| ObjectivesTo evaluate the effectiveness, toxicity and clinical application of the hepatic arterial infusion and embolized with the Chinese midicine and transcatheter arterial chemoembolization(TACE) in treating patients with primary liver cancer(PLC). And compared the changes of Traditional Chinese Medicine (TCM) syndromes pre—and post—operation, concluded the effects and advantages of the interventiona therapy of TCM.Methods232 patients were enrolled in this retrospective research.72 patients in the treated group and 160 patients in the control group. The patients in the treated group were received infusion and embolized with the Chinese midicine such as Curcuma oil, Arsenic trioxide, Brucea javanical oil. The patients in the control group were received TACE, the chemotherapy medicine including epirubicin,5-fluorouracil, Calcium leucovorin, cisplatin, or mitomycin. Collected and compared the tumor volume, the level of alpha fetal protein (AFP), the function of liver and kidney, the Karnofsky performance status (KPS), the mean survival time, median survival time,3,6,9 months,1-and 2-year cumulative survival rate, the side effects after the interventional therapy. Datas were statistics and analysis by using SPSS 12.0 software.ResultsFrom Jan.2007 to Dec.2009,232 patients from Guangdong hospital of TCM were enrolled in this retrospective research. The last follow-up date is December,31th,2009.72 patients in the treated group and 160 patients in the control group, there was no statistical significance in age, sex, liver function grades, disease stage, composition ratio of pathological diagnosis and clinical diagnosis, intervention frequency and TCM Syndromes-type between the two groups(P>0.05).In the treated group, no patient attained complete remission(CR) and 18 partial rimission(PR),the objective response rate(ORR) being 25.0%. In the control group, no patient attained CR and 38 PR, the ORR being 23.8%. The disease control rate(DCR) in both two groups was 72.2% and 71.3% respectively. There was no significant statistic differences between the two groups (P>0.05).In the level of AFP, the total effective rate in the treated group and the control group was 34.7%(25/72)and 30.6%(49/160) respectively, the inhibitory rates being 51.4%(37/72)and 47.5%(76/160). There was no significant statistic differences between the two groups (P>0.05).In the treated group, the mean survival time, median survival time (MST),3,6,9 months,1-and 2-year cumulative survival rate was 10.8±1.9 months,10.5months,85.3%,73.7%,71.2%,48.6% and 20.8% respectively, while in the control group was 11.4±2.2 months,9.8months,84.2%,72.5%,69.8%,46.2% and 20.1% respectively. There was no significant statistic differences in MST between the two groups(P>0.05). In the same time, there was no significant statistic differences in survival rate between the two groups(P>0.05).The patients in the treated group had a rise in KPS compared to the pre-operation(P<0.05), but there was no significant change in the control group(P>0.05).TBIL, ALT and AST all showed increase in both the two groups, but the increase of TBIL, ALT and AST was significant in the control group, there was significant difference(P<0.05). There was no significant difference in ALP between the two groups(P>0.05).There was no obviously change on serum creatinine(Cr) and blood urea nitrogen(BUN) in the treated group after operation, but the control group raised of 150.25±2.98(umol/L) on Cr and 9.12±3.20 (mmol/L) on BUN. It was Significant difference on test of P<0.05 between the two groups.Hematological toxicity was one of the adver effect. There was decrease in red blood cell (RBC)of patients in both two groups, especially in the control group (P<0.05). The patients in both two groups showed similar decrease in platelet(PLT), there was no significant(P>0.05).17 patients had myelosuppression in the treated group, while 60 patients in the control group, there was significant statistic differences between the two groups (P<0.05).Compared with the pre-operation, the patients in the treated group has significantly improved in the clinical symptoms of fatigue and abdominal distension (P<0.05). While in the control group, fatigue and poor cppetite become more serious. In the treated group,22(26.9%)patients had fever,14(19.4%) patients had nausea and vomiting, while in the control group was 61(38.1%),39(24.4%)patients. There was statistically significant difference on fever, nausea and vomiting between the two group(P<0.05).Both the two groups have changed greatly in syndromes of TCM(P<0.05), especially in the Qizhixueyu, Shiyubojie, Pixuganyu and Ganshenyinxu. Berore the operation, the most cases of the PLC rounds at the Qizhixueyu(52.6%, 122/232), Pixuganyu(16.4%,38/232) and the Shiyubojie(15.1%,35/232). After the operation, the most cases of the PLC rounds at the Qizhixueyu(35.7%, 90/232) and Ganshenyinxu (20.6%,52/232). There were less cases of in the Qizhixueyu and Shiyubojie, more cases of in the Pixuganyu and Ganshenyinxu.Conclusions1. There was no statistical significance in the total response rate of the tumor, decreasing the level of AFP and in 3,6,9 months,1-and 2-year cumulative survival rate, MST and the mean survival period between the two groups.2. The patients in the treated group had a rise in KPS and improved the physical state.3. The major adverse effects were hepatic, renal and hematological toxicity, especially in the control group. It can be concluded that the interventional therapy of TCM has a better security than TACE.4. The patients in the treated group had significantly improved in the clinical symptoms of fatigue and abdominal distension. The occurrence of adverse events such as fever, nausea and vomiting were obviously lower in the treated group than those in the control group. Both the two groups have changed greatly in syndromes of TCM, especially in the Qizhixueyu, Shiyubojie, Pixuganyu and Ganshenyinxu. After the operation, there were less cases of in the Qizhixueyu and Shiyubojie, more cases of in the Pixuganyu and Ganshenyinxu. It can be concluded that the two interventional therapies can make the syndromes changed in the short term. |
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