消麻散联合芪归六君颗粒治疗恶性肿瘤含紫杉醇类化疗方案发生CIPN的临床疗效分析

Clinical Study of Xiaoma Powder Combined with Qi Gui Liujun Granules for the Treatment of Peripheral Polyneuritis in Cancer Patients Induced by Taxane-including Chemotherapy

目的观察消麻散联合芪归六君颗粒治疗恶性肿瘤含紫杉醇类化疗方案发生相关周围神经毒性(chemotherapy-induced peripheral neuropathy,CIPN)属中医气血两虚证的临床疗效。方法全部病例为西南医科大学附属中医医院2018年1月-2020年12月住院肿瘤患者共318例,均接受含紫杉醇类药物方案初始化疗并且发生了周围神经毒性,中医辨证为气血两虚。所有患者分为治疗组162例和对照组156例,其中治疗组用芪归六君颗粒以开水搅匀冲服,同时选择发生CIPN部位予以消麻散溻渍治疗,中药每日一剂,连服2周,消麻散每日1次,连用1周。对照组给予甲钴胺分散片0.5 g,分早、中、晚每日三次口服。观察两组治疗周围神经毒性疗效、中医证候量表评分(乏力、麻木、疼痛、感觉障碍等)、生活质量评分(KPS)和不良反应。结果①两组治疗后CIPN疗效对比差异具有统计学意义(P<0.05);②两组治疗后中医证候量表评分对比(乏力、麻木、疼痛、感觉障碍等)差异具有统计学意义(P<0.05);③两组治疗后KPS评分对比差异具有统计学意义(P<0.05);④两组均未出现治疗相关严重不良反应。结论消麻散联合芪归六君颗粒治疗恶性肿瘤含紫杉醇类化疗方案发生CIPN属于气血两虚证者的疗效确切。

Objective To observe the clinical efficacy of Xiaoma Powder combined with Qi Gui Liujun Granules for the treatment of taxane-including chemotherapy-induced peripheral polyneuritis(CIPN)differentiated as the syndrome of deficiency of both qi and blood.Methods A total of 318 cases with CIPN hospitalized in Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University from January,2018 to December,2020 were divided into trial group(162 cases)and control group(156 cases).Both groups received initial taxane including chemotherapy and then peripheral neurotoxicity occurred.The patients in the two groups were differentiated as the syndrome of deficiency of both qi and blood.The trial group was given oral use of Qi Gui Liujun Granules(one dose per day for 2 weeks) combined with external application of Xiaoma Powder (once per day for one week) on the CIPN foci,and the control group was given mecobalamin dispersible tablets(0.5 g,tid)orally. The treatment for the two groups lasted for one week. The curative effect for peripheral polyneuritis,the scores of TCM syndrome such as fatigue, numbness, pain, and sensory disorder, the Karnofsky Performance Status (KPS) scores for the quality of life, and adverse reaction were observed in the two groups. Results After treatment,the difference of the efficacy of CIPN was statistically significant between the two groups(P < 0.05). The differences of the scores of TCM syndrome(fatigue,numbness,pain,and sensory disturbance) and KPS scores in the two groups after treatment were also statistically significant(P < 0.05). During treatment, no treatment-related severe adverse reactions were found in the two groups. Conclusion Xiaoma Powder combined with Qi Gui Liujun Granules exert certain efficacy for the treatment of taxane-including chemotherapy-induced peripheral polyneuritis(CIPN)differentiated as the syndrome of deficiency of both qi and blood,which is worthy of further research and expanding their clinical application.