首页|五灵胶囊治疗肝郁脾虚兼血瘀型乙型肝炎肝纤维化的疗效

五灵胶囊治疗肝郁脾虚兼血瘀型乙型肝炎肝纤维化的疗效

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目的 探讨五灵胶囊治疗肝郁脾虚兼血瘀型乙型肝炎肝纤维化的疗效及安全性。方法 将2020年5月—2022年5月就诊于西安市第八医院且符合纳入标准及排除标准的90例患者作为研究对象。将患者随机分为3组。A组单用核苷酸类似物[恩替卡韦胶囊或(和)富马酸替诺福韦二吡呋酯片]治疗。B组单用五灵胶囊治疗。C组用五灵胶囊联合核苷酸类似物治疗。观察指标包括中医证候积分,肝硬度值(liver stiffness measurement,LSM),FIB-4指数(fibrosis 4 score,FIB-4)值,肝纤维化指标透明质酸(hyaluronic acid,HA),Ⅲ型前胶原(type Ⅲ procollagen,PCⅢ),Ⅳ型胶原(Collagen Ⅳ,Ⅳ-C),层黏连蛋白(laminin,LN),肝功能指标[丙氨酸氨基转移酶(alanine transaminase,ALT),天冬氨酸氨基转移酶(aspartate transaminase,AST)、总胆红素(total bilirubin,TBiL)、碱性磷酸酶(alkaline phosphatase,ALP)、谷氨酰转肽酶(glutamyl transpeptidase,GGT)],HBV DNA,腹部B超,血、尿、粪常规,心电图等。比较各组患者治疗前后症状及相关指标的变化,并评价治疗的安全性。结果 治疗24周后,C组患者的中医证候积分由(19。25±6。12)分降至(7。12±2。32)分,LSM由(13。2±2。48)kPa降至(5。24±3。14)kPa,FIB-4 值由(2。67±0。94)降至(1。72±0。84),显著优于A组和B组(P<0。05)。HA由(126。42±64。28)ng·mL-1 降至(66。72±21。26)ng·mL-1,PCⅢ由(25。42±10。67)ng·mL-1 降至(12。39±5。62)ng·mL-1,Ⅳ-C由(109。78±30。42)ng·mL-1 降至(65。70±16。26)ng·mL-1,LN由(118。72±30。34)ng·mL-1 降至(71。12±10。42)ng·mL-1,以上指标改善情况显著优于A组和B组(P<0。05);3组患者的肝功能均明显改善,C组患者的血清ALT由(86。13±16。72)U·L-1 降至(36。68±14。25)U·L-1,AST由(49。65±9。85)U·L-1 降至(31。34±8。45)U·L-1,ALP由(104。69±13。28)U·L-1 降至(62。53±9。56)U·L-1,改善情况显著优于A组和B组(P<0。05)。C组及A组患者的HBV DNA较治疗前均明显下降,2组间比较差异无统计学意义(P>0。05),但均显著优于B组(P<0。05)。C组患者的门静脉内径由(13。21±1。11)mm降至(10。85±0。68)mm,脾静脉内径由(8。42±1。36)mm降至(5。86±0。62)mm,脾脏长度由(126。45±3。26)mm降至(114。21±4。15)mm,脾脏厚度由(45。13±2。19)mm降至(38。24±1。46)mm。C组患者的改善情况显著优于A组和B组(P<0。05)。结论 对于中医辨证为肝郁脾虚兼血瘀的乙型肝炎肝纤维化患者,用五灵胶囊联合核苷类似物治疗,可以提高临床疗效,改善临床症状,降低中医证候积分,降低肝纤维化相关指标,逆转肝纤维化,且临床应用安全,无患者出现与研究有关的肾功能、血常规、尿常规及心电图异常,仅个别患者出现轻度不良反应,无需特别处理即缓解。
Efficacy of Wuling Capsules on liver fibrosis with liver depression,spleen defiency and blood stasis type B hepatitis
Objective To explore the efficacy and safety of Wuling Capsules in treating liver fibrosis of hepatitis B with liver depression,spleen deficiency,and blood stasis type.Methods The patients who were admitted to Xi'an Eighth Hospital during May 2020 and May 2022 and met the inclusion and exclusion criteria were screened,and they signed the informed consent form.90 patients were randomized into 3 groups with different intervention regimens.Group A was treated with nucleotide analogues alone,including Entecavir Capsules or/and Tenofovir Disoproxil Fumarate Tablets,taken as required.Group B was treated with Wuling Capsules,5 capsules at a time,3 times a day,half an hour after meals.Group C was treated with Wuling Capsules combined with nucleotide analogues.The indexes were compared among groups,including traditional Chinese medicine(TCM)syndrome score,liver stiffness measurement(LSM),fibrosis 4 score(FIB-4),hyaluronic acid(HA),type Ⅲ procollagen(PCⅢ)and type Ⅳ Collagen(Ⅳ-C),liver function,alanine transaminase(ALT),aspartate transaminase bilirubin(TBiL),alkaline phosphatase(ALP),glutamyl transpeptidase(GGT),HBV DNA,and the images of ultrasound and electrocardiogram,etc..The changes of symptoms and related outcomes before and after treatment in each group were compared,and the safety was evaluated under the requirement of the Internal Ethics Committee of Xi'an Eighth Hospital.Results After 24 weeks of treatment,the TCM syndrome score of group C patients decreased from(19.25±6.12)points to(7.12±2.32)points,the LSM decreased from(13.2±2.48)kPa to(5.24±3.14)kPa,and the FIB-4 value decreased from(2.67±0.94)to(1.72±0.84),significantly better than group A and group B(P<0.05).The HA decreased from(126.42±64.28)ng·mL-1 to(66.72±21.26)ng·mL-1,PC Ⅲ decreased from(25.42±10.67)ng·mL-1 to(12.39±5.62)ng·mL-1,Ⅳ-C decreased from(109.78±30.4)ng·mL-1 to(65.70±16.26)ng·mL-1,LN decreased from(118.72±30.34)ng·mL-1 to(71.12±10.42)ng·mL-1,and the improvement was significantly better than that of Group A and Group B(P<0.05).The liver function of all 3 groups of patients improved significantly.The serum ALT of group C decreased from(86.13±16.72)U·L-1 to(36.68±14.25)U·L-1,AST decreased from(49.65±9.85)U·L-1 to(31.34±8.45)U·L-1,and ALP decreased from(104.69±13.28)U·L-1 to(62.53±9.56)U·L-1,with significant improvement compared with group A and group B(P<0.05).The HBV DNA of patients in Group C and Group A decreased significantly compared with before treatment,with no statistically significant difference between the 2 groups(P>0.05),but the both groups were significantly better than Group B(P<0.05).The inner diameter of the portal vein in Group C decreased from(13.21±1.11)mm to(10.85±0.68)mm,the inner diameter of the splenic vein decreased from(8.42±1.36)mm to(5.86±0.62)mm,the length of the spleen decreased from(126.45±3.26)mm to(114.21±4.15)mm,and the thickness of the spleen decreased from(45.13±2.19)mm to(38.24±1.46)mm.Conclusion For patients with hepatitis B liver fibrosis,Wuling Capsules with nucleoside analogues therapy can improve the clinical efficacy,improve the clinical symptoms,and reduce the TCM syndrome score.Wuling Capsules can reverse hepatic fibrosis by reducing the related indexes of hepatic fibrosis with high safety.

Wuling Capsuleshepatitis Bchronicliver fibrosisliver function

杨明博、杨璞叶、阚洪敏、郭雅玲、任艳叶

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西安市第八医院中医肝病科,西安 710061

五灵胶囊 乙型病毒性肝炎 慢性 肝纤维化 肝功能

西安市"科技+"行动计划-(17)医学研究项目陕西省重点研发计划项目陕西省卫健委健康科研基金项目

20YXYJ0001252021SF-4122021D005

2024

西北药学杂志
西安交通大学,陕西省药学会

西北药学杂志

CSTPCD
影响因子:0.912
ISSN:1004-2407
年,卷(期):2024.39(5)