参桃软肝丸方合羟基喜树碱介入治疗大肝癌的预后因素分析

目的 观察口服参桃软肝丸合羟基喜树碱(Hydroxycamptothecine，HCPT)介入治疗52例中晚期大肝癌的临床疗效，分析影响大肝癌预后的相关因素。方法 85例患者随机分为治疗组52例与对照组33例，治疗组口服参桃软肝丸方合肝动脉插管局部灌注HCPT；对照组以肝癌介入的常规疗法经导管动脉内化疗栓塞(transcatheter arterial chemoembolization，TACE)作为标准对照。从瘤体变化评价两组的临床疗效，用Cox比例风险模型进行预后因素分析，采用Kaplan-Meier法进行生存分析。结果(1)治疗组瘤体有效率为19．2％，稳定率为82．7％，对照组分别为21．2％，81．8％，两组比较差异无显著性(P>0．05)；(2)中位生存期治疗组为326天，对照组为262天。0．5年、1年及2年生存率治疗组分别为80．95％，41．39％，12．42％，对照组分别为64．29％，25．00％及8．33％，两组比较差异有显著性(P<0．05)；(3)3种中医辨证分型中肝盛脾虚型与肝热血瘀型在生存期、生存率方面疗效相当，差异无显著性(P>0．05)，但与肝‘肾阴虚型比较，差异有显著性(P<0．05)；(4)影响预后的有利因素为治疗方法，治疗组优于对照组(P<0．05)。影响预后的危险因素有中医分型、临床分期及肝功能。肝盛脾虚型预后最好，肝热血瘀型次之，肝‘肾阴虚型最差；临床分期越晚，预后越差；肝功能Child-Pugh分级越差，预后越差。结论(1)参桃软肝丸合HCPT介入治疗大肝癌在生存率、生存期方面优于单纯TACE；(2)不同中医证型对预后有一定影响；(3)中医药局部与全身的配合治疗可作为大肝癌非手术治疗的有效手段之一。

Analysis on the Prognostic Factors in Patients with Large Hepatocarcinoma Treated by Shentao Ruangan Pill and Hydroxycamptothecine

ObjectiveTo observe the effect of intervention therapy with Shentao Ruangan pill (SRP) and hydroxycamptothecine (HCPT) in treating 85 patients with middle advanced large hepatocarcinoma, and to analyze the factors that could affect the prognosis. MethodsEighty five patients were randomly divided into the treated group (n=52) and the control group (n=33). The treated group was treated by oral taking of SRP combined with local perfusion of HCPT through hepatic artery catheterization, while to the control group, the conventional therapy, transcatheter arterial chemoembolization (TACE) was conducted for control. The clinical efficacy of treatment in the two groups was evaluated by the change of tumor size, the factors related with prognosis were analyzed using Cox proportional hazards model and the analysis of survival conducted by Kaplan Meier method. Results(1) The tumor size reducing rate in the treated group was 19 2% and the tumor size stabilizing rate was 82 7%, while those in the control group was 21 2% and 81 8% respectively, comparison of the criteria between the two groups showed insignificant difference (P>0 05); (2) The median survival time, 0 5- year, 1- year and 2- year survival rate in the treated group was 326 days, 80 95%, 41 39% and 12 42% respectively, those in the control group was 262 days, 64 29%, 25 00% and 8 33% respectively, comparison between the two groups showed significant difference (P<0 05) ; (3) Among the 3 TCM types in patients, the survival time and rates in patients of Gan excess with Pi deficiency type was similar to those in patients of Gan heat with blood stasis type showing insignificant difference (P>0 05), but as compared with those in patients of Gan Shen Yin deficiency type, the difference was significant (P<0 05) ; (4) Beneficial factor to the prognosis were therapeutic method, that used in the treated group was superior to that used in the control group. The risk factors to the prognosis were TCM type, clinical stage and liver function. Patients of Gan excess with Pi deficiency type had the optimal prognosis, those of Gan heat with blood stasis type the next and of Gan Shen Yin deficiency the worst. The later the clinical stage and the worse the Child Pugh grade of liver function was, the worse the prognosis would be. Conclusion(1) SRP combined with HCPT intervention treatment is superior to the simple TACE treatment in elevating patients' survival rate and time; (2) There are some relations between TCM types and prognosis; (3) Local Chinese drug therapy combined with systemic therapy could be one of the effective measures of non operational therapy in treating large hepatocarcinoma.