Meta AnalysisID 2615
巨大戟醇甲基丁烯酸酯治疗光化性角化病：随机对照试验的系统评价
CRD42019130809
Ingenol mebutate for the treatment of actinic keratoses. PICO: P (Population): actinic keratoses in any part of the body; I (Intervention): ingenol mebutate; C (Comparator): placebo or other topical treatment; O (Outcome
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Record Fields
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- Meta Analysis Id
- 2615
- Evidence Id
- 11173
- Core Evidence Id
- 11173
- Source Meta Analysis Id
- 2567
- Herb2 Meta Analysis Id
- HBMA002567
- Crd Id
- CRD42019130809
- Title
- Ingenol mebutate for the treatment of actinic keratoses: a systematic review of randomized controlled trials
- Review Question
- Ingenol mebutate for the treatment of actinic keratoses. PICO: P (Population): actinic keratoses in any part of the body; I (Intervention): ingenol mebutate; C (Comparator): placebo or other topical treatment; O (Outcome): cure.
- Study Type Included
- Randomized clinical trials.
- Condition Being Studied
- Actinic keratosis (AKs) is the most frequent pre-malignant skin disease in the white population, and is a result of DNA damage due to cumulative dose of UV radiation absorbed during life. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. The lesions are considered part of a disease continuum, with the potential for the development of invasive squamous cell carcinoma (SCC), and a marker for an increased risk of non-melanoma skin cancer. Recent data indicates that the progression of a single AK to SCC ranges between 0-0.53% per year, although no definable clinical characteristics distinguish which actinic keratosis lesions pose a risk, and what proportion of actinic keratosis lesions will progress into a carcinoma. Several treatments are currently available for the treatment of AK, and these treatments vary in terms of dosing regimens and their associated compliance, efficacy and safety. Because cancer prevention is the main reason for treatment, and it is currently impossible to predict which lesions might become cancerous, participant complete clearance (PCC) or an equivalent efficacy outcome would be the best measure to compare the relative efficacy of the treatments available for AK.
- Participant
- Patients (immunocompetent adults ≥ 18 years of age) diagnosed with grade I (slightly palpable, more easily felt than seen), II (moderately thick hyperkeratotic, easily felt) or grade III (frankly visible and hyperkaratotic AK (10) on the face, forehead, scalp, hands, forearm and mucosal areas.
- Animal
- Human Disease Modelled
- Intervention
- Ingenol mebutate (IM) is a macrocyclic diterpene ester, which is approved for the field therapy of AKs. Patients treated with IM develop a marked local inflammatory reaction with erythema, scaling, erosions and pustules with a peak on day 4 of the treatment. The exact underlying mode of action of IM is still not completely understood, but a dual mechanism of action is proposed: at high concentrations (>100μM) causes rapid mitochondrial disruption leading to necrosis, and at low concentrations (10-1000 nM) stimulates a localized inflammatory response via activation of the PKC pathway and apoptosis. Li et al also demonstrated that IM is a substrate of P-glycoprotein, an ABC drug transporter, which facilitates dermal penetration of IM inducing vascular damage in a mouse model.
- Comparator Control
- Placebo or other topic treatment for actinic keratosis: 5-fluorouracil (5-FU), imiquimod, topical diclofenac.
- Main Outcome
- - Complete clearance of lesions in the treatment area, as rated by the physician at the end of the treatment (proportion of participants with 100% clearance of lesions present at baseline or all actinic keratosis lesions). - Incidence of patients with serious, treatment-related local or systemic adverse effects. Measures of effect At the end of the treatment (short-term).
- Outcome Measure
- Additional Outcome
- - Partial clearance: the proportion of participants with 75% clearance of lesions present at baseline). - Patients withdrawing from the study because of treatment-related adverse effects. - Patients satisfaction, as measured by the study. Measures of effect At the end of the treatment (short-term).
- Study Method
- Intervention, Systematic review
- Keyword
- Carcinoma, Squamous Cell; Disease Progression; Diterpenes; Humans; Keratosis, Actinic; Risk Factors; Skin; Skin Neoplasms; Treatment Outcome
- Contact
- Edina Koga da Silva [email protected]
- Organisational Affiliation
- Federal University of Sao Paulo - UNIFESP The Cochrane Collaboration https://www.unifesp.br/
- Funding Source
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English, Portuguese-Brazil
- Country
- Brazil
- Review Stage
- Review Ongoing
- First Submission Date
- 2019-04-09
- Registration Date
- 2019-07-16
- Anticipated Start Date
- 2019-03-29
- Anticipated Completion Date
- 2020-01-30
- Title Cn
- 巨大戟醇甲基丁烯酸酯治疗光化性角化病：随机对照试验的系统评价
- Title En
- Ingenol mebutate for the treatment of actinic keratoses: a systematic review of randomized controlled trials
- Bilingual Status
- complete