This study was to evaluate the effect of a Chinese genetic engineering product of rhG-CSF (Lishengsu) on leukopenia induced by chemoradiotherapy in patients with malignant solid tumors. One hundred and forty cases of leukopenia following chemoradiotherapy for malignant tumors were treated with Lishengsu. When the total leukocyte counts (WBC) less than 3.0 x 10(9)/L or the absolute neutrophil count (ANC) less than 2.0 x 10(9)/L, Lishengsu was given 75 micro g/day subantaneously and the administration was stopped when the WBC counts rose up to 4.0 x 10(9)/L or higher, or the ANC counts reached 2.5 x 10(9)/L or more. The results showed that peripheral leukocyte counts in all patients following the treatment with Lishengsu were recovered and the average time of its administration was 4.8 days. The rate of its efficaciousness was 96.4%. It is concluded that Lishengsu could elevate nadirs of leukopenia and significantly shortened time period of leukopenia below 4.0 x 10(9)/L with acceptable mild side effects, decrease complications of infection so that the chinese product of rhG-CSF facilitates chemoradiotherapy significantly.
Adult ; Aged ; Antineoplastic Agents ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; adverse effects ; therapeutic use ; Humans ; Leukopenia ; drug therapy ; Male ; Middle Aged ; Neoplasms ; complications ; drug therapy ; Recombinant Proteins

Myelosupression is the major dose-limiting toxicity in most chemotherapeutic drugs. To evaluate the curative effect of a domestic product of rhG-CSF on chemotherapy-induced leukopenia, 132 patients with malignancies were enrolled, including 80 patients with lung cancer, 35 patients with breast cancer, 10 patients with nasopharyngeal carcinoma, 3 patients with non-Hodgkin's lymphoma, 2 patients with gastric carcinoma and 2 patients with bone metastasis. Total of 528 cycles of chemotherapy were performed. The results showed that according the grade of leukopenia, the different daily doses of the domestic product of rhG-CSF were administered: 75 micro g/d for 3 days, 150 micro g/d for 4 days and 300 micro g/d for 5 days, in grade I-II, grade III and grade IV groups, respectively, the times of recovery to normal level of white blood cells were 2.5, 4.2 and 7 days in 3 groups, respectively. In conclusion, The Chinese product of rhG-CSF shortened the duration of leukopenia and accelerated the hematologic recovery, which shows only slight side effects, so that patients receive the optimal doses of chemotherapy and completed the planned schedule on time.
Adolescent ; Adult ; Aged ; Antineoplastic Agents ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; adverse effects ; therapeutic use ; Humans ; Leukopenia ; drug therapy ; Male ; Middle Aged ; Neoplasms ; drug therapy ; Recombinant Proteins

OBJECTIVETo evaluate the efficacy and safety of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) hydrogel in wound healing in patients with deep partial thickness burn.

METHODSThe study was a multicenter, randomized, double-blind, placebo-controlled parallel clinical trial. Three hundred and twenty-one patients (302 cases finally fulfilled the protocol) with deep partial thickness burn were divided into A group (n = 200, with treatment of rhGM-CSF hydrogel, 100 microg/10 g/100 cm2/d), C group (n = 102,with treatment of placebo). Side-effect, systemic condition, wound healing time, wound healing rate, and total effective rate at different time points were observed.

RESULTSThere were no obvious differences in vital signs, wound secretion, wound edge reaction, blood and urine routine, liver and kidney function between two groups (P > 0.05). No side-effect was observed. The median wound healing time was 17 days in A group, which was obviously shorter than that in C group (20 days, P < 0.01). The mean wound healing rate in A group was 24.5%, 70.5%, 95.3%, 99.6% respectively on 8th, 14th, 20th, 28th day after treatment, which were obviously higher than that in C group (15.1%, 51.4%, 84.6%, 97.1%, respectively, P < 0.01). The total effective rates in A group on 8th, 14th, 20th day after treatment were also higher than that in C group (P < 0.01).

CONCLUSIONrhGM-CSF hydrogel can significantly accelerate wound healing in patients with deep partial thickness burn with certain safety.

