[Recombinant human interleukin-11 in the prevention of chemotherapy-induced thrombocytopenia].

Abstract

OBJECTIVE:

To evaluate the efficacy and toxicity of domestic recombinant human interleukin-11 (rhIL-11) in the prevention of chemotherapy-induced thrombocytopenia.

METHODS:

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.

RESULTS:

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%).

CONCLUSION:

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.

• Authors: Da-tong Chu, Bing-he Xu, San-tai Song, Xue-hua Mao, Shun-chang Jiao, Ai-lian Zhang
• Journal: Zhonghua zhong liu za zhi [Chinese journal of oncology] (Zhonghua Zhong Liu Za Zhi) Vol. 25 Issue 3 Pg. 272-4 (May 2003) ISSN: 0253-3766 [Print] China
• PMID: 12839693 (Publication Type: Clinical Trial, English Abstract, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Interleukin-11
• Recombinant Proteins

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (adverse effects)
• Cross-Over Studies
• Double-Blind Method
• Humans
• Interleukin-11 (adverse effects, therapeutic use)
• Middle Aged
• Neoplasms (blood, drug therapy)
• Recombinant Proteins (therapeutic use)
• Thrombocytopenia (prevention & control)