| 摘要: | 研究目的：評估高血壓病人從其他血管收縮素接受器阻斷劑（ARBs）換成candesartan之後對治療結果的影響，評估藥品替代之後的療效、安全性和病人滿意度。療效評估包括換藥前後的血壓變化和達目標血壓值的人數比率，安全性則是評估病人將藥物換成candesartan是否產生副作用或嚴重不良反應。
研究方法：這是非隨機分派（non-randomized）、開放性（open labeled）且自我比較（self-controlled）的研究。依據收案條件納入2004年8月至2004年11月所有使用candesartan的門診病人，開始進入研究過程。研究進行的時間從2004年8月至2005年5月止，為期九個月。在藥物替換成candesartan之後，分別在第2至4週、12週、24週，評估病人回醫院門診測量的血壓，及換藥之前病歷的血壓紀錄，換藥後2至4週、12週和24週的血壓分別和換藥之前的血壓比較，評估其療效。除了評估血壓值，也評估病人達到目標血壓值的人數比率，比較換藥前和換藥後符合目標血壓值的人數比率。副作用是以電話訪談的方式進行追蹤，詢問是否產生副作用或發生嚴重不良反應，在第2至4週、12週和24週分別進行第一次、第二次和第三次評估，並調查病人對於換藥結果的滿意度。收集紀錄病人的血壓值和副作用資料並加以整理，之後進行統計分析。
研究結果：依據納入和排除標準共納入了586位病人，而最後有494位病人納入本研究，進行第一次的電話訪談。訪談的494人中其平均年齡為61.7±12.4歲，有53%是男性，47%是女性。換藥前、換藥後2至4週、12週和24週，病人的血壓值分別為143.3/86.1, 140.8/84.1, 137.9/82.9和137.0/82.6 mmHg，和換藥前比較具有明顯的差異（p<0.01）。病人達到目標血壓值的人數及其比率，換藥前是142人（37%），換藥後2至4週是142人（37%），換藥後12週是160人（41%），和換藥前比較並沒有明顯差異，而換藥後24週是182人（47%），和換藥前比較具有顯著差異（p<0.01）。產生副作用的比率在藥品替代之後2至4週、12週和24週分別為103人（21%），26人（6%）和4人（1%），換藥後12週及24週的副作用發生率和換藥後2至4週比較，有明顯降低（p<0.001），而換藥後24週的副作用發生率和12週比較，也有明顯降低（p=0.001），故三次病人產生的副作用發生率明顯減少。然而，有68人（15%）由於副作用或血壓控制不滿意停用candesartan，換成其他降血壓藥治療。藥品替代之後2至4週、12週和24週的滿意度分別為494位病人中有428人（87%）滿意、425位病人中有400人（94%）滿意和389位病人中有378人（97%）滿意，三組之間的滿意度並沒有顯著差異。
結論：本研究納入494位病人，其中有389人（79%）完成三次評估，約八成的病人持續使用candesartan至少六個月以上，而且有更好的降血壓效果，大多數的副作用是在病人換藥後2至4週產生，隨著藥品使用時間的延長而自行緩解，並沒有產生任何嚴重的不良反應，符合臨床上藥品有效性和安全性的要求，而且近九成的病人滿意candesartan的治療結果，顯示candesartan適合作為其他血管收縮素接受器阻斷劑治療高血壓的替代藥品。
Objective: To evaluate clinical outcomes of subjects whose therapy was converted from other ARBs to candesartan, determine the efficacy and safety of candesartan in patients with hypertension, and patients’ satisfaction. Efficacy analysis was the changes in blood pressure and number of patients meeting their goal blood pressure before and after therapeutic interchange. Safety analysis was to evaluate if patients have side effects or severe adverse drug reaction.
Methods: A non-randomized, open-labeled and self-controlled study. All eligible outpatients taking candesartan entered into the study from August 2004 to November 2004. After converting to candesartan, baseline and blood pressure during 2 to 4-week, 12-week and 24-week clinic visits were compared to assess efficacy. The rate of subjects attaining blood pressure goal after conversion were compared to baseline. Side effects were followed up by telephone interview at 2 to 4, 12 and 24 weeks. Patients’ satisfaction with outcome of therapeutic interchange was assessed. The values of blood pressure and side effects were recorded and collected.
Results: Eligible outpatients were 586 patients, and 494 patients were enrolled in the study and completed the first evaluation by telephone interview. The 494 interviewed patients had a mean age of 61.7 ± 12.4 years, 53% were male and 47% were female. Mean baseline blood pressure, 2 to 4 - week, 12 - week, and 24 - week after drug conversion were 143.3/86.1, 140.8/84.1, 137.9/82.9, and 137.0/82.6 mmHg, respectively（p<0.01 vs. baseline）. The rate of subjects achieving blood pressure goal were 142（37%）at baseline, 142（37%）at 2 to 4 weeks, and 160（41%）at 12 weeks（p values no significant difference vs. baseline）and 182（47%）at 24 weeks（p< 0.01 vs. baseline）, respectively. The incidence of side effects at 2 to 4 weeks, 12 weeks and 24 weeks were 21%（n=103）, 6%（n=26）, and 1%（n=4）, respectively（p<0.001 vs. 2 to 4 weeks, p=0.001 vs. 12 weeks）. Sixty-eight（15% of all subjects）discontinued candesartan due to side effects or unsatisfying blood pressure. Patients’ satisfaction at 2 to 4, 12, and 24 weeks were 428（87%） of the 494 patients, 400（94%）of the 425 patients and 378（97%）of the 389 patients, respectively（P>0.05 vs. 2 to 4 weeks）.
Conclusions: There were 494 patients enrolled in the study and 389 （79%）patients completed the study. Patients who can tolerate the conversion from ARBs to candesartan at least six months achieved better blood pressure control. Most side effects appeared during 2 to 4 weeks and resolved steadily with time, and no serious adverse drug reactions happened. Approximately 90 percentages of patients were satisfied with clinical outcomes of therapeutic interchange. Candesartan is an appropriate substitution for other angiotensin Ⅱ receptor blockers. |
