| [Background]In our country, the morbidity and mortality of lung cancer ranks first in the malignant tumor. Elderly patients with non-small cell lung cancer (NSCLC) have unique physiological and pathological characteristics, such as physiological function degradation, more complications and lateness of correct diagnosis, so the oncologists can’t simply copy the treatment of young patients when making treatment plans for elderly patients. Exploring effective, small side effects and good tolerance treatments, which can improve the quality of life and prolong survival in elderly patients with advanced NSCLC, has become the focus of cancer researches.Argon-helium cryoablation which has many advantages such as small trauma, fast repair, no serious complications and strong targeting, has brought new hope for elderly patients with advanced NSCLC. A unique mode of "green treatment" has been presented by oncology department in Dongfang Hospital of Beijing university of Chinese medicine. It concludes a treatment of local argon-helium cryoablation combined with traditional Chinese medicine (TCM) on the basis of syndrome differentiation and treatment. Medicinal broth, Chinese patent medicine and injection of TCM can be used for treatment according to syndrome and stage of disease. Hope to provide reliable clinical data for formulating a better therapeutic regimen of advanced NSCLC.[Objective]1. To observe and assess the effect and security of argon-helium cryoablation combined with TCM, in order to provide reliable clinical data for formulating better therapeutic regimen of advanced NSCLC.2. To investigate characteristic of distribution and developing of syndrome in advanced NSCLC after argon-helium cryoablation.[Methods]130NSCLC elderly patients with stage ⅢB and Ⅳ were included in this study. Patients were divided into2groups. The group of Combination of traditional Chinese and western medicine (group I) including65patients were given the treatments of TCM combined with best supportive care (BSC) after argon-helium cryoablation. The group of western medicine multi-modality (group II) including65patients were given the treatments of western medicine treatments. Western medicines were given based on the NCCN clinical practice guidelines of NSCLC in2011. The principle of TCM treatment including medicinal broth, Chinese patent medicine and injection were formulated according to syndrome differentiation and treatment. Main observation indexes included postoperative survival and overall survival. Secondary observation indexes included imaging evaluation and clinical curative effect evaluation. Besides, performance status (PS) scores, quality of life (QOL) scores, and TCM syndrome were observed and analyzed at1day before operation, postoperative1week, postoperative1month and postoperative3month respectively.[Results]1. Baseline data comparison The number of patients whose smoking index were more than400in group I was higher than group II, with statistical difference (P<0.05). There were no significant differences on the other baseline information such as gender, age, primary site of tumor, clinical classification, pathological type, TNM staging, PS score, metastatic sites, the degree of differentiation, basic diseases, pre-operative tumor markers between the two groups.2. Imaging curative effect evaluation There were no significant differences on the size and location of surgical tumor, and the number of operation (P>0.05). The efficient of imaging evaluation during the surgery of group Ⅰ (95.38%) was higher than group Ⅱ (96.92%), but no statistical difference (P>0.05). There were no significant differences on the efficient of imaging evaluation1month after surgery of group I was46.15%, while group Ⅱ was41.54%. There were no statistical differences (P>0.05). The efficient of imaging evaluation of group Ⅰ (41.54%) was higher than group Ⅱ (32.31%)3month after surgery, but no statistical difference (P>0.05).3. Short-term curative effect evaluation①The PS score of group I was superior to group Ⅱ1month and3month after surgery respectively (P<0.05). There was no statistical difference1week after surgery (P>0.05).②The QOL score of group I (47.85±2.78) was higher than group Ⅱ (46.15±3.43)3month after surgery, with statistical difference(P<0.05). The score of group I at3month after surgery(47.85±2.78) was higher than those before surgery(46.78±3.65), with statistical difference(P<0.05). The score of group Ⅱ at1week after surgery(45.08±3.37) was lower than those before surgery(46.78±3.65), with statistical difference(P<0.05).③The improvement of expectoration, god fatigue, and loss of appetite in group I was superior to group II1month after surgery(P<0.05). The improvement of cough, expectoration,god fatigue, dry throat, and loss of appetite in group I was superior to group II3month after surgery(P<0.05).4. Postoperative complicationsThere were no significant differences on the incidence of complications before surgery(P>0.05). The most common complications were aggravating cough, pain of surgical site, hemoptysis and blood in phlegm. The relief time of cough in group I (5.11±2.17d) was shorter than group II (6.68±3.12d), with statistical difference(P<0.05). The relief time of pain in group I (3.47±1.92d) was shorter than group II (5.35±2.06d), with statistical difference(P<0.05).5. The long-term curative effect evaluationThe postoperative survival and the overall survival (OS) of group I was higher than group II respectively, but no statistical difference (P>0.05). The progression free survival time of group I (7months) was higher than group II (5months) respectively, with statistical difference(P<0.05).The patients who were more than75years old, or IIIB, or high differentiation, or PS score=3in group I benefited with significantly longer survival rates.6. Prognostic factors analysisIt showed that TNM staging, smoking index, PS score, degree of differentiation, and CEA levels were the factors influencing prognosis in Kaplan Meier analysis. The COX regression analysis showed that degree of differentiation were independent prognosis factors7. Evolutions of TCM syndromes①There were27types of TCM syndromes in total.②The mainly syndrome element could be mainly sum as4patterns:the deficiency of Qi, deficiency of Yin, phlegm-damp and blood stasis. There were no statistical differences on the frequency of deficiency of Qi, phlegm-damp at different time points respectively. The frequency of deficiency of Yin decreased1months after surgery, with statistical difference(P<0.05). The frequency of blood stasis increased1months and3months after surgery, with statistical difference(P<0.05).③Syndrome of intermingled deficiency and excess was the main deficiency-excessiveness syndromes, which increased after surgery with the progression of the disease (P<0.05)[Conclusion]1. The treatment of argon-helium cryoablation combined with TCM could shorten the relief time of postoperative complications, and improve the PS scores, QOL scores, and clinical syndrome such as cough, expectoration, fatigue, dry throat, and loss of appetite. TCM treatment after surgery could help to alleviate postoperative complications. The treatment of argon-helium cryoablation combined with TCM is well worth spreading.2. The treatment of argon-helium cryoablation combined with TCM could lengthen the PFS. The patients who were75years of age and older, or IIIB, or high differentiation, or PS score=3could get the survival benefit.3. TNM staging, smoking index, PS score, degree of differentiation and CEAlevels were the factors influencing prognosis in Kaplan Meier analysis. The COX regression analysis showed that the degree of differentiation were independent prognosis factors.4. Deficiency of Qi, deficiency of Yin, phlegm-damp and blood stasis were the most common syndrome elements. Syndrome of intermingled deficiency and excess was the main deficiency-excessiveness syndromes, which increased after surgery with the progression of the disease. |
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