| Objective To investigate the efficacy and safety of Qijiao Shengbai Capsule in the prevention and treatment of leukopenia caused by lung cancer chemotherapy(the deficiency of qi and blood),and to clinically use Qijiao Shengbai Capsule to prevent and treat leukopenia caused by chemotherapy of lung cancer(the deficiency of qi and blood)to provide reference and basis.Methods A clinical trial was conducted using a multicenter,central randomized,double-blind,and positive drug control in strict accordance with GCP regulations.Subjects were included in the trial in strict accordance with the trial protocol.The treatment group was given a platinum-containing chemotherapy for lung cancer combined with Sijia Shengbai Capsule,and the control group was given a platinum-containing chemotherapy plus Andorin capsule,and the treatment and observation were conducted for 20 days.The subjects were interviewed within 3 days prior to enrollment,at 5±1 day of treatment,at 10±1 day of treatment,at 15±1 day of treatment,and 20±1 day of treatment,and the effectiveness and safety evaluation sites were collected.The various test data required for statistical analysis.The data collected included TCM symptom scores,blood routine,urine routine,routine routines,occult blood,liver function,renal function,electrocardiogram,and vital signs.The data was analyzed by SPSS 20.0 to evaluate the effectiveness and seaurity of Qijiao Shengbai Capsule.TCM syndromes were quantified by using the integral method.Changes in TCM syndrome scores,and the efficacy of TCM symptoms and signs before and after treatment were compared.Result1.In this study,a total of 135 patients with leukopenia due to lung cancer chemot herapy(air and blood deficiency syndrome)were enrolled.Among them,24 cases wer e shed,1 case was excluded,and the remaining 110 cases successfully completed thetrial,including 73 cases in the treatment group and 37 cases in the control group.2.The main efficacy indexes:①There was no significant difference in the baseline data of white blood cell count and neutrophil count between the two groups before treatment(P>0.05).②There was no significant difference between the two groups in the number of white blood cell count and neutrophils count(P>0.05).③There was no significant difference in white blood cell count and neutrophil count between the two groups before and after treatment(compared visit 1 with visit 5)(P>0.05).④ The distribution of the number of cases of the four leukocytopenia visits in the two groups was statistically significant(P<0.05).There was no statistically significant difference in the number of visits between the two groups(P<0.05);The count of cases,neutropenia in the two groups,visit two,visit three,visit four,visit five inspections,the difference was not statistically significant(P>0.05).3.Changes of secondary efficacy indicators:①There was no significant difference in the distribution of TCM syndrome scores between the two groups before treatment(P>0.05)·②Comparison of TCM syndrome scores before and after treatment in both groups was statistically significant(P<0.05).Differences between the two groups before and after treatment were compared between groups,and the difference was statistically significant(P<0.05).③The efficacy of TCM syndromes in the two groups was statistically significant(P<0.05).④Comparison of single symptom scores before and after treatment in both groups was statistically significant(P<0.05).⑤There was no significant difference in the two groups of fatigue,shortness of breath,lazyness,dizziness,palpitation and insomnia(P>0.05).There was a statistically significant difference between the two groups in the chlorosis and spontaneous perspiration groups(P<0.05).⑥The number of follow-up chemotherapy groups in the two groups was 98.6%in the treatment group and 97.3%in the control group.There was no significant difference between the two groups.4.Changes in safety indicators:①Liver and kidney function:After treatment in the two groups,there was no significant change in liver and kidney function.The difference between the control group and the AST before and after treatment was statistically significant(P<0.05),but the average value remained at the normal level.②Blood routine:After treatment,the difference between RBC and HGB in the control group and RBC and PLT in the treatment group was statistically significant(P<0.05).③There was no significant difference in urine routine,routine routine and electrocardiogram between the two groups(P>0.05).④In the control group,there was 1 case of diarrhea,1 case of vomiting,and 1 case of discomfort in the epigastric area in the control group.There was 1 case of skin rash in the treatment group and improved after discontinuation.Conclusion ①Qijiao Shengbai Capsule can reduce the white blood cell count and neutrophil count reduction rate of patients with leukopenia(blood and blood deficiency syndrome)caused by platinum-based chemotherapy for lung cancer to a certain extent.②Qijiao Shengbai Capsule can effectively reduce the lung cancer patients with platinum drugs chemotherapy leukopenia(qi and blood deficiency)patients with fatigue,shortness of breath,lazy words,pale complexion,dizziness,palpitations,insomnia,spontaneous perspiration syndrome manifestations.③The Qijiao Shengbai Capsule can increase the follow-up chemotherapy acceptance rate of platinum-based chemotherapy patients with lung cancer.④Silicon capsules have higher safety and fewer toxic and side effects. |
