Abstract:To observe the efficacy and safety of Qijiaoshengbai Capsules in preventing and treating leukopenia(qi and blood deficiency syndrome) caused by chemotherapy of lung cancer.Methods:A total of 171 lung cancer chemotherapy patients who were treated in Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Gansu Provincial Cancer Hospital,Beijing Chinese Medicine Hospital Affiliated to Capital Medical University,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Guangdong Provincial Hospital of Traditional Chinese Medicine from December 2015 to January 2018 were selected.Methods of randomized double-blind,placebo-controlled,central randomized,multi-center competition enrollment were used to randomize patients who met the diagnostic criteria to treatment and control groups,and they were given the treatment of a double-blind period of 21 days.The main efficacy indicators were white blood cell(WBC) and neutrophil count and indexing.TCM syndromes and symptoms scores were secondary efficacy indicators.Glutamic oxaloacetic transaminase(GOT),glutamate-pyruvate transaminase(GPT),urea nitrogen(BUN),serum creatinine(CRE),red blood cell(RBC),hemoglobin(Hb) and platelets(PLT) were used as safety indicators,the efficacy was counted after treatment.Results:The WBC detection value at visit point 5 of the treatment group was compared with that at visit point 1,and the difference was statistically significant(P<0.05),indicating that Qijiaoshengbai Capsules and Anduolin Capsule both had the effect of preventing and treating WBC reduction after chemotherapy.Qijiaoshengbai Capsules had obvious function of increasing the decrease of WBC in patients' peripheral blood.WBC grading of peripheral blood at visit point 2 of the two groups of patients were compared,the difference was statistically significant(P=0.018 2),indicating that Qijiaoshengbai Capsules had the effect of preventing and treating the decline of peripheral blood WBC grading caused by chemotherapy.After treatment,the neutrophils of the two groups were compared at each visit point within and between the groups,and there was no statistically significant difference(P>0.05),indicating that Qijiaoshengbai Capsules and Anduolin Capsules both had the effect of preventing and treating neutrophil decline after chemotherapy.The baseline of TCM syndromes and symptoms of the two groups minus the difference within the 5 visit groups were compared,and the difference was statistically significant(P<0.01).The baseline of TCM syndromes and symptoms of the two groups minus the difference between the 5 visit groups were compared,differences of the total scores of the TCM syndromes(P=0.017),Shenpi fatigue(P=0.011 7),and pale complexion(P=0.004),palpitations and insomnia(P=0.05) and other single symptoms were statistically significant(P<0.05),indicating that the treatment group had obvious advantages in improving TCM syndrome and Shenpi fatigue,pale complexion and palpitations and insomnia and other single symptoms.During the clinical trials,there were no serious adverse reactions or events in the two groups of patients,and no abnormalities in the RBC,Hb,PLT,GOT,GPT,BUN,CRE and other indicators were found in the two groups after treatment.Conclusion:Qijiaoshengbai Capsules and Anduolin Capsules both have the efficacy of preventing and treating leukopenia after chemotherapy and obviously improving the clinical syndrome.And Qijiaoshengbai Capsules has the effect of preventing and treating patients' peripheral blood WBC grading decline,and has no adverse reactions,and has no obvious effect on peripheral blood,liver and kidney functions,etc.