Burns ; drug therapy ; Double-Blind Method ; Female ; Granulocyte-Macrophage Colony-Stimulating Factor ; adverse effects ; therapeutic use ; Humans ; Hydrogels ; therapeutic use ; Male ; Placebos ; Recombinant Proteins ; Wound Healing

The study was to observe the effect of rhG-CSF (lishengsu) in treating leukopenia caused by radiotherapy and chemotherapy in patients with breast cancer. 100 cases of breast cancer received modified radical mastectomy were randomized into two groups with the same treatment of one cycle chemotherapy using the protocol of CAF at two weeks after the operations and then radiotherapy. The patients in treated group received rhG-CSF 75 micro g per day s.c. for 5 - 7 days constantly, and additional 3 - 5 days according to leukopenia during radiotherapy. The patients in control group did not receive rhG-CSF during the chemo- and radio-therapy. The results shows that nadir of WBC and neutrophil counts in the treated group was higher than that in control significantly. In conclusion, effect of lishengsu on leucopenia in process of chemotherapy and radiotherapy shows definite therapeutic effect, the side effects are not remarkable.
Adult ; Breast Neoplasms ; therapy ; Combined Modality Therapy ; Female ; Granulocyte Colony-Stimulating Factor ; adverse effects ; therapeutic use ; Humans ; Leukopenia ; drug therapy ; Middle Aged ; Recombinant Proteins

Objective: To compare the time of the recovery of neutrophils or leukocytes by pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF) in the myelosuppressive phase after induction chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients. At the same time, the incidences of infection and hospitalization were compared. Methods: A prospective randomized controlled trial was conducted in patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017. The patients were randomly divided into two groups according to a 1:1 ratio: PEG-rhG-CSF group and rhG-CSF group. The time of neutrophil or leukocyte recovery, infection rate and hospitalization interval were compared between the two groups. Results: 60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group. There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups (P>0.05) . The median time (range) of ANC or WBC recovery in patients with PEG-rhG-CSF and rhG-CSF were 19 (14-35) d and 19 (15-26) d, respectively, with no statistical difference (P=0.566) . The incidences of infection in the PEG-rhG-CSF group and the rhG-CSF group were 90.0%and 93.3%, respectively, and there was no statistical difference (P=1.000) . The median days of hospitalization (range) was 20.5 (17-49) days and 21 (19-43) days, respectively, with no statistical difference (P=0.530) . Conclusions: In AML patients after induction therapy, there was no significant difference between the application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time.
Granulocyte Colony-Stimulating Factor/therapeutic use* ; Humans ; Induction Chemotherapy/adverse effects* ; Leukemia, Myeloid, Acute/drug therapy* ; Neutropenia ; Neutrophils ; Prospective Studies ; Recombinant Proteins

OBJECTIVETo evaluate the clinical efficacy of Yiqi Jianpi Recipe (YJR) in treating cancer-related fatigue (CRF) after chemotherapy in lung cancer patients. Methods Totally 124 lung cancer patients were assigned to the treatment group (63 cases) and the control group (61 cases) according to random digit table. All patients received pre-set chemotherapy regimens according their conditions. Patients in the treatment group took YJR Decoction from the 1st day of chemotherapy, one dose per day for 2 successive weeks, while those in the control group took no Chinese medical decoction. Changes of each dimensional scoring and the total scoring were observed by cancer fatigue scale (CFS) in the two groups one day before chemotherapy, on the 3rd day and the 14th day after chemotherapy. The degree of bone marrow depression and recombinant human granulocyte colony-stimulating factor (rhG-CFS) doses were also observed after chemotherapy.

RESULTSCompared with one day before chemotherapy in the same group, scorings for emotional, perceptional, and somatologic dimensions, and the total scoring significantly increased on the 3rd day in the treatment group, as well as on the 3rd and the 14th day in the control group (P <0. 01). Scorings for emotional, perceptional, and somatologic dimensions, and the total scoring significantly decreased more at the fourteenth day after chemotherapy than at the 3rd day after chemotherapy (P <0. 01). There was statistical difference in the scoring for perceptional dimension at day 3 between the treatment group and the control group (P <0.01). However, scorings for emotional, perceptional, and somatologic dimensions, and the total scoring significantly decreased more at the fourteenth day after chemotherapy in the treatment group, with statistical difference when compared with those in the control group (P <0. 01). The occurrence rate of bone marrow depression was 70. 97% (44/62) in the treatment group and 68. 85% (42/61) in the control group. There was no significant difference in the occurrence rate between the two groups (χ2=0. 540, P >0.05). There was no statistical difference in rhG-CFS doses between the two groups (χ2=0. 696, P >0. 05).

