A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor

Conditions
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Chemotherapy-induced Thrombocytopenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prescriptions explicitly given to the injection of Baijieyi; confirmed by histopathological or cytological examination of malignant tumors and chemotherapy; 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; male or female, aged 18-85 years; The main research information required is complete. Exclusion Criteria: using other platelets of chemicals or biological products in the in the chemotherapy cycle used Baijieyi; using drugs which can cause thrombocytopenia in the in the chemotherapy cycle used Baijieyi; bone marrow dysfunction or bone marrow involvement; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | For prevention | 56 days | 
| Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L | For treatment | 28 days after the administration of Baijieyi | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle | For prevention | 56 days | 
| the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle | For prevention | 56 days | 
| The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle | For prevention | 56 days | 
| the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L | For treatment | 28 days after the administration of Baijieyi | 
| the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L | For treatment | 28 days after the administration of Baijieyi | 
| The number of platelet transfusions | For treatment | 28 days after the administration of Baijieyi |