BPC-157在骨科与再生医学中的人体证据:疗效与安全性的系统评价。
完整摘要 · 中文译文
身体保护化合物-157(BPC-157)是一种合成十五肽,在运动员群体中常用于肌肉骨骼损伤的恢复,尽管其缺乏人体使用的监管批准,且证据主要局限于动物模型。本项遵循PRISMA的系统综述已前瞻性注册于PROSPERO(CRD420261406325),旨在评估BPC-157在人体中用于骨科和再生目的的有效性与安全性。检索了截至2026年6月1日的电子数据库(Embase、PubMed、Cochrane Library和ClinicalTrials.gov)。合格条件包括在任何适应症下、于人类参与者中研究BPC-157的定量和定性研究。分别使用美国国立卫生研究院无对照组前后对照研究质量评估工具和GRADE框架评估方法学质量和证据确信度。根据SWiM指南对结果进行叙述性综合。三项研究(n=30)符合纳入标准,包括一项关节腔内注射BPC-157治疗膝关节疼痛的回顾性研究(n=16),一项膀胱内灌注BPC-157治疗间质性膀胱炎的回顾性初步研究(n=12),以及一项评估静脉注射BPC-157安全性的前瞻性初步研究(n=2)。所有研究均报告大多数参与者的症状得到改善,且无治疗相关不良事件,但均被判定为方法学质量差。由于存在严重的偏倚风险、间接性和不精确性,总体证据确信度被评定为极低。因此,BPC-157不应被使用 在伦理批准、受监管、高质量的临床试验之外,临床上尚未在人类中使用。
完整摘要 · 英文原文
or mzyjp23@nottingham.ac.uk Body Protective Compound-157 (BPC-157) is a synthetic pentadecapeptide popular among athletic populations for musculoskeletal injury recovery, despite lacking regulatory approval for human use and evidence being largely limited to animal models. This PRISMA-compliant systematic review, prospectively registered with PROSPERO (CRD420261406325), aimed to evaluate the efficacy and safety of BPC-157 for orthopaedic and regenerative purposes in humans. Electronic databases (Embase, PubMed, Cochrane Library and ClinicalTrials.gov) were searched up to 1 June 2026. Eligibility included quantitative and qualitative studies investigating BPC-157 for any indication in human participants. Methodological quality and certainty of evidence was assessed using the National Institutes of Health Quality Assessment Tool for Before-After Studies With No Control Group and GRADE framework respectively. Findings were narratively synthesised in accordance with SWiM guidance. Three studies (n=30) met the inclusion criteria, consisting of a retrospective study of intra-articular BPC-157 injections for knee pain (n=16), a retrospective pilot study of intravesical BPC-157 for interstitial cystitis (n=12), and a prospective pilot study evaluating intravenous BPC-157 safety (n=2). All studies reported symptom improvement in most participants without treatment-related adverse events, but were judged to be of poor methodological quality. Overall certainty of evidence was rated very low due to serious risk of bias, indirectness and imprecision. Accordingly, BPC-157 should not be used clinically in humans outside ethically approved, regulated, high-quality clinical trials.