Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Collaborative Innovation Center of Hematology, Huazhong University of Science and Technology, Wuhan, China.
Technol Health Care. 2023;31(6):2363-2380. doi: 10.3233/THC-220537.
Currently, the frequency of coagulation dysfunction associated with chimeric antigen receptor-T cell (Car-T) therapy cannot yet be determined.
We performed a systematic review and meta-analysis to examine the prevalence of abnormal laboratory tests related to coagulation disorders in patients receiving Car-T therapy and provide a reference for future risk assessment mechanisms.
We searched PubMed, Embase, and Web of Science for relevant studies and evaluated their quality using the methodology index of non-random research (MINORS). 2672 quotations were retrieved via systematic searches. After screening of titles, abstracts and full-text, 45 trials involving 2541 patients were ultimately included. 41 studies reported the incidence of thrombocytopenia, 8 studies reported the rate of low fibrin, 4 trials reported the rate of APTT or PT abnormalities and only 3 trials reported the incidence of venous thromboembolism (VTE). We performed a quantitative meta-analysis to explore the incidence of thrombocytopenia following Car-T treatment. The incidence of hypofibrinogenemia, VTE, and abnormal APTT or PT was only qualitatively assessed, as fewer reports were included in this study.
The overall incidence of thrombocytopenia associated with Car-T therapy was 45.8% (95%[CI], 0.384-0.533). The highest rates of thrombocytopenia occurred in patients with multiple myeloma (60.1%, 95%[CI], 0.507-0.688) and aged between 18 to 60 (50%, 95%[CI], 0.367-0.633). There was greater prevalence of thrombocytopenia in BCMA-Car-T therapy of 58.7% (95%[CI], 0.482-0.685). Thrombocytopenia occurred most frequently in Car-T patients treated with a dosage of 1 × 105-1 × 106 cell/kg, at a rate of 66.2% (95%[CI], 0.561-0.749).
Overall, 45.8 percent of patients receiving Car-T treatment suffered from thrombocytopenia. Multiple myeloma patients, ages between 18-60, a dose of 1 × 105-1 × 106 cell/kg and BCMA-Car-T therapy are all considered high-risk factors.
目前，嵌合抗原受体 T 细胞（Car-T）治疗相关凝血功能障碍的频率尚无法确定。
我们进行了系统评价和荟萃分析，以检查接受 Car-T 治疗的患者中与凝血障碍相关的异常实验室检查的患病率，并为未来的风险评估机制提供参考。
我们在 PubMed、Embase 和 Web of Science 中检索了相关研究，并使用非随机研究方法学指数（MINORS）评估了它们的质量。通过系统搜索共检索到 2672 条引文。经过标题、摘要和全文筛选，最终纳入了 45 项试验，涉及 2541 名患者。41 项研究报告了血小板减少症的发生率，8 项研究报告了低纤维蛋白血症的发生率，4 项试验报告了 APTT 或 PT 异常的发生率，只有 3 项试验报告了静脉血栓栓塞症（VTE）的发生率。我们进行了定量荟萃分析，以探讨 Car-T 治疗后血小板减少症的发生率。由于本研究纳入的报告较少，因此仅对低纤维蛋白血症、VTE 和 APTT 或 PT 异常的发生率进行定性评估。
与 Car-T 治疗相关的血小板减少症的总体发生率为 45.8%（95%[CI]，0.384-0.533）。血小板减少症发生率最高的是多发性骨髓瘤患者（60.1%，95%[CI]，0.507-0.688）和 18 至 60 岁年龄组（50%，95%[CI]，0.367-0.633）。BCMA-Car-T 治疗的血小板减少症发生率更高，为 58.7%（95%[CI]，0.482-0.685）。血小板减少症在接受 1×105-1×106细胞/kg 剂量治疗的 Car-T 患者中最常见，发生率为 66.2%（95%[CI]，0.561-0.749）。
总体而言，接受 Car-T 治疗的患者中有 45.8%患有血小板减少症。多发性骨髓瘤患者、18 至 60 岁年龄组、1×105-1×106细胞/kg 剂量和 BCMA-Car-T 治疗均被认为是高危因素。
