目的 对临床常用治疗膝骨关节炎（knee Osteoarthritis，KOA）的5种中成药使用中药有效性评价整合证据链法（integrated evidence chain-based efficacy evaluation of traditional Chinese medicine，Eff-iEC）和推荐分级的评估、制订和评价系统（grading of recommendations assessment,development and evaluation，GRADE）进行证据评价。方法 并行采用国际通用的GRADE系统与符合中医药特点的Eff-iEC，对指南/共识高频推荐的5种中成药开展双体系证据评价。同时运用Meta分析评价其临床有效性及安全性，并以临床有效率等核心指标进行证据判别。结果 GRADE评价显示，受限于随机对照试验（randomized controlled trial，RCT）在盲法及发表偏倚等瑕疵，5种中成药中金天格胶囊、痹祺胶囊被评价为C级（低级证据），其余均为B级（中级证据）。Eff-iEC法则实现了不同的证据分层：金天格胶囊（AA＋B＋）、壮骨关节胶囊（BAA）及痹祺胶囊（AA＋B＋）评价为“高级证据”；尪痹片/胶囊（BA＋B＋）、仙灵骨葆胶囊（BA＋B＋）评价为“中级证据”。Meta分析显示，中成药联合西医常规治疗可显著提升KOA临床总有效率（RR：1.15～1.26，均P＜0.05）。尪痹片/胶囊（RR＝0.41）、仙灵骨葆（RR＝0.57）等能显著降低不良反应风险，体现了明确的“增效减毒”价值。结论 Eff-iEC体系与GRADE在证据评价方面各有优势，Eff-iEC评价体系较GRADE系统能更全面地评价中医药的有效性证据，避免了因试验设计瑕疵导致的价值低估，但未来仍需开展高质量RCT进一步夯实证据的确定性。

Objective An evidence assessment was conducted on five commonly used traditional Chinese patent medicines for the treatment of knee osteoarthritis (KOA), using the integrated evidence chain-based efficacy evaluation of traditional Chinese medicine (Eff-iEC) method and the grading of recommendations assessment,development and evaluation (GRADE) system. Methods The internationally recognized GRADE system and Eff-iEC method, which aligns with the characteristics of TCM, were applied in parallel to evaluate the evidence for five high-frequency recommended CPMs from clinical guidelines and expert consensuses. Simultaneously, a Meta-analysis was performed to evaluate their clinical efficacy and safety, using the clinical effective rate as a core indicator for evidence determination. Results GRADE assessment showed that, due to limitations in randomized controlled trials (RCTs) such as blinding and publication bias, among the five Chinese patent medicines, Jintiange Capsules and Biqi Capsules were rated as Grade C (low-quality evidence), while the rest were rated as Grade B (moderate-quality evidence). In contrast, the Eff-iEC method provided different evidence stratification: Jintiange Capsules (AA+B+), Zhuangguguanjie Capsules (BAA), and Biqi Capsules (AA+B+) were identified as high-level evidence. Wangbi Tablets/Capsules (BA+B+), Xianling Gubao Capsules (BA+B+) were identified as moderatelevel evidence. The Meta-analysis showed that CPMs combined with conventional Western medical therapy significantly improved the overall clinical effective rate (RR range 1.15—1.26, all P < 0.05). Notably, Wangbi Tablets/Capsules (RR = 0.41), Xianling Gubao Capsules (RR = 0.57), significantly reduced the risk of adverse reactions, demonstrating efficacy enhancement and toxicity reduction effects. Conclusion The Eff-iEC system and GRADE each have their own advantages in evidence evaluation. The Eff-iEC evaluation system can more comprehensively assess the efficacy evidence of traditional Chinese medicine compared to the GRADE system, avoiding underestimation of value due to flaws in trial design. However, high-quality RCTs are still needed in the future to further strengthen the certainty of the evidence.

R285.64

中国中医科学院科技创新工程（CI2026A02018）；北京市中医药科技发展资金项目（BJZYYB-2025-18）；北京中医药薪火传承“新3＋3”工程尚天裕“三名”传承工作室建设项目