Clinical Observation Of Jiawei Xiaochaihu Decoction Combined With Sorafenib In The Treatment Of Middle And Advanced Primary Liver Cancer

1 purpose of researchThis paper used a randomized controlled study and evaluated the effectiveness and safety of Jiawei Xiaochaihu Decoction in the treatment of middle and advanced primary liver cancer compared with sorafenib alone.To provide a clinical basis for the treatment of TCM and Sorafini with middle and advanced primary liver cancer,in order to find more effective treatment programs for middle and advanced primary liver cancer.2 research methodA total of 53 patients were included in the inpatient and outpatient treatment of Chengdu University of traditional Chinese Medicine from 2018.12 to 2020.12,Among them,the experimental group combined with sorafenib(referred to as the combined group of traditional Chinese medicine)27 cases;In the control group,26 cases of sorafenib;The targeted group used solafenib(400mg bid)alone,and the traditional Chinese medicine group combined with flavored small firewood soup based on the targeted treatment group.With one month as the treatment cycle,both patients were treated for two cycles,the Objective Response Rate(ORR)and Disease Control Rate(DCR)of both patients were assessed on RECIST1.1 and the TCM syndrome grade,KPS score and AFP level were compared to evaluate the effectiveness of Jiawei Xiaochaihu Decoction combined with Sorafinib in the treatment of middle and advanced primary hepatocellular cancer.Comparing the comparison of toxicity and safety indicators of the two patients to evaluate the safety of Jiawei Xiaochaihu decoction combined with Sorafenib in the treatment of middle and advanced primary liver cell cancer.All data were statistically analyzed by SPSS26.0 to represent the difference in P< 0.05.3 Results3.1 Baseline data: gender,age,drinking history,hepatitis history,KPS score,Child-Pugh classification,BCLC stage,AFP,previous treatment,TCM syndrome,safety indicators(blood routine,liver and kidney function,coagulation function).By baseline comparative analysis,the differences between the two groups were not significant(P> 0.05)and were comparable.3.2 Observation index of curative effect: main curative effect index: ORR、DCR;secondary curative effect index: TCM symptom,KPS score,,the AFP;3.2.1 Main curative effect index: in Chinese medicine group,CR:0 cases PR:3cases,SD:9 cases,PD:15 cases,And the ORR、DCR of the combined group were11.11%,44.44%;in targeting group,CR:0 cases,PR:2 cases,SD:8 cases,PD:16 cases,ORR、DCR were 7.69%,38.46%;Comparison ORR、DCR efficacy between the two groups,The combination group was slightly higher than the target group,but the difference was not significant(P=0.626,P>0.05).3.2.2 secondary efficacy index:(1)TCM syndrome grade: 5 groups of right and side pain,chest tightness,fatigue,depression,and abdominal distension,Significant difference(P<0.05),Three groups of diarrhea,less food,nausea and vomiting were slightly improved compared with before,But the difference is not statistical(P>0.05);The target group improved significantly in right side pain and abdominal distension,Significant difference(P<0.05);Chest tightness too deep,depression,diarrhea,less food,nausea and vomiting 5 groups slightly improved,But the differences are not statistically significant(P>0.05),The fatigue is worse than before,But the difference is not statistical(P>0.05);Comparison between the two groups after treatment,Significant differences in chest tightness,depression and fatigue(P<0.05).(2)KPS score: the KPS score was significantly improved compared with the previous group(P<0.05);compared with the targeted group,with no statistical significance(P>0.05);After comparison between the two groups,the KPS score improved significantly compared with the target group(P<0.05).(3)After comparison between AFP: and targeted groups,AFP was decreased compared with previous,but the results had no statistical significance(P>0.05).After the two groups,TCM combination decreased slightly compared with the targeted group,but had no statistical significance(P>0.05).3.3 side effects:The incidence and severity of hand and foot skin syndrome,diarrhea,oral ulcer and proteinuria in the combined group were lower than those in the targeted group(P<0.05);The occurrence and severity of rash,hypertension and nosebleed in the combined 3 groups were lower,but less different than in the target group(P> 0.05).3.4 safety evaluation: After treatment,the blood routine,liver and kidney function and coagulation function of the two groups were not significantly different from those before treatment(P>0.05).4 ConclusionOn the basis of sorafenib combined with traditional Chinese medicine can improve the level of DCR、ORR、AFP to a certain extent compared with sorafenib alone,but the difference has reached no statistical significance.However it can significantly improve the symptoms of traditional Chinese medicine and KPS score,improve the quality of life,and produce less sorafenib and other related toxicity.After safety analysis,Jiawei Xiaochaihu Decoction is well safe,so the joint scheme is worth the further clinical promotion and application.