CONCLUSIONYJD could significantly relieve CRF after chemotherapy in lung cancer patients, and obviously attenuate the effect of CRF on their daily life.

Antineoplastic Agents ; adverse effects ; therapeutic use ; Biomedical Research ; Drug Therapy ; Drugs, Chinese Herbal ; therapeutic use ; Fatigue ; chemically induced ; drug therapy ; Granulocyte Colony-Stimulating Factor ; Humans ; Lung Neoplasms ; drug therapy ; Recombinant Proteins

OBJECTIVE: To investigate the effect of recombinant human granulocyte colony stimulating factor (rhG-CSF) on the clinical efficacy and flow cytometry (FCM) minimal residual disease (MRD) of patients with acute myeloid leukemia (AML) after initial induction therapy in the real world. METHODS: The clinical data of 44 AML patients who were diagnosed for the first time in the Department of Hematology, The Second Hospital of Anhui Medical University, and received the initial induction therapy were retrospectively analyzed. According to whether rhG-CSF was used after treatment, these patients were divided into control group and therapy group. The complete remission (CR) rate, duration of neutropenia, incidence of infection, duration of fever, cost of antibiotics drugs, length of hospital stay, FCM MRD, and relapse-free survival (RFS) time were compared between the two groups. RESULTS: The CR rate in the control group was 60%, and 74% in the therapy group (P=0.3429). The duration of neutropenia was (21.28±7.91) days in the control group and (14.79±3.07) days in the therapy group (P=0.0016). The duration of fever was (12.80±7.31) days in the control group and (9.11±7.48) days in the therapy group (P=0.0136). While, there were no statistically significant differences between the two groups in the incidence of infection, cost of antibacterial drugs, length of hospital stay and RFS time (all P>0.05). In addition, it is particularly noteworthy that among the patients who finally obtained CR in the therapy group, 66% of them had myeloid precursor cells detected by peripheral blood FCM (accounting for 2.25%±0.99%) at the time of the first release of neutropenia, which was easy to be misdiagnosed as MRD positive. CONCLUSION rhG-CSF not only don't affect the clinical remission rate after the initial induction treatment of AML, but also significantly shortens the time of duration of neutropenia and fever, however, it may affect the analysis of peripheral blood FCM MRD detection results when the neutropenia is released for the first time.
Flow Cytometry ; Granulocyte Colony-Stimulating Factor/therapeutic use* ; Humans ; Induction Chemotherapy/adverse effects* ; Leukemia, Myeloid, Acute/therapy* ; Neoplasm, Residual/etiology* ; Neutropenia ; Recombinant Proteins/therapeutic use* ; Retrospective Studies ; Treatment Outcome

The efficacy and safety of Lishengsu (a rhG-CSF preparation) were evaluated for treatment of chemotherapy-induced leukopenia. 327 cases of leukopenia with grade I-IV induced by chemotherapy were subcutaneously administered at 2.5 - 5.0 micro g/(kg x d) of Lishengsu, and hemogram and the side effects were observed. The results showed that Lishengsu had satisfactory effect to cure leukopenia after chemtherapy, with an effective rate of 99.4% (325/327), the side effects were quite slight. It is concluded that Lishengsu is efficient and safe for patients with leukopenia, and can be used as an adjuvant drug for treatment of leukopenia after chemotherapy.
Adolescent ; Adult ; Aged ; Drug-Related Side Effects and Adverse Reactions ; Female ; Granulocyte Colony-Stimulating Factor ; therapeutic use ; Hemoglobins ; analysis ; Humans ; Leukocyte Count ; Leukopenia ; blood ; chemically induced ; drug therapy ; Male ; Middle Aged ; Neoplasms ; blood ; drug therapy ; Platelet Count ; Recombinant Proteins ; Treatment Outcome

OBJECTIVETo explore the efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in the prophylaxis of chemotherapy-induced neutropenia.

