双膦酸盐类药物治疗慢性非细菌性骨髓炎的疗效评价与分析

doi:10.7518/hxkq.2024.2024241

华西口腔医学杂志 ›› 2025, Vol. 43 ›› Issue (1): 98-105.doi: 10.7518/hxkq.2024.2024241

双膦酸盐类药物治疗慢性非细菌性骨髓炎的疗效评价与分析

李丹丹(), 于竹君, 聂成, 邹紫鑫, 王建莉()

口腔疾病防治全国重点实验室国家口腔医学中心国家口腔疾病临床医学研究中心四川大学华西口腔医院药剂科，成都 610041

收稿日期:2024-06-25 修回日期:2024-10-25 出版日期:2025-02-01 发布日期:2025-01-22
通讯作者: 王建莉 E-mail:1126468651@qq.com;wangjianli0804@163.com
作者简介:李丹丹，主管药师，硕士，E-mail：1126468651@qq.com
基金资助:
四川大学华西口腔医院探索与研发项目(RD-01-2023-09)

Evaluation and analysis of efficacy in bisphosphonate treatment of chronic nonbacterial osteomyelitis

Li Dandan(), Yu Zhujun, Nie Cheng, Zou Zixin, Wang Jianli()

State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & Dept. of Pharmacy, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China

Received:2024-06-25 Revised:2024-10-25 Online:2025-02-01 Published:2025-01-22
Contact: Wang Jianli E-mail:1126468651@qq.com;wangjianli0804@163.com
Supported by:
Research and Development Program of West China Hospital of Stomatology, Sichuan University(RD-01-2023-09)

摘要/Abstract

摘要：

目的评价双膦酸盐类药物在慢性非细菌性骨髓炎治疗中的有效性和安全性，分析影响疗效的药物因素，以期为临床治疗提供参考依据并进一步推动临床合理用药。方法检索PubMed、Medline、Embase、Cochrane、ISI Web of Knowledge、中国知网、维普以及万方数据库中关于双膦酸盐类药物治疗慢性非细菌性骨髓炎的临床研究，并进行文献分析。结果检索到双膦酸盐类药物治疗慢性非细菌性骨髓炎的临床研究病例共489例，临床表现平均完全缓解率为80.37%，实验室检查平均完全缓解率为80.56%，影像学检查平均完全缓解率为79.22%。除奥帕膦酸钠外，利塞膦酸钠、伊班膦酸钠、帕米膦酸钠、阿仑膦酸钠、奈立膦酸钠及唑来膦酸钠6种双膦酸盐均展现了较好的疗效，平均完全缓解率分别为100%、100%、81.64%、87.50%、69.23%及69.23%。在帕米膦酸钠组中，给药剂量0.5~1 mg/kg（单次最大剂量≤60 mg）亚组、给药频率每3月1次亚组平均完全缓解率均优于其他亚组。结论双膦酸盐类药物可用于治疗慢性非细菌性骨髓炎，其疗效受到不同药物类型、给药剂量及给药频率的影响。帕米膦酸钠的最佳给药剂量及给药频率分别为0.5~1 mg/kg（单次最大剂量≤60 mg）、每3月1次。

关键词: 双膦酸盐, 慢性非细菌性骨髓炎, 疗效, 药物因素

Abstract:

