的耐受性和有效性(S)氨氯地平与外消旋氨氯地平在高血压:系统回顾和荟萃分析。

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刘F,邱M,翟SD

的耐受性和有效性(S)氨氯地平与外消旋氨氯地平在高血压:系统回顾和荟萃分析。

咕咕叫Res中国Exp。2010年2月,71(1):1至29。doi: 10.1016 / j.curtheres.2010.02.005。

PubMed ID
24683248 (在PubMed
]
文摘

背景:氨氯地平是一种钙通道阻滞剂心绞痛和高血压的管理规定。外消旋混合物,氨氯地平(R) - (S)包含氨氯地平同分异构体,但只有(S)氨氯地平为活跃的一部分具有治疗活动。根据药理研究,它仍不确定如果(S)氨氯地平单独有相似的疗效和减少相关的不良事件(AEs)与外消旋混合物。目的:系统回顾和荟萃分析的目的是确定的有效性和耐受性(S)氨氯地平与外消旋氨氯地平。方法:进行系统的文献检索MEDLINE (1966 - 2009), EMBASE(1966 - 2009),科克伦中央登记的对照试验(问题3,2009),中国生物医学数据库(1978 - 2009)和中国国家知识网络(1980 - 2009)。相关的所有随机对照试验比较(S)氨氯地平2.5毫克和外消旋氨氯地平5.0 mg治疗高血压是包括在审查中。结果收集措施是心血管事件,收缩压(SBP)、舒张压(菲律宾)和AEs。质量评估使用修改后的Jadad量表进行临床试验,试验被认为是低质量(得分0 - 3)或高质量的(得分4 - 7)。包括研究的荟萃分析是使用RevMan软件执行。结果:229年引用识别,214被排除在外后筛选标题,摘要或全文。 Fifteen RCTs were included, of which 13 were in Chinese and 2 in English. Based on the Jadad Scale score, 3 of the RCTs were classified as high quality (score 5 or 6) and the remaining 12 as low quality (score 1-3). None of the trials evaluated cardiovascular events beyond 40 weeks. Meta-analysis of the 15 trials indicated that (S)-amlodipine was not significantly different from racemic amlodipine in the effect on BP. When only high-quality studies were included, after 4 weeks' treatment, the weighted mean difference (WMD) of SBP and DBP decrease (1 study) was -2.84 (95% CI, -6.42 to 0.74) with (S)-amlodipine and -1.71 (95% CI, -3.48 to 0.06) with racemic amlodipine. After 8 weeks' treatment, the WMD of SBP and DBP decrease (2 studies) was -1.13 (95% CI, -5.29 to 3.03) and -1.34 (95% CI, -2.67 to -0.01), respectively. The risk difference (RD) for the number of patients who experienced AEs with (S)-amlodipine and racemic amlodipine was found to be -0.04 (95% CI, -0.06 to -0.02). When all the trials were included, (S)-amlodipine treatment was associated with significantly less edema than racemic amlodipine (RD, -0.02; 95% CI, -0.03 to 0.00); however, when only high-quality studies (2 studies) were included, no difference was found between the 2 groups (RD, 0.01; 95% CI, -0.02 to 0.03). One high-quality study found significant differences in increases in aspartate and alanine aminotransferase activities in the 2 groups (RD, 0.08; 95% CI, 0.01 to 0.05). No significant differences between the 2 groups were found in the incidence of headache (RD, 0.00; 95% CI, -0.02 to 0.01) or flushing (RD, -0.01; 95% CI, -0.02 to 0.00). CONCLUSIONS: The majority of the clinical trials comparing (S)-amlodipine and racemic amlodipine treatment were low quality (12/15 [80%]). According to the limited evidence, there were no significant differences between (S)-amlodipine 2.5 mg and racemic amlodipine 5.0 mg in controlling BP. When all the trials were considered, (S)-amlodipine treatment was associated with significantly less edema than racemic amlodipine; however, when only high-quality trials were included, no significant difference was found. More long-term, high-quality RCTs with cardiovascular events as the primary outcome are needed to compare the safety and efficacy of (S)-amlodipine and racemic amlodipine.

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