1. 上海中医药大学附属曙光医院肿瘤科,上海,201203
2. 复旦大学附属中山医院中西医结合科,上海,200032
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范越, 厉天瑜, 张雯, 等. 健脾解毒方防治大肠癌术后化疗相关周围神经病变的临床研究[J]. 上海中医药杂志, 2018,52(10):49-53.
FAN Yue, LI Tianyu, ZHANG Wen, et al. Clinical study on Jianpi Jiedu Decoction in preventing and treating chemotherapy-related peripheral neuropathy in postoperative patients with colorectal cancer[J]. Shanghai Journal of Traditional Chinese Medicine, 2018,52(10):49-53.
范越, 厉天瑜, 张雯, 等. 健脾解毒方防治大肠癌术后化疗相关周围神经病变的临床研究[J]. 上海中医药杂志, 2018,52(10):49-53. DOI: 10.16305/j.1007-1334.2018.10.013.
FAN Yue, LI Tianyu, ZHANG Wen, et al. Clinical study on Jianpi Jiedu Decoction in preventing and treating chemotherapy-related peripheral neuropathy in postoperative patients with colorectal cancer[J]. Shanghai Journal of Traditional Chinese Medicine, 2018,52(10):49-53. DOI: 10.16305/j.1007-1334.2018.10.013.
目的:观察健脾解毒方防治大肠癌术后化疗相关周围神经病变的临床疗效。 方法:将64例大肠癌术后患者随机分为对照组和治疗组,每组32例。对照组予XELOX化疗方案,治疗组在化疗基础上加服健脾解毒方。两组计划疗程均为8个化疗周期,观察化疗完成周期、出现首次慢性累积性化疗相关周围神经病变(CIPN)症状周期、奥沙利铂计划治疗剂量的完成率以及3~4度骨髓抑制发生次数,比较美国国立癌症研究所-药物常见毒性分级标准量表(NCI-CTCAE)分级、癌症治疗功能评价系统/妇科肿瘤组-神经毒性评价工具量表(FACT/GOG-Ntx)评分、肿瘤患者神经毒性问卷(PNQ)分级及血清IL-1β水平的变化情况。 结果:①最终完成试验者60例,治疗组31例,对照组29例。②两组在化疗完成周期方面比较,差异无统计学意义(P>0.05)。两组奥沙利铂计划治疗剂量完成率比较,差异有统计学意义,治疗组明显高于对照组(P<0.05)。两组出现首次累积性CIPN症状周期比较,差异有统计学意义,治疗组明显晚于对照组(P<0.05)。两组3~4度骨髓抑制发生次数比较,差异无统计学意义(P>0.05)。③化疗中与化疗后组内比较,两组NCI-CTCAE分级、FACT/GOG-Ntx评分差异均有统计学意义(P<0.05)。组间化疗中比较,NCI-CTCAE分级、FACT/GOG-Ntx评分差异有统计学意义,治疗组明显低于对照组(P<0.05);组间化疗后比较,NCI-CTCAE分级、FACT/GOG-Ntx评分差异有统计学意义,治疗组明显低于对照组(P<0.05)。④化疗中与化疗后组内比较,两组PNQ1分级差异均有统计学意义(P<0.05),而两组PNQ2分级差异均无统计学意义(P>0.05)。组间化疗中比较,PNQ1分级、PNQ2分级差异有统计学意义,治疗组分级明显低于对照组(P<0.05);组间化疗后比较,PNQ1分级、PNQ2分级差异有统计学意义,治疗组明显低于对照组(P<0.05)。⑤治疗前与化疗半程、化疗后组内分别比较,两组IL-1β水平差异均有统计学意义(P<0.05);治疗组IL-1β水平明显降低,而对照组IL-1β水平明显升高(P<0.05)。组间化疗半程比较,IL-1β水平差异有统计学意义,治疗组明显低于对照组(P<0.05);组间化疗后比较,IL-1β水平差异有统计学意义,治疗组明显低于对照组(P<0.05)。 结论:健脾解毒方可明显减轻大肠癌术后化疗的致周围神经病变毒性,提高患者接受化疗的依从性和耐受性,使化疗获益最大化,进而提高患者的生存质量。
Objective:To observe the clinical efficacy of Jianpi Jiedu Decoction in preventing and treating chemotherapy-related peripheral neuropathy in postoperative patients with colorectal cancer. Methods64 postoperative patients of colorectal cancer were randomly divided into the control group and treatment group, 32 cases in each group. The control group was treated with XELOX chemotherapy regimen, and the treatment group was treated with Jianpi Jiedu Decoction based on the treatment for the control group, with a course of 8 cycles of chemotherapy. The cycle of chemotherapy completion, the cycle of first-time occurrence of chronic and cumulative chemotherapy-induced peripheral neuropathy (CIPN) symptoms, completion rate of planned therapeutic dose of oxaliplatin and frequency of 3-4 degree myelosuppression were observed. The changes of NCI-CTCAE grades, FACT/GOG-Ntx score, PNQ grades and serum IL-1β level were compared. Results:①Finally 60 patients completed the trial, among 31 cases in the treatment group and 29 cases in the control group. ②There was no statistically significant difference on chemotherapy completion cycle between the two groups (P>0.05). There was statistically significant difference on completion rate of planned therapeutic dose of oxaliplatin between the two groups, and the