[Recombinant Human Interleukin 11 (Mega) Promotes Thrombopoiesis in Cancer Patients with Chemotherapy-Induced Myelosuppression]
A randomized, selfcross-over and placebo-controlled clinical trial has been taken to evaluated the curative efficacy of rhIL-11 (Mega) for thrombocytopenia in 29 cancer patients with severe myelosuppression induced by chemotherapy. Twenty-five micro g/kg of Mega or placebo was administered subcutaneously once daily starting 24 hours after the completion of chemotherapy, and continuing for 7 to 14 days or until the platelet count reached 300 x 10(9)/L. The results from those in 118 cases performed phase II clinical trial, showed that there were 29 cases with platelet count less than 50 x 10(9)/L in placebo cycle, but there was only 1 case in Mega cycle. The percentage of the patients with platelet count less than 50 x 10(9)/L in placebo cycle of placebo + Mega group was higher than that of Mega + placebo group. The nadir and platelet counts on day 21 after chemotherapy in Mega cycle were 2.04 and 1.43 times more than those in placebo cycle, respectively. The data show that Mega had significant thrombopoietic activity with a long lasting oction for the patients experienced severe myelosuppression. It significantly increases the likelyhood of avoiding thrombocytopenia in cancer patients undergoing chemotherapy and shortens the duration of thrombocytopenia.
Chu
Da-Tong
DT
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China; The Hospital Affiated to the Academy of Military Medical Sciences, Beijing 100039, China; Cancer Hospital of Fujian Province, Fuzhou 350014, China; The PLA General Hospital, Beijing 100853, China; Cancer Hospital of Tianjin, Tianjin 300060, China; Medicinal Biotechnology Center of Beijing SL Pharmaceutical Co. Ltd, Beijing 100041, China.
Xu
Bing-He
BH
Song
San-Tai
ST
Mao
Xue-Hua
XH
Jiao
Shun-Chang
SC
Zhang
Ai-Lian
AL
Cong
Jie
J