国产重组人白细胞介素-11衍生物预防和治疗化疗所致血小板减少症的Ⅱ期临床试验
[Phase II clinical trial on China manufactured recombinant human interleukin-11 derivative in the prevention and treatment of chemotherapy-induced thrombocytopenia].
作者信息
Wang Xing-yuan, Feng Feng-yi, Song San-tai, Wang Hua-qing, Zhang Mao-hong, Liu Jian, Liu Xu-yi, Xu Li-gong, Zhang Yang
机构信息
Department of Medical Oncology, Cancer Institute (Hospital), Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100021, China.
出版信息
Zhonghua Zhong Liu Za Zhi. 2005 Jun;27(6):373-6.
OBJECTIVE
This phase II clinical trial was designed to evaluate the efficacy and toxicity of recombinant human interleukin-11 (rhIL-11) derivative manufactured in China in the prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients.
METHODS
A total of 100 cancer patients with chemotherapy-induced thrombocytopenia (< or = 75 x 10(9)/L) were studied by self-cross control. Ninty-one of them received 2 cycles of chemotherapy. In the first cycle (control cycle) the patients received chemotherapy only, while in the second cycle (treatment cycle), the patients were given subcutaneous injection of rhIL-11 derivative (40 microg.kg(-1).d(-1)) once daily after chemotherapy for 10 consecutive days or more until platelet count reached > or = 300 x 10(9)/L.
RESULTS
- The patients with platelet count of < or = 75 x 10(9)/L was 89/89 in the control cycle and 44/89 in the treatment cycle (P = 0.00). The recovery time to the normal platelet count was 1-47 days (median 9 days) in the control cycle, and 1-18 days (median 5.5 days) in treatment cycle (P = 0.00). 2. Patients with platelet count of < or = 50 x 10(9)/L was 56/89 in the control cycle and 20/89 in the treatment cycle (P = 0.00). The recovery time to normal platelet count was 1-31 days (median 9 days) in the control cycle and 3-13 days (median 6 days) in the treatment cycle (P = 0.05). 3. The median nadir platelet count was 44 x 10(9)/L (range: 10 x 10(9)/L-75 x 10(9)/L) in the control cycle, and 83 x 10(9)/L (range: 10 x 10(9)/L-310 x 10(9)/L) in the treatment cycle (P = 0.00). The time of recovery to the normal platelet count was 1-31 days (median 6 days) in the control cycle, and 0-13 days (median 2 days) in the treatment cycle (P = 0.00). 4. Nine of 89 evaluable patients required platelet transfusion in the control cycle versus 1 of 89 patients in treatment cycle (P = 0.01), and the total platelet transfusion was 10 times in the control cycle versus once in the treatment cycle (P = 0.01). 5. The major adverse events associated with rhIL-11 derivative were: headache, fatigue, myalgia/arthralgia, edema and palpitation, etc.
CONCLUSION
rhIL-11 derivative can be safely and effectively used for the prevention and treatment for chemotherapy-induced thrombocytopenia.
目的
本II期临床试验旨在评估国产重组人白细胞介素-11（rhIL-11）衍生物预防和治疗癌症患者化疗所致血小板减少症的疗效和毒性。
方法
采用自身交叉对照研究100例化疗所致血小板减少症（≤75×10⁹/L）的癌症患者。其中91例患者接受2周期化疗。第1周期（对照周期）仅接受化疗，第2周期（治疗周期）在化疗后皮下注射rhIL-11衍生物（40μg·kg⁻¹·d⁻¹），每日1次，连续10天或更长时间，直至血小板计数≥300×10⁹/L。
结果
- 对照周期血小板计数≤75×10⁹/L的患者为89/89例，治疗周期为44/89例（P=0.00）。对照周期血小板计数恢复至正常的时间为1～47天（中位数9天），治疗周期为1～18天（中位数5.5天）（P=0.00）。2. 对照周期血小板计数≤50×10⁹/L的患者为56/89例，治疗周期为20/89例（P=0.00）。对照周期血小板计数恢复至正常的时间为1～31天（中位数9天），治疗周期为3～13天（中位数6天）（P=0.05）。3. 对照周期血小板计数最低值中位数为44×10⁹/L（范围：10×10⁹/L～75×10⁹/L），治疗周期为83×10⁹/L（范围：10×10⁹/L～310×10⁹/L）（P=0.00）。对照周期血小板计数恢复至正常的时间为1～31天（中位数6天），治疗周期为0～13天（中位数2天）（P=0.00）。4. 89例可评估患者中，对照周期9例需要输注血小板，治疗周期为1例（P=0.01），对照周期血小板输注总量为10次，治疗周期为1次（P=0.01）。5. rhIL-11衍生物相关的主要不良事件有：头痛、乏力、肌痛/关节痛、水肿、心悸等。
结论
rhIL-11衍生物可安全有效地用于预防和治疗化疗所致血小板减少症。
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