C型肝炎病人接受長效性干擾素及雷巴威林合併治療期間體適能、疲倦、睡眠困擾之改變及其相關性之探討

Abstract

長效型干擾素 (Pegylated interferon α, Peg-IFN α)合併雷巴威林 (Rribavirin)為目前C型肝炎病人的標準治療方法，其藥物副作用造成病人諸多困擾 (例如：疲倦及睡眠困擾)及身體活動下降，甚至使病人中斷治療。許多研究證實，維持持續的身體活動及運動，可改善慢性疾病病人的疲倦及睡眠困擾，並改善生活品質，然而，對於此類病人執行運動的可行性仍未清楚，且尚未有研究探討C型肝炎以長效型干擾素及雷巴威林合併治療過程中體適能、疲倦及睡眠等症狀的相關性，故本研究目的為：(1)探討C型肝炎病人接受Peg-IFN α/RBV合併治療六個月內之疲倦、睡眠困擾及體適能的變化；(2)探討C型肝炎病人接受長期Peg-IFN α/RBV合併治療之體適能與疲倦及睡眠困擾的相關性；(3)探討C型肝炎接受Peg-IFN α/RBV合併治療的病人影響其體適能的重要相關因子。 本研究為前瞻性縱貫式研究，於北部某醫學中心的肝膽腸胃科門診進行收案，研究對象為C型肝炎且預計接受Peg-IFN α/RBV合併治療的病人 (N = 66，平均年齡48.2歲)，共進行四次訪視，分別為治療前 (T0)、治療期間第二個月 (T1)、第四個月 (T2)及第六個月 (T3)。資料收集包含結構式問卷及體適能活動測量，問卷內容包含：基本屬性及疾病因素、疲倦症狀量表及睡眠困擾，體適能測量包含：身體質量指數、手部握力、髖屈曲肌力、膝伸直肌力、三十秒坐站及六分鐘走路測試。資料分析將以次數、百分比、平均值、標準差呈現各變項之數值，以重複測量變異數疲倦及睡眠困擾之變化趨勢，並以廣義估計方程式分析體適能的變化趨勢，並探討影響體適能之重要相關因子。研究結果顯示：(1)治療期間疲倦程度比治療前嚴重，高峰期出現在治療期間第二個月；(2)睡眠困擾隨著治療時間增加越來越嚴重；(3)隨著治療期間，身體質量指數 (β = -0.275, p < .0001)達統計上顯著下降；(4)手部握力 (β = -0.803 , p =.003)達統計上顯著下降，三十秒坐站測試 (β = 0.349, p = .049)及膝部伸直肌力 (β = 0.624, p < .0001)則達顯著上升，但皆未達最小臨床差異值的標準；(5)影響體適能的因子包含年齡、性別、身體活動功能、有無過去病史、疲倦對生活干擾的程度、睡眠充足的程度及治療時間。 本研究結果發現C型肝炎接受Peg-IFN α/RBV治療病人之體適能可維持在一般健康成人的標準範圍，推測治療期間給予運動措施是可行的，除此，疲倦對生活干擾及睡眠充足的程度會影響體適能變化，而身體質量指數是唯一顯著下降的變項，故應針對處理疲倦對生活干擾、睡眠充足的程度及減緩體重下降的程度給予衛教，以改善病人在治療期間對體適能的影響。

Combination therapy with pegylated interferon (Peg-IFN α) and ribavirin (RBV) is an available standard treatment for patients with hepatitis C virus (HCV) infection. However, patients suffered from many adverse effects (e.g., fatigue and sleep disturbance) and physical activity decreased during therapy, even discontinued the therapy. The fatigue, sleep disturbance and quality of life might improve through regular exercise. However, the accurate feasibility of exercise regimen in the patients is unclear. In addition, there were no studies to explore the changes and relation among physical fitness, fatigue, and sleep disturbance in patients with HCV under Peg-IFN α/RBV therapy. Therefore, the aims of this study were to (1) explore the changes of the level of fatigue, sleep disturbance and physical fitness with HCV during 6 months of Peg-IFN α/RBV therapy; (2) examine the relations of fatigue, sleep disturbance and physical fitness with HCV during 6 months of Peg-IFN α/RBV therapy; (3) and identify the associated factors of physical fitness. This prospective longitudinal study recruited patients with HCV under Peg-IFN α/RBV therapy from the gastroenterology outpatient clinics of teaching medical center hospital in northern Taiwan (N = 66, average age 48.2 years old). The eligible patients completed four times data collection, which were before treatment (baseline, T0), 2 (T1), 4 (T2) and 6 (T3) months during treatment respectively. The set of questionnaires included demographic and clinical disease characteristics of patient, Fatigue Symptom Inventory, Medical Outcomes Study Sleep Scale and Physical Fitness test, which was consisted of body mass index (BMI), grip strength, hip flexors muscle strength, knee extensors muscle strengh, 30-s chair stand test (30-CST) and the Six-Minute Walk Test (6MWT). Data analysis was performed by descriptive statistics (e.g., number, percentile, mean and standard deviation) and inferential statistics (e.g., repeated measure ANOVA and Pearson’s γ) to explore the information and relation among study variables. Moreover, generalized estimating equation (GEE) were used to explore the associated factors of physical fitness.The results showed that (1) fatigue was more distress than baseline and peak reached at T2; (2) sleep disturbance became more distress with monthly; (3) the BMI (β = -0.275, p < .0001) had statistical significant decrease; (4) hand grip (β = -0.803 , p =.003), 30-CST (β = 0.349, p = .049) and knee extensors muscle strength (β = 0.624, p < .0001) had a statistically significant difference, but they didn’t reach the clinically significant difference; (5) the associated factors of physical fitness were age, gender, physical performance, comorbidity, fatigue inference with functioning, sleep adequacy and time of treatment. This study found that the patient with HCV under Peg-IFN α/RBV therapy can maintain their physical performance as the same level with health adults during therapy. We speculated that exercise intervention is feasible for the patient during therapy. In addition, the fatigue inference with functioning and sleep adequacy had impact on physical fitness and the BMI was the only variable significantly decreased. Therefore, it should provide education to deal with fatigue inference with functioning, sleep adequacy and decrease the range of body weight (e. g. diet education) for improving the impact factors.