Abstract
目的
评价595 nm脉冲染料激光（pulsed dye laser, PDL）治疗面颈部鲜红斑痣的临床疗效，并探讨影响疗效的主要因素。
方法
回顾性分析259例经595 nm PDL治疗的面颈部鲜红斑痣的临床资料，采用自身前后对照的方式，对治疗前及治疗后的照片进行疗效评价，PDL治疗终点为轻度紫癜。纳入病例男82例，女177例；年龄1月～63岁。对影响疗效的因素进行单因素分析筛选后使用有序多分类logistic回归分析，探讨影响疗效的主要因素。并统计患者的不良反应。
结果
595 nm PDL治疗面颈部鲜红斑痣基愈病例57例（22.0%），显效病例106例（40.9%），有效病例68例（26.3%），总有效例数231例，总有效率为89.2%。无效病例28例（10.8%）。有序多分类logistic回归分析显示皮损颜色分型、皮损面积、皮损部位及治疗次数是影响疗效的因素，而皮损增厚与疗效无关。红型比紫红型疗效好〔比值比（OR）=2.748, P<0.05〕，面积≤10 cm2者疗效比面积>10 cm2的患者更好（OR=2.094, P<0.05），皮损位于面中部者疗效比位于颈部者差（OR=0.190, P<0.05）、面中及面周部者疗效比位于颈部者疗效差（OR=0.243, P<0.05）；治疗3次以上者疗效优于治疗1～3次者（OR=0.508, P<0.05）。患者均未发生较严重的不良反应。
结论
皮损位于颈部、红型、面积≤10 cm2者适合使用595 nm PDL治疗，且宜治疗3次以上。性别、年龄、皮损增厚均不影响治疗效果。
Keywords: 鲜红斑痣, 595 nm脉冲染料激光, 疗效
Abstract
Objective
To assess the efficacy of 595 nm pulsed dye laser (PDL) in the treatment of facial and neck port-wine stains (PWSs), and to explore the main factors affecting the efficacy.
Methods
A total of 259 PWS cases who were treated with 595 nm PDL were retrospectively enrolled and their clinical information was analyzed in the study. Before- and after-treatment comparison of individual patient was done by comparing patient photographs taken before and after PDL treatment of the PWSs in order to assess the treatment efficacy, using mild purpura as the endpoint of the PDL treatment. A total of 82 male and 177 female cases were included, with patient age ranging between 1 month and 63 years. Univariate analysis was done to select factors influencing the treatment efficacy. Then, ordered multivariate logistic regression analysis was performed to evaluate the main factors affecting the efficacy. Statistics of adverse reaction of patients were also collected.
Results
Of the 259 patients covered in the study, 57 (22%) had achieved complete clearing of PWS, 106 (40.9%) showed significant improvement, and 68 (26.3%) showed moderate improvement, amounting to a total of 231 effective treatment cases, indicating a 89.2% overall rate of effective treatment. There were 28 ineffective treatment cases (10.8%). Ordered multivariate logistic regression analysis showed that the color of PWS, the area of PWS, anatomical sites of PWS and the number of treatment sessions were the main factors affecting the therapeutic efficacy, while proliferation did not affect the therapeutic efficacy. Red-type PWS had better treatment efficacy than that of the purple-type PWS (odds ratio [OR]=2.748, P<0.05). Patients with PWS≤10 cm2 showed better treatment efficacy than those with PWS>10 cm2 (OR=2.094, P<0.05). Treatment efficacy of PWS located in the central section of the face was not as good as those located on the neck (OR=0.190, P<0.05), and the treatment efficacy of PWS located in the central and lateral section of the face was not as good as those located on the neck (OR=0.243, P<0.05). Patients who had more than 3 treatment sessions showed better efficacy than those who had 1-3 sessions of treatment (OR=0.508, P<0.05). No patients incurred any serious adverse reactions.
Conclusion
Patients with PWS located on the neck, red-type PWS and area ≤10 cm2 are suitable for treatment with 595 nm PDL and there should be more than three sessions of treatment. Patient sex, age, or proliferation do not affect the treatment effect.
