预防桡动脉痉挛的前瞻性随机双盲研究

目的在使用维拉帕米的基础上,观察维拉帕米加量或联用硝酸甘油预防经桡动脉介入诊疗中桡动脉痉挛（rad ial artery spasm,RAS）的效果。方法前瞻性入选经桡动脉冠状动脉介入治疗的患者,按照随机、双盲原则将患者分为A组（维拉帕米200μg）、B组（维拉帕米1 mg）和C组（维拉帕米200μg＋硝酸甘油200μg）。在动脉鞘管置入后,随机给予不同药物。使用造影证实的临床RAS定义。记录并比较各组患者RAS和不良反应的发生率。结果共入选患者621例,其中A组205例、B组206例、C组210例。三组患者的基线资料比较,差异均无统计学意义。单因素方差分析显示,A组患者RAS发生率高于B组（17.1%比10.2%,P=0.045）和C组（17.1%比9.5%,P=0.029）,B组和C组间差异无统计学意义（10.2%比9.5%,P=0.870）。Logistic回归分析显示,B组和C组比A组发生RAS相对风险分别降低了32.1%（P=0.038）和43.8%（P=0.017）。不良反应A组和C组相似,均较少。B组不良反应发生率高于A组（9.7%比2.4%,P=0.003）和C组（9.7%比3.8%,P=0.019）。结论在经桡动脉介入诊疗中，推荐国人使用维拉帕米200μg＋硝酸甘油200μg预防RAS，该剂量安全、有效，且不良反应较少。

Prospective, randomized and double-blind study on prevention of radial artery spasm

Objective To compare the effect of different dosage of verapamil and a cocktail therapy（verapamil 200 μg plus nitroglycerin 200 μg） in the prevention of radial artery spasm（RAS） during transradial PCI.Methods It is a prospective,randomized and double-blind clinical trial.Patients who received transradial coronary intervention were divided into three groups： group A（verapamil 200 μg）,group B（verapamil 1mg） and group C（verapamil 200 μg plus nitroglycerin 200 μg）.Different drug protocols were given randomly to the patients after sheath insertion. The diagnostic criteria is clinical definition of RAS documented by angiography. The incidence of RAS and adverse effects in each group was compared. Results A total of 621 patients were enrolled, and there were 205 in group A, 207 in group B and 210 in group C. The baseline characteristics were of no difference among the three groups. Univariate analysis showed that the incidence of RAS in group A is higher than that in group B （ 17. 1% vs. 10. 2% ,P =0. 045） and in group C （17. 1% vs. 9. 5% ,P =0. 029）, but there was no statistical difference in the RAS incidence between group B and C （10. 2% vs. 9. 5% , P = 0. 870）. Binary logistic regression analysis showed that the relative risk of RAS in group B decreased by 32. 1% compared with group A （ P = 0. 038 ） , and the relative risk in group C decreased by 43.8% compared with group A （P=0. 017）. The incidences of adverse effect were similar in groups A and C, but was higher in group B when compared with group A （9.7% vs. 2.4% , P = 0. 003 ） and C （ 9. 7% vs. 3.8% , P = 0. 019 ）, respectively. Conclusion Verapamil 200 μg plus nitroglycerin 200 μg is recommended to prevent RAS during transradial coronary intervention in Chinese.