Clinical Observation On Prevention Of Peripheral Neurotoxicity Caused By Oxaliplatin Chemotherapy With Wenjing Tongmai Granule

Objective: to investigate the clinical efficacy of Wenjing Tongmai granule in preventing peripheral neurotoxicity induced by oxaliplatin chemotherapy.Methods: from June 2021 to June 2022,96 patients with advanced colorectal cancer who met the inclusion criteria of the study and were scheduled to receive XELOX regimen were collected.According to random,double-blind,control and placebo design,patients were randomly divided into treatment group(n = 48)and control group(n = 48)at 1:1.The treatment group was treated with Wenjing Tongmai granule on the basis of chemotherapy,and the control group was treated with placebo granule on the basis of chemotherapy.Its usage and dosage are the same as those of traditional Chinese medicine granules.The same number of traditional Chinese medicine granules or placebo granules were distributed and packaged in groups,but neither the researchers nor the subjects knew the grouping.The incidence of peripheral neurotoxicity,TCM symptom score,pain score(NRS method),human serum nerve growth factor(NGF)level,FACT-Ntx scale score and KPS score were compared between the two groups after 4 cycles of chemotherapy.Results: 1.Incidence of peripheral neurotoxicity: After 4 cycles of chemotherapy,the incidence of OIPN in the treatment group was 53.49%,while in the control group it was 87.80%,with a statistically significant difference(P<0.01);In the treatment group,there were 20 cases with OIPN grade 0,16 cases with grade I,6 cases with grade II,1 case with grade III,and 0 cases with grade IV;In the control group,there were 5 cases of grade 0,6 cases of grade I,15 cases of grade II,15 cases of grade III,and 0 cases of grade IV.The treatment group was mainly concentrated in grades 0-I,while the control group was mainly concentrated in grades II-III.The difference between the two groups was statistically significant(P<0.01)through rank sum test.2.Traditional Chinese Medicine Symptoms:After 4 cycles of chemotherapy,the total score of traditional Chinese medicine symptoms in the treatment group was significantly lower than that in the control group(P<0.01);Among them,the treatment group had significantly better TCM symptom scores in four aspects: limb numbness,chills,local tingling,and poor flexion and extension compared to the control group(P<0.05).3.NRS pain score: After 4 cycles of chemotherapy,the pain score of the treatment group was significantly lower than that of the control group(P<0.01).4.Comparison of serum NGF levels: Inter group comparison: After 2 cycles of chemotherapy and 4 cycles of chemotherapy,the NGF detection content in the treatment group was significantly higher than that in the control group during the same period(P<0.01).Intragroup comparison: The NGF detection content in the treatment group after 2 cycles of chemotherapy was lower than that before chemotherapy,with a highly significant difference(P=0.000);The NGF content level after 4 cycles of chemotherapy was significantly lower than that after 2 cycles of chemotherapy in this group(P=0.000).The NGF content level in the control group after 2 cycles of chemotherapy was significantly lower than that before chemotherapy in this group,with a significant difference(P=0.000);The NGF content level after 4 cycles of chemotherapy was significantly lower than that after 2 cycles of chemotherapy in this group,with a significant difference(P=0.000).5.FACT-Ntx scale score: After 4 cycles of chemotherapy,the treatment group was significantly better than the control group,with a significant difference(P=0.000).6.Changes in KPS score: The number of cases with increased,stable,and decreased KPS scores in the treatment group was 17,19,and 7,respectively,while in the control group was 2,25,and 14,respectively.The change in KPS score in the treatment group was significantly better than that in the control group,and the difference was statistically significant(P=0.001).7.Safety:There was no obvious adverse reaction in the treatment group,and only 2cases of mild transaminase increase in the control group.Conclusion: Wenjing Tongmai granule can reduce the incidence and degree of peripheral neurotoxicity caused by oxaliplatin chemotherapy,improve limb numbness,chills,local tingling and other TCM symptoms related to peripheral neurotoxicity,and relieve neuralgia.Reduce the decrease of nerve growth factor content caused by oxaliplatin chemotherapy,improve the quality of life of patients treated with oxaliplatin,and there are no obvious side effects.