捐血者不良反應及其特質與生化值之分析

研究目的：捐血的過程是安全的，但是仍有一些捐血不適反應發生。在人體的健康重要指標有鐵質狀況、身體質量指數及血壓的狀態。本研究主要目是探討發生捐血不適反應的危險因子及鐵蛋白及運鐵蛋白飽和度和身體質量指數及血壓的相關性。研究方法及資料：使用回顧性病例對照研究設計，調查 2010 年 至 2013 年捐血不適反應的危險因子。比較有、無不適反應的捐血者之間的: 性別、年齡、身體質量指數 (body mass index, BMI)、捐血狀態、捐血量、捐血地點、捐血前收縮壓（systolic blood pressure, SBP）及捐血前舒張壓 (diastolic blood pressure, DBP）等變項。使用多元邏輯回歸分析以評估年齡、性別和捐血狀態對捐血不適反應的聯合效應；進一步我們分別使用化學發光免疫分析三明治法、定時終點法和比濁法分別在首次和常規男性捐血者中測定了血清鐵蛋白 (ferritin)、血清鐵 (serum iron) 和總鐵結合能力（total iron binding capacity, TIBC）。運鐵蛋白飽和度計算公式為100 x 血清鐵/ TIBC。統計分析包括兩次樣本 t 檢定、卡方檢定、Pearson 相關係數和多元線性回歸分析。鐵蛋白和運鐵蛋白飽和度平均值與 BMI、年齡、SBP、DBP 和職業別亦分析比較。研究結果： 在多變項羅吉斯回歸分析中: 年齡小於35歲的捐血者 （odd ratio, OR，2.99，95% CI，2.57-3.48）、女性（OR，3.30，95% CI，2.62-4.15）、首次捐血者 （OR，6.40，95% CI，5.17-7.93）、捐500 mL （OR，2.22，95% CI，1.83-2.69）、捐血前SBP ＜124 mmHg（OR，1.25，95% CI，1.05-1.48）， BMI ＜24 kg / m2（OR，1.67，95% CI，1.42-1.96）與發生不良反應的相關性增加。利用聯合效應分析結果顯示: 年齡小於35歲的首次女性捐血者發生不良反應的勝算比是年齡≥35歲重複男性捐血者的100.57倍（OR，100.57，95% CI，48.45-208.75）。常規男性捐血者和首次男性捐血者相比，鐵蛋白和運鐵蛋白飽和度平均值較低，但仍在安全範圍內。在首次和常規的男性捐血者中，BMI 與血清對數鐵蛋白間呈現正相關，但與運鐵蛋白飽和度並沒有正相關的現象。BMI ≥24 kg / m2且年齡在40歲以上的首次男性捐血者分別比BMI <24 kg / m2及40歲以下族群的平均血清鐵蛋白高1.37倍。在正常的男性捐血者中，BMI ≥24 kg / m2 和年齡大於40歲的者，血清鐵蛋白數值分別升高1.25和1.18倍。首次男性捐血者血壓SBP≥120/DBP≥80，≥120/ <80和<120 /≥80 mmHg的和正常血壓者相比，血清鐵蛋白數值分別平均高出1.65、1.54和2.59倍。在首次和常規男性捐血者中，BMI ≥24 kg / m2子群體的鐵蛋白數值高於BMI <24 kg / m2子群體，但在運鐵蛋白飽和度數值上並無差異。結論與建議：本研究結果有助於識別捐血者產生捐血不良的風險因素，進而可制定預防不良反應的適當策略。其次，異常的血壓 (SBP / DBP) 只與首次捐血的男性之鐵蛋白數值升高有關，而在常規男性捐血者並無此現象。

Objective: The process of blood donation is considered safe, but some adverse events have been reported. Iron status, body mass index (BMI) and blood pressure (BP) are all important health indicators. We examined the factors influencing the health of blood donors from two aspects: risk factors for adverse events and ferritin and transferrin saturation levels and their correlations with BMI and BP.Methods and Materials: For the first aspect, we investigated the risk factors for adverse events after blood donation between 2010 and 2013 using a retrospective case-control study design. Variables such as gender, age, BMI, donation status, donation volume, donation site, pre-donation systolic blood pressure (SBP), and pre-donation diastolic blood pressure (DBP) were compared between donors with and without adverse events. Multiple logistic regression analysis was performed to assess the joint effects of age, gender, and donation status on adverse events. For the second aspect, we determined serum ferritin, serum iron, and total iron binding capacity (TIBC) by chemilumiescent immunoassay sandwich method, timed-endpoint method, and turbidimetric method, respectively, in first-time and regular male blood donors. Transferrin saturation was calculated as 100 x serum iron/TIBC. Statistical analyses included two-sample t-test, chi-square test, Pearson correlation coefficient, and multiple linear regression.Comparisons of ferritin and transferrin saturation mean values with BMI, age, SBP, DBP, and occupation were conducted.Results: On multivariate logistic regression analysis, blood donors aged ＜35 years (OR, 2.99, 95% CI, 2.57-3.48), of female gender (OR, 3.30, 95% CI, 2.62-4.15), with first-time donor status (OR, 6.40, 95% CI, 5.17-7.93), with donation of 500 mL (OR, 2.22, 95% CI,1.83-2.69), with predonation SBP＜124 mmHg (OR, 1.25, 95% CI,1.05-1.48), and with BMI ＜24 kg/m2 (OR, 1.67, 95% CI,1.42-1.96) were associated with increased likelihood of adverse event. Further analysis with joint effects method revealed that first-time female donors aged ＜35 years are associated with the highest odds of adverse events when compared with repeat male donors aged ≧35 years (OR, 100.57, 95 % CI, 48.45–208.75). In addition, ferritin and transferrin saturation mean values of regular male blood donors were lower than those of first-time male blood donors, but remained within the safe range. There was positive correlation between BMI and serum log ferritin, but not with transferrin saturation value, in first-time and regular male blood donors. First-time male donors with BMI ≥24 kg/m2 and aged over 40 demonstrated 1.37-fold higher serum ferritin on average. Among regular male donors, significant effects of BMI ≥24 kg/m2 and age >40 years were observed with 1.25- and 1.18-fold higher serum ferritin levels, respectively. First-time male donors with SBP≥120/DBP≥80, ≥120/<80, and <120/≥80 mmHg had on average 1.65-, 1.54-, and 2.59-fold higher serum ferritin levels, respectively, than those with normal blood pressure. Ferritin level was higher in BMI ≥24 kg/m2 subgroup than in BMI <24 kg/m2 subgroup among first-time and regular male donors, but no differences were found for transferrin saturation values.Conclusion and Suggestions: First, these results should prove useful in identifying donors at risk and planning appropriate strategies for the prevention of adverse effect .Second, abnormal SBP/DBP is associated with increased ferritin level in first-time male blood donors.