Clinical Research Of Xiaoshuan Enteric-coated Capsules Against Neurotoxicity Of Oxaliplatin

Aim:The purpose of this study is to investigate the prevention and treatment of Xiaoshuan Enteric-coated Capsules on neurotoxicityof oxaliplatin,which is one of the main drugs for colorectal cancer treatment.Methods:?The cases of gastrointestinal malignancies with oxaliplatin treatment from January 2018 to December 2018 were collected.The patients basic information,use of oxaliplatin,incidence rate of neurotoxicity and other clinical related indexes were recorded.And according to chi-square and Logisticregression analysis,we investigated the effect of Xiaoshuan Enteric-coated Capsules on preventing and relieving the neurotoxicity of oxaliplatin.?Seventy consecutive patients of oncology department of Laiyang Central Hospital of Yantai City were randomized into control group(n=35)and experimental group(n=35),which with the treatment of XELOX regimen,specifically:oxaliplatin130mg/m~2 intravenously d1;capecitabine 1000mg/m~2 bid oral d1-14,3 weeks for 1cycle,8 cycles in total from January 2019 to September 2019.In the experimental group,Xiaoshuan Enteric-coated Capsules were given from the first day of the first cycle to the end of the last cycle,2 capsules at a time tid.The drugs which may affect neurological symptoms during chemotherapy were not given for all patients,and the strict shelter was taken.With the specialized grading standards established by the tumor development center of Sanofi-syn-thelabo,the drug development institution,the incidence and occurrence of neurotoxicity were regular ly evaluated in both groups.The incidences of other adverse reactions such as myelosuppression and liver damage were investigated in both groups.Results:?Xiaoshuan Enteric-coated Capsules were associated with the incidence rate of neurotoxicity of oxaliplatin[OR=0.300,95%CI(0.221,0.407)].?The incidences of acute neurotoxicity in the control group and the experimental group were 65.6%and69.7%(p>0.05).After 4 cycles were finished,the prevalences of neurotoxicity in the control group and the experimental group of chronic neurotoxicity were 37.5% and 27.3%.The prevalence of neurotoxicity was no statistical significance between the two groups(p>0.05).After 8 cycles were finished,the prevalences of neurotoxicity in the control group and the experimental group were 68.8%and 36.4%.The prevalences of neurotoxicityin in the experimental group was lower than that in the control group(p<0.05),and the prevalence of neurotoxicity at grade 3 in the experimental group was lower than that in the control group(p<0.05).The incidence of myelosuppression in the experimental group was also lower than that in the control group(p<0.05).Conclusion:Xiaoshuan Enteric-coated Capsules can reduce the incidence and the development of neurotoxicity of oxaliplatin.Furthermore,Xiaoshuan Enteric-coated Capsules can reduce the incidence of myelosuppression and exhibit no toxicity in the liver and kidney of patients.