软坚散结法治疗痰瘀交结型高脂血症性脂肪肝的临床疗效观察

【目的】观察具有软坚散结作用的经验方心脉康片治疗痰瘀交结型高脂血症性脂肪肝的临床疗效及安全性。【方法】采用分层随机原则将64例痰瘀交结型高脂血症性脂肪肝患者随机分成试验组和对照组,每组各32例。2组患者均予禁酒以及对饮食、运动和生活规律进行指导的常规处理,在此基础上,对照组给予阿托伐他汀钙片治疗,试验组给予阿托伐他汀钙片联合心脉康片治疗,疗程为12周。观察2组患者治疗前后血脂总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]、肝功能指标谷丙转氨酶(ALT)/谷草转氨酶(AST)]和腹部B超评分的变化情况,并评价2组的中医证候疗效及安全性。【结果】(1)研究过程中,试验组和对照组分别有1例和2例患者退出,实际纳入研究试验组31例,对照组30例。(2)中医证候疗效方面,疗程结束后,试验组的总有效率为87.09%,对照组为73.33%,试验组的疗效明显优于对照组(P<0.05)。(3)血脂方面,治疗后,2组患者的TC、TG、LDL-C水平均较治疗前降低,HDL-C水平均治疗前升高(P<0.05),且试验组对TC、TG、LDL-C水平的降低作用和对HDL-C水平的升高作用均明显优于对照组(P<0.05)。(4)B超评分方面,治疗后,2组患者的B超评分均较治疗前明显降低(P<0.05),且试验组对B超评分的降低作用明显优于对照组(P<0.05)。(5)治疗后,2组患者的血清ALT、AST水平均较治疗前明显降低(P<0.05);但治疗后组间比较,差异均无统计学意义(P>0.05)。(6)观察过程中,2组患者的血常规、离子、肌酶、肾功能等均未见明显异常。【结论】心脉康片治疗痰瘀交结型高脂血症性脂肪肝,疗效确切且安全性高,初步证明软坚散结法是治疗痰瘀交结型高脂血症性脂肪肝的一种新思路和新方法。

Clinical Observation on Therapy of Softening Hardness and Dissipating Mass for Treatment of Hyperlipidemic Fatty Liver of Phlegm Blended with Blood Stasis Syndrome

Objective To observe the clinical efficacy and safety of Xinmai Kang Tablets,an experienced formula with the actions of softening hardness and dissipating mass,for the treatment of hyperlipidemic fatty liver of phlegm blended with blood stasis syndrome.Methods Sixty-four hyperlipidemic fatty liver patients with phlegm blended with blood stasis syndrome were divided into trial group(N=32)and control group(N=32)with the stratified random sampling method.The two groups were given routine treatment such as prohibition against alcoholic drinks and guidance for diet,exercises and daily life.Additionally,the control group was given oral use of Atorvastatin Calcium Tablets,and the trial group was given oral use of Xinmai Kang Tablets together with Atorvastatin Calcium Tablets.The observation period lasted 12 weeks.Before and after treatment,we detected the levels of blood lipid indicators of total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C)and high density lipoprotein cholesterol(HDL-C),the hepatic function indicators of alanine transaminase(ALT)and aspartate transaminase(AST),and abdominal type B ultrasonography scores.After treatment,the efficacy for traditional Chinese medicine(TCM)syndrome manifestations and the safety in the two groups were evaluated.Results(1)During the trial,one case from the trial group and 2 cases from the control group quitted the trial,and the final case number of trial group was 31 and that of the control group was 30.(2)At the end of the trial,the total effective rate for TCM syndrome in the trial group was 87.09%and that in the control group was 73.33%,the therapeutic efficacy of the trial group being superior to that of the control group(P<0.05).(3)After treatment,TC,TG and LDL-C levels were decreased and HDL-C level was increased in the two groups(P<0.05 compared with those before treatment).The trial group had stronger effect on decreasing TC,TG and LDL-C levels and on increasing HDL-C level than the control group(P<0.05).(4)Type B ultrasonography scores in the two groups after treatment were decreased(P<0.05 compared with those before treatment),and the decrease in the trial group was superior to that in the control group(P<0.05).(5)After treatment,the levels of ALT and AST in the two groups were obviously lowered(P<0.05 compared with those before treatment),but the differences between the two groups after treatment were insignificant(P>0.05).(6)During the trial,no abnormalities were found in the blood routine test,ions,enzymes,or renal function of the two groups.Conclusion Xinmai Kang Tablets are effective and safe for the treatment of hyperlipidemic fatty liver of phlegm blended with blood stasis syndrome,and the results indicate that therapy of softening hardness and dissipating mass would be a new method for the treatment of hyperlipidemic fatty liver of phlegm blended with blood stasis syndrome.