Meta-analysis and Trial Sequential Analysis of Effectiveness and Safe ty of Compound Banmao Capsules Combined with Different Chemoradiotherapy in the Treatment of Primary Hepatic Carcinoma / 中国药房

ABSTRACT

OBJECTIVE：To systematically evaluate th e efficacy and safety of Compound banmao capsules combined with different chemoradiotherapy in the treatment of primary hepatic carcinoma （PHC）. METHODS ：Retrieved from CBM ，CNKI， Wanfang database ，VIP，PubMed，Embase and Cochrane Library during the inception to Sept. 2020，randomized controlled trial （RCTs），cohort study about Compound banmao capsules combined with different chemoradiotherapy plans （trial group ）versus different chemoradiotherapy plans （control group ）were collected. After literature screening and data extraction ，the quality of included RCTs were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator mannual 5.1.0. Newcastle Ottawa scale was used to evaluate the quality of cohort 502） studies；Rev Man 5.3 software was used for Meta-analysis ；TSA 0.9.5.10 Beta software was used for trail sequential analysis，and GRADE Profiler 3.6.1 software was used for evidence quality evaluation of RCT and cohort studies . RESULTS：A total of 15 RCTs were included ，involving com 1 148 patients. Meta-analysis showed that effective rate of trial group was significantly higher than that of control group [RR ＝0.80，95％CI（0.73，0.88），P＜0.000 01]. The results of subgroup analysis according to different chemotherapy plan showed that the effective rate of trial group combined with TACE and three dimensional conformal radiotherapy were significantly higher than control group （P＜0.05）. The survival rate of trial group was significantly higher than control group [RR ＝0.81，95％CI（0.74，0.89），P＜0.000 1]；the results of subgroup analysis according to different survival time showed that 1-year，2-year and 3-year survival rates of trial group were significantly higher than control group（P＜0.05）. The incidence of myelosuppression in trial group was significantly lower than control group ，and the natural killer cell count and T cell count of trial group were significantly higher than control group （P＜0.05）. There was no statistical significance in AFP content and liver function index between 2 groups（P＞0.05）. Trial sequential analysis showed that there was definite evidence for better effective rate of Compound banmao capsules combined with TACE. GRADE evaluation results showed that the evidence level of effective rate was intermediate ，the evidence level of survival rate and incidence of myelosuppression was low，and other indicators were very low. CONCLUSIONS ：Compound banmao capsules combined with different chemoradiotherapy in the treatment of PHC has significant efficacy and good safety ，especially in combination with TACE ，and the evidence level of effective rate is intermediate.