论文部分内容阅读
Objective: To confirm the efficacy and safety of fifth new drug Pai-Neng-Da capsule in the treatment of Leukopenia with unknown causes.Method: From March 2013 to June 2015,96 cases of patients with unknown causes of Leukopenia were treated with Pai-Neng-Da capsule,Leucogen and combination of the two drugs.The leukocyte count,TCM Syndrome and improvement of life quality of three groups before and after treatment were observed.Liver and kidney function,infection,gastrointestinal reactions and other adverse reactions in the course of treatment were also monitored.Result: Regarding toleukocyte count,the total effective rates were 51.6%,46.7%and 74.3% in Pai-Neng-Da capsule group,Leucogen group and the combination group.There were no significant differences (P > 0.05) in the efficacy between Pai-Neng-Da capsule group and Leucogen group,while the combination group preceded to that of the single drug groups,with significant difference (P < 0.05).Regarding to TCM Syndrome,the total effective rates in Pai-Neng-Da,Leucogen and the combination group were 87.1%,46.7%and 94.3%,respectively.There were statistically significant differences between Pai-Neng-Da group and Leucogen group (P < 0.05),while no significant differences between Pai-Neng-Da group and the combination (P > 0.05).SF-36 score was significantly different in each group before and after treatment (P < 0.05).Comparison among groups: There were significant differences in the improvement of SF-36 score between Pai-Neng-Da capsule group and Leucogen group (P < 0.05),while no significant differences between Pai-Neng-Da and the combination group (P > 0.05).All cases had complete test and no obvious adverse reaction was found.Conclusion: The effect of fifth new drug Pai-Neng-Da capsule in treatment of Leukopenia with unknown causes is similar to that of Leucogen.The combination can further improve efficacy with no obvious adverse reactions.