Objective:To observe the therapeutic effect and toxicity of local Kanseran injection in combination with chemotherapy in advanced NSCLC patients.Methods:A total of 18 cases was recruited in this study. After desensitization,Kanseran injection was injected into tumor mass through fibrobronchoscope,2 mg every time,once per week. Meanwhile,MVP regimen was administered.Results:Of the 18 patients,1 was completely relieved,7 cases were partially relieved. The response rate was 44.4%. After treatment,when examined by fibrobronchoscope the tumor masses of 15 patients became smaller. The main side effects were fever,alopecia and gastrointestinal reaction,which were mild and tolerable.Conclusion:Local Kanseran injection into tumor mass in conjunction with chemotherapy is effective and safe in the treatment of advanced NSCLC patients with bronchus obstruction.

Objective:To evaluate the tolerance and safety of Zhengbiguanjie tablets in healthy volunteers to provide the safe dose range for phase II clinical trial. Methods:Totally 36 healthy volunteers were randomly divided into five single dose groups at different doses ranging from 400 mg to 3200 mg per day and two multiple dose groups with 1600 mg and 2400 mg for continuous 7 days. The tol-erance and safety of the tablets were observed. Results: All vital signs were normal in all the volunteers in both single and multiple dose tests. Although some indicators turned into abnormal after the administration, it was not significant for clinical judgment. Neither drug combination nor serious adverse reactions were shown during the trial. However, two mild adverse events occurred and disap-peared later without any treatment. Conclusion:All the volunteers have good tolerance to Zhengbiguanjie tablets. The study proved the safety of Zhengbiguanjie tablets at single and multiple dose.