Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan ; Outpatient Oncology Unit, Kyoto Prefectural University of Medicine Hospital, Kyoto 602-8566, Japan.
J Oncol. 2013;2013:139740. doi: 10.1155/2013/139740. Epub 2013 Nov 7.
Objective. To evaluate the efficacy of Goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients. Patients. Colorectal cancer patients (N = 29) who received ≥4 weeks of Goshajinkigan for oxaliplatin-induced peripheral neuropathy during chemotherapy at Kyoto Prefectural University of Medicine were (Goshajinkigan group) compared to 44 patients who had not received Goshajinkigan during the same period (non-Goshajinkigan group). Main Outcome Measures. The effect of Goshajinkigan was graded as curative, effective, stabilizing, or deleterious. The relationships between the grade of peripheral neuropathy and the dose of oxaliplatin in the Goshajinkigan and non-Goshajinkigan groups were evaluated. Results. The effect of Goshajinkigan on peripheral neuropathy in the Goshajinkigan group was curative, effective, stabilizing, and deleterious in 3.4, 20.7, 69.0, and 6.9% of patients, compared to the effect in the non-Goshajinkigan group (4.5, 15.9, 45.5, and 34.1%). The ratio of deleterious effects was significantly different between these two groups (P = 0.04). A Kaplan-Meier analysis in relation to the cumulative dose of oxaliplatin showed that the incidence of grade 3 peripheral neuropathy tended to be less in the Goshajinkigan group (P = 0.05). There were no significant differences in time to treatment failure and severe adverse events between these two groups. Conclusions. Goshajinkigan prevented exacerbation of oxaliplatin-induced peripheral neuropathy. This trial is registered with UMIN000009956.
目的。评价加味八珍汤治疗结直肠癌患者奥沙利铂诱导性周围神经病变的疗效。
患者。京都府立医科大学在化疗期间接受加味八珍汤治疗奥沙利铂诱导性周围神经病变且治疗时间≥4 周的结直肠癌患者(加味八珍汤组)与同期未接受加味八珍汤治疗的 44 例患者(非加味八珍汤组)相比。
主要观察指标。将加味八珍汤的疗效评为治愈、有效、稳定和无效。评估加味八珍汤和非加味八珍汤组患者周围神经病变的严重程度与奥沙利铂剂量之间的关系。
结果。加味八珍汤组患者周围神经病变的疗效为治愈、有效、稳定和无效的比例分别为 3.4%、20.7%、69.0%和 6.9%,而非加味八珍汤组患者的比例分别为 4.5%、15.9%、45.5%和 34.1%。两组之间有害作用的比例有显著差异(P = 0.04)。奥沙利铂累积剂量与 Kaplan-Meier 分析的关系表明,加味八珍汤组 3 级周围神经病变的发生率有降低趋势(P = 0.05)。两组之间的治疗失败时间和严重不良事件无显著差异。
结论。加味八珍汤可预防奥沙利铂诱导性周围神经病变的恶化。本试验已在 UMIN000009956 注册。