Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2026, Vol. 31 ›› Issue (9): 1286-1296.doi: 10.12092/j.issn.1009-2501.2026.09.015
Received:2025-08-01
Revised:2025-12-02
Online:2026-09-26
Published:2026-10-08
CLC Number:
Zishun GAO, Yunxia LI. Research progress in immunotherapy and emerging technologies for osteoarthritis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(9): 1286-1296.
| 药物名称 | 靶点/作用 | 目的 | 受试者情况 | 给药方案 | 随访时间 | 试验结果 | 试验编号/文献编号 |
| 阿达木单抗 | TNF | 评估在侵蚀性HOA患者疗效 | 43人,18治疗,25安慰剂 | 40 mg,皮下注射,间隔14 d | 3个月 | 无缓解疼痛 | ACTRN12612000791831[ |
| 评估在疼痛性HOA患者疗效 | 85人,41治疗,37安慰剂组 | 40 mg,皮下注射,间隔15 d | 6个月 | 无缓解疼痛 | NCT00597623[ | ||
| 依那西普 | TNF-α | 评估在侵蚀性HOA患者疗效 | 90人,45治疗,45安慰剂组 | 50 mg,皮下注射,间隔7 d | 6个月 | 无缓解疼痛 | NTR1192[ |
| 鲁吉珠单抗 | IL-1α/β | 评估在侵蚀性HOA患者中的疗效、安全性 | 110人,49治疗,61安慰剂组 | 200 mg,皮下注射,间隔14 d | 6个月 | 无缓解疼痛 | NCT02384538[ |
| 评价在伴有滑膜炎的KOA患者中的疗效 | 347人,随机分配治疗组和安慰剂组 | 25、100或200 mg组,皮下注射,间隔14 d | 13个月 | 无缓解疼痛和抗炎效果 | NCT02087904[ | ||
| 卡那单抗 | IL-1β | 评估全髋关节或全膝关节置换术的发生率 | 10 061人,随机分配治疗组和安慰剂组 | 50、150或300 mg,皮下注射,间隔3个月 | 3.7年 | 置换率降低 | NCT01327846[ |
| 托珠单抗 | IL-6 | 评价在HOA患者中的疗效 | 91人,45治疗,46安慰剂组 | 8 mg/kg,静脉注射,间隔4周 | 3个月 | 无缓解疼痛 | NCT02477059[ |
| 奥替利单抗 | GM-CSF | 评价在HOA患者中的疗效、安全性 | 44人,22治疗,22安慰剂组 | 180 mg,皮下注射,间隔1个月 | 10周 | 无缓解疼痛 | NCT02683785[ |
| 地诺单抗 | RANKL | 评估在侵蚀性HOA患者 结构修饰的影响 | 100人,51治疗,49安慰剂组 | 60 mg,皮下注射,间隔3个月 | 48周 | 具有结构修饰作用 | 2015-003223-53[ |
| 他尼珠单抗 | NGF | 评价在KOA患者安全性和镇痛功效 | 450人,每组75治疗,75安慰剂组 | 10、25、50、100或200 μg/kg,静脉注射,间隔 56 d | 16周 | 疼痛减轻和功能改善 | NCT00394563[ |
| 他尼珠单抗 | NGF | 评价 在OA患者中的疗效 | 2.5、5 mg,皮下注射,间隔16周/ 24周 | 24周 | 缓解疼痛 | NCT02697773 NCT02709486 NCT02528188[ | |
| 甲氨蝶呤 | 抗炎 | 评估HOA患者疼痛和结构进展的影响 | 64人,32治疗,32安慰剂组 | 10 mg,口服,间隔1周 | 12个月 | 无缓解疼痛 | NCT01068405[ |
| 甲氨蝶呤 | 抗炎 | 评估在对KOA患者的症状益处 | 155人,77治疗,78安慰剂组 | 10、25 mg,口服,间隔1周 | 6个月 | 缓解疼痛、僵硬和功能减轻 | ISRCTN77854383[ |
| 评估在对KOA患者的症状益处 | 215人,108治疗,107安慰 剂组 | 15 mg,口服,间隔1周 | 52周 | 无缓解疼痛 | NCT03815448[ | ||
| 泼尼松龙 | 抗炎 | 评价在KOA患者的疗效和安全性 | 92人,46治疗,46安慰剂组 | 10 mg,口服,每天1次 | 6周 | 缓解疼痛 | NTR5263[ |
| 秋水仙碱 | 抗炎 | 评价在HOA患者的疗效和安全性 | 100人,50治疗,50安慰剂组 | 0.5 mg,口服,每天2次 | 12 周 | 无缓解疼痛 | NCT04601883[ |
| 评价是否能降低全膝关节置换术和全髋关节置换术的发生率 | 5 522人, 2 762名治疗,2 760安慰剂组 | 0.5 mg,口服,每天1次 | 3/6个月 | 较低发生率 | ACTRN12614000093684[ | ||
| 羟氯喹 | 抗炎 | 评估对KOA患者疼痛和活动能力方面的 疗效 | 166人,83名治疗,83安慰剂组 | 400 mg, 口服, 每天1次 | 36 周 | 缓解疼痛 | DOI: |
