant improvements in cognitive function based on the Stroop test (∆ median 8.57 vs. 2.46; Z − 4.503 vs. − 1.762; p < 0.0001 vs. 0.078) and MoCA- Ina (∆ mean 1.53 vs. 0.72; Z − 2.99 vs. − 2.05; p < 0.003 vs. 0.04) versus placebo in between-group and between-subject analyses, respectively. Administration of curcumin extract with intermittent dose escalation regimen proved to be safe and able to improve cognitive function of CICI patients clinically and statistically significant.
期刊介绍:
Advances in Traditional Medicine (ADTM) is an international and peer-reviewed journal and publishes a variety of articles including original researches, reviews, short communications, and case-reports. ADTM aims to bridging the gap between Traditional knowledge and medical advances. The journal focuses on publishing valid, relevant, and rigorous experimental research and clinical applications of Traditidnal Medicine as well as medical classics. At the same time, the journal is devoted to communication among basic researcher and medical clinician interested in the advancement of Traditional Medicine. Topics covered by the journal are: Medical Classics & History; Biomedical Research; Pharmacology & Toxicology of Natural Products; Acupuncture & Moxibustion; Sasang Constitutional Medicine; Diagnostics and Instrumental Development; Clinical Research. ADTM is published four times yearly. The publication date of this journal is 30th March, June, September, and December.