解毒化瘀退黄方对乙肝相关CNLCⅣ期湿热瘀阻证患者炎症介质的影响及临床疗效

Effect and clinical efficacy of Jiedu Huayu Tuihuang Prescription on inflammatory factors in patients with dampness-heat stasis syndrome at CNLCⅣstage related HBV

目的观察解毒化瘀退黄方对乙肝相关中国肝癌分期(CNLC)Ⅳ期湿热瘀阻证患者的临床疗效及安全性。方法选取2021年1月至2022年6月于我院肝病科确诊为乙肝相关CNLCⅣ期湿热瘀阻证患者72例,随机分为对照组、观察组,每组36例;对照组采用西医治疗,观察组给予西医治疗+解毒化瘀退黄方口服,疗程均为12周,随访24周。比较两组治疗前及治疗4、12周后肿瘤大小、肿瘤个数、中医证候积分、细胞因子、肿瘤标志物、生化指标、Child-Pugh分级评分、体力及功能状态评分、患者生存率。结果治疗4周后,观察组瘤体大小较对照组增长缓慢,观察组的临床证候积分、白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)、甲胎蛋白(AFP)、甲胎蛋白异质体-L3(AFP-L3)、总胆红素(TBIL)、凝血酶原时间(PT)、Child-Pugh分级较对照组降低且ALB较对照组升高,观察组KPS较对照组降低延缓;治疗12周后,观察组瘤体大小及个数较对照组增长缓慢,观察组的临床证候积分、肿瘤坏死因子α(TNF-α)、IL-1β、IL-6、AFP、AFP-L3、异常凝血酶原(DCP)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、TBIL、PT、Child-Pugh分级均较对照组降低且白蛋白(ALB)较对照组升高,观察组KPS较对照组降低延缓,ZPS较对照组升高较慢;观察组较之对照组的临床疗效及生存率较高。结论解毒化瘀退黄方能抑制乙肝相关CNLCⅣ期湿热瘀阻证患者的肿瘤增长,降低中医证候积分、TNF-α、IL-1β、IL-6、AFP、AFP-L3、DCP、ALT、AST、TBIL、PT、Child-Pugh分级评分水平,改善肝功能,延缓体力及功能状态的恶化,明显提高乙肝相关CNLCⅣ期湿热瘀阻证患者的临床疗效及带瘤生存质量。

Objective To observe the clinical efficacy and safety of Jiedu Huayu Tuihuang Prescription in patients with dampness-heat stasis syndrome at CNLCⅣstage related HBV.Methods From January 2021 to June 2022,72 patients with dampness-heat stasis syndrome at the CNLCⅣstage related HBV were diagnosed at the Hepatology Department of our hospital.The patients were randomly divided into a control group and a Prescription group,each consisting of 36 cases.The control group was treated with western medicine,and the Prescription group received western medicine and Jiedu Huayu Tuihuang Prescription orally.The courses of treatment in the two groups were 12 weeks,with a 24-week follow-up.Before treatment and at 4 and 12 weeks after treatment,we compared several aspects in the two groups.These aspects included tumor size,tumor number,TCM syndrome score,cytokine levels,tumor markers,biochemical indices,Child-Pugh grading score,physical and functional status score,and survival rate of patients.Results After 4 weeks of treatment,the tumor size of the Prescription group increased slowly compared to the control group.Furthermore,the clinical syndrome score,IL-1β,IL-6,AFP,AFP-L3,TBIL,PT and Child-Pugh grades of the Prescription group decreased,and ALB increased compared to the control group.The KPS also decreased and delayed in the Prescription group.After 12 weeks of treatment,in the Prescription group,the size and number of tumors increased slowly compared with the control group.The clinical syndrome score,TNF-α,IL-1β,IL-6,AFP,AFP-L3,DCP,ALT,AST,TBIL,PT and Child-Pugh grades in the Prescription group were lower than those in the control group,and ALB was higher than that in the control group.KPS in the Prescription group was lower than that in the control group.ZPS increased slowly compared with the control group.The clinical efficacy and survival rate of the prescription group were higher than that of control group.Conclusion Jiedu Huayu Tuihuang Prescription can inhibit tumor growth on patients with dampness-heat stasis syndrome at CNLCⅣstage related HBV.It also reduces TCM syndrome scores and levels of TNF-α,IL-1β,IL-6,AFP,AFP-L3,DCP,ALT,AST,TBIL,PT and Child-Pugh grading,Liver function also improved.This treatment delays the deterioration of physical strength and functional status,significantly improving the clinical efficacy and life quality with tumor of patients with dampness-heat stasis syndrome at CNLCⅣstage related HBV.