Department of Laser Medicine, Chinese PLA General Hospital, Beijing 100853, China.
Department of Laser Medicine, Chinese PLA General Hospital, Beijing 100853, China.
Photodiagnosis Photodyn Ther. 2014 Jun;11(2):134-40. doi: 10.1016/j.pdpdt.2014.03.004. Epub 2014 Mar 16.
The major side-effect of photodynamic therapy (PDT) on port wine stains (PWS) is pain during the treatment. Although several strategies for controlling the pain during topical PDT achieve a reduction in the levels of pain, none were completely effective and convenient. This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of an oral analgesic for the treatment of pain in PDT on PWS.
Fifty-eight patients with PWS on the face were included. The treatment and placebo groups were selected by computer randomization. The patients, doctor and statistician were blinded to the patients' groups. The analgesic contained 5mg of oxycodone in combination with 325 mg of acetaminophen. The patient took the tablet orally 30 min before PDT. The patient was injected intravenously with 4-5mg/kg photosensitizer PSD-007 within 5 min, and then the lesion was exposed to a 532 nm laser immediately for 30-60 min at 100 mW/cm(2). The intensity of the pain during irradiation, the characteristic and beginning time of pain, and adverse effects were recorded. A visual analog scale (VAS) was used to assess the pain.
The time of the pain beginning was 8.31 ± 4.58 min in the treatment group and 7.10 ± 3.54 min in the placebo group, which was not significantly different (P=0.266). The VAS score in the treatment group was 7.88 ± 1.52 compared with 8.17 ± 1.12 in the placebo group, with no significant difference (P=0.422). The subgroup of age, gender, lesion location and classification between two groups had similar VAS score (P>0.05). No serious adverse events were reported. This study found that oral oxycodone 5mg/acetaminophen 325 mg was completely ineffective for pain relief, and age, gender, lesion location and classification did not influence the pain perception and the analgesic effect. The challenge of controlling pain during PDT on PWS remains.
光动力疗法（PDT）治疗葡萄酒色斑（PWS）的主要副作用是治疗过程中的疼痛。尽管有几种控制局部 PDT 治疗疼痛的策略可以降低疼痛程度，但都不是完全有效和方便的。本随机、双盲、安慰剂对照临床试验旨在评估一种口服镇痛药治疗 PWS PDT 疼痛的疗效和安全性。
纳入 58 例面部 PWS 患者。采用计算机随机分组，将患者分为治疗组和安慰剂组。患者、医生和统计人员对患者分组均不知情。镇痛药含有 5mg 羟考酮和 325mg 对乙酰氨基酚。患者在 PDT 前 30 分钟口服片剂。患者在 5 分钟内静脉注射 4-5mg/kg 的 PSD-007 光敏剂，然后立即在 100mW/cm2 下用 532nm 激光照射病变 30-60 分钟。记录照射过程中的疼痛强度、疼痛特征和开始时间以及不良反应。采用视觉模拟评分（VAS）评估疼痛。
治疗组疼痛开始时间为 8.31±4.58min，安慰剂组为 7.10±3.54min，差异无显著性意义（P=0.266）。治疗组 VAS 评分为 7.88±1.52，安慰剂组为 8.17±1.12，差异无显著性意义（P=0.422）。两组间年龄、性别、病变部位和分类的亚组 VAS 评分相似（P>0.05）。未报告严重不良事件。本研究发现，口服羟考酮 5mg/对乙酰氨基酚 325mg 完全无效缓解疼痛，年龄、性别、病变部位和分类不影响疼痛感知和镇痛效果。控制 PWS PDT 疼痛的挑战仍然存在。
