参苓白术散治疗肺脾气虚型小细胞肺癌化疗相关腹泻的临床研究OA

Objective To observe the clinical efficacy and safety of Shenling Baizhu Powder in treating chemotherapy-related diarrhea(CRD)with lung-spleen qi deficiency pattern in patients with small cell lung cancer(SCLC).Methods Seventy SCLC patients meeting the inclusion and exclusion criteria were randomly divided into a treatment group and a control group,with 35 cases in each group.The control group received irinotecan+cisplatin(IP)regimen chemotherapy,and the treatment group was given Shenling Baizhu Powder orally in addition to the same chemotherapy,with 14 days of medication per chemotherapy cycle.Both groups underwent 2 cycles of chemotherapy.The incidence and severity of diarrhea,time to first diarrhea onset,duration of diarrhea,usage of antidiarrheal medication,and improvement in traditional Chinese medicine(TCM)clinical syndrome were compared between the two groups.Chemotherapy efficacy and adverse reactions were also evaluated.Results Sixty-five patients completed the trial and were included in the statistical analysis(32 in the treatment group,33 in the control group).The incidence of diarrhea in the treatment group was 31.25％,significantly lower than 57.58％in the control group(P<0.05).Diarrhea severity was primarily grade 1 in the treatment group,while it was mainly grade 2 in the control group(P<0.05).The duration of diarrhea in the treatment group was shorter than that in the control group(P<0.05).No significant difference was observed in the time to first diarrhea onset between the two groups(P>0.05).The proportion of patients using antidiarrheal medication and the total dosage of loperamide in the treatment group were lower than those in the control group,while the rates of significant and partial improvement in TCM syndrome were higher in the treatment group,with statistically significant differences(all P<0.05).The objective response rate(ORR)in the treatment group was lower than that in the control group(28.12％vs 33.33％),and the disease control rate(DCR)was higher(75.00％vs 72.73％),but the differences were not statistically significant(P>0.05).There were no significant differences in the incidence rates of other adverse reactions between the two groups(P>0.05).Conclusion Shenling Baizhu Powder can reduce the incidence and severity of diarrhea,decrease the usage of antidiarrheal medication,shorten the duration of diarrhea,and improve TCM clinical syndrome in SCLC patients receiving irinotecan-based chemotherapy,with a good safety profile.