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| Name | Class |
|---|---|
| Tianjin Sinobioway Biomedicine Co.Ltd. | UNKNOWN |
| Hunan Children's Hospital | OTHER_GOV |
| Children's Hospital of Chongqing Medical University | OTHER |
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This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Interferon α-2b Spray | Experimental |
| |
| Ribavirin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Interferon α-2b Spray | Drug | Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour). |
| Measure | Description | Time Frame |
|---|---|---|
| The defervesce rate during treatment by 72 hours | Body temperature returned to normal,and remain at least 24 hours. | Measure the body temperature every 4 hours from starting of treatment to the 96th hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal blood routine | White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0". | Before admission and 72th hours after treatment. |
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Inclusion Criteria:
Subjects should meet all of the following:
Exclusion Criteria:
Subjects should be excluded if meet any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | 201102 | China |
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| ID | Term |
|---|---|
| D006557 | Herpangina |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Yuying Children's Hospital of Wenzhou Medical University |
| OTHER |
| Qilu Children's Hospital of Shandong University | OTHER |
| Children's Hospital of Kaifeng City | UNKNOWN |
| Shenzhen Children's Hospital | OTHER_GOV |
| Zunyi Medical College | OTHER |
| Changhai Hospital | OTHER |
| Anhui Provincial Children's Hospital | OTHER |
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| Ribavirin | Drug | Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ). |
|
| The significant efficiency rate |
Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved. |
| From starting of treatment to the 48th hour. |
| The effective rate | Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved. | From starting of treatment to the 72th hour. |
| The ineffective rate | After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty. | From starting of treatment to the 96th hour. |
| The total effective rate | Total effective rate = efficiency rate + effective rate. | From starting of treatment to the 96th hour. |
| Total hospital stay | From starting of treatment to the 96th hour. |
| Appetite improvement | From starting of treatment to the 96th hour. |
| Myocardial enzymes and electrocardiogram | Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal. | Before admission and 72th hours after treatment. |
| The condition of herpes and ulcers subside | Clinical examination to check herpes subsided, ulcer wounds smaller, with or | Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour. |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004457 | Echovirus Infections |