Zhou Ling, Dong Jianxia, Deng Zehui, Wang Shaojuan, Fu Mengjie, Peng Jingjing, Zhang Jian
Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Front Med (Lausanne). 2025 Aug 29;12:1591366. doi: 10.3389/fmed.2025.1591366. eCollection 2025.
A primary goal of this study was to systematically assess the efficacy of rituximab (RTX) in treating cryoglobulinemic vasculitis (CV).
A prospectively registered meta-analysis was conducted to examine eligible randomized controlled trials (RCTs) or cohort studies through searches across PubMed, Embase, Cochrane Library, and Web of Science, with a search period up to February 12, 2025. Data analysis was conducted utilizing STATA 16.0.
Incorporating data from 12 studies involving 287 patients, CV patients who received RTX therapy demonstrated notable complete clinical response outcomes (Rate = 0.67, 95% confidence interval (95%CI): 0.61, 0.73) and a good clinical response rate. In addition, patients showed significant relief in symptoms such as skin purpura and skin ulcer (Rate = 0.92, 95%CI: 0.86,0.98). The meta-analysis findings indicated a notable enhancement in serum C4 levels in CV patients following treatment (mean difference (MD) = 0.06, 95%CI: 0.04, 0.07), both at 6-month (MD = 0.07, 95%CI: 0.05, 0.09) and 12-month (MD = 0.07, 95%CI: 0.03, 0.11) follow-ups. These findings suggest a gradual improvement in the underlying condition. The levels of IgM were significantly reduced following treatment (MD = -0.48, 95%CI: -0.65, -0.31), both at 6-month (MD = -1.05, 95%CI: -1.57, -0.52) and 12-month (MD = -0.59, 95%CI:-0.80, -0.38) follow-ups. The levels of cryoglobulin were also decreased following treatment (MD = -0.53, 95%CI: -0.80, -0.26), both at 6-month (MD = -0.67, 95%CI: -0.99, -0.35) and 12-month (MD = -0.67, 95%CI: -1.15, -0.19) follow-ups. Similarly, rheumatoid factor (RF) levels significantly decreased after treatment (MD = -318.20,95%CI:-364.66,-271.73) and remained low at the 6-month follow-up (MD = -287.78, 95%CI:-511.58,-63.97).
The meta-analysis supports the favorable clinical efficacy of rituximab in the management of CV patients. However, further validation through additional high-quality RCTs is warranted to solidify its effectiveness.
本研究的主要目标是系统评估利妥昔单抗（RTX）治疗冷球蛋白血症性血管炎（CV）的疗效。
进行了一项前瞻性注册的荟萃分析，通过检索PubMed、Embase、Cochrane图书馆和Web of Science来审查符合条件的随机对照试验（RCT）或队列研究，检索期截至2025年2月12日。使用STATA 16.0进行数据分析。
纳入了12项研究中的287例患者的数据，接受RTX治疗的CV患者显示出显著的完全临床缓解结果（率=0.67，95%置信区间（95%CI）：0.61，0.73）和良好的临床缓解率。此外，患者的皮肤紫癜和皮肤溃疡等症状有显著缓解（率=0.92，95%CI：0.86，0.98）。荟萃分析结果表明，CV患者治疗后血清C4水平显著升高（平均差（MD）=0.06，95%CI：0.04，0.07），在6个月（MD=0.07，95%CI：0.05，0.09）和12个月（MD=0.07，95%CI：0.03，0.11）随访时均如此。这些发现表明潜在病情逐渐改善。治疗后IgM水平显著降低（MD=-0.48，95%CI：-0.65，-0.31），在6个月（MD=-1.05，95%CI：-1.57，-0.52）和12个月（MD=-0.59，95%CI：-0.80，-0.38）随访时均如此。治疗后冷球蛋白水平也降低（MD=-0.53，95%CI：-0.80，-0.26），在6个月（MD=-0.67，95%CI：-0.99，-0.35）和12个月（MD=-0.67，95%CI：-1.15，-0.19）随访时均如此。同样，类风湿因子（RF）水平治疗后显著降低（MD=-318.20，95%CI：-364.66，-271.73），在6个月随访时仍较低（MD=-287.78，95%CI：-511.58，-63.97）。
荟萃分析支持利妥昔单抗治疗CV患者具有良好的临床疗效。然而，需要通过更多高质量的RCT进行进一步验证以巩固其有效性。
