摘要
目的:通过观察健脾通脉汤对于颈动脉斑块患者斑块及血脂的改善情况来验证其临床疗效。方法:采用前瞻性、随机、对照临床研究方法。收集60例颈动脉斑块患者,按随机数字表法分为治疗组和对照组各30例,对照组给予辛伐他汀20 mg每晚1次口服、拜阿司匹林100 mg每晚1次口服的西医治疗,治疗组给予健脾通脉汤口服治疗,疗程3个月。观察治疗前后受试者颈动脉斑块的Crouse积分、总斑块数、不稳定斑块数、总胆固醇(TC)、低密度脂蛋白(LDL)、甘油三酯(TG)及中医证候积分的变化情况,并将血肌酐(Scr)、肌酸激酶(CK)、谷丙转氨酶(ALT)及谷草转氨酶(AST)作为安全性指标一并观察。结果:60例患者全部完成临床研究,经过3个月的治疗,治疗组Crouse积分明显降低(P<0.05),且疗效优于对照组(P<0.05),治疗组中医疗效亦优于对照组(P<0.05),两组总斑块数、不稳定斑块数、甘油三酯(TG)的改变较治疗前均不具有统计学意义(P>0.05),两组低密度脂蛋白(LDL)、总胆固醇(TC)均较治疗前降低(P<0.05),但两组组间比较无统计学差异(P>0.05)。而在安全性指标方面,两组较治疗前均未见显著升高(P>0.05)。结论:健脾通脉汤能明显降低颈动脉斑块患者的Crouse积分并改善中医临床证候,且疗效优于西药对照组,而在降低低密度脂蛋白(LDL)及总胆固醇(TC)方面疗效与西药对照组相同,未见明显毒副作用,但对于总斑块数、不稳定斑块数及甘油三酯(TG)在3个月的治疗周期内未见明显改变。
Objective ： To verify the clinical efficacy of Jianpi Tongmai Decoction on the improvement of plaque and blood lipids in patients with carotid plaques. Methods ： The prospective, randomized and controlled clinical research method was adopted and 60 patients with carotid plaques were collected, who were then divided into treatment group and control group （ 30 cases in each group ） according to random number table method. Patients in control group were treated with Western medicine, and were given 20 mg of Simvastatin and 100 mg of Bay-aspirin once every night for oral administration while those in the treatment group were given an oral treatment of Jianpi Tongmai Decoction for 3 months. The changes of crouse score, total plaque number, unstable plaque number, total cholesterol （ TC ）, low- density lipoprotein （ LDL ）, triglyceride （ TG ） and TCM syndrome scores were observed before and after treatment. Meanwhile, the serum creatinine （ Scr ）, creatine kinase （ CK ）, alanine transaminase （ ALT ） and aspartate transaminase （ AST ） were also observed as safety indicators. Results ： All the 60 patients completed the clinical studies. After three months of treatment, the crouse score of the treatment group was significantly decreased （ P〈0.05 ）, with better curative effect than that of the control group （ P〈0.05 ）. The TCM efficacy in the treatment group was also better than that in the control group （ P〈0.05 ）. The changes of total plaque number, unstable plaque number and TG were not statistically significant compared with those before the treatment （ P〉0.05 ）. The levels of LDL and TC in the two groups were lower than those before treatment （ P〈0.05 ）, but there was no significant difference between the two groups （ P〉0.05 ）. As for the safety indicators, there was no significant increase in both groups after treatment （ P〉0.05 ）. Conclusion ： Jianpi Tongmai Decoction can significantly reduce the cronse score of patients with carotid plaques and improve the clinical TCM syndrome, with better effect than that in the control group. It has the same effect as the Western medicine in reducing LDL and TC, with no obvious side effects. There were no significant changes in the total number of plaques and unstable plaques and TG within the 3-month treatment cycle.
作者
田蔚然
孙怡春
朱立峰
TIAN Weiran;SUN Yichun;ZHU Lifeng(Tianshan Branch of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200051,China)
出处
《辽宁中医药大学学报》
CAS
2017年第6期62-66,共5页
Journal of Liaoning University of Traditional Chinese Medicine
基金
上海市卫计委中医药事业发展三年行动计划项目(ZY3-FWMS-2-1018)
上海市基层名老中医传承研究工作室建设项目(JCZYGZS-016)
上海市"治未病"预防保健服务体系建设项目(ZY3-FWMS-1-1001-KYSJ-25)
关键词
颈动脉斑块
中医药防治
健脾通脉汤
carotid plaque
prevention and treatment by traditional Chinese medicine
Jianpi Tongmai Decoction
