CAJ | 학술논문

目的观察熊去氧胆酸(UDCA)、UDCA联合泼尼松龙、UDCA联合硫唑嘌呤3种方案治疗对原发性胆汁性肝硬化(PBC)的疗效,并评价影响疗效的危险因素.方法 82例初诊PBC患者随机分为单用UDCA(U组,28例)、UDCA联合泼尼松龙(UP组,27例)、UDCA联合硫唑嘌呤(UA组,27例)3个治疗组,在治疗第0、3、6、12个月采集临床、实验室资料及药物不良反应.主要采用重复测量的方差分析和COX回归进行统计学处理.结果 UP组患者较U组及UA组在乏力和瘙痒程度上有明显改善(P=0.015和P=0.037),U组、UA组无改善.3组患者治疗后丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、碱性磷酸酶(ALP)、谷氨酰转肽酶(GGT)、总胆红素、直接胆红素(DBIL)和IgM均下降,组内比较差异有统计学意义(P＜0.05),3组间比较差异无统计学意义(P＞0.05).发生疾病进展的患者Mayo危险性评分高(P=0.018)、凝血酶原时间(PT)延长(P=0.042).UP组血糖升高2例、满月脸5例、多毛1例;UA组白细胞下降2例,胆绞痛1例,U组未出现药物不良反应.ALP、GGT、总胆固醇基线水平高是生化缓解的危险因素(P=0.015).总胆红素、DBIL、总胆汁酸增高、PT延长不利于肝生化缓解(P=0.075).结论 3种方案对PBC患者肝脏生化指标、IgM的改善作用相近,UDCA联合泼尼松龙方案可减轻乏力、瘙痒症状,单用UDCA方案不良反应发生率最低.Mayo危险性评分高、PT延长的患者疾病易进展;高水平的ALP、GGT、总胆固醇是生化缓解的危险因素;高水平的总胆红素、DBIL、总胆汁酸、PT不利于生化缓解.
목적 관찰웅거양담산(UDCA)、UDCA연합발니송룡、UDCA연합류서표령3충방안치료대원발성담즙성간경화(PBC)적료효,병평개영향료효적위험인소.방법 82례초진PBC환자수궤분위단용UDCA(U조,28례)、UDCA연합발니송룡(UP조,27례)、UDCA연합류서표령(UA조,27례)3개치료조,재치료제0、3、6、12개월채집림상、실험실자료급약물불량반응.주요채용중복측량적방차분석화COX회귀진행통계학처리.결과 UP조환자교U조급UA조재핍력화소양정도상유명현개선(P=0.015화P=0.037),U조、UA조무개선.3조환자치료후병안산전안매(ALT)、천동안산전안매(AST)、감성린산매(ALP)、곡안선전태매(GGT)、총담홍소、직접담홍소(DBIL)화IgM균하강,조내비교차이유통계학의의(P＜0.05),3조간비교차이무통계학의의(P＞0.05).발생질병진전적환자Mayo위험성평분고(P=0.018)、응혈매원시간(PT)연장(P=0.042).UP조혈당승고2례、만월검5례、다모1례;UA조백세포하강2례,담교통1례,U조미출현약물불량반응.ALP、GGT、총담고순기선수평고시생화완해적위험인소(P=0.015).총담홍소、DBIL、총담즙산증고、PT연장불리우간생화완해(P=0.075).결론 3충방안대PBC환자간장생화지표、IgM적개선작용상근,UDCA연합발니송룡방안가감경핍력、소양증상,단용UDCA방안불량반응발생솔최저.Mayo위험성평분고、PT연장적환자질병역진전;고수평적ALP、GGT、총담고순시생화완해적위험인소;고수평적총담홍소、DBIL、총담즙산、PT불리우생화완해.
Objective The aims of this study were to compare the clinical and laboratory responses to ursodeoxycholic acid (UDCA) monotherapy with the combination therapy of UDCA plus prednisolone/azathioprine in primary biliary cirrhosis(PBC),and to investigate the risk factors affecting the therapeutic responses.Methods Eighty-two patients with untreated PBC were divided randomly into three groups.Group U (28 patients) received UDCA alone,group UP(27 patients) received UDCA and pr ednisolone,while group UA (27 patients ) received UDCA and azathioprine.The clinical and laboratory data were recorded after treated for 3,6 and 12 months.Repeated measures ANOVA and COX regression model were used for statistical analysis.Results Fatigue and pruritus were improved only in group UP(P=0.015 and P=0.037 respectively).Alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyl transferase (GGT),total bilirubin (TBIL),direct bilirubin (DBIL) and IgM in the 3 groups were decreased (P＜0.05),while there was no statistical significant difference between the three groups (P＞0.05).The patients with disease progression had higher Mayo risk score (MRS) (P=0.018) and prolonged prothrombin time (PT)(P=0.042).In group UP,side-effect associated with glucocorticosteroids occurred in eight patients while there was no side-effect in group U.High baseline levels of ALP、GGT and CHO were risk factors for biochemical remission(P=0.015).The increase of DBIL,TBIL,total bile acid(TBA) and PT did not contribute to the prediction of biochemical remission ( P=0.075 ).Conclusion There are no differences among the three groups in the improvement of hepatic biochemical data and IgM.The combination therapy of UDCA with prednisolone could relieve fatigue and itching.The disease of patients with higher Mayo risk score and prolonged PT tend to progress.High baseline levels of ALP,GGT and CHO are risk factors for biochemical remission.High baseline levels of TBIL,DBIL,TBA and PT could not predict biochemical remission.The incidence of adverse effect is lowest when treated with UDCA alone.