The Efficacy Observation Of Combination Sodium Santharidinate And Vitamin B₆Injection With Cisplatin In The Treatment Of Malignant Pleural Effusion Due To Non Small Cell Lung Cancer

ObjectiveTo observe the efficacy and safety of sodium cantharidinate and Vitamin B6injection in combination with cisplatin perfused from central venous catheters in the treatment of malignant pleural effusion due to non small cell lung cancer. To elucidate clinical evidence which can improve the curative effect, reduce adverse reactions, choice and use reasonable therapeutic drug for malignant pleural effusion of non-small cell lung cancer.Materials and MethodsSource of case:53cases of patients of non-small cell lung cancer combined with moderate to large pleural malignant effusion which were pathologically or cytologically diagnosed were selected in Shandong provincial hospital affiliated Shandong University from2011.01to2012.03, divided into observation group and the control group randomly,27cases in observation group and26cases in control group. There are no significant difference of the clinical features between the two groups, such as age, gender, KPS (P>0.05)Methods:All the patients of two groups were treated by doeetaxel combined with cisplatin. The patients received docetaxel75mg/m2on day1; and eisplatin30mg/m2on day2-4. The chemotherapy wes repeated every21days. All of53patients were retained by the central venous catheter in the pleural cavities. After the pleural effusion was drained completely, the patients were re-examinated by B-ultrasonic. Sodium santharidinate and vitamin B6injection40ml were administered to the pleural cavities in treatment group, once every2days, with Cis-platinum40mg, twice one week. The total treatment was two weeks. And the control group was only treated by cis-platinum40mg, on day2after the pleural effusion was drained completely and the chemotherapy was over, once a week, and the total period of treatment was also two weeks.Observation index:(1) efficient:Efficacy of Treatment for Malignant Pleural Effusion was based on WHO Millar criteria, which is divided into four grades: complete remission (CR):effusion disappear, symptoms remission with maintaining at least4weeks; Part of the remission (PR):effusion was significantly reduced by more than50%, symptoms remission with maintaining at least4weeks; Stability (SD):the reduction of effusion is less than50%without the increasing trend and symptoms remission partly; Invalid (PD):effusion no increase or decrease. CR+PR is the total effective rate;(2) the improvement rate of the life quality (KPS scores) after treatment;(3) adverse reaction:fever, chest pain, etc.;Statistical methods:All statistics were computed using the SPSS17.0statistical software package. Measurement data used t test,and for categorical data which is expressed by proportions, were analyzed by x2test and Fisher’s exact test when appropriate. All the hypothesis tests used double laterals and Significance was established at P<0.05.Results1. Effective rateCR of the treatment group was17cases (63.0%), PR was7patients (25.9%), SD was2cases (7.4%), and PD was1cases (3.7%). The total effective rate was88.9%(24/27). CR of the control group was9cases (34.6%), PR9cases (26.9%), SD8cases (30.7%), PD2cases (7.8%), and the total effective rate was61.5%(16/26). There were significant differences between the two groups (P<0.05).2. Comparison of Improvement rate of the life quality12cases of the observation group had improved life quality significantly (44.4%),13cases had improved not significantly (48.2%), and no2cases hadn’t improved any more (7.4%), and no cases decreased improvement rate (0%). The total improvement rate was92.6%(25/27). The datas of the control group were improvement significantly7patients (26.9%), improvement not significantly11patients (42.2%), no improvement6patients (23.1%), improvement decreased2cases (7.8%), and the total improvement rate was69.1%(18/26). Significant differences were examined between the two groups (P<0.05).3. Comparison of adverse reaction21cases of the treatment group was found fever after drug injection(77.8%),18cases had chest pain(66.7%), in which15cases was mild chest pain, without the drug treatment, and symptoms remission themselves,3patients was moderate to severe chest pain. Six patients had different degrees of nausea or nausea with vomiting symptoms (22.2%).20cases of the control group had fever after drug injection(76.9%),21cases had chest pain(80.8%), in which17cases had mild chest pain and4patients had moderate to severe chest pain. There are11patients who had nausea or nausea with vomiting symptoms, which proportion was42.3%. The rate of gastrointestinal reaction in the treatment group was lower than that of the control group, and the difference was significant statistically (P<0.05). Other adverse reactions of the two groups like fever and chest pain had no statistical differences (P>0.05). All of the two groups of patients did not have serious adverse reactions like re-expansion pulmonary edema and acute respiratory distress, and they didn’t have allergic reactions.ConclusionsPerfusion of Sodium santharidinate and vitamin B6injection combined with cisplatin from central venous catheter has obvious efficacy in treatmenting malignant pleural effusion of non-small cell lung cancer. And it can significantly improve the life quality of the patients with mild adverse reactions, safely and reliably.