芪藤通痹熏洗液联合神经节苷脂预防mFOLFOX6方案化疗所致神经毒性的随机、对照临床观察

Clinical effect of Qiteng Tongbi fumigant combined with ganglioside in preventing neurotoxicity caused by mFOLFOX6 chemotherapy：A randomized controlled study

摘要:

目的：旨在观察芪藤通痹熏洗液联合神经节苷脂预防结直肠癌患者术后使用mFOLFOX6方案化疗所引起的神经毒性的有效性及安全性，从而为中西医结合方法防治化疗所致周围神经毒性提供临床依据。方法：将符合纳入标准的180例接受mFOLFOX6方案化疗的结直肠癌患者随机分为治疗组1（芪藤通痹熏洗液联合神经节苷脂+化疗）、治疗组2（神经节苷脂+化疗）、对照组（单纯化疗），每组各60例。各组均以14 d为1个疗程，共治疗12个疗程。观察并分析各组治疗前后奥沙利铂神经毒性的发生情况、肌电图变化及不良反应。结果：治疗组1、治疗组2、对照组周围神经毒性发生率有显著差异（χ2=21.899，P=0.000）。3个组的外周神经毒性出现时间分别为（129.920±4.615）、（104.680±3.912）和（49.190±3.699） d，差异均有统计学意义（F=4 422.520，P=0.000）。3个组的腓总神经的感觉神经传导速度（sensory nerve conduction velocity，SNCV）分别为 （52.74±4.01）、（45.55±4.21）和（35.79±7.67） ｍ/s；运动神经传导速度（motor nerve conduction velocity，MNCV）分别为（48.98±3.95）、（44.69±4.18）和（37.89±6.65） ｍ/ｓ，差异均有统计学意义（F=135.472，P=0.000；F=70.334，P=0.000）。3个组的主要不良反应发生率均相似，差异无统计学意义（P>0.05）。结论：芪藤通痹熏洗液联合神经节苷脂可明显减少mFOLFOX6方案化疗所致神经毒性的发生率，且不增加治疗相关性不良反应，有望成为治疗化疗药物奥沙利铂所致神经毒性的优效、无毒方法，在临床可以进一步推广应用。

Abstract:

Objective：To investigate the clinical effect and safety of Qiteng Tongbi fumigant combined with ganglioside in preventing neurotoxicity caused by mFOLFOX6 chemotherapy in colorectal cancer patients，and to provide clinical evidence for integrated tradi－tional Chinese and Western medicine therapy in the treatment of peripheral neurotoxicity caused by chemotherapy. Methods：A total of 180 colorectal cancer patients who met the inclusion criteria and received mFOLFOX6 chemotherapy were randomly divided into treatment group 1（Qiteng Tongbi fumigant combined with ganglioside+chemotherapy），treatment group 2（ganglioside+chemotherapy），and control group（chemotherapy alone），with 60 patients in each group. Each course of treatment was 14 days，and all patients were treated for 12 courses. The three groups were evaluated and compared in terms of the incidence rate of peripheral neurotoxicity caused by oxaliplatin，electromyography（EMG） changes，and adverse reactions after treatment. Results：There was a significant differ－ence in the incidence rate of peripheral neurotoxicity between the treatment group 1，the treatment group 2，and the control group（χ2=21.899，P=0.000）. The time to peripheral neurotoxicity in the three groups was （129.920±4.615），（104.680±3.912），and （49.190±3.699） d，respectively，and there was a significant difference between the three groups（F=4 422.520，P=0.000）. There were significant differences between the three groups in sensory nerve conduction velocity（SNCV） and motor nerve conduction velocity（MNCV） of the common peroneal nerve[SNCV：（52.74±4.01） m/s vs. （45.55±4.21） m/s vs. （35.79±7.67） m/s，F=135.472，P=0.000；MNCV：（48.98±3.95） m/s vs. （44.69±4.18） m/s vs. （37.89±6.65） m/s，F=70.334，P=0.000]. There were no significant differences in the incidence rates of major adverse reactions between the three groups（P>0.05）. Conclusion：Qiteng Tongbi fumigant combined with ganglioside can significantly reduce the incidence rate of peripheral neurotoxicity caused by mFOLFOX6 chemotherapy and does not increase treatment-related adverse reactions. It is expected to become a superior and non-toxic treatment method for neurotoxicity caused by the chemotherapy drug oxaliplatin and holds promise for clinical application.