BMC Med:合并或不合并糖尿病患者的收缩压控制在目标范围内的临床益处

2022-08-06 从医路漫漫 MedSci原创

血压较低和较高的患者之间可能出现基线特征不平衡(如疾病严重程度或共病),这可能会使研究结论产生偏差。

背景:大量研究表明,降低高血压患者的血压可降低血压相关不良后果的风险。然而,抗高血压药物开始和治疗的最佳血压目标仍未解决并存在争议,特别是在糖尿病患者中。收缩压干预试验(SPRINT) 和控制糖尿病血压心血管风险行动(ACCORD-BP) 的相互矛盾的结果给临床医生带来了困境和不确定性,相互矛盾的指南建议证明了这一点。尽管指南建议对有或无糖尿病的患者实施更严格的血压目标,但血压目标的下限尚不明确。此外,尚不清楚额外的治疗益处是否保持在非常低的血压水平(如110-120 mmHg)。临床试验和观察性研究中获得的血压分析结果通常用于设定有或无糖尿病或冠心病[患者的血压治疗目标。这种与达到血压的临床结果相关的分析将是有吸引力的,因为它们基于反映临床医生真实临床实践的患者实际血压水平,而不是计划随机组的意向性治疗比较。然而,这些分析有几个局限性。血压较低和较高的患者之间可能出现基线特征不平衡(如疾病严重程度或共病),这可能会使研究结论产生偏差。此外,结合干预组和对照组患者的回归分析可以替代超出BP的随机治疗效果,特别是当试验中两组之间存在显著的治疗差异时。

SPRINT和ACCORD-BP试验获得的部分重叠血压水平为研究具有相似但较低的血压水平(如收缩压[SBP]110–120 mmHg)的患者的治疗效果提供了独特的机会。因此,在目前的研究中,我们采用倾向评分法,在两项随机临床试验中将强化血压组(“参照组”)中达到不同血压水平的患者与对照组的患者进行匹配。

目的:基于这些跨组的可比数据,我们的研究旨在探索降低伴或不伴糖尿病的高血压患者主要心血管事件的最佳血压范围。

方法:我们对非糖尿病人群中的收缩压干预试验(SPRINT)和糖尿病受试者中的糖尿病血压控制心血管风险行动(ACCORD-BP)试验进行了二次分析。在每次试验中,我们使用倾向评分法将强化血压组的患者与标准血压组的患者进行匹配。来自强化血压组的具有不同血压水平的个体被用作“参照”对于每一层,试验特定的主要结果(即心肌梗死(MI)、未导致MI的急性冠状动脉综合征、中风、急性失代偿性心力衰竭(HF)或SPRINT的心血管死亡的复合结果;非致命性MI、非致命性中风或ACCORD-BP的心血管死亡)通过Cox回归进行比较。

结果:无论治疗分配如何,观察到平均血压和复合心血管事件发生率之间存在非线性关系。主要结果的显著治疗获益仍在SBP 110-120 mmHg(风险比,SPRINT为0.59 [95% CI,0.46,0.76];雅阁血压为0.67 [0.52,0.88],SBP为120-130毫米汞柱,斯普林特为0.47 [0.34,0.63],但雅阁血压不为0.93 [0.70,1.23]。次要转归包括全因死亡率、心血管死亡率、心肌梗死、中风和心力衰竭,结果相似。在舒张压维持在60-70 mmHg的患者中,强化降压治疗存在益处,但不明显。

表1在ACCORD试验中,强化血压控制组和标准血压控制组中倾向评分匹配的患者的特征

图1 SPRINT和ACCORD试验主要结果在强化血压对照组中的发生率和95%可信区间。与标准对照组中的匹配患者相比,每100患者年的发病率按以下顺序显示:A在SPRINT试验中达到SBP,B在ACCORD试验中达到SBP,C在SPRINT试验中达到DBP,D在ACCORD试验中达到DBP

图2强化血压控制组和标准血压控制组的主要转归和次要转归的发生率和HR。在SPRINT和ACCORD研究中,与标准血压对照组的匹配患者相比,根据达到的SBP和DBP水平,每100患者年和小时的强化血压治疗效果的发生率,主要结局为B心血管死亡、C心肌梗死、D中风、E心力衰竭和F全因死亡。在SPRINT研究中,通过添加年龄、性别、种族、临床CVD史、CKD史、血脂异常史、高血压治疗史、阿司匹林治疗史、当前吸烟、当前饮酒、CVD的10年风险、身体质量指数、SBP、DBP、BLU、氯化物、肌酸酐、心率、eGFR、葡萄糖、HDL-C、LDL-C、钾、钠、总胆固醇和甘油三酯的变量,通过拟合逻辑回归模型来计算倾向评分;ACCORD试验中的年龄、性别、种族、临床CVD史、心脏病史、血脂异常史、高血压治疗史、血脂异常治疗史、当前吸烟、当前饮酒、身体质量指数、SBP、DBP、腰围、肌酐、CPK、eGFR、葡萄糖、HDL-C、LDL-C、钾、总胆固醇和甘油三酯

图3强化血压治疗组的SBP和舒张压的样条分析。综合主要结果(阴影代表95%可信区间的上限和下限)的HR相对于SBP的140 mmHg和DBP的90 mmHg。结位于所达到的SBP和DBP的第10、30、70和90百分位数。多变量模型根据年龄、性别、种族、临床心血管病史、高血压治疗史、血脂异常治疗史、当前吸烟、当前饮酒、身体质量指数、SBP、DBP、eGFR、葡萄糖、HDL-C、LDL-C、钾、总胆固醇和甘油三酯等变量进行调整

结论:无论糖尿病状态如何,SBP 低至110-120 mmHg可以有持续的治疗获益。极低的血压水平似乎会增加心血管事件和全因死亡率。

原文出处:Li C,  Chen K,  Shi G,et al.Clinical benefit of systolic blood pressure within the target range among patients with or without diabetes mellitus: a propensity score-matched analysis of two randomized clinical trials.BMC Med 2022 Jun 20;20(1)

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