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| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
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To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pudilan Xiaoyan Oral Liquid | Drug | In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions. |
| 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio of Body Temperature to Normal | The Ratio of Body Temperature to Normal(Lower Than 37.3ºC) | 7 days |
| Change of liver function | Observation of liver function in at least 3000 patients before and after medication.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase.To observe whether the above liver function indexes appear abnormal once after medication. |
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Inclusion Criteria:
Exclusion Criteria:
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To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanming Xie, BA | Contact | 86-13911112416 | datamining5288@163.com | |
| Qing Miao, doctor | Contact | 86-13910812309 | wlxing@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, BA | Institute of Basic Research in Clinical Medicine, China Academy of Chinese | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40117581 | Derived | Wang M, Wang L, Liu F, Chen R, Wang Z, Cui X, Li Y, Xie Y. Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study. JMIR Res Protoc. 2025 Mar 21;14:e65789. doi: 10.2196/65789. |
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| ID | Term |
|---|---|
| C000627984 | Pudilan xiaoyan |
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| 7 days |
| Change of renal function | Observation of renal function in at least 3000 patients before and after medication.The renal function includes creatinine,usea nitrogen.To observe whether the above renal function indexes appear abnormal once after medication. | 7 days |