Study On The Sodium Cantharidate And Vitamin B6Injection Combined With Concurrent Chemo-radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma

ObjectiveThe clinical randomized controlled trial was undertaken to evaluate the efficacy andside effects of sodium cantharidate and vitamin B6injection combined withconcurrent chemo-radiotherapy for locally advanced nasopharyngealcarcinoma(LA-NPC).MethodsAccording to the inclusion and exclusion criteria, patients with LA-NPC undergoingchemo-radiotherapy who were charged in the First Affiliated Hospital of JinanUniversity between May and November2013were selected as participants of thisstudy.49patients with LA-NPC were randomized into two groups:24cases inobservation group were treated sodium cantharidate and vitamin B6injectioncombined with concurrent chemo-radiotherapy(CCRT), whereas25cases in controlgroup received CCRT. The patients’ routine blood test, liver and kidney function andMRI examination of nasopharynx and neck to assess the efficacy and safety ofsodium cantharidate and vitamin B6injection combined with CCRT for LA-NPC. Atthe end of all treatment, two groups of patients’ TCM clinical symptoms, functionalstatus and acute toxicity during treatment were observed and compared. Statisticanalysis were performed with SPSS13.0. Statistical methods included statisticaldescription, t-test, χ2test, rank sum test and repeated measurement ANOVA.Results1. The comparison of general information of patients with LA-NPC showed that thedifferences among both groups were insignificant statistically(P>0.05). The twogroups were well-balanced and comparable.2. The reduction of leukocyte count in observation group was lower than in control group(F＝4.01， P＝0.004＜0.05). The inhibition of erythrocyte count andhemoglobin in observation group was less severe than in control group, so did therecovery(the values of F were respectively3.55and6.47, the values of P wererespectively0.015and0.000), whereas it didn’t consider that the changes of liver andkidney function in both groups were different statistically(P＞0.05).3. The short-term efficiency rate in observation group increased by15.5%comparingwith control group, the difference of the short-term effect between both groups wasstatistically significant(Z＝-1.977＞1.96，P＝0.048＜0.05).4. To compare the change of KPS score in two groups before and after treatment, theresults showed that the overall improvement rate was62.5%in observation group and36.0%in control group, the difference of two groups was statistically significant bythe rank sum test(Z＝-2.052＞1.96，P＝0.040＜0.05).5. Security Analysis: No one case of Ⅳ degree of myelosuppression and Ⅲ, Ⅳdegree of liver and kidney dysfunction was reported by all patients during treatment,4cases of patients with Ⅲ degree of low white blood cell were found in control groupto need to receive granulocyte colony-stimulating factor to stimulate the bone marrowhematopoietic function.49patients were not found to have Ⅳ degree of non-bloodsystem acute toxic reactions such as oral mucositis, nausea, vomiting, hair loss andskin reactions; The reduction of leukocyte count and acute oral mucositis are moresevere in control group than that in observation group (the value of P wererespectively0.000and0.023).Conclusion1. Sodium cantharidate and vitamin B6injection can significantly ameliorate clinicalsymptoms, stimulate leukocyte count, improve the short-term efficacy and thepatient’s functional status which help to improve the quality of patients’ life.2. The acute toxicity rate in observation group is lower than in control group, and sideeffects such as the reduction of leukocyte count and acute oral mucositis are moresevere in control group than that in observation group.3. Sodium cantharidate and vitamin B6injection is a effect regimen for LA-NPC with relatively lower side effects, it is worthy of large scale clinical application andpromotion for LA-NPC.