厄贝沙坦/氢氯噻嗪复方片剂治疗中国高血压病患者的达标率分析

目的分析高血压患者接受厄贝沙坦／氢氯噻嗪复方制剂（商品名：安博诺）治疗的达标率。方法本研究为多中心、开放、单一治疗组的研究。共入选968例轻、中度高血压病患者,均采用安博诺治疗8周。经药物清洗1～2周后,给予初始剂量安博诺1片／d治疗,治疗2周末,如未达标（目标血压：舒张压〈85mm Hg,1mm Hg = 0．133 kPa）则增加厄贝沙坦150mg继续服用2周;在第4周末仍未达标则再增加氢氯噻嗪12．5mg（即安博诺2片／d）直至8周试验结束。结果对入选的968例轻、中度高血压病患者进行意向治疗人群分析,完成8周随访的920例患者进行符合方案人群分析。（1）治疗1周时,收缩压／舒张压与治疗前比较,分别降低11．8／8．56mm Hg,P 〈 0．01;治疗8周时,收缩压／舒张压分别降低21．97／16．08mm Hg,P 〈 0．01。（2）治疗2周血压达标的患者526例,占57．17％;4周时血压达标患者703例,占76．41％;8周时达标患者769例,占83．59％。（3）在治疗的8周中服用安博诺1片／d为637例,占总病例数的69．24％;服用安博诺1片＋厄贝沙坦150mg／d为211例,占总病例数的22．93％;安博诺2片／d为72例,占总病例数的7．82％。（4）入组的968例高血压病患者进行意向治疗人群分析,其中有903例患者没有任何不良反应,占总研究病例数的93．29％。结论安博诺治疗中国轻、中度高血压病达标率高,不良反应较少。

The control rate of irbesartan/hydrochlorothiazide combination regimen in the treatment of Chinese patients with mild to moderate hypertension

Objectives To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) combination tablets (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.Methods In this multi-center, open, single therapy trial, the enrolled patients aged 18-75 were treated with irbesartan/HCTZ combination tablets for 8 weeks. The initial dose comprised one tablet of irbesartan(150 mg)/HCTZ(12.5 mg)once a day during the first 2 weeks. If diastolic blood pressure was greater than 85 mm Hg at the end of the second or fourth weeks, irbesartan (300 mg)/HCTZ(12.5 mg) once a day or irbesartan(300 mg)/HCTZ(25 mg) once a day were added respectively.Results In 968 patients with mild to moderate hypertension enrolled, 920 patients were followed up for 8 weeks. (1)After 1 week of treatment, irbesartan/HCTZ combination tablets lowered systolic blood pressure by 11.87 mm Hg and diastolic blood pressure by 8.54 mm Hg (P<0.01). After 8 weeks of treatment, the corresponding decreases were 21.97mm Hg and 16.08 mm Hg, respectively (P<0.01). (2)After 2, 4 and 8 weeks of treatment, 526, 703 and 769 patients reached blood pressure target (diastolic blood pressure less than 85 mm Hg). The control rates were 57.17%, 76.41% and 83.59%, respectively. (3)Among the 920 patients who completed the trial, 637 patients took irbesartan (150 mg)/HCTZ(12.5mg) once a day (69.24%), 211 patients took irbesartan(300 mg)/HCTZ(12.5 mg) once a day (22.93 %), and 72 patients took irbesartan(300 mg)/HCTZ(25 mg) once a day(7.82%). (4)In the intention-to-treat analysis, no adverse reaction was observed in 903 patients (93.29% of the patients enrolled).Conclusions When irbesartan/HCTZ combination regimen are used in the treatment of patients with mild to moderate primary hypertension, the proportion of patients reaching blood pressure target is high and adverse reactions are rare.