相較於慢性腎病患者（chronic kidney disease）和一般族群，末期腎病患者（end-stage renal disease）併有心血管疾病的危險性更高，因心血管併發症而死亡的比率佔所有死亡原因的30-50%。針對一般族群，血管張力素轉換酶抑制劑（angiotensin-converting enzyme inhibitors, ACEI）與血管張力素受體阻斷劑（angiotensin II receptor blockers, ARB）在心血管疾病保護效果的研究相當多，但針對末期腎病患者之心血管疾病保護效果的研究則不多，目前尚缺乏ACEI或（和）ARB（ACEI/ARB）對腹膜透析患者是否具心血管保護效果之研究。此外，殘餘腎功能的保存對腹膜透析病患是一項相當重要的預後因子，影響了病患的長期存活、生活品質、營養狀態，雖然ACEI或ARB針對腹膜透析患者之殘餘腎功能保護效果已有文獻證實，但仍欠缺國人腹膜透析患者的相關研究。因此本研究主要重點在於評估ACEI/ARB在腹膜透析患者是否有心血管疾病保護效果，並且再驗證ACEI/ARB對於殘餘腎功能的保護效果。
　　本研究共納入245位自民國79年至94年於台南市國立成功大學醫學院附設醫院腎臟科接受長期腹膜透析治療之病患。回溯性檢閱病歷並記錄相關資料，包括：病患基本資料、透析期間用藥史、疾病史、住院原因與期間、心血管疾病發生日期與疾病種類、死亡日期與原因、不良反應事件的發生、透析量評估、各項臨床檢驗數據等。排除透析未滿6個月、透析治療前已罹患癌症、臨床資料不完整的病患，共計50位，以195位病患進行分析。本研究以SAS 9.1統計套裝軟體進行各項分析，採用Kaplan-Meier存活率分析與Log-rank檢定方法，檢測ACEI/ARB和其他因素對存活率、心血管疾病的發生或3年內變為無尿之影響，再以Cox-proportional hazard regression校正基礎共變項後作為多變項分析法。
　　心血管疾病保護效果的研究中，195位腹膜透析病患依是否使用ACEI/ARB至少6個月以上區分為治療組與對照組，排除46位使用ACEI/ARB未滿6個月的病患。治療組共有42位病患，而對照組有107位患者從未使用過ACEI/ARB。兩組基本資料方面，治療組平均年齡較輕、平均透析期間較長以及男性比率較多（43 ± 14 vs. 49 ± 16歲；5.4 ± 3.3 vs. 3.7 ± 2.7年；54.8% vs. 37.4%; p<0.05）。治療組有較多比率併用的鈣離子阻斷劑（calcium channel blockers, CCB）（66.7% vs. 46.7%, p<0.05）。進入透析時和透析期間臨床檢驗數據，治療組平均血壓均高於對照組（p<0.05）。以多變項分析校正基礎共變項後，影響所有原因死亡率之預後因子包括年齡、併有心血管疾病或糖尿病、平均收縮壓、平均舒張壓、血清白蛋白值與殘餘腎功能。影響心血管疾病相關死亡率之預後因子包括：年齡、殘餘腎功能、併有心血管疾病或糖尿病、血脂異常與鈣磷乘積。影響心血管疾病發生率之預後因素包括年齡、併有心血管疾病或糖尿病、平均收縮壓、鈣磷乘積、使用ACEI/ARB大於6個月以上。針對腹膜透析患者，本研究結果顯示ACEI/ARB的使用對所有原因死亡率和心血管疾病相關死亡率無明顯的影響，但使用ACEI/ARB大於6個月以上可顯著的降低70%心血管疾病發生的危險性（RR 0.13-0.96, p=0.042）。
　　殘餘腎功能保護效果的研究中，195位腹膜透析病患排除5位從未作過殘餘腎功能檢查、38位進入透析治療前殘餘GFR為0或尿量小於100 ml的病患，以152位進入透析時仍有殘餘腎功能的病患進行分析。依ACEI/ARB的使用至少6個月以上區分為治療組與對照組，排除41位使用ACEI/ARB未滿6個月的病患。治療組共有73位病患，79位對照組患者從未使用過ACEI/ARB。兩組基本資料方面，治療組平均年齡較輕、平均透析期間較長以及進入透析時的殘餘腎功能較低（44 ± 14 vs. 47 ± 16歲；4.9 ± 2.6 vs. 3.7 ± 2.6年；2.6 ± 2.1 vs. 3.5 ± 2.5 ml/min/1.73 m2 p<0.05）；進入透析時和透析期間臨床檢驗數據，治療組平均血壓均高於對照組（p<0.05）。以多變項分析校正基礎共變項後，影響病患3年內變為無尿的預後因素包括：男性、進入透析時殘餘腎功能的多寡、併有腦血管疾病、高血壓或糖尿病、併用CCB或Statins、以及平均收縮壓。雖然使用ACEI/ARB大於6個月以上對於3年內變為無尿無明顯的影響，但我們觀察到隨著ACEI/ARB使用的期間越長，病患變為無尿的時間也越長，且ACEI/ARB使用18個月以上病患變為無尿的時間明顯長於對照組（p<0.05）。因此進行事後分析發現，使用ACEI/ARB大於18個月以上可降低46%病患3年內變為無尿的危險性（RR 0.54, 95% CI 0.22-0.90, p=0.033）。此外在腹膜透析患者，治療組和對照組在咳嗽和高血鉀之發生率並無顯著差異（40.86% vs. 36.45%; 33.33% vs 44.86%, p>0.05）。
　　因此本研究證實使用ACEI/ARB至少六個月以上可降低70%心血管疾病的發生率，但對於所有原因死亡率和心血管疾病死亡率並沒有差異。可能原因在於透析患者原本就屬於心血管疾病的高危險群，可能又併有許多疾病和危險因子，因此無法靠單一藥品治療就可以改善長期預後，血壓的控制也可能需要多種降血壓藥品才能控制良好。因此建議須針對多重危險因子積極治療，包括控制血壓、血脂、血糖、保存病患的殘餘腎功能、維持血磷值、鈣磷乘積和營養狀態的平穩等。目前何種降血壓藥品對腹膜透析患者特別有助益尚無定論，本研究顯示ACEI/ARB的使用可減少心血管疾病的發生率，且咳嗽和高血鉀副作用與對照組無差異，因此對於腹膜透析患者使用ACEI/ARB是安全的。因此除了心衰竭病患或預防性使用於心肌梗塞後的患者可優先考慮ACEI/ARB外，ACEI/ARB亦可作為腹膜透析患者降血壓藥品的第一線選擇。此外，本研究事後分析顯示使用ACEI/ARB大於18個月以上可降低病患3年內變為無尿之危險性，然而需要進一步的研究來證實。

　　Background: Cardiovascular (CV) disease is a leading cause of morbidty and mortality in end-stage renal disease (ESRD) patients. Angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB), effective treatments for hypertension and CV disease, are known to improve prognosis in chronic renal failure and hemodialysis patients. The CV protection effects of ACEI and ARB on peritoneal dialysis (PD) patients remian unclear. In addition, residual renal function (RRF) is an important predictor of outcome in PD patients. We investigated protection effects of ACEI and/or ARB (ACEI/ARB) on all-cause mortality, CV-related mortality, CV events and development of anuria in 3 years in patients undergoing long-term PD therapy.
