Chu Da-tong, Xu Bing-he, Song San-tai, Mao Xue-hua, Jiao Shun-chang, Zhang Ai-lian
Department of Medical Oncology, Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China.
Zhonghua Zhong Liu Za Zhi. 2003 May;25(3):272-4.
To evaluate the efficacy and toxicity of domestic recombinant human interleukin-11 (rhIL-11) in the prevention of chemotherapy-induced thrombocytopenia.
A randomized, self-crossover and placebo-controlled trial was conducted, with rhIL-11 and placebo classified randomly as drug A and drug B. Patients were randomly assigned to group AB or group BA. 25 microg/kg body weight of drug A or drug B was administered subcutaneously once daily starting 24 hours after chemotherapy and continued for 7 to 14 days or until the platelet count reached > or = 300 x 10(9)/L.
118 patients were evaluable in the efficacy study. When compared with the placebo treated cycle, the results showed that rhIL-11 was able to significantly increase the platelet count at the nadir and d21 after chemotherapy, with a increase of 60.7% and 86.1% (both P < 0.001). The mean duration of thrombocytopenia (< 100 x 10(9)/L) in rhIL-11 treated cycle was 1.0 +/- 2.0 days as compared to 6.9 +/- 5.3 days in placebo treated cycle. The side effects were ache (24.6%), swelling (16.1%) and knurl (11.9%) at the injection site, hyperaemia of conjunctiva (16.1%), edema (8.5%), palpitation (6.8%) and fatigue (5.1%).
rhIL-11, possessing significant thrompoietic activity, significantly increases the likelihood of avoiding chemotherapy-induced thrombocytopenia and shorten the duration of thrombocytopenia. Its side effects are mild and manageable.
评价国产重组人白细胞介素-11（rhIL-11）预防化疗所致血小板减少症的疗效和毒性。
进行一项随机、自身交叉、安慰剂对照试验，将rhIL-11和安慰剂随机分为药物A和药物B。患者随机分为AB组或BA组。化疗后24小时开始，每日1次皮下注射药物A或药物B 25μg/kg体重，持续7至14天或直至血小板计数达到≥300×10⁹/L。
118例患者纳入疗效研究。与安慰剂治疗周期相比，结果显示rhIL-11能够显著提高化疗后最低点和第21天的血小板计数，分别增加60.7%和86.1%（均P<0.001）。rhIL-11治疗周期血小板减少（<100×10⁹/L）的平均持续时间为1.0±2.0天，而安慰剂治疗周期为6.9±5.3天。副作用为注射部位疼痛（24.6%）、肿胀（16.1%）和硬结（11.9%），结膜充血（16.1%）、水肿（8.5%）、心悸（6.8%）和乏力（5.1%）。
rhIL-11具有显著的促血小板生成活性，显著增加避免化疗所致血小板减少症的可能性，并缩短血小板减少症的持续时间。其副作用轻微且可控制。
