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Herpes zoster (HZ) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the sensory ganglia. Postherpetic neuralgia (PHN) often occurs after herpes zoster heals and persists for a long time. At present, clinically anticonvulsants (such as gabapentin, pregabalin) and antidepressants (such as amitriptyline) are clinically first-line drugs for the treatment of PHN, which are not usually effective to treat PHN well, as well as to alleviate patients' bad mental symptoms. Esketamine, as a well-known N-methyl-D-aspartate receptor inhibitor, has both analgesic and antidepressant effects with extremely few incidence of respiratory depression, delirium, hallucinations, nausea and vomiting. Therefore, we hypothesize that esketamine could relieve PHN and Anxiety and depression-like symptoms symptoms in patients with PHN. This study intended to compare the efficacy of pregabalin, amitriptyline combined with esketamine therapy and pregabalin combined with amitriptyline therapy for alleviating PHN, and to further explore the feasibility and safety of esketamine in the treatment of PHN as well as underlying the mechanism of esketamine on the PHN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator |
| |
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine | Drug | The in-hospital intervention process is divided into a titration phase and an effect evaluation phase. After admission, all patients received pregabalin 150mg twice for one day and amitriptyline 12.5mg one piece per night. The treatment group was combined with intranasal esketamine three times per day, and individualized concentration titration was performed within 5 days. Set the initial dosage to 10mg for nasal drops. If the score is less than 5 points compared to the basic value, the dose is increased by 5 mg each time. When the dose reaches 25mg, the increment of the dose will be adjusted to 10mg. If the score is reduced by ≥5 points compared to the basic value, the current dose will be maintained and the titration will end. The titration phase will be finished when the titration dose reaches 35mg or untolerable adverse reactions occurs. Finally, a 7 tesla scan was performed on the right-hand patients with herpes on the body to explore the effect of ketamine on the brain network. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scales | The score to assess the pain degree | Baseline, once for the period of drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lieju Wang, Master | Contact | 18758131223 | 11518264@zju.edu.cn | |
| Min Yan, Doctor | Contact | zryanmin@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Yan, Doctor | The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University anesthesiology department | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline | Drug | The titration process in the control group with saline are the same as those in the treatment group with esketamine. |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |