Clinical Study On The Prevention And Treatment Of Delayed Diarrhea Caused By Irinotecan By Jianpi Yiqi Recipe

Objective:According to different genotypes of uridine diphosphate glucuronosyltransferase 1A1*28(UGT1A1*28),the efficacy and safety of invigorating spleen and replenishing Qi for preventing late-onset diarrhea in patients with advanced colorectal cancer treated with irinotecan-based regimen were studied.Methods:A total of 41 patients with advanced colorectal cancer who were treated in China-Japan Friendship Hospital from October 2016 to December 2017 were stratified according to the UGT1A1*28 genotypes.They were divided into the experimental group and the control group according to whether the patients were willing to take traditional Chinese medicine(Astragalus Mongholicus 30g,Codonopsis Pilosula 15g,dried tangerine peel 10g,Pinellia ternata 10g,Rhizoma Dioscoreae 30g,Atractylodes Macrocephala 15g,Poria cocos 10g,licorice 10g,Amomum villosum 10g,woody 10g,berberine 6g,Coix seed 30g as the basic composition,added and subtracted with the symptoms).The experimental group took oral administration of Jianpi Yiqi Chinese Herbal Decoction which was uniformly made by the decoction chamber of the China-Japan Friendship Hospital from the day before administering the irinotecan-containing regimen to the last day of 2 consecutive cycles of chemotherapy.Each dose was evenly divided into 2 packages and the dosage was to take 1 package(100ml)half an hour after breakfast and dinner.The control group only received chemotherapy which contained irinotecan and did not take oral medicine.After 2 cycles,the patients were evaluated for therapeutic effects,including the occurrence of diarrhea,clinical symptom scores,and KPS scores which were recorded before and after treatment.At the same time,complete blood count,liver and kidney function,and electrocardiogram were performed before and after each cycle of chemotherapy to evaluate the side effects.Results:1.UGT1A1*28 genotypes were performed on 41 patients,32 patients were TA6/6 wild type(78.05%),9 patients were TA6/7 heterozygous type(21.95%),and no TA7/7 homozygous mutant was found.2.Before the treatment,there were no statistically significant differences in baseline such as gender,age,primary tumor site,metastatic sites,number of chemotherapy lines,targeted drug,KPS scores,and clinical symptom scores(P>0.05).After 2 cycles of treatment,among the subgroup of TA6/7 genotype,there were statistically differences in the incidence of diarrhea,clinical symptom scores,changes of KPS scores,the incidence of neutropenia and leukocyte decline if compared between the experimental group and the control group(P<0.05).However,there was no significant difference in the incidence of diarrhea after 2 cycles of treatment in 32 TA6/6 wild-type patients.Conclusion:The effect of invigorating spleen and replenishing qi on different patients who have differfent UGT1A1*28 genotypes has been shown to relieve the late-onset diarrhea caused by irinotecan.