5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患中药物因素影响的分析

doi:10.7518/hxkq.2023.2023210

华西口腔医学杂志 ›› 2023, Vol. 41 ›› Issue (6): 701-707.doi: 10.7518/hxkq.2023.2023210

5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患中药物因素影响的分析

李丹丹(), 于竹君, 聂成, 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:2023-07-07 修回日期:2023-09-28 出版日期:2023-12-01 发布日期:2023-11-27
通讯作者: 王建莉 E-mail:1126468651@qq.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-)

Analysis of drug factors in 5-aminolevulinic acid photodynamic therapy for oral potentially malignant disorder

Li Dandan(), Yu Zhujun, Nie Cheng, 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:2023-07-07 Revised:2023-09-28 Online:2023-12-01 Published:2023-11-27
Contact: Wang Jianli. E-mail:1126468651@qq.com
Supported by:
Research and Develop Program, West China Hospital of Stomatology Sichuan University(RD-01-202309);Correspondence: Wang Jianli, E-mail: wangjianli0804@163.com

摘要/Abstract

摘要：

目的探讨药物因素对5-氨基酮戊酸（ALA）光动力疗法治疗口腔潜在恶性疾患疗效的影响，以期提高临床疗效及推动临床合理用药。方法检索Pubmed、ISI Web of Knowledge数据库、中国知网、维普以及万方数据库中关于ALA光动力疗法治疗口腔潜在恶性疾患的临床研究，并进行文献分析。结果检索到ALA光动力疗法治疗口腔潜在恶性疾患的临床研究病例共690例，平均完全缓解率为65.94%；16.8%氨基酮戊酸甲酯乳膏组、局部外用组、每周1次组及预激活时间2~4 h组优于其他亚组，平均完全缓解率分别为100%、66.91%、78.28%及77.54%。结论药物因素对5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患疗效有直接影响，从药物改良的角度开发新的口腔ALA制剂是提高疗效的重要途径。

关键词: 5-氨基酮戊酸, 光动力疗法, 药物因素, 口腔潜在恶性疾患, 新制剂

Abstract:

Objective This study aimed to analyze the influence of drug factors on the efficacy of 5-aminolevulinic acid (ALA) photodynamic therapy for oral potentially malignant disorder to improve clinical efficacy and promote clinical rational drug use. Methods Literature on the treatment of oral potentially malignant disorder by using ALA photodynamic therapy was collected and analyzed from PubMed, ISI Web of Knowledge database, CNKI, VIP, and Wanfang database. Results A total of 690 cases were collected, with an average complete response rate of 65.94%. The groups treated with 16.8% methyl aminolevulinate cream, local topical, once a week, and pre-activation time of 2-4 hours were better than the other subgroups, with average complete response rates of 100%, 66.91%, 78.28%, and 77.54%, respectively. Conclusion Drug factors have direct influence on the curative effect. The development of novel oral ALA formulations from the perspective of drug improvement is an important strategy to improve efficacy.

Key words: 5-aminolevulinic acid, photodynamic therapy, drug factors, oral potentially malignant disorder, novel formulations

中图分类号:

R 781.5

李丹丹, 于竹君, 聂成, 王建莉. 5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患中药物因素影响的分析[J]. 华西口腔医学杂志, 2023, 41(6): 701-707.

Li Dandan, Yu Zhujun, Nie Cheng, Wang Jianli.. Analysis of drug factors in 5-aminolevulinic acid photodynamic therapy for oral potentially malignant disorder[J]. West China Journal of Stomatology, 2023, 41(6): 701-707.

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疾病类型	样本数/例	完全缓解/例	完全缓解率/%	平均完全缓解率/%
合计	690	455	-	65.94
OLK	309	124	0~100	40.13
OE	95	88	0~100	92.63
OVH	105	104	80~100	99.05
OLP	181	139	0~100	76.80

剂型及浓度	疾病类型	样本数/例	完全缓解/例	平均完全缓解率/%
4%ALA凝胶	OLP	10	3	30.00
5%ALA凝胶	OLP	30	14	46.67
10%ALA凝胶	OLK	5	2	40.00
20%ALA凝胶	OLK	67	43	64.18
	OE	95	88	92.63
	OVH	105	104	99.05
	OLP	116	107	92.24
10%ALA乳膏	OLK	52	33	63.46
20%ALA乳膏	OLK	67	43	64.18
16.8%MAL乳膏	OLP	14	14	100.00
20%ALA水溶液	OLK	58	1	1.72
98%ALA水溶液	OLK	42	2	4.76
98%ALA水溶液	OLP	10	0	0.00
30 mg/kg ALA水溶液	OLK	18	0	0.00
118 mg ALA散剂	OLP	1	1	100.00

给药途径	疾病类型	样本数/例	完全缓解/例	平均完全缓解率/%
局部外用	OLK	296	122	41.22
	OE	95	88	92.63
	OVH	105	104	99.05
	OLP	181	139	76.80
口服	OLK	7	0	0.00
局部注射	OLK	6	2	33.33

给药频率	疾病类型	样本数/例	完全缓解/例	平均完全缓解率/%
单次	OLK	48	5	10.42
	OLP	1	1	100.00
每月1次	OLK	13	2	15.38
	OLP	35	25	71.43
每2周1次	OLK	96	71	73.96
每周1次	OLK	90	35	38.89
	OVH	105	104	99.05
	OE	95	88	92.63
每周2次	OLK	62	11	17.74
每周10次	OLP	145	113	77.93

预激活时间	疾病类型	样本数/例	完全缓解/例	平均完全缓解率/%
30 min	OLK	12	2	16.67
	OLP	10	0	0.00
1.5~2 h	OLK	157	17	10.83
	OE	95	88	92.63
	OVH	105	104	99.05
	OLP	157	125	79.62
2~4 h	OLK	124	93	75.00
	OLP	14	14	100.00
4~5 h	OLK	16	12	75.00

5-氨基酮戊酸光动力疗法治疗口腔潜在恶性疾患中药物因素影响的分析

Analysis of drug factors in 5-aminolevulinic acid photodynamic therapy for oral potentially malignant disorder

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活性成分	商品名	剂型	用药途径	适应证	批准国家
ALA	Levulan	20%溶液	外用	光化性角化病	美国、欧盟
	Ameluz	10%BF-200凝胶	外用	光化性角化病	美国、欧盟
	Gleolan	30 mg/mL溶液	口服	荧光引导胶质瘤切除	美国、欧盟
	艾拉	118 mg散剂	外用	尖锐湿疣	中国
	Alacare	8 mg贴片	外用	光化性角化病	欧盟
MAL	Metvix	16.8%乳膏	外用	光化性角化病	美国、欧盟
				基底细胞癌	欧盟
				Bowen病	欧盟
氨基酮戊酸己酯	Hexvix	冻干粉	膀胱灌注	膀胱癌检查与治疗	美国、欧盟

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