目的 观察加味黄芪桂枝五物配方颗粒对防治OIPN的临床疗效。方法 共计划入组60例肠癌根治术后辅助化疗患者，分为试验组和对照组，各30例。对照组采用mFOLFOX6、XELOX化疗方案作为基础治疗，并在化疗第1天起加用中药模拟剂口服。试验组在对照组化疗基础上加用加味黄芪桂枝五物配方颗粒口服，直至化疗结束，共6个月。每一个月测定所有患者EORTC QLQ-CIPN20评分、KPS评分及EORTC QLQ-C30评分。在第1、4个月及治疗结束时进行肌电图测定。结果 ①共完成56例，对照组与试验组各28例；②在EORTC QLQ-C30评分中的疼痛和疲倦维度，从第5个月开始到结束，试验组优于对照组（P < 0.05）；③CIPN20评分方面，从第4个月开始至结束，试验组低于对照组（P < 0.05）；④EMG方面，在第4个月及结束时，无论是感觉神经还是运动神经，试验组的潜伏期延长程度、波幅降低程度及传导速度减慢程度均优于对照组（P < 0.05）；⑤两组患者间毒副反应未见统计学差异（P > 0.05）。结论 加味黄芪桂枝五物配方颗粒可防治奥沙利铂所引起的外周神经损伤，并且未见明显毒副反应，是一种安全可靠的防治OIPN药物。

Objective To observe the clinical efficacy of Modified Huangqi Guizhi Wuwu Formula Granules in the prevention and treatment of OIPN. Methods A total of 60 patients with intestinal cancer undergoing adjuvant chemotherapy after radical resection were divided into experimental group and control group, with 30 cases in each group. The control group was treated with mFOLFOX6 and XELOX as basic therapy, placebo (the simulator of traditional Huangqi Guizhi Wuwu Formula Granules for orally on the basis of chemotherapy in the control group, until the end of chemotherapy, a total of 6 months. EORTC QLQ- CIPN20 scores, KPS scores and EORTC QLQ- C30 scores were measured every month. The EMG was determined at the 1th month, 4th months and the end of treatments. Results ① A total of 56 patients completed, 28 in the control group and 28 in the experimental group; ② In terms of quality of life evaluation, the pain and fatigue dimensions in EORTC QLQ-C30 scores were better in the experimental group than in the control group from the 5th month to the end (P < 0.05); ③ In terms of CIPN20 scores, the experimental group was lower than the control group (P < 0.05); ④ In terms of EMG, in the 4th month and the end of the experiment, whether sensory or motor nerves, the degree of latency prolongation, amplitude reduction and conduction velocity reduction in the experimental group were better than those in the control group; ⑤ There was no significant difference in liver and kidney function, routine blood test and cardiogram between the 2 groups (P > 0.05). Conclusion Modified Huangqi Guizhi Wuwu Formula Granules can prevent and treat OIPN. It has no obvious toxicity and side effects, is a safe and reliable drug for the prevention and treatment of OIPN.

江苏省中医药局面上项目（NO.YB2015035）：基于TRPs通道探讨当归四逆汤对奥沙利铂神经毒性作用的研究，负责人：霍介格；江苏省卫生厅（No：BRA2015493）：益气温经复方中药对OXIN作用的临床研究，负责人：霍介格；江苏省常熟市科技局（No：CS201811），黄芪桂枝五物颗粒缓解奥沙利铂相关周围神经毒性的临床研究，负责人：陆屸。