1. Application of pegylated recombinant human granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia in patients with lymphoma: a prospective, multicenter, open-label clinical trial
Huiqiang HUANG ; Bing BAI ; Yuhuan GAO ; Dehui ZOU ; Shanhua ZOU ; Huo TAN ; Yongping SONG ; Zhenyu LI ; Jie JIN ; Wei LI ; Hang SU ; Yuping GONG ; Meizuo ZHONG ; Yuerong SHUANG ; Jun ZHU ; Jinqiao ZHANG ; Zhen CAI ; Qingliang TENG ; Wanjun SUN ; Yu YANG ; Zhongjun XIA ; Hailin CHEN ; Luoming HUA ; Yangyi BAO ; Ning WU
Chinese Journal of Hematology 2017;38(10):825-830
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.
2.Survey on vision-related quality of life for visual impairment students in special school
Ting CHEN ; Ganlin XIE ; Wenwen YE ; Zhiyong MENG ; Yuhong XIE ; Luoming HUANG ; Jianmin HU ; Liquan DONG ; Wenjian SHI
Chinese Journal of Rehabilitation Theory and Practice 2022;28(1):119-124
Objective To investigate visual impairment students' quality of life and its influencing factors in Braille learning class at Quanzhou Special School. Methods November, 2020, 52 students (aged seven to 26) with the best corrected distance visual acuity of the better eye above 0.02 were investigated with near visual acuity, contrast sensitivity and Chinese-version Low Vision Quality of Life Questionnaire (CLVQOL). The subjects were divided into second grade blindness group, first grade low vision group and second grade low vision group according to the best corrected distance visual acuity of the better eye. Results There were significant differences in distance visual acuity (Z = 45.671, P < 0.001), near visual acuity (Z = 24.972, P < 0.001), and contrast sensitivity (CS) ( Z = 13.285, P = 0.001) among three groups. There was a correlation between near visual acuity and distance visual acuity (r = 0.74, P < 0.001), CS to distance visual acuity (r = -0.58, P < 0.001) and near visual acuity (r = -0.57, P < 0.001), score of CLVQOL and CS (r = 0.44, P < 0.001). There were significant differences in the total score (Z = 10.145, P = 0.006), distance visual acuity subscale (Z = 13.586, P = 0.001), psychological adjustment subscale (Z = 7.824, P = 0.020), reading and fine work subscale (Z = 7.923, P = 0.019) of CLVQOL among the three groups. Conclusion Quality of life is different with the visual impairment for students in special school, especially the distance visual acuity, psychological adjustment and fine reading. CS correlates to the quality of life of visually impaired students, which needs to be a part of evaluation of visual function.