[A multicenter randomized phase II trial of domestic product of rhG-CSF(Rui Xue Xin) in preventing leukopenia caused by chemotherapy in patients with lung cancer].
BACKGROUND
To evaluate the effect and toxicity of the domestic product of rhG-CSF (Rui Xue Xin) in preventing leukopenia caused by chemotherapy in patients with lung cancer.


METHODS
67 patients in multicenter were randomly devided into AB group and BA group. The first cycle was a trial cycle (chemotherapy plus injection of Rui Xue Xin) , and the second cycle was a control cycle (chemotherapy alone) in AB group. On the contrast , the first cycle was a control cycle , and the second cycle was a trial cycle in BA group. The changes of white blood cell (WBC) and absolute neutrophil counts (ANC) , and the side effect of Rui Xue Xin were observed and compared between the trial cycle and control cycle.


RESULTS
Of the 67 patients , 6 cases were out of the trial because of patient compliance , and the another one case due to fever , and the other 61 cases could be used to analyze and to evaluate the effects and toxicity of Rui Xue Xin. The duration of leukopenia and neutropenia in cycle A was significantly shorter than that in cycle B ( P < 0. 01) . The nadirs of WBC and ANC following chemotherapy were remarkably higher in cycle A than those in cycle B ( P < 0. 01) . The incidence of chemotherapy delay due to WBC < 4. 0 *109 /L on the 21st day after chemotherapy in cycle A was also significantly lower than that in cycle B ( P < 0. 01) . The total rate of side effects of Rui Xue Xin was 26. 2 % , including pain and scleroma on the injection sites , weakness , fever. But , all of them were mild and didn't need to give any treatment.


CONCLUSIONS
The results demonstrate that Rui Xue Xin is able to reduce the degree of leukopenia and neutropenia , and to shorten the duration of leukopenia and neutropenia caused by chemotherapy in patients with lung cancer. The toxicity is also slight.
Zhou
Q
Q
Cancer Center , The First University Hospital , West China University of Medical Sciences , Chengdu , Sichuan 610041 , P. R. China.
Qiu
M
M
Hou
M
M
Ren
L
L
Li
L
L
Yi
C
C
Yang
Y
Y
Liu
L
L
Li
Z
Z
Xu
Y
Y
Luo
D
D
Wang
Q
Q
Zhang
L
L
Lin
J
J
Shi
J
J