| Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide with 717,000 new cases in 2007. Chronic Hepatitis B virus (HBV) infection is the predominant risk factor for HCC in Southeast Asia and Africa, and chronic hepatitis C virus (HCV) infection is the predominant risk factor for HCC in Western countries and Japan. Surgical resection has been considered the treatment of choice for long-term control of HCC. However, no more than 40% patients are surgical candidates at diagnosis. Presently there is no consensus about a common treatment strategy for patients with unresectable HCC, although several proposals have been published.In China, there has been a long history of using traditional Chinese medicine (TCM) in the treatment of liver cancer and other malignancies. As the theory of TCM in the treatment of tumors focuses on integrity and functional regulation of the whole body, which coincides with oncology of modern medicine, its position in combination therapy of liver cancer has attracted more attention. Nowadays, there have no rules to regulate and manage the performance of TCM for liver cancer.The application of database systems is more and more widely adopted in the field of medlcine. Collection and management information of liver cancer record data with database system could help to analyze the data in real time and support to make the clinical decision. The usage of a large mount of cases information united in multi-centers could also avail to reduce the deviation and repetition of clinical research, and also improve the social-economic efficiency. It is required to construct an efficacious database system that could support clinical research and ofer the proofs to establish managing policy.There are three parts included in this study. First, the demand analysis and structure design of database system. Second, the design and construction of database system. Last, a retrospective analysis of the efficacy of transarterial chemoembolization in combination with a traditional Chinese herbal medicine formula in treatment of unresectable hepatocellular carcinoma.1. Demand Analysis and Structure Design of Database SystemAims: To complete the demand analysis and structure design of database system. Methods: Through the method of consulting documents and specialists'meeting, to design the structure and demand analysis of dataase system. Results: This study sums up the representative thirty-nine retrieval requirements. We definite the data acquisition range consisiting of biology, live quality, clinicaleconomics and demography. Then we draft the datafow of database system. Finally we design the data dictionary. Conclusions: This study can lay the first stone for achieving the performance objective of database system.2. Performance Design and Constuction of Database SystemAims: To complete the performance design and construction of database system. Methods: First we design the overall functional objective of database system. Then we select the logical database system architecture. Further, we design the data integration of database system. Finally, we design the performance of each module system. Results: Database system uses browser/server architecture. Data integration of database system includes seven categories information, such as essential information for patient, doctor's advice information, record information, image data, testing data, tongue diagnosis data, pulse-taking data. Database system consists of six module systems, such as record enter, quality monitoring, clinical decision, syndrome diagnosis, tongue- pulse diagnosis, data retrieval. Conclusions: This study establishs a new method for structuring collecting and storing the clinical information of trational Chinese medicine. Further this study biulds a new practical tool which can raise the efficiency of clinical research of trational Chinese medicine.3. Retrospective Analysis of the Efficacy of Transarterial Chemoembolization in Combination with a Traditional Chinese Herbal Medicine Formula in Treatment of Unresectable Hepatocellular CarcinomaAims: Transarterial chemoembolization (TACE) is the most widely used primary treatment for unresectable hepatocellular carcinoma (HCC) due to its survival benefit, though its clinical effect is still far from satisfactory. In this study, the authors evaluated the efficacy of combined therapy with TACE and JDF granule preparation (a traditional Chinese herbal medicine formula), composed of four traditional Chinese herbal medicines in treatment of unresectable HCC. Methods: Clinical data, including baseline, performance status change, survival time of 165 patients with unresectable HCC seen between January 2002 and December 2007 were retrospectively analyzed. Among the 165 patients, 80 patients (study group) received combined therapy consisting of TACE and a long-term maintenance treatment with oral JDF granule preparation at a dose of 8g at a time, bis in die, 30 min after meals, and the remaining 85 patients (control group) received TACE alone. The survival rate of both groups was calculated by the Kaplan-Meier method, and differences in performance status change before and after treatment between the two groups were analyzed by Mann-Whitney U test. Factors possibly affecting survival were assessed by multivariate analysis in the Cox proportional hazard model. Results: The median overall survival was 9.2 months (95% CI,6.94～11.46) in the study group versus 5.87 months (95% CI,4.21～7.52) in the control group. There was a significant difference in 1, 2- and 3-year survival rate between the two groups (41.2%vs26.9%, 18.4%vs.12.6% and 9.6%vs2.4% respectively, P<0.05). After the first course of treatment, there was a greater degree of decline in performance status in the control group as compared with that in the study group (P<0.05). The Cox regression analysis showed significant independent prognostic risk factors as follows: serum hepatitis B surface antigen (HBsAg) (P=0.014), maximum tumor size (P=0.027), number of lesions (P<0.001), portal vein invasion (P<0.001) and the therapy model (P=0.006). Conclusions: TACE combined with JDF granule preparation may prolong survival of patients with unresectable HCC, and may retard the decline of life quality caused by TACE. Prospective large scale randomized controlled clinical studies are needed to further evaluate the efficacy and safety of TACE combined with traditional Chinese herbal medicine in treatment of patients with unresectable HCC.
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