参桃软肝方治疗Child-Pugh C级原发性肝癌的临床观察

Clinical Observation of Shentao Ruangan Recipe in Treating Primary Liver Cancer Classified as Child-Pugh C

【目的】观察参桃软肝方治疗Child-Pugh C级(简称Child C级)原发性肝癌的有效性及安全性。【方法】将入组的60例Child C级原发性肝癌患者,按2∶1比例随机分为治疗组40例和对照组20例。对照组给予最佳支持治疗,治疗组给予最佳支持治疗+参桃软肝方口服治疗,21 d为1个周期,共观察2个周期。观察2组患者治疗前后中医肝癌相关症状评分、肝功能Child-Pugh评分、外周血肝纤维化指标[Ⅲ型原胶原(PC-Ⅲ)、层黏蛋白(LN)、透明质酸(HA)]的变化情况,评价2组患者的瘤体稳定性疗效和安全性。【结果】(1)治疗后,治疗组的肝癌相关症状积分、肝功能Child-Pugh评分和分级情况均较治疗前明显改善(P<0.05),而对照组改善均不明显(P>0.05),组间比较,治疗组在改善肝癌相关症状积分、肝功能Child-Pugh评分和分级情况方面均优于对照组(P<0.05)。(2)治疗后,治疗组外周血HA水平有所改善,但差异无统计学意义(P>0.05),LN水平有明显改善(P<0.05),而对照组各项肝纤维化指标均无明显改善(P>0.05),组间比较,治疗组在改善外周血HA和LN水平方面优于对照组(P<0.05)。(3)治疗后,治疗组的瘤体稳定率虽较对照组略高,但差异无统计学意义(P>0.05)。(4)治疗期间,治疗组有9例(22.5%)出现I～Ⅱ级不良反应,无Ⅲ～Ⅳ级毒性反应,对照组有5例(25.0%)出现I～Ⅱ级不良反应,无Ⅲ～Ⅳ级毒性反应,2组不良反应比较,差异无统计学意义(P>0.05)。【结论】参桃软肝方治疗Child C级原发性肝癌具有较好的瘤体稳定性疗效,能保护患者的肝功能,改善患者的肝癌相关症状,且不良反应轻微,可作为Child C级肝癌患者中医药治疗的选择之一。

Objective To observe the clinical efficacy and safety of Shentao Ruangan Recipe for the treatment of primary liver cancer classified as Child-Pugh C of hepatic function. Methods A total of 60 patients of primary livercancer classified as Child-Pugh C were randomly divided into treatment group（40 cases）and control group（20 cases）with the proportion of 2∶1. The control group received the best supportive treatment,and the treatmentgroup was treated with the best supportive treatment plus oral use of Shentao Ruangan Recipe. Twenty-one daysconstituted a cycle, and the treatment covered 2 cycles. The scores of traditional Chinese medicine（TCM）symptoms associated with liver cancer, Child-Pugh scores of hepatic function, and peripheral blood hepaticfibrosis indexes including type Ⅲ procollagen（PC-Ⅲ）,laminin（LN）,hyaluronic acid（HA）in the two groupswere observed before and after treatment. The clinical effect for stabilizing the tumors and safety in the two groupswere also evaluated. Results（1）After treatment, the scores of TCM symptoms associated with liver cancer,Child-Pugh scores and grading of hepatic function in the treatment group were much improved compared with thosebefore treatment（P 〈 0.05）, while the control group had no obvious improvement（P〉0.05）.The inter-groupcomparison results showed that the improvement of the above indexes in the treatment group was superior to that in the control group（P 〈 0.05）.（2）After treatment,the levels of the peripheral blood HA（P〉0.05）and LN（P 〈0.05）in the treatment group were improved,while all of the peripheral blood hepatic fibrosis indexes in the controlgroup had no obvious improvement（P 〉 0.05）. The inter-group comparison results showed that the improvement ofthe above indexes in the treatment group was superior to that in the control group（P 〈 0.05）.（3）After treatment,the tumor-stabilizing rate in the treatment group showed an increasing trend,but the difference was insignificant（P〉0.05）.（4）During the treatment,9 cases of adverse reaction of grade I～Ⅱ while no toxic reaction of gradeⅢ ～Ⅳ were presented in the treatment group, and 5 cases of adverse reaction of grade I～Ⅱ while no toxicreaction of grade Ⅲ ～Ⅳ were presented in the control group, there being no significant difference in the twogroups（P〉0.05）. Conclusion Shentao Ruangan Recipe has better clinical effect on stabilizing the tumors,protecting hepatic function, relieving symptoms associated with liver cancer for the treatment of primary livercancer classified as Child-Pugh C,and has mild adverse reaction,which can be used as a candidate Chinese medicine for Child-Pugh C primary liver cancer.