A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China

Study Overview
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Brief Summary
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This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018. The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description
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In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.

Official Title
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A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China

Conditions
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Upper Respiratory Tract Infection, Acute Tracheobronchitis

Intervention / Treatment
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* Drug: patients under 14 years of age using Reduning injeciton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 14 and below using Reduning injection from February 2018 to December 2018. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: patients under 14 years of age using Reduning injeciton|To assess in patients using Reduning injection's clinical features and drug adverse reaction during patients' hospital stay. The registry procedure will only for patients under 14 years of age using Reduning injection,observed from February 2018 to December 2018.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Reaction | Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ratio of Body Temperature to Normal | The Ratio of Body Temperature to Normal(Lower Than 37.3ºC) | 3 days | 
| The Ratio of WBC to Normal | The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L) | 3 days | 
| The Ratio of The Antibiotic Used | Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection. | 3 days |