Objective: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in prophylaxis neutropenia after chemotherapy in patients with lymphoma. Methods: This was a multicenter, single arm, open, phase Ⅳ clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of Ⅲ/Ⅳ grade neutropenia and febrile neutropenia (FN) after each chemotherapy cycle. Meanwhile the rate of antibiotics application during the whole period of chemotherapy was observed. Results: ①Among the 410 patients, 8 cases (1.95%) were contrary to the selected criteria, 35 cases (8.54%) lost, 19 cases (4.63%) experienced adverse events, 12 cases (2.93%) were eligible for the termination criteria, 15 cases (3.66%) develpoed disease progression or recurrence, thus the rest 321 cases (78.29%) were into the Per Protocol Set. ②During the first to fourth treatment cycles, the incidences of grade Ⅳ neutropenia after prophylactic use of PEG-rhG-CSF were 19.14% (49/256) , 12.5% (32/256) , 12.18% (24/197) , 13.61% (20/147) , respectively. The incidences of FN were 3.52% (9/256) , 0.39% (1/256) , 2.54% (5/197) , 2.04% (3/147) , respectively. After secondary prophylactic use of PEG-rhG-CSF, the incidences of Ⅳ grade neutropenia decreased from 61.54% (40/65) in the screening cycle to 16.92% (11/65) , 18.46% (12/65) and 20.75% (11/53) in 1-3 cycles, respectively. The incidences of FN decreased from 16.92% (11/65) in the screening cycle to 1.54% (1/65) , 4.62% (3/65) , 3.77% (2/53) in 1-3 cycles, respectively. ③The proportion of patients who received antibiotic therapy during the whole period of chemotherapy was 34.39% (141/410) . ④The incidence of adverse events associated with PEG-rhG-CSF was 4.63% (19/410) . The most common adverse events were bone pain[3.90% (16/410) ], fatigue (0.49%) and fever (0.24%) . Conclusion During the chemotherapy in patients with lymphoma, the prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade Ⅲ/Ⅳ neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve its cure rate.

Objective To explore the diagnostic value of the combined detection of serum allograft inflammatory factor-1 (AIF-1), growth differentiation factor-15 (GDF15), and doublecortin-like kinase 1 (DCLK1) in breast cancer. Methods A total of 114 female breast cancer patients (breast cancer group) and 114 female volunteers (control group) who underwent physical examination were selected. Enzyme-Linked immunosorbent assay was applied to detect serum levels of AIF-1, GDF15, and DCLK1. Multivariate Logistic regression was used to analyze the risk factors affecting breast cancer. ROC curve was used to analyze the diagnostic value of serum AIF-1, GDF15, DCLK1 levels in breast cancer. Results The serum levels of AIF-1, GDF15, and DCLK1 in the breast cancer group were obviously higher than those of the control group (P<0.05). The expression levels of serum AIF-1, GDF15, and DCLK1 were significantly elevated in breast cancer patients with stage Ⅲ-Ⅳ, moderate and poor differentiation, lymph-node metastasis, and Ki-67 positive (P<0.05). Serum AIF-1, GDF15, and DCLK1 were risk factors for breast cancer, and the areas under the curve (AUC) for single and combined diagnosis of breast cancer for all three were 0.834, 0.753, 0.861, and 0.930, respectively. Additionally, the combined diagnosis AUC values were significantly higher than those assessed alone (Z_{combination-AIF-1}=3.479, Z_{combination-GDF15}=5.147, and Z_{combination-DCLK1}=3.121; all P<0.05). Conclusion In breast cancer patients, the serum AIF-1, GDF15, and DCLK1 levels increase. They are risk factors for breast cancer, and the combined diagnosis of the three is more effective.