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.