化痰柔肝方联合瑞舒伐他汀治疗非酒精性脂肪性肝炎的研究

发布时间：2019-04-10 21:15

【摘要】：目的:观察化痰柔肝方联合瑞舒伐他汀钙片联合治疗非酒精性脂肪性肝炎的临床效果和不良反应,客观、综合评价该治疗方法的有效性及安全性,为临床提供一种有证可循且具确切疗效的治疗方法。方法:将2015年05月1日至2016年06月30日我院门诊及住院收治的、符合纳入标准的、确诊NASH并使用化痰柔肝方、瑞舒伐他汀钙片治疗的80例病人,按就诊顺序编号并按随机数字表随机分2组,治疗组及对照组各40例。两组均配合运动及饮食疗法;对照组给予口服瑞舒伐他汀钙片,5mg/次,每日1次,温水吞服;治疗组在对照组的基础上加口服化痰柔肝方,1袋/次,每日3次,温水吞服。两组均治疗12周。于初诊首日及治疗结束后各观察记录一次肝功能(谷丙转氨酶ALT、谷草转氨酶AST、谷氨酰转肽酶GGT)、血脂(总胆固醇TC、甘油三酯TG)、肝脏超声、体重指数、中医证候、不良反应等。将收集到的数据通过SPSS21.0统计软件进行统计学分析。结果:(1)治疗组总有效率90.00%,对照组总有效率为72.50%,两组对比存在统计学意义差异(P=0.0140.05),表明在治疗非酒精性脂肪性肝炎疗效上,化痰柔肝方联合瑞舒伐他汀钙片治疗组优于瑞舒伐他汀钙片对照组。(2)在肝功能改善情况方面,两组治疗后ALT、AST、GGT均明显下降,经对比,两组的差异存在统计学意义(P0.05),表明治疗组更能改善非酒精性脂肪性肝炎患者的肝功能。(3)在血脂改善情况方面,两组治疗后TC、TG均有所下降,但治疗组优于对照组(P0.05),说明治疗组对降低非酒精性脂肪性肝炎患者的血脂水平更有效。(4)在肝脏超声改善情况方面,两组治疗后超声下脂肪肝的表现均有所减轻,以治疗组更为明显(P0.01),因此,化痰柔肝方联合瑞舒伐他汀钙片对于改善NASH的肝脏超声表现具有良好的效果。(5)体重指数下降情况方面,两组均能降低体重指数,但治疗组治疗结束后能使患者体重指数平均下降0.5个指数以上,显示出良好的效果。(6)中医证候改善情况方面,针对中医痰湿内阻型的相关证候,将其分为四大主症、三大次症以及舌脉,治疗结束后,两组均出现证候消失的病例,其中治疗组明显多于对照组(P0.05),同时治疗组无论主症、次症或舌脉均有大幅度的改善,总疗效高达95.00%,说明治疗组能明显改善证候,甚至治愈中医相关证候。(7)在安全性方面,整个治疗过程中治疗组出现1例不良反应,对照组出现3例不良反应,两药均安全可靠。结论:(1)化痰柔肝方是治疗非酒精性脂肪性肝炎的有效药物,该药治疗组临床总有效率90%,明显优于瑞伐他汀钙片对照组。(2)化痰柔肝方具有较好的改善肝功能、降低血脂水平、减轻超声脂肪肝表现、降低体重指数等方面的作用。(3)化痰柔肝方能很好的改善体态肥胖、周身困重、右胁胀闷、食少纳呆、倦怠无力、头晕恶心、腹胀便溏等中医痰湿内阻证相关症状。(4)在治疗过程中治疗组仅出现1例较轻微的不良反应,说明本药安全可靠。
[Abstract]:Objective: to observe the clinical effect and adverse reaction of Huatanluogan recipe combined with Ruishuvastatin calcium tablet in the treatment of non-alcoholic steatohepatitis, and to evaluate the efficacy and safety of this method. To provide a clinical treatment that can be documented and has a definite curative effect. Methods: from May 1, 2015 to June 30, 2016, 80 patients with NASH were diagnosed and treated with Risuvastatin calcium tablet. The patients were randomly divided into two groups: treatment group (n = 40) and control group (n = 40). The two groups were treated with exercise and diet therapy, the control group was given Rishuvastatin calcium tablets, 5mg/ once a day, and warm water swallowing, while the treatment group was treated with Huatanluogan decoction on the basis of the control group, one bag per day, three times a day, and warm water swallowing. Both groups were treated for 12 weeks. On the first day of diagnosis and after treatment, the liver function (alanine aminotransferase ALT, aspartate aminotransferase AST, glutamyl transpeptidase GGT), lipid (total cholesterol TC, triglyceride TG), liver ultrasound, body mass index, TCM syndrome) was observed and recorded. Adverse reactions, etc. The collected data were analyzed by SPSS21.0 statistical software. Results: (1) the total effective rate of the treatment group was 90.00%, that of the control group was 72.50%, there was significant difference between the two groups (P < 0.0140.05), which indicated that the therapeutic effect of non-alcoholic steatohepatitis was better than that of the control group. (2) in the improvement of liver function, the ALT,AST,GGT of the two groups decreased significantly after treatment, and compared with that of the control group, and the treatment group of Huatanruogan