A Clinical Research Of The External Use Of Wenjing Huoxue Tongluo Formula In Chemotherap-induced Peripheral Neurotoxicity

BackgroundChemotherapy-induced peripheral neuropathy (CIPN), bone marrow and gastrointestinal response after chemotherapy are the most common adverse effects of cancer treatment, now the two of latter are basically settled in clinic. Neurotoxicity widely exists in varies types of anti-cancer drugs, which still limits the dose and reduces the effect of chemotherapy in some degree. But in western medicine, no drugs capable of preventing the occurrence of CIPN or ameliorating its course are available. Therefore, how to deal with it is a big problem to be solved. External treatments of Chinese medicine as simple and practicable ways, now are popular in the treatments of other peripheral neuropathy, induced by other kind of diseases, like Diabetes mellitus, Uremia etc. Recently some researchers have began to search for the different external treatments of Chinese medicine in CIPN.ObjectivesThis study was to observe the clinic effect and safty of Wenjing Huoxue Tongluo formula on CIPN,attempted to investigate its action rule and the related factors, simultaneously to discuss on its probable mechanism and clinical application values.MethodsThis clinical research adopted prospective randomized controlled design. PTX and L-OHP are the most prevent and widely used anti-cancer drugs in our department of oncology these recent years, which also are representatively neurotoxicity drugs. And 61 cases of CIPN who had continuously received FOLFOX, XELOX, TP or TC chemotherapy for several cycles, were divided into 2 groups:therapy group and comparison group. Patients in therapy group were treated with Wenjing Huoxue Tongluo formula for external use, while the patients in comparison group immersed their limbs with warm water. Referring to the Common Toxicity Criteria of NCI and the grading standards of quality life of malignant tumor patients in our country, the research was attempted to observed the changes of symptoms, and make a comparison of its clinical classification and the scores of quality life between two groups before and after treatment. At last, The result was analyzed by applying SPSS17.0 software.Results1.The total effect rate of therapy group was 83.87%, while the control group was 43.33%.Obviously, the effect of the interventional therapy group surpassed the control group. And there were significant differences between both of two by statistical disposal (P=0.002).2. In therapy group, the total score of quality life was 42.03±4.52, higher than those in control group, which score was 38.90±5.65 (P=0.039).The statistic results indicated, after the treatment, difference had statistical sense, and the QOL of patients in therapy group were indeed improved.3. After the treatment, the total response rates of numbness, pain, sensory disturbance and coldness of limbs, were all relieved in different degree. Having the main symptoms above in pairwise comparisons, it showed that the effect to numbness of limbs was better than pain, only which had statistically significant sense (P=0.024)4. The possible relative factors for effect of Wenjing Huoxue Tongluo formula:A further analysis on therapy group patients, the total effect rate of Oxaliplatin (L-OHP) group and paclitaxel (PTX) group was 92.31%,77.78 % respectively; And the total effect rate of GradeⅠgroup and GradeⅠgroupⅡwas 85.71%,81.25% respectively. This implied that there were no statistic differences in effect among different chemotherapy drugs and different grades of CIPN (P=0.278,0.094) ConclusionsThe external use of Wenjing huoxue Tongluo formula can cure chemotherapy-induced peripheral neuropathy, and also can improve life quality of patients, so it is worthy of the further research and expanding application in clinic.