Stewart Marlene, Morling Joanne R
Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD006687. doi: 10.1002/14651858.CD006687.pub3.
Many different drugs have been suggested for the symptomatic treatment of primary Raynaud's phenomenon. Apart from calcium channel blockers, which are considered the drugs of choice, the evidence of the effects of alternative pharmacological treatments is limited. This is an update of a review first published in 2008.
To assess the effects of various drugs with vasodilator actions on primary Raynaud's phenomenon.
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched 14 May 2012), CENTRAL (Issue 4, 2012) and clinical trials databases. We contacted one pharmaceutical company and one trial author for additional information. In addition, the reference lists of relevant studies were searched for additional citations. There were no language restrictions.
Randomised controlled trials evaluating the effects of oral formulations of any drug with vasodilator effects on subjective symptoms in primary Raynaud's phenomenon. Treatment with, or comparison with, calcium channel blockers was not assessed in this review.
Two members of the review team independently assessed the trials for inclusion and their quality and extracted the data. Data extraction included adverse events. We contacted trial authors for missing data.
Eight studies involving 290 participants were included. Two trials examined the effects of captopril, the rest were single trials on single drugs. All comparisons were with placebo. The methodological quality of most trials was poor.Enalapril was associated with a small increase in the frequency of attacks per week (difference in means 0.8; 95% CI 0.43 to 1.17). The difference between the intervention groups on a subjective improvement score was non-significant. There was a significant effect of buflomedil on the frequency of attacks per week (weighted mean difference (WMD) -8.8; 95% CI -17.55 to -0.09), but there was no evidence of effect on the severity score. The proportion with fewer attacks was significantly higher on moxisylyte than on placebo (relative risk (RR) 4.33; 95% CI 1.36 to 13.81). For captopril, beraprost, dazoxiben and ketanserin there was no evidence of an effect on the frequency, severity or duration of attacks. Beraprost and moxisylyte gave significantly more adverse effects than placebo.
AUTHORS' CONCLUSIONS: Poor methodological quality, small sample sizes and the limited data available resulted in low precision of the statistical results and limited value of the overall results .The overall results show that there is no evidence for an effect of vasodilator drugs on primary Raynaud's phenomenon.
许多不同药物已被推荐用于原发性雷诺现象的对症治疗。除了被视为首选药物的钙通道阻滞剂外，其他药物治疗效果的证据有限。这是对2008年首次发表的一篇综述的更新。
评估各种具有血管舒张作用的药物对原发性雷诺现象的影响。
对于本次更新，Cochrane外周血管疾病组试验搜索协调员检索了专业注册库（最后检索时间为2012年5月14日）、CENTRAL（2012年第4期）和临床试验数据库。我们联系了一家制药公司和一位试验作者以获取更多信息。此外，还检索了相关研究的参考文献列表以获取更多引用文献。无语言限制。
评估任何具有血管舒张作用的药物口服制剂对原发性雷诺现象主观症状影响的随机对照试验。本综述未评估与钙通道阻滞剂的治疗或比较。
综述团队的两名成员独立评估试验是否纳入及其质量，并提取数据。数据提取包括不良事件。我们联系试验作者获取缺失数据。
纳入了八项研究，共290名参与者。两项试验研究了卡托普利的效果，其余为针对单一药物的单项试验。所有比较均与安慰剂进行。大多数试验的方法学质量较差。依那普利与每周发作频率的小幅增加相关（均值差异为0.8；95%置信区间为0.43至1.17）。干预组在主观改善评分上的差异无统计学意义。丁咯地尔对每周发作频率有显著影响（加权均值差异（WMD）为-8.8；95%置信区间为-17.55至-0.09），但对严重程度评分无影响证据。莫西赛利治疗后发作次数减少的比例显著高于安慰剂组（相对危险度（RR）为4.33；95%置信区间为1.36至13.81）。对于卡托普利、贝前列素、达唑氧苯和酮色林，没有证据表明对发作频率、严重程度或持续时间有影响。贝前列素和莫西赛利的不良反应明显多于安慰剂。
方法学质量差、样本量小以及可用数据有限导致统计结果的精确度低，整体结果价值有限。总体结果表明，没有证据表明血管舒张药物对原发性雷诺现象有影响。