completion rate of planned therapeutic dose of oxaliplatin in the treatment group was significantly higher than that in the control group (P<0.05). There was statistically significant difference on the cycle of first-time occurrence of cumulative CIPN symptoms between the two groups, and the first-time occurrence of cumulative CIPN symptoms of the treatment group was obviously later than that of the control group (P<0.05). There was no statistically significant difference on frequency of degree 3-4 myelosuppression between the two groups (P>0.05). ③Compared between during chemotherapy and after chemotherapy, there were statistically significant differences on NCI-CTCAE grades and FACT/GOG-Ntx score in both groups (P<0.05). During the chemotherapy, there were statistically significant differences on NCI-CTCAE grades and FACT/GOG-Ntx score between the two groups, and the NCI-CTCAE grades and FACT/GOG-Ntx score in the treatment group were obviously lower than those in the control group (P<0.05). After chemotherapy, there were statistically significant differences on NCI-CTCAE grades and FACT/GOG-Ntx score between the two groups, and the NCI-CTCAE grades and FACT/GOG-Ntx score in the treatment group were obviously lower than those in the control group (P<0.05). ④Compared between during chemotherapy and after chemotherapy, there were statistically significant differences on PNQ1 grades in both groups (P<0.05), while there were no statistically significant differences on PNQ2 grades in both groups (P>0.05). During the chemotherapy, there were statistically significant differences on PNQ1 grades and PNQ2 grades between the two groups, and the grades in the treatment group were obviously lower than those in the control group (P<0.05). After chemotherapy, there were statistically significant differences on PNQ1 grades and PNQ2 grades between the two groups, and the grades in the treatment group were obviously lower than those in the control group (P<0.05). ⑤Compared with chemotherapy before, at the half course of chemotherapy and after chemotherapy, there was statistically significant difference on IL-1β level in both groups (P<0.05), the IL-1β level was obviously decreased in the treatment group, while the IL-1β level was obviously increased in the control group (P<0.05). At the half course of chemotherapy, there was statistically significant difference on IL-1β level between the two groups, and the IL-1β level in the treatment group was significantly lower than that in the control group (P<0.05). After chemotherapy, there was statistically significant difference on IL-1β level between the two groups, and the IL-1β level in the treatment group was significantly lower than that in the control group (P<0.05). Conclusion:Jianpi Jiedu Decoction can obviously alleviate the chemotherapy-induced peripheral neuropathy after the operation of colorectal cancer, enhance the compliance and tolerance of patients to chemotherapy, maximize the benefits of chemotherapy, and thus improve the quality of life of patients.
结直肠癌术后化疗化疗相关周围神经病变健脾解毒方减毒增效
colorectal cancerpostoperative chemotherapychemotherapy-related peripheral neuropathyJianpi Jiedu Decoctionreducing toxicity and enhancing efficac
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