decoction combined with Ruishuvastatin calcium tablet was better than the control group. (2) in the improvement of liver function, both groups decreased significantly after treatment. The difference between the two groups was statistically significant (P0.05), indicating that the treatment group could improve the liver function of the patients with non-alcoholic steatohepatitis. (3) in the improvement of blood lipid, the TC,TG of the two groups decreased after treatment. However, the treatment group was better than the control group (P0.05), indicating that the treatment group was more effective in reducing the level of blood lipid in patients with non-alcoholic steatohepatitis. (4) in the improvement of liver ultrasound, After treatment, the performance of fatty liver was alleviated in both groups, especially in the treatment group (P0.01). Huatanluogan recipe combined with Risuvastatin calcium tablet has a good effect on improving the ultrasonic performance of liver in NASH. (5) in the aspect of body mass index decrease, both groups can reduce body mass index. But the treatment group can reduce the average body mass index more than 0.5 indexes after treatment, showing a good effect. (6) in the improvement of TCM syndrome, according to the related syndrome of phlegm-dampness internal obstruction in TCM, it can be divided into four main symptoms. After treatment, the syndrome disappeared in both groups, and the treatment group was significantly more than the control group (P0.05). At the same time, no matter the main symptoms, secondary symptoms or tongue veins in the treatment group, there was a significant improvement in the treatment group, both in the treatment group and in the control group (P0.05). The total curative effect was as high as 95.0%, indicating that the treatment group could significantly improve the syndrome and even cure the TCM-related syndrome. (7) in the safety aspect, 1 case of adverse reaction appeared in the treatment group and 3 cases of adverse reaction in the control group. Both drugs are safe and reliable. Conclusion: (1) Huatan Ruogan recipe is an effective drug for the treatment of non-alcoholic steatohepatitis, the total clinical effective rate of the treatment group is 90%, which is obviously better than that of the control group. (2) Huatanluogan recipe has a good improvement on liver function. (3) Huatan soft liver recipe can improve body mass obesity, body mass loss, right flutter distension, lack of appetite, fatigue, dizziness, nausea, and so on. (3) Huatan soft liver recipe can improve body mass obesity, body mass loss, right flank distension, lack of appetite, tiredness, dizziness, nausea, and so on. The symptoms related to phlegm-dampness internal obstruction of traditional Chinese medicine such as loose stool and abdominal distension. (4) in the treatment group, only one case of mild adverse reaction occurred in the treatment group, which indicated that the drug was safe and reliable.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R575
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本文编号：2456135