ObjectiveTo evaluate the effectiveness and safety of catgut embedding combined with routine medical treatment on patients with Postembolization Syndrome(PES)following Transcatheter Arterial Chemoembolization(TACE)for Hepatocellular Carcinoma,including the effects on TCM syndrome score,clinical symptoms,quality of life,liver function indicators(AST/ALT)and cancer biomarkers(AFP).MethodsIn this study,the sample size was estimated to be seventy by PASS 15 software.A total of seventy participants were collected from the Inpatient Center of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from November 2019 to December 2020.Using SPSS 25.0 software to generate random number,then the participants were randomly allocated into the control group(routine medical treatment)and the observation group(catgut embedding plus routine medical treatment)according to the proportion of 1:1.Participants in the control group received routine medical treatment only,while the observation group received catgut embedding on the basis of the control group.The main acupoints selected were ZUSANLI(ST36),NEIGUAN(PC6),QIMEN(LR14),ZHONGWAN(CV12),and the compatibility acupoints were added by different TCM syndrome,such as adding GANSHU(BL18)when the syndrome was Qi depression,adding GESHU(BL17)when blood stagnation,adding DAZHUI(GV14)when damp-heat,adding PISHU(BL20)when deficiency of spleen Qi,adding SANYINJIAO(SP6)when deficiency of Yin.The routine medical treatment was used after TACE,while catgut embedding was added once at the appearance of PES.The primary outcome was the effective rate of TCM syndrome score.The secondary outcomes included the score of clinical symptoms(liver pain,nausea and vomiting,loss of appetite,fatigue,fever,emotion and activity),quality of life score including Karnofsky Performance Status(KPS)and Zubrod Performance Status(ZPS),liver function indicators(AST/ALT)and cancer biomarkers(AFP).The safety outcomes were the incidence of adverse events and some other laboratory indicators.Using "before treatment",one to five days,two weeks follow-up period after treatment as the evaluation time point,the laboratory indicators added "before TACE"as the time point.ResultsIn the study,seventy participants were recruited and randomly allocated into the observation group and the control group by the proportion of 1:1.After eight subjects are dropped or removed,sixty-two subjects accomplished the clinical trial eventually,with thirty-one subjects in each group.1.Baseline data:there was no significant difference(P>0.05)between the two groups in demographic data(gender,age,course of disease,history of viral hepatitis B and TACE,the BCLC staging classification)and outcomes before treatment,indicating that the two groups are comparable.2.The effective rate of TCM syndrome score:The TCM syndrome score of both of groups decreased significantly(P<0.05)after treatment compare with before.After treatment,the effective rate of TCM syndrome score of the observation group was 93.5%,and the control group was 61.3%.There was a significant difference(P<0.05)between the two groups.After five days of treatment and two weeks follow-up period,the distribution of effectiveness between the two groups was different significantly(P<0.05).The score shows significant difference(P<0.05)after four days of treatment between the two groups,and the observation group was lower than the control one.3.Clinical symptoms:After treatment,the clinical symptoms such as liver pain,nausea and vomiting,loss of appetite,fatigue,emotion and activity were alleviated significantly(P<0.05)in each group compared with before.There was no significant diffirence(P>0.05)in symptoms of fever after treatment compared with before.There was a significant difference(P<0.05)in symptoms of liver pain,loss of appetite,fatigue between the two groups after treatment.While there was no significant difference(P>0.05)in symptoms of fever,nausea and vomiting.In alleviating emotion and activity,there were both significant differences(P<0.05)between the two groups.4.Quality of life:After treatment,the KPS score increased significantly(P<0.05)and the ZPS score decreased significantly(P<0.05)in both two groups compared with before.There was no significant difference(P>0.05)between the two groups in KPS score after treatment.While there was a significant difference(P<0.05)between the two groups in ZPS score after five days of treatment.5.Laboratory indicators:AST、ALT:In both two groups,both of the indicators had the tendency of increasing,and the peak value was in the three days after treatment.There was a significant difference(P<0.05)after three days of treatment in comparison of before TACE.Then the indicators had the tendency of decreasing.ALT could recover to the levels of before TACE after five days of treatment.There was no significant difference(P>0.05)in ALT after five days of treatment compared with before.AST could recover to the levels of before TACE(P>0.05)after two weeks.There was no significant difference(P>0.05)between the two groups after treatment.AFP:There was no significant difference(P>0.05)after TACE compared with before.There was no significant difference(P>0.05)between the two groups after treatment.ConclusionCatgut embedding combined with routine medical treatment can improve the effective rate of TCM syndrome score,and alleviate the symptoms of PES such as liver pain,loss of appetite,fatigue,which were better than routine medical treatment only.Meanwhile,the treatment can ameliorate emotion and activity.Also,it can improve the quality of life for patients with PES,and relieve liver damage.Thus,due to its effectiveness and safety,catgut embedding is worthy of being used for complementary treatment for the PES. |