Objective: To determine the efficacy and safety of oral caffeic acid (CA) tablet in management of primary immune thrombocytopenia(ITP).
Methods: One hundred and three ITP patients with PLT>10×10⁹/L and no serious bleeding symptoms from three centers were enrolled. According to their platelet count before CA treatment, these patients were divided into group A (PLT<30×10⁹/L), including 24 females and 27 males with median age 48(18-84)years; and group B (PLT≥30×10⁹/L), including 33 females and 19 males with median age 43(18-83)years. Patients in both groups took CA tablets orally of 300 mg three times per day for 12 consecutive weeks. Combined medicine treatment such as corticosteroids, danazol, TPO and Rituximab, which might increase the platelet count of these patients, were not allowed during CA therapy.
Results: In group A, the overall response rate was 51.0%(26/51), with 2 patients achieving complete response (CR) and 24 patients achieving response(R). Of 26 patients achieving response (CR+R), the median platelet count before CA therapy was 20.5(15-28)×10⁹/L , and the median peak platelet count after CA therapy was 63(38-112)×10⁹/L. The median time to achieving response was 4(2-10) weeks. Patients with pretreatment PLT>20×10⁹/L showed significantly better response than those PLT<20×10⁹/L (68.0% vs 34.6%, P=0.017). In group B, the CR rate was 40.4%(21/52). Frequency of CA-related adverse events was 1.94%(2/103), including mild nausea in 1 case and elevation of liver enzymes in 1 case. Both were grade 1 and transient.
Conclusion: Caffeic acid was effective in patients with ITP with few and mild adverse effects.
目的: 评价咖啡酸片治疗原发免疫性血小板减少症(ITP)的有效性和安全性。
方法: 103例PLT>10×109/L且无严重出血症状的ITP患者纳入研究。根据治疗前血小板计数将患者分为：①A组(PLT<30×109/L)：男27例，女24例，中位年龄48(18~84)岁；②B组(PLT≥30×109/L)：男19例，女33例，中位年龄43 (18~83)岁。两组患者均给予咖啡酸片0.9 g/d（分3次口服），连用12周。治疗期间避免合用糖皮质激素、达那唑、TPO、利妥昔单抗等具有升血小板作用的药物。
结果: A组51例患者总有效率为51.0%，其中完全反应(CR)2例，有效(R)24例；26例治疗有效（CR+R)患者治疗前中位PLT为20.5(15.0~28.0）×109/L，治疗后中位PLT峰值为63.0(38.0~112.0）×109/L，中位起效时间为4(2~10)周；治疗前PLT≥20×109/L的患者有效率（CR+R)优于PLT<20×109/L的患者（68.0%对34.6%，P=0.017)；年龄、性别、疾病分期与疗效无相关性（P>0.05）。B组52例患者中，21例(40.4%)获得CR。不良事件发生率为1.94% (2/103)，包括Ⅰ度肝酶升高、Ⅰ度恶心各1例，均自行好转。
结论: 咖啡酸片对ITP有较好的疗效，不良反应发生率较低且轻微。