Hillemanns Peter, Einstein Mark H, Iversen Ole Erik
Hannover Medical School, Department of Obstetrics and Gynaecology , Hannover , Germany +49 511 532 6144 ; +49 511 532 6145 ;
Expert Opin Investig Drugs. 2015 Feb;24(2):273-81. doi: 10.1517/13543784.2015.990150. Epub 2014 Dec 16.
Current treatments for high-grade cervical intraepithelial neoplasia (CIN2/3) are mainly excisional procedures, which are associated with significant side effects and pose risks for future pregnancies. An effective and safe therapy is needed to reduce the requirement for surgical interventions in women of reproductive age.
This review looks at the pharmacokinetic and clinical data for topical hexaminolevulinate (HAL) photodynamic therapy (PDT), which is currently entering late phase clinical trials for high-grade CIN. The authors include published studies in patients and volunteers but laboratory and animal studies have been excluded as have studies on other porphyrins such as Photofrin, 5-aminolevulinic acid, methyl aminolevulinate and studies reporting other clinical applications for HAL.
Topical HAL PDT has potential as a non-surgical tissue-preserving treatment for CIN and persistent oncogenic human papilloma virus infections. HAL PDT selectively treats the entire epithelial sheet, without the tissue destruction seen in excisional procedures. The authors believe that this treatment could replace surgery in a large proportion of patients. It would be of particular value to the high percentage of women who are interested in future child-bearing. If the treatment is approved, it is very likely that physicians will want to use this treatment, as many patients will be keen to consider a non-surgical option.
目前针对高级别宫颈上皮内瘤变（CIN2/3）的治疗主要是切除手术，这些手术伴有显著的副作用，并且对未来妊娠构成风险。需要一种有效且安全的疗法，以减少对育龄期女性进行手术干预的需求。
本综述着眼于外用六氨基乙酰丙酸（HAL）光动力疗法（PDT）的药代动力学和临床数据，该疗法目前正进入针对高级别CIN的后期临床试验阶段。作者纳入了针对患者和志愿者的已发表研究，但排除了实验室和动物研究，以及针对其他卟啉（如血卟啉衍生物、5-氨基乙酰丙酸、甲基氨基乙酰丙酸）的研究，还有报告HAL其他临床应用的研究。
外用HAL PDT有潜力作为一种针对CIN和持续性致癌人乳头瘤病毒感染的非手术性保留组织的治疗方法。HAL PDT可选择性地治疗整个上皮层，不会出现切除手术中所见的组织破坏。作者认为这种治疗方法可在很大比例的患者中取代手术。对于很大比例对未来生育感兴趣的女性而言，它将具有特别的价值。如果该治疗方法获批，很有可能医生会想要使用这种治疗方法，因为许多患者会热衷于考虑非手术选择。
