| Objective and Aim:The incidence and mortality rate of lung cancer ranks first in china and have been increasing year by year.More than two thirds of non-small cell lung cancer patients came with advanced diseases.And with aging,the physiological function declining and multiple basic diseases,the clinical treatments for these patients are poor.Therefore,to explore a safe,efficient,well-tolerated therapy should be a main focus in the cancer area.Represented by the ultra-low temperature cryoablation,the prospering minimally invasive treatments bring new hope to the elderly patients with advanced NSCLC who have missed the chance to seek surgical treatment.Our department persists on integrating local and systematic treatment,internal and external treatment to treat malignant tumor.We purposed the unique module of Cancer Green Treatment,which is to treat cancer with cryoablation and traditional Chinese medicine(TCM).Its core idea is to relieve the tumor burden with the method of Ba Dao,which is mainly local ablation,and harmonizing the human body applying the method of Wang Dao and Di Dao,which is mainly TCM.However,the consumptive material of cryoablation is expensive and difficult to acquire so it puts limit to the technology and patients.Therefore,out department cooperating with other hospitals tried to evaluate the short-term efficacy and safety of HJY CHS 800 001 ultra-low temperature treating system in order to promote a native cryoablation system and to put more application on Cancer Green Treatment to further develop the cryoablation technology and benefit more patients.Methods:A prospective,multi-center,randomized,parallel controlled clinical trial design was applied in this study.We evaluated the safety and short-term efficacy of this ultra-low temperature treating system on NSCLC.The participants were all stage Ⅲ,Ⅳ patients.In total 81 patients were included,41 of which were in trial group and 40 of which were in control group.The main outcome measures includes ice-ball coverage efficiency,30 days after the operation efficiency,while secondary indexes includes safety,tolerance,preoperative and postoperative quality of life.And TCM syndomes of lung cancer were studied to explore the TCM mechanism OF cryoablation on lung cancer.Results:1.Ice-ball coverage during operation:The ice-ball coverage rate of the trial group and the control group was 100%.We used Miettinen nurminen method,approximately normal method,Newcombe method to estimate the absolute value of the lower limit of 95%confidence interval of the two groups efficiency were less than test plan provision of non inferiority boundary value by 10%,so that non inferiority conclusion of this clinical study was established.2.Efficiency of the tumor burden one month post-operation:There were 41 lesions of solid tumor in the trial group received effective improvement after 30 days,whose effective rate was 97.6%.There were 39 lesions of solid tumor in the trial group received effective improvement after 30 days,whose effective rate was 95.1%.Adjusting the center effect using CMH chi square test,we found out that the estimation of difference is 3.4%,the rate of 95%confidence interval is[-4.5%;12.1%]and the absolute value of the difference of the lower limit of 95%confidence interval is 4.5%,which was less than the non inferiority boundary value by 10%,so that we could draw the non inferiority conclusion.3.Safety and tolerance:The laboratory results post-op of the trial group and the control group had no statistical significance comparing with pre-op,suggesting that the treatment has no significant impact on blood routine test and function of the heart,liver and kidney.The results suggests that the patients were well-tolerated to the treatment.Intraoperative and postoperative major complications were pneumothorax,fever,coughing up blood and pain.The incidence of pneumothorax and hemoptysis was lower than those reported in the literature.4.TCM syndromes:Nine TCM syndromes were observed in all patients included,in which there was 1 case of simple syndrome and 8 cases of complex syndrome.Qi deficiency syndrome and other elements were mainly observed.In terms of the features of the syndrome,Qi deficiency and yin deficiency were main deficiency syndromes,while phlegm and blood stasis were main excess syndromes.Before and after surgery the main syndrome was Qi deficiency,while 1 week after operation the blood stasis syndrome increased comparing with that pre-operation.5.TCM mechanism of cryoablation on lung cancer:Comprehending the literature and modern imaging techniques,the local lesion of lung cancer is active,with high metabolism and the feature of unlimited proliferation,invasion and metastasis,which reveals its unusual yang activity.The local lesion is in the obvious state of yang-heat so the microcosmic syndrome differentiation is yang-heat toxic pathogenic factor,while cryoablation forms the ice-ball with the feature of utmost yin and coldness.Therefore,the method of cryoablation could deliver yin and cold directly to the heat pathogenic area,with the features of Jie(Block),Ba(Remove)and Xiao(Ablate).Conclusion:1.Local cryoablation is safe and efficient on treating stage Ⅲ,Ⅳ NSCLC patients,with well tolerance and none hematological,cardiovascular,hepatological and kidney toxicity.Adverse effects are mild and well tolerated.Minimally invasive treatment of ultra-low temperature ablation system has non-inferiority efficacy compared with cryoablation on the efficacy,safety,tolerability.2.We proposed the use of three-dimensional reconstruction of CT on puncturing and freezing,as well as reverse position extraction method would help reduce the incidence of intraoperative and postoperative complications.3.Local microcosmic syndrome was yang-heat toxic,while the formed ice-ball had the property of cold.Abide by the principle of "Treating the heat with cold’,and using cryoablation to treat lung cancer is to treat the syndrome,which is based on syndrome differentiation and pracital.4.The treatment of cryoablation should respect the principle of "Killing the most half(of the tumor)and cease(or else the patient should die)’ and protect the Hu Chang(protection arena)to conserve the health qi. |