METHODSPatients with previously untreated non-small cell lung cancer or breast cancer and with normal bone marrow function were eligible for the trial. In the phase I trial, patients were to treated with two cycles of paclitaxel/carboplatin chemotherapy every 21 days. In cycle 1, if absolute neutrophil count (ANC) dropped below 1.0 x 10(9)/ L with fever and/or ANC dropped below 0.5 x 10(9)/L, rhG-CSF 150 microg/d was administrated until WBC > or = 10 x 10(9)/L or ANC > or = 5.0 x 10(9)/L. In cycle 2, patients were to receive a single injection of PEG-rhG-CSF (30, 60, 100, or 200 microg/kg) 48 hours after chemotherapy. Pharmacodynamic analyses were performed.

RESULTSAll the 16 patients enrolled (4 in each group) were eligible for efficacy evaluation. In cycle 1, 7 patients received rhG-CSF administration because of grade 4 neutropenia, while in cycle 2, there was only 1 episode of grade 4 neutropenia, which were in the 30 microg/kg group. In cycle 1, the mean ANC nadir of 1.37 x 10(9)/L occurred on day 13 in the 9 patients who received no rhG-CSF administration. In cycle 2, the mean ANC nadirs were 0.77 x 10(9)/L, 4.54 x 10(9)/L, 3.00 x 10(9)/L, and 5.56 x 10(9)/L, respectively, in 30, 60, 100, or 200 microg/kg group. The nadirs of the first two groups occurred on day 8 of cycle 2, while those of the other two groups appeared on day 7. After PEG-rhG-CSF administration, two mean ANC peaks were observed. The first one ranging from 20.87 x 10(9)/L to 33.61 x 10(9)/L in the 4 groups appeared on day 3 to day 4. In the 30 microg/ kg group, the mean ANC reached the second peak at 5.03 x 10(9)/L on day 14. The second peaks on day 10 in the other groups were 12.42 x 10(9)/L, 11.59 x 10(9)/L, and 18.92 x 10(9)/L, respectively. Pharmacodynamic analyses showed sustained serum concentrations of PEG-rhG-CSF during the period of neutropenia.

CONCLUSIONSPEG-rhG-CSF administration may decrease the incidence of grade 4 neutopenia and result in earlier and higher nadir ANCs. PEG-rhG-CSF has a potential of once-per-cycle administration. The ANC and serum concentration of PEG-rhG-CSF are consistent with neutrophil receptor-mediated clearance.

Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; Carboplatin ; administration & dosage ; adverse effects ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Female ; Granulocyte Colony-Stimulating Factor ; biosynthesis ; pharmacology ; therapeutic use ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Neutropenia ; chemically induced ; prevention & control ; Paclitaxel ; administration & dosage ; adverse effects ; Recombinant Proteins

To investigate the efficaciousness of recombinant human granulocyte colony-stimulating factor (G-CSF) combined with recombinant human erythropoietin (EPO) in the treatment of patients with myelodysplastic syndrome (MDS), the hematological changes in the blood and bone marrow along with clinical features after treatment with G-CSF and EPO in 15 patients were observed. Patients were subcutaneously injected with G-CSF 300 microg/d for 10 days, then injected with EPO 100 U/(kg x d) for 10 days. The results showed that the obvious improvements in granulocytes of blood were found in 10 patients with MDS, improvements in erythrocytes of blood were observed in 7 patients with MDS. No serious side effects occured is all treated patients. In conclusion, treatment of G-CSF in combination with EPO is effective for patients with MDS.
Adult ; Aged ; Drug Therapy, Combination ; Erythrocyte Count ; Erythropoietin ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Fever ; chemically induced ; Granulocyte Colony-Stimulating Factor ; administration & dosage ; adverse effects ; therapeutic use ; Headache ; chemically induced ; Humans ; Injections, Subcutaneous ; Leukocyte Count ; Male ; Middle Aged ; Myelodysplastic Syndromes ; drug therapy ; pathology ; Recombinant Proteins ; Treatment Outcome