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目的 评价国产重组人白细胞介素 11(rhIL 11)预防肿瘤化疗患者血小板减少的疗效及不良反应。方法 采用随机双盲自身交叉对照研究方法 ,将试验药品和安慰剂分为A药和B药 ,入选患者随机分为AB组或BA组。在化疗结束后 2 4h开始用药 ,2 5 μg kg体重 ,皮下注射 ,每日 1次 ,连续用药 7～ 14d或至血小板计数≥ 30 0× 10 9 L。结果 有 118例可评价疗效。rhIL 11可显著升高化疗后血小板最低值和化疗第 2 1天血小板值 ,升高幅度分别达 6 0 .7%和 86 .1% (P <0 .0 0 1) ;治疗周期出现血小板减少 (<10 0× 10 9 L)的持续时间为 1.0± 2 .0d ,而对照周期为 6 .9± 5 .4d。主要不良反应为注射部位疼痛 (2 4 .6 % )、红肿 (16 .1% )、硬结 (11.9% )、结膜充血 (16 .1% )、水肿 (8.5 % )、心悸(6 .8% )、乏力 (5 .1% )等 ,大都程度较轻 ,无其他严重不良反应。结论 rhIL 11具有明显的促血小板生成作用 ,可显著减少肿瘤患者化疗后血小板减少的发生 ,缩短血小板减少的持续时间。不良反应较轻且较易处理。
Objective To evaluate the efficacy and adverse reactions of domestic recombinant human interleukin 11 (rhIL 11) in preventing thrombocytopenia in patients undergoing chemotherapy. Methods A randomized, double-blind, self-controlled crossover study was conducted. The drugs and placebo were divided into drug A and drug B. The patients were randomly divided into AB group and BA group. The treatment started 24 hours after the chemotherapy, 25 g kg body weight, subcutaneous injection, once daily, for 7 to 14 consecutive days or to platelet count ≥ 30 0 × 109 L. Results 118 cases can be evaluated efficacy. rhIL 11 could significantly increase the platelet count after chemotherapy and the platelet count at 21 days after chemotherapy, with the increase of 67.7% and 86.1% (P <0.01), respectively; the thrombocytopenia (<10 0 × 10 9 L) duration was 1.0 ± 2.0 days, while the control period was 6.9 ± 5.4 days. The main adverse reactions were pain in the injection site (24.6%), inflamed (16.1%), induration (11.9%), conjunctival hyperemia (16.1%), edema ), Weakness (5.1%), most of the less severe, no other serious adverse reactions. Conclusion rhIL 11 has a significant role in promoting platelet production, which can significantly reduce the incidence of thrombocytopenia and reduce the duration of thrombocytopenia in patients with cancer after chemotherapy. Adverse reactions are light and easy to handle.