摘要
目的评价调肝理脾方治疗非酒精性脂肪性肝病(non-alcoholic fatty liver disease,NAFLD)肝郁脾虚证的临床疗效和安全性。方法将99例肝郁脾虚证NAFLD患者按随机数字表法分为治疗组66例和对照组33例,分别给予调肝理脾方及安慰剂治疗,每日1剂,疗程均为12周。两组在药物治疗同时均予以生活方式干预(包括中度有氧运动、中等程度的热量限制、改变饮食组分)。观察两组患者治疗前后的临床症状、CT指标、肝功能及血脂情况。结果与本组治疗前比较,治疗后两组症状总积分降低(P<0.01),且治疗组低于对照组(P<0.05);治疗后治疗组肝脾CT比值升高(P<0.01),治疗组高于对照组(P<0.01);治疗后治疗组谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(GGT)均降低(P<0.05,P<0.01),对照组ALT降低(P<0.05),且治疗组ALT、AST、GGT均低于对照组(P<0.05);两组治疗后总胆固醇(TC)、甘油三酯(TG)均降低(P<0.05),且治疗组低于对照组(P<0.05)。组间疗效比较,治疗组中医证候总有效率为79.69%(51/64),腹部CT总有效率为54.69%(35/64),肝功能总有效率为67.65%(23/34),血脂总有效率为67.39%(31/46);对照组中医证候总有效率为56.25%(18/32),腹部CT总有效率为25.00%(8/32),肝功能总有效率为33.33%(6/18),血脂总有效率为55.56%(10/18);两组疗效比较,治疗组均优于对照组(P<0.05,P<0.01)。结论调肝理脾方配合生活方式干预治疗NAFLD肝郁脾虚证,能够安全、有效地改善患者临床症状,提高肝脾CT比值,并起到保肝抗炎和降脂的作用。
Objective To evaluate the efficacy and safety of Tiaogan Lipi Recipe （TLR） in trea- ting non-alcoholic fatty liver disease （NAFLD） patients of Gan stagnation Pi deficiency syndrome （GSP- DS）. Methods A randomized, double blind, placebo-controlled clinical trial was performed. Totally 99 NAFLD patients of GSPDS were randomly allocated into two groups, 66 patients in the treatment group （treated with TLR, one dose per day） and 33 patients in the control group （treated with placebos, one dose per day）. The therapeutic course for all was 12 weeks. All patients received lifestyle interventions including moderate aerobic exercise, moderate caloric restriction, and dietary changes. Clinical symp- toms, CT indices, liver functions and blood lipids were observed before and after treatment. Results Af- ter 12 weeks of treatment, the total score of clinical symptoms decreased in the two groups （P 〈0.01）, and it was lower in the treatment group than in the control group （P 〈0.05）. Liver/spleen CT ratio in- creased in the treatment group （P 〈0.01 ）, and it was higher in the treatment group than in the controlgroup （P 〈0.01 ）. After treatment levels of alanine aminotransferase （ALT）, aspartate aminotransferase CAST）, gamma-glutamyl transferase （GG＇I） all decreased in the treatment group （P 〈0.05, P 〈0.01 ）, while levels of ALT decreased in the control group （P 〈0.05）. Besides, all the 3 levels mentioned above were lower in the treatment group than in the control group （P 〈0.05）. Levels of total cholesterol （CHO） and triglyceride （TG） decreased in the two groups （P 〈0.05）, and they were lower in the treatment group （P 〈0.05）. Total effective rates of TCM syndrome, abdominal CT, liver functions, and blood lipids were 79.69% （51/64 cases）, 54.69% （35/64 cases）, 67.65% （23/34 cases）, and 67.39% （31/46 ca- ses） in the treatment group, while they were 56.25% （18/32 cases）, 25.00% （8/32 cases）, 33.33% （6/18 cases）, and 55.56% （10/18 cases） in the control group. All were superior in the treatment group （P 〈 0.05, P 〈 0.01, respectively）. Conclusion TLR combined with lifestyle intervention could safely and effectively improve clinical symptoms of NAFLD patients of GSPDS, elevate liver/spleen CT ratios, and play a role in liver protection, anti-inflammation, and lowering blood lipids.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2015年第4期401-405,共5页
Chinese Journal of Integrated Traditional and Western Medicine
基金
北京市中医药科技发展资金科技提升专项(No.KJTS2011_01)
北京市医院管理局重点医学专业发展计划项目(No.ZYLX201411)
关键词
非酒精性脂肪性肝病
调肝理脾方
肝郁脾虚
临床疗效
CT比值
non-alcoholic fatty liver disease
Tiaogan Lipi Recipe
Gan stagnation and Pi deficiency
clinical effect
CT ratio
