EVALUATION OF THE EFFICIENCY OF ALPHA-LIPOIC ACID AND IPIDACRINE HYDROCHLORIDE FOR THE PREVENTION OF PACLITAXEL-INDUCED PERIPHERAL NEUROPATHY ACCORDING TO THE TOTAL NEUROPATHY SCORE

I S Holotiuk, A Ye Kryzhanivska, S I Holotiuk, S V Maliborska, V V Holotiuk
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Abstract

To evaluate the efficacy of combination of alpha-lipoic acid and acetylcholinesterase inhibitor (ipidacrine hydrochloride) to prevent the development and improve the course of paclitaxel-induced peripheral neuropathy (PIPN) in patients with breast cancer according to the Total Neuropathy Score.32 patients with breast cancer T1-4N0-3M0 received six cycles of polychemotherapy according to the AT scheme (paclitaxel, doxorubicin) or ET scheme (paclitaxel, epirubicin). Patients were randomized into two groups - without (group I) or with (group II) medication for prevention of neuropathy. A comprehensive neurological examination of patients was performed according to all ten parameters of the Total Neuropathy Score before chemotherapy, and after third and sixth cycles of chemotherapy. Each parameter was evaluated from 0 (no deficit) to 4 (no function/the most severe deficit). The scores obtained from the scale were summarized to obtain a total score from 0 to 40.The use of alpha-lipoic acid in combination with an acetylcholinesterase inhibitor (ipidacrine hydrochloride) significantly reduces the symptoms and severity of PIPN. The manifestations of PIPN in patients of the control group were significantly more severe compared to the group in which the study drugs were used. The average severity of neuropathy after 3 and 6 cycles was 1.75 and 2.62 in group I, and 1.12 and 1.62 - in group II, respectively (improvement by 15.75% (p < 0.05) and 25.00% (p < 0.001) after 3 and 6 cycles).Proposed combination of alpha-lipoic acid and ipidacrine hydrochloride led to a statistically significant reduction in the severity of PIPN, and thus to improvement of the functional capacity and quality of life of patients.
根据神经病变总分评价α -硫辛酸与盐酸ipidacrine对紫杉醇诱导的周围神经病变的预防效果
为评价α -硫辛酸联合乙酰胆碱酯酶抑制剂(盐酸ipidacrine)预防乳腺癌患者外周血神经病变(PIPN)发展及改善病程的疗效,根据总神经病变评分,32例T1-4N0-3M0型乳腺癌患者按照AT方案(紫杉醇、阿霉素)或ET方案(紫杉醇、表柔比星)分别接受6个周期的多药化疗。患者被随机分为两组-不使用(I组)或使用(II组)预防神经病变的药物。化疗前及化疗第3、6个周期后,根据总神经病评分(Total Neuropathy Score)的10个参数对患者进行全面的神经学检查。每个参数从0(无缺陷)到4(无功能/最严重缺陷)进行评估。将量表得分汇总,得到总分0 ~ 40分。α -硫辛酸与乙酰胆碱酯酶抑制剂(盐酸ipidacrine)联合使用可显著减轻PIPN的症状和严重程度。对照组患者的PIPN表现明显比使用研究药物组严重。治疗3、6个疗程后,I组神经病变平均严重程度分别为1.75、2.62,II组为1.12、1.62(治疗3、6个疗程后分别改善15.75% (p < 0.05)、25.00% (p < 0.001))。α -硫辛酸联合盐酸ipidacrine可显著降低PIPN严重程度,从而改善患者的功能能力和生活质量。
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