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摘要: 难治性高血压(resistant hypertension, RH)是指在改善生活方式基础上应用可耐受的足够剂量且合理的3种降压药物(包括一种噻嗪类利尿剂)治疗至少4周后, 诊室和诊室外(包括家庭血压或动态血压监测)血压值仍在目标水平之上, 或至少需要4种降压药物才能使血压达标, 目前尚缺乏有效的治疗方案。去肾交感神经术(renal sympathetic denervation, RDN)作为RH的一种治疗手段, 在病理生理机制上已被基础实验证实。早期Ⅰ代RDN的临床试验结果并不统一, Ⅱ代RDN改进了消融技术并在最近的高血压临床试验应用中得到了阳性结论, 同时RDN用于治疗其他疾病的临床试验也产生了阳性结果。但由于目前尚无对肾交感神经活动的具体评估方法, 无法准确筛选出适宜行RDN的人群, 故其临床应用仍存在争议。Abstract: The diagnosis of resistant hypertension is made when a patient's blood pressure(BP)is not under control after taking appropriate lifestyle measures and treatment with optimal or best-tolerated doses of 3 antihypertensive medications (a diuretic should be 1 component) for at least 4 weeks or 4 drugs are required to control BP. The inadequate BP control is confirmed by BP measurements of office and out-of-office (ambulatory BP monitoring and Home BP monitoring). Resistant hypertension lacks effective treatment. As a treatment method of resistant hypertension, the pathophysiology of renal sympathetic denervation(RDN) has been confirmed by basic research. Although early studies using the first-generation came to different conclusions, recent clinical trials have reached a positive result with a radiofrequency ablation system of the second-generation.However, the evaluation method for the activity of the renal sympathetic nerve is not clear so that it is hard to accurately screen out the patients who are appropriate for RDN. The clinical application of RDN is still controversial.利益冲突 无
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表 1 Ⅰ代RDN与Ⅱ代RDN主要临床试验及其结果
临床试验 血压入选标准 样本量 基线血压(mmHg) 随访时间(月) SBP[RDN组/对照组或RDN组－对照组 P值 诊室血压 24 h动态血压 Ⅰ代RDN SYMPLICITY RH* 45 SBP≥160 未应用 12 -27/-17 0.020 HTN-1[32] SYMPLICITY RH*且除 100 SBP≥160或SBP≥ 应用，但未在所有入 6 -33/-11 ＜0.001 HTN-2[33-35] 外T1DM 150(合并T2DM 选样本中测定 SYMPLICITY RH* 535 SBP≥160 SBP≥135 6 △SBP：-2.39 0.260 HTN-3[36] (-6.89~2.12) △24 h SBP：-1.96 0.980 (-4.97~1.06) SYMPLICITY RH* 41 SBP≥160 SBP＞135 6 △SBP：-8.64 0.169 HTN-Japan[39] (-21.12~3.84) △24 h SBP：-6.15 0.087 (-13.23~0.94) SYMPLICITY RH* 67 未报道 白天SBP 135~149或 6 △24 h SBP：-3.5 0.150 Flex[40] 白天DBP 90~94 (-8.5~1.5) DENER-HTN[41] RH* 101 SBP≥140或DBP≥90 白天平均SBP≥135 6 △24 h SBP：-5.9# 0.033 或白天平均DBP≥85 (-11.3~-0.5) SYMPATHY[42] RH* 124 平均BP：(169±25)/ 白天平均SBP：160± 6 △SBP：-8.2# 0.069 (96±16) 17且白天平均DBP： (-17.1~0.7) 93±15 △24 h SBP：1.0 0.805 (-7.1~9.1) RDN伴OSA[43] RH*合并 60 SBP≥140 白天平均SBP≥135 3 △SBP：-17# 0.002 中重度OSA (-27~-6) △24 h SBP：-9 0.008 (-17~-3) Ⅱ代RDN SPYRAL HTN-ON RH*合并 80 150≤SBP＜180且DBP 140≤平均SBP＜170 6 △SBP -6.8 0.021 MED[22] ≥90 (-12.5~-1.1) △24 h SBP -7.4 0.005 (-12.5~-2.3) SPYRAL HTN-OFF 轻中度高 80 150≤SBP＜180且 140≤平均SBP＜170 3 △SBP：-7.7 0.016 MED[23] 血压§ DBP≥90 (-14.0 ~-1.5) △24 h SBP -5.0 0.041 (-9.9~-0.2) *除外eGFR＜45 ml/(min·1.73 m2)、继发性高血压、肾脏解剖结构及一般情况不适合行RDN术的患者，且所有患者在入组前均予≥3种降压药物规范治疗，基线血压为在规律口服降压药物(血管紧张素转换酶抑制剂/血管紧张素受体拮抗剂、β受体拮抗剂、钙通道阻滞剂、利尿剂)治疗下测定；#DENER-HTN研究比较了RDN联合标准的阶梯降压治疗和单纯阶梯降压治疗的血压变化，两组血压下降幅度平均差为-5.9 mmHg；§20~80岁轻中度高血压，所有入选者在入组前均已停用降压药物，基线血压为停用降压药物3~4周时测定，所有入选者均经肾血管造影等排除了不适合行RDN术的情况；RDN：去肾交感神经术；RH：难治性高血压；T1DM：1型糖尿病；T2DM：2型糖尿病；OSA：阻塞性睡眠呼吸暂停；SBP：收缩压；DBP：舒张压；△SBP：收缩压变化；△24 h SBP：24 h动态收缩压变化; eGFR:估算的肾小球滤过率 
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