Curative Effect Observation On Fumigation-washing Therapy For Oxaliplatin-induced Peripheral Neuropathy

Objective: This clinical trial is to observe the curative effect of Saussurea in Xinjiang geoherbs drug fumigation treatment of oxaliplatin induced neuropathy.It included changes in Levi grading,NTX score change,EMG velocity,quality of life and safety in patients with peripheral neuropathy.Methods: According to the standard of diagnosis and the calculation formula of the sample size,the theoretical sample content of this trial was72,but the actual number of eligible cases were 60.According to the design of drug clinical trials,60 cases were randomly divided into treatment group(30 cases interfered by Saussurea Tong luo formula)and control group(30 cases treated by the Mecobablamin).The investigational drugs were administered with chemotherapy(oxaliplatin based)two cycles after administration,continuous observation of 1 courses of treatment.Observing the use of traditional Chinese medicine fumigation after washing each index change,which includes Levi score,NTX score change,bilateral median nerve(finger to wrist),peroneal nerve(dorsal to ankle)of sensory nerve conduction velocity(SCV)and motor nerve conduction velocity(MCV),and the KPS score.the experiment data of the two groups were compared by SPSS22.0 with two-sided test,and if P value less than 0.05 was considered as statistically significant difference and vice versa.Result:(1)The general data of both groups was comparable as no significant differences(P>0.05)by chi-square and T test in age,sex,KPS scoring column rank and testing.(2)Clinical evaluation: The clinical efficacy was evaluated by chi square test or Fisher exact test,After treatment in two groups,(1)On Oxaliplatin Levi grading evaluation,The treatment group of 26 cases were effective,and the total effective rate was 86.67%,In the control group,15 cases were effective and the total effective rate was 50%.After Fisher test,the two groups were statistically significant(P=0.0048).(2)NTX-12 comments: T test,p < 0.05,two groups have statistical significance.(3)EMG evaluation: Two groups of MCV median nerve,MCVperoneal nerve,SCV median nerve,SCV peroneal nerve evaluation,P>0.05,indicating that the difference was not statistically significant.(4)Two groups of KPS score by rank sum test(P > 0.05),learned that the curative effect was not significant.(5)Through the evaluation of drug related adverse events,patient compliance and drug safety,known that the test drug in this test is safe and reliable,and the side effect is not significant.Conclusion: In this clinical trial,Saussurea Tong luo Decoction fumigation on nerve conduction velocity and the physical condition improved compared with the control group,the effect is not significant,not statistically significant,while,Levi grading was statistically significant,which showed that the clinical efficacy of OXPIN was better than that of the control group.Saussurea Tong luo Decoction in the test during the study period,good safety.