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Objective evaluation of the alleviating effects of Goshajinkigan on peripheral neuropathy induced by paclitaxel/carboplatin therapy: A multicenter collaborative study

机译:多沙金菊根对紫杉醇/卡铂治疗所致周围神经病缓解作用的客观评估:一项多中心协作研究

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摘要

Paclitaxel/carboplatin chemotherapy for cancer (TC therapy) exhibits neurotoxicity and causes peripheral neuropathy at a high frequency, which is difficult to cope with. In this study, we investigated the efficacy of Goshajinkigan, a traditional Japanese herbal medicine, for TC therapy-induced peripheral neuropathy. The subjects included in our study were patients with ovarian or endometrial cancer who underwent TC therapy and developed peripheral neuropathy. The patients were randomly divided into Group A, comprising of 14 patients (vitamin B12 treatment), and Group B, comprising of 15 patients (vitamin B12 + Goshajinkigan treatment). The observation period was 6 weeks following treatment initiation, and the evaluation items were as follows: i) the current perception threshold (CPT value) of the peripheral nerve, ii) visual analogue scale for numbness, iii) National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade of neurotoxicity, and iv) a questionnaire on the subjective symptoms of peripheral neuropathy (functional assessment of cancer therapy-taxane). These were compared between the groups and no significant differences were noted in any item. However, CTCAE grade 3 neurotoxicity developed in 2 patients (14.3%) after 6 weeks of administration in Group A, whereas no neurotoxicity was observed in Group B. When the change in the frequency of abnormal CPT ratio at 6 weeks of administration from that before treatment was compared between the groups, the frequency of abnormal value was significantly lower in Group B than in Group A (p<0.05). This suggests that Goshajinkigan inhibits the progression of peripheral neuropathy.
机译:用于癌症的紫杉醇/卡铂化疗(TC治疗)表现出神经毒性,并引起高频周围神经病变,难以应对。在这项研究中,我们调查了传统的日本草药Goshajinkigan在TC治疗引起的周围神经病变中的疗效。我们研究的对象是接受TC治疗并出现周围神经病变的卵巢癌或子宫内膜癌患者。将患者随机分为A组(包括14例患者)(维生素B12治疗)和B组(包括15例患者)(维生素B12 + Goshajinkigan治疗)。观察期为治疗开始后的6周,评估项目如下:i)周围神经的当前知觉阈值(CPT值),ii)麻木的视觉模拟量表,iii)美国国家癌症研究所的通用术语标准不良事件v3.0神经毒性等级,以及iv)关于周围神经病的主观症状的问卷调查表(癌症治疗-紫杉烷的功能评估)。在各组之间进行了比较,在任何项目中均未发现明显差异。但是,A组在给药6周后有2例患者发生了CTCAE 3级神经毒性(14.3%),而B组则未观察到神经毒性。当给药6周时异常CPT比率的频率从之前改变比较两组间的治疗结果,B组的异常值发生频率明显低于A组(p <0.05)。这表明Goshajinkigan抑制周围神经病变的进展。

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