Chemotherapy-induced Thrombocytopenia
Conditions
Brief summary
The aim of this retrospective study is to review and describe the safety and the efficacy of recombinant human interleukin-11 (I) i (Baijieyi), using information already recorded in 20 medical records, The time periods include May 8th of 2008 to december 31st of 2016.
Interventions
None listed
Sponsors
Angde Biotech Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. prescriptions explicitly given to the injection of Baijieyi; 2. confirmed by histopathological or cytological examination of malignant tumors and chemotherapy; 3. treatment: platelet count had reached below 75×10\^9/L after the treatment of chemotherapy and before using Baijieyi; prevention: patients with chemotherapy at the beginning of the preventive administration of BaiJieyi, and chemotherapy is same with previous cycle; 4. male or female, aged 18-85 years; 5. The main research information required is complete.
Exclusion criteria
1. using other platelets of chemicals or biological products in the in the chemotherapy cycle used Baijieyi; 2. using drugs which can cause thrombocytopenia in the in the chemotherapy cycle used Baijieyi; 3. bone marrow dysfunction or bone marrow involvement; 4. There are other causes of thrombocytopenia, such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenic purpura, and hypersplenism, in the course of the use of Baijieyi.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L | 28 days after the administration of Baijieyi | For treatment |
| Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L, respectively, from the first time below 75×10^9/L at the chemotherapy cycle and the last chemotherapy cycle | 56 days | For prevention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle | 56 days | For prevention |
| The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle | 56 days | For prevention |
| the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L | 28 days after the administration of Baijieyi | For treatment |
| The number of platelet transfusions | 28 days after the administration of Baijieyi | For treatment |
| the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L | 28 days after the administration of Baijieyi | For treatment |
| the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle | 56 days | For prevention |
Other
| Measure | Time frame |
|---|---|
| adverse events, serious adverse events, laboratory tests, ECG | 28 days after the administration of Baijieyi |
Countries
China
Outcome results
None listed