摘要（荷兰）：目的 采用双盲随机安慰剂对照实验，研究利妥昔单抗(人鼠嵌合型抗CD20单抗) 清除B细胞在原发性干燥综合征患者中的疗效和安全性。

方法 根据修订的美国-欧洲协作组标准诊断活动性原发性干燥综合征。唾液腺刺激分泌率≥0.15 ml/min的患者在第1天和第15天输注利妥昔单抗（1000mg）或安慰剂。患者随机分配到利妥昔单抗组和安慰剂组(比例=2：1)。并第5、12、24和48周随访。主要观察终点为唾液腺刺激流率，次要观察终点包括功能、实验室和主观参数。

结果 总共30例（29例女性）原发干燥综合征患者随机分配到两组。利妥昔治疗组患者年龄为(43±11)岁，病程(63±50)个月，而安慰剂组年龄(43±17)岁，病程(67±63)个月。结果发现，与安慰剂组相比，利妥昔组的唾液刺激流率较基线值有明显改善 (P = 0.038)，且多种试验指标（B细胞和RF水平）、主观参数（多维疲乏量表得分和干燥症状VAS得分）及腺体外表现也如此。另外，与基线值相比，利妥昔治疗组可明显改善刺激唾液流率(P = 0.004)和其他一些指标(如 B细胞和RF水平、未刺激唾液流率、泪腺功能、多维疲乏量表得分、SF-36健康问卷得分及干燥VAS得分) 。

结论：利妥昔是治疗原发性干燥综合征安全有效的生物制剂。

附原文 Abstract OBJECTIVE: To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sj?gren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial. METHODS: Patients with active primary SS, as determined by the revised American-European Consensus Group criteria, and a rate of stimulated whole saliva secretion of > r =0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables. RESULTS: Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean +/- SD age of the patients receiving rituximab was 43 +/- 11 years and the disease duration was 63 +/- 50 months, while patients in the placebo group were age 43 +/- 17 years and had a disease duration of 67 +/- 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P = 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor [RF] levels), subjective parameters (Multidimensional Fatigue Inventory [MFI] scores and visual analog scale [VAS] scores for sicca symptoms), and extraglandular manifestations. Moreover, in comparison with baseline values, rituximab treatment significantly improved the stimulated whole saliva flow rate (P = 0.004) and several other variables (e.g., B cell and RF levels, unstimulated whole saliva flow rate, lacrimal gland function on the lissamine green test, MFI scores, Short Form. 36 health survey scores, and VAS scores for sicca symptoms). One patient in the rituximab group developed mild serum sickness-like disease. CONCLUSION: These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.

引自：Meijer JM, Meiners PM, Vissink A, et al. Effectiveness of rituximab treatment in primary Sj?gren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8. 摘要（荷兰）：目的 采用双盲随机安慰剂对照实验，研究利妥昔单抗(人鼠嵌合型抗CD20单抗) 清除B细胞在原发性干燥综合征患者中的疗效和安全性。

方法 根据修订的美国-欧洲协作组标准诊断活动性原发性干燥综合征。唾液腺刺激分泌率≥0.15 ml/min的患者在第1天和第15天输注利妥昔单抗（1000mg）或安慰剂。患者随机分配到利妥昔单抗组和安慰剂组(比例=2：1)。并第5、12、24和48周随访。主要观察终点为唾液腺刺激流率，次要观察终点包括功能、实验室和主观参数。

结果 总共30例（29例女性）原发干燥综合征患者随机分配到两组。利妥昔治疗组患者年龄为(43±11)岁，病程(63±50)个月，而安慰剂组年龄(43±17)岁，病程(67±63)个月。结果发现，与安慰剂组相比，利妥昔组的唾液刺激流率较基线值有明显改善 (P = 0.038)，且多种试验指标（B细胞和RF水平）、主观参数（多维疲乏量表得分和干燥症状VAS得分）及腺体外表现也如此。另外，与基线值相比，利妥昔治疗组可明显改善刺激唾液流率(P = 0.004)和其他一些指标(如 B细胞和RF水平、未刺激唾液流率、泪腺功能、多维疲乏量表得分、SF-36健康问卷得分及干燥VAS得分) 。

结论：利妥昔是治疗原发性干燥综合征安全有效的生物制剂。

附原文 Abstract OBJECTIVE: To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sj?gren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial. METHODS: Patients with active primary SS, as determined by the revised American-European Consensus Group criteria, and a rate of stimulated whole saliva secretion of > r =0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables. RESULTS: Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean +/- SD age of the patients receiving rituximab was 43 +/- 11 years and the disease duration was 63 +/- 50 months, while patients in the placebo group were age 43 +/- 17 years and had a disease duration of 67 +/- 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P = 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor [RF] levels), subjective parameters (Multidimensional Fatigue Inventory [MFI] scores and visual analog scale [VAS] scores for sicca symptoms), and extraglandular manifestations. Moreover, in comparison with baseline values, rituximab treatment significantly improved the stimulated whole saliva flow rate (P = 0.004) and several other variables (e.g., B cell and RF levels, unstimulated whole saliva flow rate, lacrimal gland function on the lissamine green test, MFI scores, Short Form. 36 health survey scores, and VAS scores for sicca symptoms). One patient in the rituximab group developed mild serum sickness-like disease. CONCLUSION: These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.

引自：Meijer JM, Meiners PM, Vissink A, et al. Effectiveness of rituximab treatment in primary Sj?gren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8.