祛湿化瘀方治疗湿热蕴结型非酒精性脂肪肝临床疗效

Clinical Efficacy of Qushi Huayu Granules in Treating Non-alcoholic Fatty Liver Disease(NAFLD)with Dampness-heat Accumulation

目的:观察祛湿化瘀方治疗湿热蕴结型非酒精性脂肪肝(NAFLD)的临床疗效。方法:将来源于2018年7月至2020年5月之间在上海中医药大学附属岳阳中西医结合医院门诊及住院的符合湿热蕴结型NAFLD中西医诊断标准及纳入标准的60例患者按随机、对照、双盲、双模拟方式分为观察组和对照组。观察组予以祛湿化瘀方颗粒剂联合当飞利肝宁胶囊模拟剂,对照组予以祛湿化瘀方颗粒模拟剂联合当飞利肝宁胶囊。两组服药疗程均为24周,观察患者中医证候积分、肝脏影像学[Fibroscan受控衰减参数(CAP)值、上腹部计算机断层扫描(CT)肝/脾比值]、肝脏血清酶学[丙氨酸氨基转移酶(ALT)、γ-谷氨酰转移酶(γ-GT)]及其他相关安全性指标情况。结果:(1)观察组中医证候总有效率为89.29%(25/28),对照组为48.15%(13/27),观察组优于对照组(Z=-3.582,P<0.01)。与本组治疗前比较,两组患者主证、次证总积分均较治疗前明显改善(P<0.05),与对照组治疗后比较,观察组在主证及次证总积分、右胁肋部胀痛积分、脘腹胀满或疼痛积分、大便黏腻不爽积分、小便色黄积分的改善上明显优于对照组(P<0.05)。(2)观察组肝脏Fibroscan CAP值有效率为75.00%(21/28),对照组为48.15%(13/27),与对照组治疗后比较,观察组疗效更明显(Z=-1.968,P<0.05)。(3)观察组肝脏血清酶学有效率75.00%(21/28),较对照组44.44%(12/27)改善明显(Z=-2.018,P<0.05),与本组治疗前比较,治疗后两组患者血清ALT、γ-GT值均明显降低(P<0.05,P<0.01),与对照组治疗后比较,观察组改善更明显(P<0.05)。(4)两组肝脏CT疗效有效率分别为67.86%(19/28)、30.77%(8/26),观察组疗效更明显(Z=-2.507,P<0.05)。结论:祛湿化瘀方用于湿热蕴结型NAFLD患者的临床治疗,安全有效,提高了中医药在论治NAFLD方面的循证依据等级,值得深入临床研究及推广应用。在中医证候、肝脏酶学(ALT、γ-GT)、肝脏影像学(Fibroscan CAP值、上腹部CT肝/脾比值)方面的改善上,祛湿化瘀方相较于当飞利肝宁胶囊更具优势。

Objective To observe the clinical efficacy of Qushi Huayu granules in treating non-alcoholic fatty liver disease(NAFLD)with dampness-heat accumulation.Method Sixty NAFLD patients with the syndrome of dampness-heat accumulation treated in the outpatient and inpatient departments of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from July 2018 to May 2020 were selected according to the diagnostic criteria and inclusion criteria of both traditional Chinese medicine(TCM)and Western medicine.The patients were assigned into a control group and an observation group by a random,controlled,double-blind,and double simulated method.The observation group was treated with Qushi Huayu granules combined with the mimetic agent of Dangfei Liganning capsules,and the control group was treated with Dangfei Liganning capsules combined with the mimetic agent of Qushi Huayu granules.The treatment course of both groups was 24 weeks.The TCM symptom scores,liver imaging parameters[controlled attenuation parameter(CAP)in Fibroscan and liver-to-spleen ratio in upper abdominal computerized tomography(CT)],serum levels of alanine aminotransferase(ALT)andγ-glutamyl transpeptidase(γ-GT),and safety indicators of the two groups were measured.Result①The total response rate in terms of TCM symptoms in the observation group was 89.29%(25/28),which was higher than that(48.15%,13/27)in the control group(Z=-3.582,P<0.01).The total score of the primary and secondary symptoms in both groups of patients declined after treatment(P<0.05),and the observation group outperformed the control group in decreasing the total score of the main and secondary symptoms as well as the scores of right rib swelling pain,abdominal fullness and distension or pain,sticky stool,and yellow urine(P<0.05).②The response rate in terms of Fibroscan CAP of the liver in the observation group was 75.00%(21/28),which was higher than that(48.15%,13/27)in the control group(Z=-1.968,P<0.05).③The response rate in terms of the serum enzyme levels in the observation group was 75.00%(21/28),which was higher than that(44.44%,12/27)in the control group(Z=-2.018,P<0.05).The serum levels of ALT andγ-GT in the two groups declined after treatment(P<0.05,P<0.01)and were lower in the observation group than in the control group(P<0.05,P<0.01).④The response rate in terms of liver CT in the observation group was 67.86%(19/28),which was higher than that(30.77%,8/26)in the control group(Z=-2.507,P<0.05).Conclusion Qushi Huayu granules were safe and effective in the clinical treatment of NAFLD patients with the syndrome of dampness-heat accumulation,which improved the evidence in TCM treatment of NAFLD and was worthy of in-depth clinical research and promotion.Qushi Huayu granules outperformed Dangfei Liganning capsules in terms of TCM symptoms,serum levels of ALT andγ-GT,and liver imaging parameters.