Herz Naomi D, Engeda Joseph, Zusterzeel Robbert, Sanders William E, O'Callaghan Kathryn M, Strauss David G, Jacobs Samantha B, Selzman Kimberly A, Piña Ileana L, Caños Daniel A
Center for Devices and Radiological Health, United States Food and Drug Administration , Silver Spring, Maryland.
J Womens Health (Larchmt). 2015 Apr;24(4):261-71. doi: 10.1089/jwh.2014.4980. Epub 2015 Mar 20.
Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies.
We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information.
Ninety percent of the studies evaluated included ≤ 35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT.
Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex.
多项针对心力衰竭患者的研究表明，心脏再同步治疗（CRT）可显著改善运动能力、生活质量、心脏左心室功能并提高生存率，但值得注意的是，这些研究中女性入组人数不足。病因学和病理生理学差异可能导致不同性别对这种治疗的反应不同。观察到的女性代表性不均衡表明，许多心力衰竭女性要么不符合当前临床试验中接受CRT的临床标准，要么在这些研究中未得到适当招募和保留。
我们对截至2014年5月的CRT使用临床试验和登记处进行了系统的文献综述，这些研究按性别分层结果或报告了纳入女性的百分比。183项研究包含了性别特异性信息。
90%的评估研究纳入的女性≤35%。56篇文章包含有效性数据，报告了特定结局参数的反应情况。与男性相比，女性在特定参数上表现出更显著的改善。在报告住院或死亡风险比的研究中，女性通常从CRT中获益更大。
我们的综述证实，CRT试验中女性的代表性明显不足，并且植入CRT设备时，女性的治疗反应等同于或优于男性，而按性别报告的不良事件没有差异。
