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


CONCLUSIONS
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.
Chu
Da-tong
DT
Department of Medical Oncology, Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China.
Xu
Bing-he
BH
Song
San-tai
ST
Mao
Xue-hua
XH
Jiao
Shun-chang
SC
Zhang
Ai-lian
AL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D017370:Interleukin-11 / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy; D011994:Recombinant Proteins / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000517:prevention & control*
D000970:Antineoplastic Agents; D017370:Interleukin-11; D011994:Recombinant Proteins