Okamura Keisuke, Shirai Kazuyuki, Okuda Tetsu, Urata Hidenori
Department of Cardiovascular Diseases, Fukuoka University Chikushi Hospital, Japan.
Intern Med. 2018 Jan 1;57(1):1-12. doi: 10.2169/internalmedicine.9059-17. Epub 2017 Oct 16.
Objective A clinical trial (REQUIRE) was started to investigate the use of an ultrasound renal denervation system in the treatment of resistant hypertension (RHT). We analyzed the prevalence of patients who were eligible for inclusion in this cross-sectional study at the time of screening. Methods Nine-hundred ninety-nine consecutive hypertension (HT) patients who were treated in our hospital as outpatients were classified into the following categories: patients treated with at least 3 types of antihypertensive drugs including diuretic agents who were eligible for enrolment in SYMPLICITY HTN-Japan (SH-J) with an office systolic blood pressure (SBP) of ≥160 mmHg, who were ≤80 years of age, and an estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m (RHT-S); and patients who were treated similar medications and who were eligible for enrolment in REQUIRE, with an SBP of ≥150 mmHg, ≤75 years of age, and an eGFR of ≥40 mL/min/1.73 m (RHT-R). We investigated the proportion of patients in each category. We also investigated HT patients (1,423 cases) who were enrolled in the Chikushi Anti-Hypertension Trial (CHAT), a research network that includes general practitioners. Results Eleven patients (1.1%) with RHT-S and 18 patients (1.8%) with RHT-R were identified. After the exclusion of patients with secondary HT and a diastolic blood pressure (DBP) of <90 mmHg (applied in REQUIRE), 5 patients (0.5%) with RHT-S and 4 patients (0.4%) with RHT-R remained. In the analysis of the CHAT study, only 2 (0.1%) patients with RHT-R remained. Conclusion The number of eligible patients in the REQUIRE trial was decreased, largely due to the strict age restriction and the new DBP limitation. The prevalence of eligible patients in REQUIRE was estimated to be approximately 0.5 to 0.8 times that in SH-J. Since patient enrollment will be difficult, drastic measures may be required to recruit eligible patients.
目的 启动一项临床试验（REQUIRE），以研究超声肾去神经支配系统在难治性高血压（RHT）治疗中的应用。我们分析了筛查时符合纳入这项横断面研究条件的患者的患病率。方法 将我院门诊治疗的999例连续性高血压（HT）患者分为以下几类：接受至少3种包括利尿剂在内的抗高血压药物治疗、符合参加日本Symplicity HTN研究（SH-J）条件、诊室收缩压（SBP）≥160 mmHg、年龄≤80岁且估计肾小球滤过率（eGFR）≥45 mL/min/1.73 m²的患者（RHT-S）；接受类似药物治疗、符合参加REQUIRE条件、SBP≥150 mmHg、年龄≤75岁且eGFR≥40 mL/min/1.73 m²的患者（RHT-R）。我们调查了每类患者的比例。我们还调查了参加筑紫抗高血压试验（CHAT，一个包括全科医生的研究网络）的HT患者（1423例）。结果 确定了11例（1.1%）RHT-S患者和18例（1.8%）RHT-R患者。排除继发性HT患者和舒张压（DBP）<90 mmHg的患者（REQUIRE适用）后，剩余5例（0.5%）RHT-S患者和4例（0.4%）RHT-R患者。在CHAT研究分析中，仅剩余2例（0.1%）RHT-R患者。结论 REQUIRE试验中符合条件的患者数量减少，主要是由于严格的年龄限制和新的DBP限制。REQUIRE中符合条件患者的患病率估计约为SH-J中的0.5至0.8倍。由于患者入组困难，可能需要采取严厉措施来招募符合条件的患者。
