| Objective: Primary bronchial lung cancer is one of the most common malignant tumors and the incidence of it has risen considerably in the past few years. Most of them (75-80%) are non-small-cell lung cancer (NSCLC). So, the study on NSCLC is very important. Because most new chemotherapy drugs have been developed, the effects of western medicine (WM) alone have much risen. But they do not reach ideality. Many traditional Chinese medicine (TCM) doctors also do many studies. After sum up these resources of TCM, we find that the deficiency of qi and yin and the stagnation of phlegm and blood stasis is the major syndrome when advanced NSCLC is diagnosed. Integrated TCM and WM treatment can also improve the quality of life, improve and control clinical symptoms. So, we select the injection of shengmaiyin whom is the traditional prescription of invigorating qi and yin and meihuadianshewan whom is the famous prescription of promoting blood circulation and removing blood stasis and .relieving heat and poison to treat the stage IIIB or stage IV NSCLC patients who are treated firstly with chemotherapy drugs according to these resources. To compare the response, time to progress(TTP), survival time, quality of life(QOL) and cost-effectiveness ratio between shengmaiinjection plus meihuadianshewan plus NP (Vinorelbine and Cisplatin) regimen and NP regimen alone in primary patients with advanced non-small cell lung cancer (NSCLC, stage IIIB-IV).Verifying the effects of TCM treating tumor and provide scientific basis for preliminarily selecting the optimal plan. Methods: Seventy-seven patients with locally advanced or metastatic non-small cell lung cancer were randomized to receive shengmaiinjection plus meihuadianshewan plus NP regimen (group A n=38) or a comparator arm of NP regimen alone (group B n=39). The therapeutic plan of group A and B are as follows: Group A: The dose of Cisplatin is 60-80mg/m2.intravenous drip, in a day or in two-three days; Usage: the dose of Vinorelbine is 25mg/ m .intravenous drip, day 1 and day 8 every cycle is 21 days. Continuous 2-4 cycles; when the chemical treatment is under the way, the liquid of glucose 250 ml plus shengmaiinjection 50ml also begin to be infused into body. Usage: intravenous drip, once a day, continuous 21 days, after four weeks, the plan is to be repeated. Continuous 2-4 months; meihuadianshewan Usage: two grain, three times a day, and continuous 2-4 months. Group B: The dose of Cisplatin is 60-80mg/ m2 .intravenous drip, in a day or in two-three days; Usage: the dose of Vinorelbine is 25mg/ m2.intravenous drip, day 1 and day 8 .Every cycle is 21 days. Continuous 2-4 cycles; both regimens were repeated every 21 days for 2-4 cycles. Results: when the trial finishes, two patients do not finish the treatment plan and four patients lose follow up in group A. There are two and three patients in group B. Datum of these eleven patients have been deleted from statistics. After eleven patients are deleted, group A and B respectively has 32 and 34 patients. The objective response rates(including CR,PR,NC,PD) of group A and B respectively are 0,28.13%, 53.12%, 18.75%, and 0,26.47%, 44.12%, 29.41%, P > 0.05; Times to progress respectively are 175.22 days ( 5.84months) and 129.88 days (4.33months), P < 0.05; median survival times respectively are 277.06 days (9.24months) and 221.68 days (7.39months), P < 0.05; 1-year survival probabilities respectively are 40.63% and 32.35%, P < 0.05; The quality of life , the scores of KPS , the symptom and sign of TCM of group A were improved significantly, P < 0.05.Cost-effectiveness analysis goes on in those patients who have completed three cycles in two groups. Thee cost/tumor control ratios and cost/1 year survival probabilities of Group A and B respectively are 552.19, 595.68and 1104.51, 1299.56, P < 0.05; leukopenia ,haemoglobin ,platelet, and nausea ,vomiting in group B are more serious than those in group A, P < 0.05; No other serious side effects occurred in either group. Conclusion: The present study indicates that the patients with advanced NSCLC t...
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