title: The association between treatment reactions and treatment efficiency of Hemoporfin-photodynamic therapy on port wine stains: A prospective double blind randomized controlled trial.
abstract: BACKGROUND
  Research has focused on treatment efficiency and/or treatment reactions of photodynamic therapy (PDT) on port-wine stain (PWS). But few studies reported the association between them. Hence, here we investigated the association between the treatment efficiency and treatment reactions after Hemoporfin (HMME) mediated photodynamic therapy (PDT) on PWS through a prospective study.
  
  
  METHODS
  Patients (n=50) with PWS were randomly assigned to the HMME group or the placebo group. Three quit after the first treatment, and forty-seven received two sessions of treatment at an 8-week interval. They were given the treatment at day 1 and evaluations were performed at day 1, day 4 and week 8 in each session. HMME group was treated with HMME while the placebo group was given normal saline instead in the first session, double-blindly. While in the second session, both groups received HMME-PDT treatment.
  
  
  RESULTS
  After a single treatment, swelling was more severe in younger patients (p<0.05) and the lesion far from centro-facial showed more severe pruritus and scab. Compared with a single treatment, burning sensation had a higher occurrence rate, while burning sensation and scab were less severe in the second treatment. Importantly, severity of scab and pain (5min after irradiation) were found possibly correlated with the treatment efficiency.
  
  
  CONCLUSIONS
  HMME-PDT on PWS induces several treatment reactions, including pruritus, burning sensation, pain, swelling, blisters and scab. Two sessions of treatments do not have any accumulation effects on treatment reactions. And there might be a positive correlation between treatment efficiency and the severity of scab or pain (at early stage of the therapy), which might help in regulating treatment modalities.
authors.affiliation: Department of Dermatology, Xiangya Hospital, Central South University, China. Electronic address: valyantang@163.com.
authors.forename: Yan
authors.initials: Y
authors.lastname: Tang
authors.affiliation: Department of Dermatology, Xiangya Hospital, Central South University, China. Electronic address: xiehongfu1964@aliyun.com.
authors.forename: Hongfu
authors.initials: H
authors.lastname: Xie
authors.affiliation: Department of Dermatology, Xiangya Hospital, Central South University, China. Electronic address: liji_xy@csu.edu.cn.
authors.forename: Ji
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Dermatology, Xiangya Hospital, Central South University, China. Electronic address: jiandanxyyy@163.com.
authors.forename: Dan
authors.initials: D
authors.lastname: Jian
mesh_terms: D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D004311:Double-Blind Method; D005260:Female; D006415:Hematoporphyrins / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D019339:Port-Wine Stain / Q000188:drug therapy* / Q000473:pathology*; D012867:Skin / Q000187:drug effects / Q000473:pathology / Q000528:radiation effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006415:Hematoporphyrins; D017319:Photosensitizing Agents; C494379:hematoporphyrin monomethyl ether
keywords: HMME-PDT; Port-wine stain; Treatment efficiency; Treatment reactions