Department of Dermatology, the First Hospital of Wuhan, Wuhan 430022, China.
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
Photodiagnosis Photodyn Ther. 2019 Sep;27:408-414. doi: 10.1016/j.pdpdt.2019.07.009. Epub 2019 Jul 13.
Photodynamic therapy is an effective treatment for actinic keratosis. 5-aminolevulinic acid nanoemulsion (BF-200 ALA) and methyl-5-aminolevulinate (MAL) are both prodrugs for the treatment of actinic keratosis with photodynamic therapy. A comparison of the efficacy and safety between the drugs is critical for clinical practice.
To investigate if photodynamic therapy in combination with BF-200 ALA is superior to photodynamic therapy with MAL for actinic keratosis.
We performed a meta-analysis to investigate the combination of photodynamic therapy with BF-200 ALA and with MAL. The PubMed, Cochrane Library, Web of Science and EMBASE databases were searched to select eligible randomized controlled trials. Our search was conducted on April 1, 2019, and included the search terms "5-aminolevulinic acid nanoemulsion or BF-200 ALA", "methyl-5-aminolevulinate or methyl aminolaevulinate" and "actnic keratosis". Cochrane Risk of Bias Tool was used to estimate the risk of bias.
The meta-analysis consisted of 5988 actinic keratosis lesions in five eligible randomized controlled trials, with a total of 2953 actinic keratosis lesions treated with BF-200 ALA and 3035 actinic keratosis lesions treated with MAL. BF-200 ALA in combination with photodynamic therapy showed significantly higher overall complete clearance rates (RR: 1.07, 95% CI 1.02-1.12, p = 0.01) and 3 month complete clearance rates (RR: 1.09, 95% CI 1.06-1.12, p < 0.00001) compared to MAL. A subgroup analysis was performed for photodynamic therapy combined with BF-200 ALA, revealing increased complete clearance rates of grade II-III lesions in comparison with MAL (RR: 1.24, 95% CI 1.05-1.46, p = 0.01). Compared with MAL, the pooled relative risk for the meta-analysis for recurrence was 0.67 (95% CI 0.48-0.92, p = 0.01) at 12 month after BF-200 ALA treatment.
Photodynamic therapy with BF-200 ALA has a 9% better chance of complete clearance at 3 months and a 24% better chance of grade II-III lesions after treatment than with MAL for patients with actinic keratosis.
光动力疗法是治疗光化性角化病的有效方法。5-氨基酮戊酸纳米乳（BF-200 ALA）和甲氨基酮戊酸（MAL）都是光动力疗法治疗光化性角化病的前体药物。比较这两种药物的疗效和安全性对临床实践至关重要。
探讨光动力疗法联合 BF-200 ALA 是否优于 MAL 光动力疗法治疗光化性角化病。
我们进行了一项荟萃分析，以研究光动力疗法联合 BF-200 ALA 和 MAL 的疗效。我们检索了 PubMed、Cochrane 图书馆、Web of Science 和 EMBASE 数据库，以选择合格的随机对照试验。我们的检索于 2019 年 4 月 1 日进行，检索词包括“5-氨基酮戊酸纳米乳或 BF-200 ALA”、“甲氨基酮戊酸或甲基氨基酮戊酸”和“光化性角化病”。Cochrane 偏倚风险工具用于评估偏倚风险。
荟萃分析纳入了 5 项合格的随机对照试验中的 5988 例光化性角化病病变，共 2953 例光化性角化病病变接受 BF-200 ALA 治疗，3035 例光化性角化病病变接受 MAL 治疗。BF-200 ALA 联合光动力疗法显示出更高的总完全清除率（RR：1.07，95%CI 1.02-1.12，p=0.01）和 3 个月完全清除率（RR：1.09，95%CI 1.06-1.12，p<0.00001），与 MAL 相比。对 BF-200 ALA 联合光动力疗法进行了亚组分析，结果显示与 MAL 相比，II 级-III 级病变的完全清除率增加（RR：1.24，95%CI 1.05-1.46，p=0.01）。与 MAL 相比，BF-200 ALA 治疗后 12 个月的复发 pooled relative risk 为 0.67（95%CI 0.48-0.92，p=0.01）。
与 MAL 相比，光动力疗法联合 BF-200 ALA 治疗光化性角化病患者，在治疗后 3 个月的完全清除率提高 9%，II 级-III 级病变的完全清除率提高 24%。
