Meta AnalysisID 4676
Oleogel-S10（桦木三萜）临床疗效和安全性的系统文献综述
CRD42021251552
What is the efficacy, safety and tolerability of Oleogel-S10 for the treatment of wounds associated with dystrophic epidermolysis bullosa (DEB), junctional EB (JEB), and Kindler EB.
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 4676
- Evidence Id
- 13234
- Core Evidence Id
- 13234
- Source Meta Analysis Id
- 4644
- Herb2 Meta Analysis Id
- HBMA004644
- Crd Id
- CRD42021251552
- Title
- A systematic literature review of the clinical efficacy and safety of Oleogel-S10 (birch triterpenes)
- Review Question
- What is the efficacy, safety and tolerability of Oleogel-S10 for the treatment of wounds associated with dystrophic epidermolysis bullosa (DEB), junctional EB (JEB), and Kindler EB.
- Study Type Included
- Since EB is a rare genetic condition, although the hierarchy of evidence is valid with randomised controlled trials (RCTs) published in peer-reviewed journals being the preferred gold standard evidence, other prospective and retrospectively collected evidence in the population of interest will also be eligible. Eligible study designs will include: • RCTs; • Non-randomised comparative studies; • Non-comparative, single-arm experimental studies; • Open-label extension trials; • Retrospective and prospective observational cohort studies. Case series, case studies and case reports will be listed for reference but will not form part of data extraction and evidence synthesis. Natural history studies and registries collecting cross-sectional and longitudinal data will not be eligible for inclusion in this review.
- Condition Being Studied
- Epidermolysis bullosa (including dystrophic, junctional and Kindler EB). Epidermolysis bullosa (EB) is a group of disorders caused by more than 1, 000 known mutations in at least 20 genes encoding anchoring proteins of the dermo-epidermal junction. Defects of these proteins lead to different levels of cleavage within the skin according to their location in the dermo-epidermal junction. Based on the revised EB consensus classification published in 2020, EB is divided into four major categories, based on the level of skin cleavage: • EB Simplex (EBS); • Junctional EB (JEB); • Dystrophic EB (DEB); • Kindler EB. Disease onset is usually from birth in all types of EB, however severity differs greatly and can impact the length of time to diagnosis. The hallmark of most EB subtypes remains skin blistering as a result of mechanical force, with associated recurrent and persistent wounds. Many wounds in EB are classified as partial-thickness wounds, as the level of skin cleavage in the four major EB subtypes extends at maximum into the dermis. The total body wound burden of EB wounds has a decisive effect on the quality of life, as it relates to pain, itching, and the complexity of wound care.
- Participant
- The population of interest is adults and children (from birth), with EB of subtypes DEB (inclusive of DDEB and RDEB), JEB and Kindler EB. The population of EB simplex patients is not of interest, while mixed populations will be eligible where EBS is the minority (<50%), or where subtypes of interest are reported separately.
- Animal
- Human Disease Modelled
- Intervention
- The intervention of interest is Oleogel-S10 (birch triterpenes).
- Comparator Control
- Any comparators picked up by association will also be eligible, for patients in the same population. Trials and studies with a placebo control arm (such as the vehicle control gel found in EASE, for example), one with best supportive care (BSC) or physician directed standard of care (SoC), or with no comparator, will also be eligible.
- Main Outcome
- All clinical efficacy, safety and tolerability outcomes will be eligible, including any patient reported outcomes (PROs). This may include but are not limited to: • Clinical efficacy: time to wound healing measures, change from baseline in body surface area (BSA) covered by wounds, changes in wound burden (e.g. EBDASI); • Safety and tolerability: adverse events (of any type and severity), discontinuations; • PROs: health related quality of life in patients and/ or carers, and other quality of life aspects such as pain, itch, activities of daily living (ADL), procedural pain, and dressing changes.
- Outcome Measure
- Additional Outcome
- None.
- Study Method
- Intervention, Narrative synthesis, Systematic review
- Keyword
- Adult; Betula; Betulaceae; Child; Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional; Humans; Maximum Tolerated Dose; Oleogels; Organic Chemicals; Patient Safety; Safety; Treatment Outcome; Triterpenes; Wound Healing; Wounds and Injuries
- Contact
- Christine Worsley [email protected]
- Organisational Affiliation
- Tolley Health Economics
- Funding Source
- Amryt Pharma PLC
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- England
- Review Stage
- Review Ongoing
- First Submission Date
- 2021-04-26
- Registration Date
- 2021-04-27
- Anticipated Start Date
- 2021-04-20
- Anticipated Completion Date
- 2021-06-30
- Title Cn
- Oleogel-S10（桦木三萜）临床疗效和安全性的系统文献综述
- Title En
- A systematic literature review of the clinical efficacy and safety of Oleogel-S10 (birch triterpenes)
- Bilingual Status
- complete