Objective This study aimed to analyze the influence of drug factors on the efficacy of bisphosphonate for chronic nonbacterial osteomyelitis to provide a reference for clinical treatment and promote clinical rational drug use by evaluation of effectiveness and safety of bisphosphonate treatment of chronic nonbacterial osteomyelitis. Methods Literature on the treatment of chronic nonbacterial osteomyelitis by using bisphosphonate was collected and analyzed from PubMed, Medline, Embase, Cochrane, ISI Web of Knowledge, CNKI, VIP, and Wanfang databases. Results A total of 489 cases were collected, with an average complete response rate of clinical presentation, laboratory tests and imaging findings of 80.37%, 80.56% and 79.22%, respectively. Except for opadronate, risedronate, ibandronate, pamidronate, alendronate, neidronate and zoledronate showed good efficacy, and the average complete response rates were 100%, 100%, 81.64%, 87.50%, 69.23% and 69.23%, respectively.The study found that in the pamidronate group, the average complete response rate of 0.5-1 mg/kg (maximum single dose≤60 mg) subgroup and the frequency of administration once every 3 months subgroup were better than other subgroups. Conclusion Bisphosphonate could be used to treat chronic nonbacterial osteomyelitis, which of efficacy were affected by different drug types, dose and frequency of administration. The optimal dose and frequency of administration of pamidronate were 0.5-1 mg/kg (maximum single dose≤60 mg) and once every 3 months, respectively.

Key words: bisphosphonate, chronic nonbacterial osteomyelitis, efficacy, drug factor

中图分类号:

R782.3

李丹丹, 于竹君, 聂成, 邹紫鑫, 王建莉. 双膦酸盐类药物治疗慢性非细菌性骨髓炎的疗效评价与分析[J]. 华西口腔医学杂志, 2025, 43(1): 98-105.

Li Dandan, Yu Zhujun, Nie Cheng, Zou Zixin, Wang Jianli. Evaluation and analysis of efficacy in bisphosphonate treatment of chronic nonbacterial osteomyelitis[J]. West China Journal of Stomatology, 2025, 43(1): 98-105.

图/表 5

表 1

表 2

表 3

表 4

表 5

BP在国内外获批情况

药物类型	适应证	批准国家	给药方案
帕米膦酸钠	恶性肿瘤相关高钙血症	中国、美国、欧盟、日本	静滴，每疗程至少间隔7 d。1）中国、欧盟：总剂量15~90 mg，单次或按总剂量分成2~4次，每日1次；2）美国：总剂量60~90 mg，单次；3）日本：总剂量30~45 mg，每日1次
	癌症骨转移性疼痛	中国、美国、欧盟、日本	静滴。1）中国：30~90 mg/次，每4周1次或90 mg/次，每3周1次；2）欧盟、美国：90 mg/次，每4周1次或90 mg/次，每3周1次；3）日本：90 mg/次，每隔4周1次
	Paget’s病	欧盟、美国	静滴，每疗程至少间隔6月。1）欧盟：①总剂量180 mg：30 mg/次，每周1次或60 mg/次，每2周1次；②总剂量210 mg：首次30 mg，后60 mg/次，每2周1次；2）美国：30 mg/次，每日1次，连续3 d
	成骨不全	日本	静滴，每日剂量≤60 mg，连续3 d为1疗程。1）<2岁：0.5 mg/kg/次，每日1次，每隔2月1疗程；2）≥2岁且<3岁：0.75 mg/kg/次，每日1次，每隔3月1疗程；3）≥3岁：1 mg/kg/次，每日1次，每隔4月1疗程
阿仑膦酸钠	Paget’s病	美国	口服：40 mg/次，每日1次，连续6月
阿仑膦酸钠	骨质疏松	中国、美国、欧盟、日本	口服。1）中国、美国、欧盟：70 mg/次，每周1次或10 mg/次，每日1次；2）日本：35 mg/次，每周1次或5 mg/次，每日1次
唑来膦酸钠	恶性肿瘤相关高钙血症	中国、美国、欧盟、日本	静滴：4 mg/次，单次或再次至少间隔7 d
	癌症骨转移性疼痛、多发性骨髓瘤	中国、美国、欧盟、日本	静滴：4 mg/次，每3~4周1次
	Paget’s病	中国、美国、欧盟	静滴：5 mg/次，每次至少间隔1年
	骨质疏松	中国、美国、欧盟、日本	静滴：5 mg/次，每年1次
伊班膦酸钠	恶性肿瘤相关高钙血症	中国、欧盟	静滴：2~4 mg/次，单次
	癌症骨转移性疼痛	中国、欧盟	静滴。1）中国：4~6 mg/次，每3~4周1次；2）欧盟：6 mg/次，每3~4周1次；口服：欧盟：50 mg/次，每日1次
	骨质疏松	中国、美国、欧盟、日本	静滴。1）中国：2 mg/次，每3月1次；2）美国：3 mg/次，每3月1次；3）日本：1 mg/次，每月1次。口服：1）中国、美国、欧盟：150 mg/次，每月1次；2）日本：100 mg/次，每月1次
利塞膦酸钠	Paget’s病	美国、欧盟、日本	口服。1）美国、欧盟：30 mg/次，每日1次，连续2月；2）日本：17.5 mg/次，每日1次，连续2月
利塞膦酸钠	骨质疏松	中国、美国、欧盟、日本	口服。1）中国、美国、欧盟：5 mg/次，每日1次或35 mg/次，每周1次或75 mg/次，每月连续2 d或150 mg/次，每月1次；2）日本：2.5 mg/次，每日1次或17.5 mg/次，每周1次或75 mg/次，每月1次

