Wu Audrey H, Ballantyne Christie M, Short Beth C, Torre-Amione Guillermo, Young James B, Ventura Hector O, Eisen Howard J, Radovancevic Branislav, Rayburn Barry K, Lake Kathleen D, Yancy Clyde W, Taylor David O, Mehra Mandeep R, Kubo Spencer H, Fishbein Daniel P, Zhao Xue-Qiao, O'Brien Kevin D
Division of Cardiology, Department of Medicine, University of Washington, Seattle, Washington, USA.
Am J Cardiol. 2005 Feb 1;95(3):367-72. doi: 10.1016/j.amjcard.2004.09.035.
Although small, randomized trials have shown that statin use is associated with decreased risks of mortality and severe rejection, no study has examined statin therapy as used in actual practice in large numbers of heart transplant recipients. We analyzed data from the Heart Transplant Lipid Registry (n = 12 centers). Patients were included if they underwent transplantation between 1995 and 1999, survived >/=30 days after transplantation, and had >/=30 days of Registry follow-up. Multivariable Cox regression models, with propensity scoring performed to adjust for nonrandom allocation of statin therapy, were performed to determine the association of statin therapy with death and fatal rejection. The study included 1,186 patients, with a mean follow-up of 580 +/- 469 days; 937 patients (79%) received statin therapy. Overall, 71 patients (6%) died and 40 (3.4%) had fatal rejection. The statin group had a lower frequency of death (4% vs 13.7%, p <0.0001) and fatal rejection (2.4% vs 7.2%, p = 0.0001). Using multivariable Cox regression, with propensity scoring included to adjust for likelihood of receiving statin therapy, statin use was the only factor associated with lower risk of death (hazard ratio 0.29, 95% confidence interval 0.13 to 0.67) and fatal rejection (hazard ratio 0.27, 95% confidence interval 0.09 to 0.78). This study represents the largest population of heart transplant recipients analyzed for the relation between statin therapy and clinical outcomes in actual practice. Statin therapy was significantly associated with lower risk of death and fatal rejection, benefits that were independent of lipid values.
尽管小型随机试验表明，使用他汀类药物可降低死亡率和严重排异反应的风险，但尚无研究考察他汀类药物疗法在大量心脏移植受者实际治疗中的应用情况。我们分析了心脏移植脂质登记处（12个中心）的数据。纳入的患者需在1995年至1999年间接受移植，移植后存活≥30天，且在登记处随访≥30天。采用多变量Cox回归模型，并进行倾向评分以调整他汀类药物疗法的非随机分配，以确定他汀类药物疗法与死亡和致命性排异反应之间的关联。该研究纳入了1186例患者，平均随访时间为580±469天；937例患者（79%）接受了他汀类药物治疗。总体而言，71例患者（6%）死亡，40例（3.4%）发生致命性排异反应。他汀类药物治疗组的死亡频率较低（4%对13.7%，p<0.0001），致命性排异反应频率也较低（2.4%对7.2%，p = 0.0001）。使用多变量Cox回归，并纳入倾向评分以调整接受他汀类药物治疗的可能性，使用他汀类药物是与较低死亡风险（风险比0.29，95%置信区间0.13至0.67）和致命性排异反应风险（风险比0.27，95%置信区间0.09至0.78）相关的唯一因素。这项研究是在实际治疗中分析他汀类药物疗法与临床结局之间关系的最大规模心脏移植受者群体研究。他汀类药物疗法与较低的死亡风险和致命性排异反应风险显著相关，这些益处与血脂水平无关。
