Clinical Observation Of Qijingshengbai Granules In Preventing And Treating Neutropenia Caused By Chemotherapy On Patients With NSCLC

Objective: This trial was conducted to observe the clinical effect of Qijing Shengbai granules in preventing and treating neutropenia caused by chemotherapy on patients with NSCLC and also to provide clinical validations for the research and development of this new drug. Methods: According to the standard of diagnosis and the calculation formula of the sample size,the theoretical sample content of this trial was 72,but the actual number of eligible cases were 53.According to the design of drug clinical trials,53 cases were randomly divided into treatment group(27 cases interfered by Qijing Shengbai granules)and control group(26 cases treated by the simulation agents of Qijing Shengbai granules).The investigational drugs were administered in sync with periodical chemothera peutics during the observation period of 42±7 days.According to the grading standard of neutropenia,evaluation criterion of clinical symptom efficiency of TCM and determination standard of KPS,the experiment data of the two groups were compared by SPSS22.0 with two-sided test,and if P value less than 0.05 was considered as statistically significant difference and vice versa. Result:(1)The general data of both groups was comparable as no significant differences(P>0.05) by chi-square test in age,sex,disease course and TNM staging.(2)Clinical evaluation:(1)After two cycles of chemotherap in both groups,the Rank test showed no differences in the incidence of neutropenia(P>0.05).But neutropeni as in stage III and IV occurred in the control group were significantly higher than the treatment group and the degree of IV especially.Therefore,the statistical difference was not significant.But it can be seen from the specific proportion and the number of cases to find that the treatment group has the relative superiority.(2) Two groups of TCM syndrome curative effect by rank-sum test,P>0.05.Inefficiencies of the two groups all rise,but the control group was more. Even if there is no statistically significant difference,but from the number of cases and the proportion of ineffective treatment can be seen,the treatment group has a weak advantage.(3)Comparison of the efficacy of two groups of primary andsecondary symptoms after the rank sum test,there was a significant difference between two main symptoms of mental fatigue and weakness,and Secondary symptoms of sweating and lazy words two times in the treatment group(P < 0.05).(4) KPS scores of the two groups by rank sum test(P>0.05),learned that the curative effect was not significant.(5)Through the evaluation of drug related adverse events,patient compliance and drug safety,known that the test drug in this test is safe and reliable and the side-effect is not significant. Conclusion: In this clinical trial,prevention and cure of the incidence of neutropenia by chemotherapy in patients with Qijing Shengbai granules and improvement of syndrome of deficiency of Qi and blood in TCM,to improve the physical condition compared with the control group,the therapeutic effect was not significant and it did not have statistical significance,but for the symptoms of fatigue,weakness,sweating,lazy words can be significantly improved.