摘要
目的:探讨辛伐他汀在80岁以上的高龄老年人中应用的安全性及有效性。方法:65例随机分成三组:40 mg组25例,20 mg组20例,对照组20例。治疗组每晚服用辛伐他汀40mg或20mg,对照组不服用任何调脂药物。分别在治疗前、治疗后的第2、4、6周抽血查血脂、肝功能、肾功能、肌酶,并同时观察有无肌痛、肌无力、肌炎、肌溶解、头晕、恶心等临床症状。结果:治疗组随着用药时间延长,TC、LDL—C逐渐降低,20mg治疗组在第4周出现显著差异,TC下降幅度为20.5%,LDL-C下降幅度为24.6%。 40mg治疗组第2周即出现显著差异,TC下降幅度为16.7%。LDL-C下降幅度为28%。两组6周TC和LDL—C下降幅度分别为27.8%、30%和34.9%、37.2%。TG也有降低,但无显著差异(P>0.05)。HDL未见升高,相反也有轻度下降,但无统计学差异(P>0.05)。观察不良反应:20mg和40mg治疗组与对照组不适的发生率相似,均有头晕和胃部不适.ALT、AST、CK、Cr的改变无统计学差异(P>0.05)。结论:80岁高龄老年人对他汀类药物的耐受性良好,不良反应轻微.但对于胆石症病人应小心,若合并胆汁郁积应作为他汀类药物的禁忌;辛伐他汀40mg比20mg降低TC及LDL-C更显著。在密切检测肝肾功能、肌酶的情况下,有动脉粥样硬化指征的高龄老年人也应当尽早、适量地应用他汀类药物。
Objective: To investigate the safety and efficacy of simvastatin using in patients elder than 80 years old. Methods: 65 consecutive patients were divided into three groups randomly: Group one (n=25) were given with 40mg simvastatin per day at night, group two (n=20) were given with 20 mg simvastatin, group three (n=20) were given with placebo per day at night. Before treatment and the second, fourth and sixth week after the treatment respectively, lipid, liver function, kidney function and CK were checked by exsanguinations and the symptom of the myalgia, muscle disability, muscle inflammation, headache, and naupathia were observed by clinical examination. Results: The total cholesterol(TC) and low density lipoprotein cholesterol(LDL-C) of the patients of the treatment were lower than before during the period of their taking medicine. There were marked efficacy in the treatment of the group two with 20mg simvastatin in the forth week; there were 20.5% proportional reduction in the TC and 24.6% proportional reduction in the LDL-C.The marked efficacy of the 40mg simvastatin was taken in the second week.There were 16.7% proportional reduction in TC and 28% proportional reduction in LDL-C.The TC and LDL-C of both groups reduced 27.8%,30% and 34.9%, 37.2% in the sixth week respectively, the TG was also lower than before but no statistical discrepancy (P>0.05). The HDL did not increase, but reduced lightly in reverse, and there was no statistical discrepancy (R>0.05). Observed adverse reaction:The adverse reactions happened in simvastatin groups were same as contrast group,such as light in head and stomach indisposed. There were no statistical discrepancy among the ALT, AST,CK and Cr in each group.Conclusions:To reduce the TC and LDL-C,40mg simvastatin was more effective than 20mg simvastatin in the elder patients who were above 80 years old, the adverse reactions were slightly because of the similarity of adverse reactions both in simvastatin group and placebo group. Under the examination of the liver function, kidney function and CK instantly, the elder patient with atherosclerotic symptom should take the statins timely and appropriately.
出处
《中国医药导刊》
2004年第4期281-282,285,共3页
Chinese Journal of Medicinal Guide