| 评估对HOA患者症状的改善效果 | 196人,98名治疗,98安慰剂组 | 400 mg口服, 每天1次 | 24周 | 无缓解疼痛 | NCT01148043[ | ||
| 评估对HOA患者的镇痛效果 | 210人,105名 治疗,105安慰剂组 | 200至400 mg, 口服,每天1次 | 12月 | 无缓解疼痛 | ISRCTN91859104[ |
Table 1 Clinical trials of immunotherapy drugs in OA
| 药物名称 | 靶点/作用 | 目的 | 受试者情况 | 给药方案 | 随访时间 | 试验结果 | 试验编号/文献编号 |
| 阿达木单抗 | TNF | 评估在侵蚀性HOA患者疗效 | 43人,18治疗,25安慰剂 | 40 mg,皮下注射,间隔14 d | 3个月 | 无缓解疼痛 | ACTRN12612000791831[ |
| 评估在疼痛性HOA患者疗效 | 85人,41治疗,37安慰剂组 | 40 mg,皮下注射,间隔15 d | 6个月 | 无缓解疼痛 | NCT00597623[ | ||
| 依那西普 | TNF-α | 评估在侵蚀性HOA患者疗效 | 90人,45治疗,45安慰剂组 | 50 mg,皮下注射,间隔7 d | 6个月 | 无缓解疼痛 | NTR1192[ |
| 鲁吉珠单抗 | IL-1α/β | 评估在侵蚀性HOA患者中的疗效、安全性 | 110人,49治疗,61安慰剂组 | 200 mg,皮下注射,间隔14 d | 6个月 | 无缓解疼痛 | NCT02384538[ |
| 评价在伴有滑膜炎的KOA患者中的疗效 | 347人,随机分配治疗组和安慰剂组 | 25、100或200 mg组,皮下注射,间隔14 d | 13个月 | 无缓解疼痛和抗炎效果 | NCT02087904[ | ||
| 卡那单抗 | IL-1β | 评估全髋关节或全膝关节置换术的发生率 | 10 061人,随机分配治疗组和安慰剂组 | 50、150或300 mg,皮下注射,间隔3个月 | 3.7年 | 置换率降低 | NCT01327846[ |
| 托珠单抗 | IL-6 | 评价在HOA患者中的疗效 | 91人,45治疗,46安慰剂组 | 8 mg/kg,静脉注射,间隔4周 | 3个月 | 无缓解疼痛 | NCT02477059[ |
| 奥替利单抗 | GM-CSF | 评价在HOA患者中的疗效、安全性 | 44人,22治疗,22安慰剂组 | 180 mg,皮下注射,间隔1个月 | 10周 | 无缓解疼痛 | NCT02683785[ |
| 地诺单抗 | RANKL | 评估在侵蚀性HOA患者 结构修饰的影响 | 100人,51治疗,49安慰剂组 | 60 mg,皮下注射,间隔3个月 | 48周 | 具有结构修饰作用 | 2015-003223-53[ |
| 他尼珠单抗 | NGF | 评价在KOA患者安全性和镇痛功效 | 450人,每组75治疗,75安慰剂组 | 10、25、50、100或200 μg/kg,静脉注射,间隔 56 d | 16周 | 疼痛减轻和功能改善 | NCT00394563[ |
| 他尼珠单抗 | NGF | 评价 在OA患者中的疗效 | 2.5、5 mg,皮下注射,间隔16周/ 24周 | 24周 | 缓解疼痛 | NCT02697773 NCT02709486 NCT02528188[ | |
| 甲氨蝶呤 | 抗炎 | 评估HOA患者疼痛和结构进展的影响 | 64人,32治疗,32安慰剂组 | 10 mg,口服,间隔1周 | 12个月 | 无缓解疼痛 | NCT01068405[ |
| 甲氨蝶呤 | 抗炎 | 评估在对KOA患者的症状益处 | 155人,77治疗,78安慰剂组 | 10、25 mg,口服,间隔1周 | 6个月 | 缓解疼痛、僵硬和功能减轻 | ISRCTN77854383[ |
| 评估在对KOA患者的症状益处 | 215人,108治疗,107安慰 剂组 | 15 mg,口服,间隔1周 | 52周 | 无缓解疼痛 | NCT03815448[ | ||
| 泼尼松龙 | 抗炎 | 评价在KOA患者的疗效和安全性 | 92人,46治疗,46安慰剂组 | 10 mg,口服,每天1次 | 6周 | 缓解疼痛 | NTR5263[ |
| 秋水仙碱 | 抗炎 | 评价在HOA患者的疗效和安全性 | 100人,50治疗,50安慰剂组 | 0.5 mg,口服,每天2次 | 12 周 | 无缓解疼痛 | NCT04601883[ |
| 评价是否能降低全膝关节置换术和全髋关节置换术的发生率 | 5 522人, 2 762名治疗,2 760安慰剂组 | 0.5 mg,口服,每天1次 | 3/6个月 | 较低发生率 | ACTRN12614000093684[ | ||
| 羟氯喹 | 抗炎 | 评估对KOA患者疼痛和活动能力方面的 疗效 | 166人,83名治疗,83安慰剂组 | 400 mg, 口服, 每天1次 | 36 周 | 缓解疼痛 | DOI: |
| 评估对HOA患者症状的改善效果 | 196人,98名治疗,98安慰剂组 | 400 mg口服, 每天1次 | 24周 | 无缓解疼痛 | NCT01148043[ | ||
| 评估对HOA患者的镇痛效果 | 210人,105名 治疗,105安慰剂组 | 200至400 mg, 口服,每天1次 | 12月 | 无缓解疼痛 | ISRCTN91859104[ |
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