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Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy individuals with erythromycin skin test | The researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
| |
| healthy individuals with azithromycin skin test | The researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
| |
| healthy individuals with physiological saline | The researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | The researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the occurrence of type 1 hypersensitivity reaction | The results are observed within 20 ~ 30 minutes after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus. | 20-30 minutes after injection |
| Determine the occurrence of type 4 hypersensitivity reaction | The results are observed within 48-72 hours after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus. | 48-72 hours after injection |
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Inclusion Criteria:
Exclusion Criteria:
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The study is conducted in healthy adults aged 18-65 years, and there is no gender restriction for the subjects.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunzhao Xu | Contact | 0086-13814606776 | xuyz@ntu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yunzhao Xu | Affiliated Hospital of Nantong University | Study Director |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Azithromycin | Drug | The researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form. |
|
| physiological saline | Other | The researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form. |
|
| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |