目的系统评价真实世界中贝利尤单抗治疗中国成人狼疮性肾炎(LN)患者的有效性和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、万方、中国知网、维普、中国生物医学文献数据库,搜集贝利尤单抗治疗中国成人L...目的系统评价真实世界中贝利尤单抗治疗中国成人狼疮性肾炎(LN)患者的有效性和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、万方、中国知网、维普、中国生物医学文献数据库,搜集贝利尤单抗治疗中国成人LN患者的真实世界研究,检索时限均从建库至2023年7月7日。由2位评价员独立筛选文献、提取资料并评价纳入研究的质量后,采用RevMan 5.3软件进行Meta分析。结果共纳入10篇真实世界研究,包括253例中国成人LN患者。Meta分析结果显示,贝利尤单抗治疗中国成人LN患者的肾脏完全缓解率、肾脏部分缓解率、不良反应发生率分别为61%(95%CI为46%~76%,P<0.00001)、23%(95%CI为2%~44%,P=0.03)、30%(95%CI为16%~43%,P<0.00001);贝利尤单抗可显著降低24 h尿蛋白水平(MD=-1.71,95%CI为-3.02~-0.40,P=0.01)、尿总蛋白肌酐比值(MD=-1.76,95%CI为-2.06~-1.46,P<0.00001)、系统性红斑狼疮疾病活动度指数(MD=-8.63,95%CI为-12.12~-5.13,P<0.00001)和糖皮质激素用量(MD=-18.65,95%CI为-31.82~-5.48,P=0.006),显著升高补体C3水平(MD=0.19,95%CI为0.08~0.30,P=0.0006)和补体C4水平(MD=0.06,95%CI为0.02~0.09,P=0.001),但不能改善血清肌酐水平和估算肾小球滤过率(P>0.05)。结论贝利尤单抗对中国成人LN患者具有良好的有效性和安全性。展开更多
Context: Manifestations of systemic lupus erythematosus (SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current...Context: Manifestations of systemic lupus erythematosus (SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current strategies are insufficient to control disease. Objective: To assess the safety of intense immunosuppression and autologous hematopoietic stem cell support in patients with severe and treatment-refractory SLE. Design, Setting, and Participants: A single-arm trial of 50 patients with SLE refractory to standard immunosuppressive therapies and either organ-or life-threatening visceral involvement. Patients were enrolled from April 1997 through January 2005 in an autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT) study at a single US medical center. Interventions: Peripheral blood stem cells were mobilized withcyclophosphamide (2.0 g/m2) and granulocyte colony-stimulating factor (5 μ g/kg per day), enriched ex vivo by CD34 + immunoselection, cryopreserved, and reinfused after treatment with cyclophosphamide (200 mg/kg) and equine antithymocyte globulin (90 mg/kg). Main Outcome: Measures The primary end point was survival, both overall and disease-free. Secondary end points included SLE Disease Activity Index (SLEDAI), serology (antinuclear antibody [ANA] and anti-double-stranded (ds) DNA), complement C3 and C4, and changes in renal and pulmonary organ function assessed before treatment and at 6 months, 12 months, and then yearly for 5 years. Results: Fifty patients were enrolled and underwent stem cell mobilization. Two patients died after mobilization, one from disseminated mucormycosis and another from active lupus after postponing the transplantation for 4 months. Forty-eight patients underwent nonmyeloablative HSCT. Treatment-related mortality was 2% (1/50). By intention to treat, treatment-related mortality was 4% (2/50). With a mean follow-up of 29 months (range, 6 months to 7.5 years) for patients undergoing HSCT, overall 5-year survival was 84% , and probability of disea展开更多
目的分析系统性红斑狼疮(systemic lupus erythematosus,SLE)与丙型肝炎病毒(hepatitis C virus,HCV)、乙型肝炎病毒(hepatitis B virus,HBV)、EB病毒(Epstein-Barr vrius,EBV)、巨细胞病毒(cytomegalovirus,CMV)感染关系。方法选取2017...目的分析系统性红斑狼疮(systemic lupus erythematosus,SLE)与丙型肝炎病毒(hepatitis C virus,HCV)、乙型肝炎病毒(hepatitis B virus,HBV)、EB病毒(Epstein-Barr vrius,EBV)、巨细胞病毒(cytomegalovirus,CMV)感染关系。方法选取2017年8月至2020年4月我院90例SLE患者作为观察组,另选取90例健康体检者作为对照组。比较两组、不同病情程度及不同抗中性粒细胞胞浆抗体(anti-neutrophil cytoplasmic antibodies,ANCA)、抗心磷脂抗体(anticardiolipin antibody,ACA)阳性患者HCV、HBV、EBV、CMV阳性率,分析病毒感染与SLE的关系,并随访1个月,比较狼疮肾炎与非狼疮肾炎患者各病毒抗体阳性率。结果(1)观察组HCV、HBV、EBV和CMV阳性率高于对照组(x^2=7.457,P=0.006;x^2=27.321,P<0.01;x^2=35.573,P<0.01;x^2=6.586,P=0.010);(2)HCV、HBV、EBV和CMV阳性为SLE发生危险因素(OR分别为5.076、7.517、10.724、5.925,P均小于0.05);(3)SLE活动期患者HCV、HBV、EBV、CMV阳性率高于稳定期(x^2=8.076,P=0.005;x^2=24.437,P<0.01;x^2=17.058,P<0.01;x^2=3.976,P=0.046);(4)ANCA阳性SLE患者EBV阳性率低于ANCA阴性(x^2=39.429,P<0.01);(5)狼疮肾炎患者HCV、HBV、EBV、CMV阳性率高于非狼疮肾炎患者(x^2=5.517,P=0.019;x^2=11.073,P=0.001;x^2=5.882,P=0.015;x^2=28.940,P<0.01)。结论CMV、HBV及HCV感染对SLE患者自身抗体无影响,EBV感染可能通过SLE患者自身抗体ANCA参与SLE病情进展。展开更多
文摘Context: Manifestations of systemic lupus erythematosus (SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current strategies are insufficient to control disease. Objective: To assess the safety of intense immunosuppression and autologous hematopoietic stem cell support in patients with severe and treatment-refractory SLE. Design, Setting, and Participants: A single-arm trial of 50 patients with SLE refractory to standard immunosuppressive therapies and either organ-or life-threatening visceral involvement. Patients were enrolled from April 1997 through January 2005 in an autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT) study at a single US medical center. Interventions: Peripheral blood stem cells were mobilized withcyclophosphamide (2.0 g/m2) and granulocyte colony-stimulating factor (5 μ g/kg per day), enriched ex vivo by CD34 + immunoselection, cryopreserved, and reinfused after treatment with cyclophosphamide (200 mg/kg) and equine antithymocyte globulin (90 mg/kg). Main Outcome: Measures The primary end point was survival, both overall and disease-free. Secondary end points included SLE Disease Activity Index (SLEDAI), serology (antinuclear antibody [ANA] and anti-double-stranded (ds) DNA), complement C3 and C4, and changes in renal and pulmonary organ function assessed before treatment and at 6 months, 12 months, and then yearly for 5 years. Results: Fifty patients were enrolled and underwent stem cell mobilization. Two patients died after mobilization, one from disseminated mucormycosis and another from active lupus after postponing the transplantation for 4 months. Forty-eight patients underwent nonmyeloablative HSCT. Treatment-related mortality was 2% (1/50). By intention to treat, treatment-related mortality was 4% (2/50). With a mean follow-up of 29 months (range, 6 months to 7.5 years) for patients undergoing HSCT, overall 5-year survival was 84% , and probability of disea
