原创力文档a randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 12：一项随机研究hexaminolevulinate光动力疗法治疗宫颈上皮内瘤变12.pdfVIP
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a randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 12：一项随机研究hexaminolevulinate光动力疗法治疗宫颈上皮内瘤变12
Research
GYNECOLOGY
A randomized study of hexaminolevulinate
photodynamic therapy in patients with
cervical intraepithelial neoplasia 1/2
Peter Hillemanns, MD; Francisco Garcia, MD, MPH; Karl Ulrich Petry, MD;
´
Vladimır Dvorak, MD; Oliver Sadovsky, MD; Ole-Erik Iversen, MD;
Mark H. Einstein, MD, MS
OBJECTIVE: The objective of the study was to investigate the efficacy clear dose effect with a statistically significant response in
and safety of hexaminolevulinate (HAL) photodynamic therapy (PDT), a the HAL 5% group of 95% (18/19 patients) compared to 57%
novel therapy for women with cervical intraepithelial neoplasia (CIN) (12/21 patients) in the placebo group (P .001) was observed at
1/2, to define the appropriate population and endpoints for a phase 3 3 months in women with CIN 2, including an encouraging 83% (5/6
program. patients) clearance of HPV 16/18 compared to 33% (2/6 patients)
in the placebo group at 6 months. The treatment was easy to use
STUDY DESIGN: This was a double-blind, randomized, placebo-
and well accepted by patients and gynecologists. Only local self-
controlled, dose-finding study that included a total of 262 women
limiting adverse reactions including discharge, discomfort, and
with biopsy-confirmed CIN 1/2 based on local pathology. Patients
spotting were reported.
received 1 or 2 t
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