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《中华消化外科杂志》2018年10月第17卷第10期论著

肝移植术后应用巴利昔单克隆抗体诱导的无糖皮质类固醇激素免疫抑制治疗方案的临床疗效

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引用本文:
张冬华,陈榕,王轩,等.肝移植术后应用巴利昔单克隆抗体诱导的无糖皮质类固醇激素免疫抑制治疗方案的临床疗效[J].中华消化外科杂志,2018,17(10):997-1001.DOI:10.3760/cma.j.issn.1673-9752.2018.10.006.
【摘要】

目的:探讨肝移植术后应用巴利昔单克隆抗体诱导的无糖皮质类固醇激素免疫抑制治疗方案的临床疗效。
方法:采用回顾性队列研究方法。收集2010年1月至2016年10月南京中医药大学附属八一医院收治的227例行肝移植患者的临床病理资料。227例患者中,125例术后采用巴利昔单克隆抗 体+他克莫司+吗替麦考酚酯片的无糖皮质类固醇激素免疫抑制治疗方案,设为无激素组;102例术后常规采用糖皮质类固醇激素+他克莫司+吗替麦考酚酯片免疫抑制治疗方案,设为激素组。观察指标:(1)随访和生存情况比较。(2)两组患者术后感染、排斥反应、胆道狭窄发生情况比较。采用门诊和电话方式进行随访,了解患者术后生存情况及感染、排斥反应、胆道狭窄发生情况。随访时间截至2017年6月。正态分布的计量资料以±s表示,组间比较采用t检验。偏态分布的计量资料以M(P25,P75)和M(范围)表示,组间比较采用秩和检验。计数资料比较采用x2检验。采用Kaplan-Meier法绘制生存曲线和计算生存率,采用Log-rank检验进行生存分析。
结果:(1)随访和生存情况比较:两组患者均获得术后随访,随访时间为9~89个月,中位随访时间为45个月。无激素组患者术后1、3年总体生存率分别为93.25%、85.24%,激素组患者分别为89.89%、74.22%,两组患者术后总体生存情况比较,差异有统计学意义(x2=8.450,P<0.05)。(2)两组患者术后感染、排斥反应、胆道狭窄发生情况比较:①无激素组和激素组患者术后感染发生例数分别为25、40例,其中感染肺炎克雷伯杆菌、金黄色葡萄球菌、念珠菌、鲍曼不动杆菌、嗜麦芽窄食单胞菌例数无激素组分别为18、3、2、2、0例,激素组分别为26、6、3、3、2例,两组比较,差异有统计学意义(x2=10.149,P<0.05)。两组术后发生感染患者均予积极抗感染对症治疗,激素组3例患者因严重肺部感染死亡,两组其余患者均好转。②无激素组和激素组患者术后排斥反应发生例数分别为6、5例,两组比较,差异无统计学意义(x2=0.950,P>0.05)。两组患者排斥反应均发生于术后1周内,激素组2例患者予糖皮质类固醇激素冲击治疗,两组其余患者予调整他克莫司和吗替麦考酚酯片剂量后好转。③无激素组和激素组患者术后胆道狭窄发生例数分别为32、 8例,两组比较,差异有统计学意义(x2=12.200,P<0.05)。激素组患者胆道狭窄均发生于停用糖皮质类固醇激素后。两组胆道狭窄患者行ERCP胆道支架植入术后好转。
结论:肝移植术后应用巴利昔单克隆抗体诱导的无糖皮质类固醇激素免疫抑制治疗方案安全可行,与常规糖皮质类固醇激素免疫抑制治疗方案比较,前者可显著减少术后感染发生,不增加排斥反应,并可改善远期总体生存,具有一定优势;但增加术后胆道狭窄发生。

【Abstract】

Objective:To investigate the clinical efficacy of basiliximabinduced glucosefree corticosteroid immunosuppressive regimen after liver transplantation.
Methods:The retrospective cohort study was conducted. The clinicopathological data of 227 patients with liver transplantation who were admitted to Bayi Hospital affiliated to Nanjing University of Traditional Chinese Medicine from January 2010 to October 2016 were collected. Of the 227 patients, 125 who postoperatively received a glucosefree corticosteroid immunosuppressive regimen using a monoclonal antibody + tacrolimus + mycophenolate mofetil tablets were allocated into the hormonefree group, and 102 who were postoperatively treated with the immunosuppressive regimen using glucocorticoid steroid + tacrolimus + mycophenolate mofetil tablets were allocated into the hormone group. Observation indicators: (1) comparison of followup and survival; (2) comparison of postoperative infection, rejection and biliary stenosis between groups. Followup using outpatient examination and telephone interview was performed to detect postoperative survival, infection, rejection and biliary stenosis up to June 2017. The measurement data with normal distribution were represented as ±s, and comparison between groups was done by the t test. Measurement data with skewed distribution were described as M (P25, P75) and M (range), and comparison between groups was analyzed using the rank sum test. The count data were compared by the chisquare test. Kaplan-meier method was used to draw survival curve and calculated survival rate. Log-rank test was used for survival analysis.
Results:(1) Comparison of followup and survival: patients between groups were followed up for 9-89 months, with a median time of 45 months. The 1 and 3year overall survival rates were respectively 93.25%, 85.24% in the hormonefree group and 89.89 %, 74.22% in the hormone group, with a statistically significant difference (x2=8.450, P<0.05). (2) Comparison of postoperative infection, rejection and biliary stenosis between groups: ① The total cases with postoperative infections, cases with infection of Klebsiella pneumoniae, Staphylococcus aureus, Candida, Acinetobacter baumannii and Stenotrophomonas maltophilia were 25, 18, 3, 2, 2, 0 in the hormonefree group and 40, 26, 6, 3, 3, 2 in the hormone group, respectively, showing a statistically significant difference between groups (x2=10.149, P<0.05). The patients between groups with postoperative infection were treated with active antiinfective symptomatic treatment. Three patients in the hormone group died of severe pulmonary infection, and the remaining patients in both groups were improved. ② The cases with postoperative rejection in the hormonefree group and hormone group were 6 and 5, respectively, with no statistically significant difference (x2=0.950, P>0.05). The rejection of both groups occurred within 1 week postoperatively. Two patients in the hormone group were treated with glucocorticoid hormonal shock. The other patients in the 2 groups were improved by adjusting the amount of tacrolimus and mycophenolate mofetil tablets. ③ The cases with postoperative biliary stenosis in the hormonefree group and the hormone group were 32 and 8 respectively, with a statistically significant difference (x2=12.200, P<0.05). In the hormone group, biliary stenosis occurred after stopping glucocorticoids. The patients with biliary stenosis were improved after biliary stent implantation by endoscopic retrograde cholangio pancreatography (ERCP).
Conclusion:The basiliximabinduced glucosefree corticosteroid immunosuppressive regimen after liver transplantation is safe and feasible, and it can significantly reduce the incidence of postoperative infection and improve longterm overall survival compared with the conventional glucocorticoid immunosuppressive regimen, but increased postoperative biliary stenosis.

DOI:10.3760/cma.j.issn.1673-9752.2018.10.006
基金项目:南京军区医学科技创新重点资助项目(12Z15)
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