表 5

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类型	样本量/例	完全缓解量/例	完全缓解率/%	平均完全缓解率/%
临床表现	489	393	0~100	80.37
实验室检查	463	373	0~100	80.56
影像学检查	486	385	0~100	79.22

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双膦酸盐类药物治疗慢性非细菌性骨髓炎的疗效评价与分析

Evaluation and analysis of efficacy in bisphosphonate treatment of chronic nonbacterial osteomyelitis

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药物类型	临床表现		实验室检查		影像学检查
药物类型	样本数/例	平均完全缓解率/%	样本数/例	平均完全缓解率/%	样本数/例	平均完全缓解率/%
帕米膦酸钠	414	81.64	391	81.33	411	80.29
阿仑膦酸钠	8	87.50	8	87.50	8	87.50
唑来膦酸钠	39	69.23	39	69.23	39	69.23
奈立膦酸钠	13	69.23	13	69.23	13	69.23
伊班膦酸钠	11	100	11	100	11	100
利塞膦酸钠	1	100	1	100	1	100
奥帕膦酸钠	3	0	-	-	3	0

给药剂量	给药频率	样本数/例	平均完全缓解率/%
给药剂量	给药频率	样本数/例	临床表现	实验室检查	影像学检查
15 mg	每3月1疗程	6	100	100	100
30~60 mg	每月1疗程	43	90.7	90.7	90.7
30 mg	每3月1次	1	100	100	100
45 mg	单次	1	100	100	100
60 mg	单次	1	100	100	100
1 mg/kg	单次	1	100	100	100
	每3月1次	6	100	100	100
	每3月1疗程	40	77.5	82.35	65
	每月1次	32	100	100	100
	每月1疗程	86	75.58	75.58	75.58
1.5 mg/kg	每月1次	7	57.14	57.14	57.14
0.5~1 mg/kg*	单次	1	100	100	100
	每月1次	24	100	100	100
	每6月1疗程	1	100	100	100
	每3月1疗程	164	76.83	75	76.22

药物类型	给药剂量	给药频率	样本数/例	临床表现、实验室检查、影像学检查平均完全缓解率/%
阿仑膦酸钠	10 mg	单次	1	100
	35 mg	每周1次	1	100
	40 mg	每日1次	1	100
	70 mg	每周1次	3	66.67
	1 mg/kg	每周1次	1	100
	1.5 mg/kg	每周1次	1	100
唑来膦酸钠	0.09 mg/kg	每月1次	29	65.52
	0.025 mg/kg	每3月1次	10	80
奈立膦酸钠	100 mg	每日1次	1	100
	2 mg/kg	每3月1次	12	66.67
伊班膦酸钠	6 mg	每日1次	11	100
利塞膦酸钠	35 mg	每周1次	1	100
奥帕膦酸钠	50~100 mg	每日1次	3	0