Method: Clinical data and medical treatments were extracted from charts of 245 PD patients between 1990 and 2005. We excluded patients who were receiving PD therapy less than 6 months, with underlying malignancy, or with incomplete information. All-cause mortality, CV-related mortality, CV events, and development of anuria in 3 years were compared between patients treated with or without ACEI/ARB.
　　Statistical Analysis: We analyzed the data with adequate standard statistical method by SAS 9.1 statistical software. The outcome events were all-cause mortality, CV-related mortality, CV events, and development of anuria in 3 years. Survival and free to event was estimated by the Kaplan-Meier product-limit method, and log-rank test was used to assess the significance of difference between the two unadjusted survival curves. The association between the treatment with ACEI/ARB, all-cause mortality, CV-related mortality, CV events or development of anuria in 3 years was analyzed by means of the Cox proportional hazards regression model. The stepwise multivariate Cox model was performed to determine the independent association between the treatment with ACEI/ARB and other baseline covariates. Adjusted hazard ratios (RRs) were calculated as the antilogarithm of the β coefficient of the Cox proportional hazards regression of the outcome event with all covariates entered in the model. RRs and their 95% confidence intervals (CI) are reported. P less than 0.05 is considered significant.
　　Results: Of 245 patients with ESRD who started PD therapy during 1990 and 2005, a total of 50 patients were on dialysis for less than 6 months, with underlying malignancy, or with incomplete clinical data. The study population therefore included 195 chronic PD patients. Mean follow-up duration was 4.7 ± 2.8 years (range, 0.6 to 11.7 years). Forty two patients had been treated with ACEI/ARB (treated group) and 107 patients had not (untreated group). After adjustment of other baseline covariates, CV events were decreased significantly in the treated group, with a risk reduction of 70% (RR, 0.30; 95% CI 0.10-0.96). All-cause mortality (RR, 0.98, 95% CI 0.94-1.01) and CV-related mortality (RR, 0.98, 95% CI 0.93-1.03) did not differ between 2 groups. Other parameters included in the Cox proportional hazard regression model that independently associated with CV events or mortality are age, combined with CV disease, diabetes, or dyslipidemia, systolic blood pressure, diastolic blood pressure, calcium and phosphorus product level, and serum albumin. Moreover, treated with ACEI/ARB more than 18 months may retard time to anuria in 3 years, with a risk reduction of 46% (95% CI 0.22-0.90, p=0.033).
　　Conclusions: ACEI/ARB may dramatically reduce CV events in PD patients. However, there is no evidence to show beneficial effects from ACEI/ARB in terms of all-cause mortality or CV-related mortality. Moreover, treated with ACEI/ARB more than 18 months may have benefits on preserving RRF. These preliminary findings provide an additional support for the value of ACEI/ARB therapy in chronic PD patients. Further prospective studies are warranted.

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