Traditional Chinese Medicine syndrome analysis on oxaliplatin-induced peripheral neuropathy and clinical efficacy of Bushen Yiqi formula(补肾益气方):a prospective randomized controlled study

OBJECTIVES:To analyze the distribution characteristics of Traditional Chinese Medicine(TCM)syndromes in patients with oxaliplatin-induced peripheral neuropathy(OIPN)and observe the clinical efficacy of Bushen Yiqi formula(补肾益气方,BSYQF)in treating patients with OIPN.METHODS:A total of 89 patients with OIPN were enrolled in this study.The TCM syndrome characteristics were investigated by frequency analysis methodology after collecting and analyzing the TCM syndrome elements of the patients with the OIPN TCM syndrome element scale.Further,62 cases of cold-dampness obstruction syndrome and kidney-Qi deficiency and cold syndrome were selected and randomly divided into the control group(n=31)and the treatment group(n=31).The patients in the treatment group were treated with modified BSYQF,while those in the control group were treated with mecobalamin tablets for 3 weeks.The Levi sensory neurotoxicity score and the neuro-electrophysiological changes were observed before and after the treatment in both groups.RESULTS:The distribution of TCM syndrome types in 89 patients with OIPN were in order of kidney-Qi deficiency and cold syndrome(44 cases),cold-dampness obstruction syndrome(18 cases),Yin deficiency of liver and kidney syndrome(11 cases),blood stasis obstruction syndrome(7 cases),and dampness-heat obstruction syndrome(5 cases).Improvement in Levi sensory neurotoxicity score:After 3-week treatment,the total effective rate in the treatment group was higher than that in the control group(P<0.05).The subgroup analysis showed that the total effective rate in the treatment group of patients with kidney-Qi deficiency and cold syndrome was higher than that in the control group before and after treatment(P<0.05).Improvement in nerve conduction velocity:The sensory nerve conduction velocity of bilateral ulnar nerves improved in the control group after treatment compared with that before treatment(P<0.05).The sensory and motor nerve conduction velocities of the bilateral ulnar and bilateral peroneal nerves improved in the treatment group compared with those before treatment and after treatment in the control group(P<0.05).CONCLUSIONS:The modified BSYQF had a definite therapeutic effect on the OIPN in patients with kidney-Qi deficiency and cold syndrome and those with cold-dampness obstruction syndrome.It could effectively reduce the grade of peripheral nerve toxicity and improve nerve conduction velocity,and its curative effect was better than that of mecobalamin tablets.