摘要
目的了解大剂量缬沙坦治疗慢性肾病(CKD)的安全性和患者的耐受性。方法选择CKD患者18例,进行8周开放性研究,入选患者均给予缬沙坦口服,起始剂量为160 mg.d-1,2周后增加到320 mg.d-1,治疗开始4周后增加到640 mg.d-1,并以640 mg.d-1维持治疗4周。监测患者血压、血清肌酐和血钾,评价高剂量缬沙坦治疗CKD的安全性和患者耐受性。结果未见大剂量缬沙坦治疗CKD引起的严重药物不良反应,患者对缬沙坦的耐受性良好。试验期间,患者平均血清肌酐浓度在基础水平[(2.1±0.3)mg.dL-1]附近波动,最高值与最低值与基础水平相比,均差异无显著性(均P>0.05),患者平均血钾浓度[(5.0±0.6)mmol.L-1]与基础水平[(4.9±0.5)mmol.L-1]相近(均P>0.05)。结论高剂量缬沙坦治疗CKD安全,患者耐受性好,可同时降低血压和减少尿蛋白。
Objective To study the safeness and tolerability of high - dose valsartan （ higher than that currently approved by the Food and Drug Administration） in the treatment of chronic kidney disease （CKD）. Methods Eighteen patients with a history of diabetic or non-diabetic CKD were enrolled in an 8-week open - label trial. The patients received valsartan（ an angiotensin- receptor blocker） treatment with an initial dose of 160 mg·d^-1 PO. 2 weeks and 4 weeks later,the daily dose of the drug was increased to 320 mg and 640 rag, respectively. Treatment with the daily dose of 640 nag of the drug, which was 4 times higher than the currently approved maximum dose, lasted the subsequent 4 weeks. The safeness and tolerability of the high-dose drug was appraised by monitoring the blood pressure, serum creatinine and potassium levels of the patients. Results High-dose valsartan was well tolerated by the patients. No serious drug-related adverse reactions were encountered. The average serum creatinine concentration throughout the study fluctuated near the baseline level [ （ 2. 1 ± 0.3 ） mg·d^-1 ]. The differences between the baseline level and the maximum as well as the minimum serum creatinine concentrations were not significant（ P〉0.05, P〉0.05 ）. The average serum potassium concentration [ （5.0 ＋ 0.6 ） mmol·L^-1 ] during the 640 mg daily dose period was similar to that of the baseline level [ （4.9 ± 0.5 ） mmol·L^-1 ] （P〉0.05 ）. Conclusion Supramaximai doses of valsartan was shown to be safe and well tolerated in the treatment of patients with CKD, resulting in lowerinz of blood vressure and reduction of proteinuria.
出处
《医药导报》
CAS
2006年第8期785-787,共3页
Herald of Medicine
关键词
缬沙坦
血管紧张肽受体阻滞药
肾病
慢性
Valsartan
Angiotensin - receptor blockers
Chronic kidney disease