Keywords: Port wine stain, 595 nm pulsed dye laser, Efficacy
鲜红斑痣（port-wine stain, PWS）是一种累及皮肤（或黏膜）的毛细血管及后微静脉为主的先天性低血流量血管疾病，其实质为血管畸形[1]。本病通常于出生时即存在，表现为粉红色至红色边界清楚而形状不规则的斑片，压之可有褪色。其发病率约0.3%～0.5%，无性别倾向，遗传模式通常为散发[2]。PWS好发于面颈部，皮损的分布与胚胎时期血管系统发育异常有关[3]。PWS通常不会自然消退，若不经治疗，将随年龄增长而逐步进展，皮损颜色逐渐加深，部分患者皮损形态渐渐增厚，出现结节，易破溃出血，对患者容貌和心理造成极大影响，严重降低患者生活质量[4-5]。
PWS的治疗目标在于彻底清除病灶。脉冲染料激光（pulsed dye laser, PDL）治疗PWS临床应用广泛。本研究对我院5年间采用595 nm PDL治疗面颈部鲜红斑痣患者259例的临床疗效进行分析，以探讨影响疗效的主要因素，为临床治疗方案的选择提供参考。
1. 资料与方法
1.1. 临床资料
回顾性分析四川大学华西医院2013年1月–2018年7月使用595 nm PDL治疗的面颈部鲜红斑痣的病例共259例。本研究获四川大学华西医院伦理委员会批准并审查通过，伦理批号为2020年审（10）号。
纳入标准：①符合国际血管瘤与脉管畸形研究协会（International Society for the Study of Vascular Anomalies, ISSVA）诊断标准的鲜红斑痣患者；②皮损位于面部或颈部，颜色呈粉红至紫红色，眼科及神经科检查无异常；③既往未接受任何治疗；④治疗结束后随访至少半年。
排除标准：①合并其他皮肤疾病；②合并综合征或其他系统疾病。
根据纳入、排除标准，共纳入病例男82例，女177例；年龄1月～63岁，平均年龄（12.3±10.7）岁，将年龄分为4组：0～3岁组67例，4～10岁组66例，11～20岁组79例，20岁以上组47例。根据皮损颜色分为3型[6]：粉红型56例，红型158例，紫红型45例。根据皮损高出皮面的情况，分为3型[6]：非增厚型236例，增厚型23例，结节型0例。皮损面积≤10 cm2者163例，面积>10 cm2者96例。根据皮损位于面部或颈部的分区，一共分为5型，如图1所示：Ⅰ型：皮损仅位于面中部，30例；Ⅱ型：皮损位于面中及面周，91例；Ⅲ型：皮损仅位于面周，112例；Ⅳ型：皮损位于面周及颈部，15例；Ⅴ型：皮损仅位于颈部者，11例。治疗次数3次及以下者137例，治疗3次以上者122例。
图 1.
Zoning of facial and neck skin lesions
面颈部皮损部位分区
In the figure, region Ⅰ represents the central part of the face, region Ⅱ represents central and peripheral part of the face, region Ⅲ represents the peripheral part of the face, region Ⅳ represents the peripheral part of the face and neck, and region Ⅴ represents the neck.
1.2. 治疗方法
治疗仪器为美国Candela公司生产的Vbeam脉冲染料激光，波长595 nm，能量密度8～12 J/cm2，最常用的脉宽在0.45～10 ms之间，光斑大小7 mm或10 mm，光斑重叠0%～10%左右，配置动态喷射冷却装置（dynamic cooling device, DCD）。治疗目标为最大程度上消除皮损，同时减少副反应。治疗前签署知情同意书。治疗具体参数依据患者皮损特征而定，治疗终点为轻度紫癜。治疗结束后治疗区域外用0.1%红霉素软膏防止感染及减轻急性期反应，并用纱布冰敷20～30 min，嘱患者避光防晒，两次治疗间隔时间为6～8周。
1.3. 疗效判定
每次治疗前均清洁皮肤，拍摄面部照片。首次治疗前拍照作为自身对照，第2次治疗前拍的照片用于第1次治疗后的效果评定，以此类推。疗效由3位未参与治疗的皮肤科医师（1位主治医师和2位住院医师）通过治疗前与治疗后的皮损照片进行对比独立评估，按改善程度打分，用百分数表示，然后取3个百分数的平均值，来进行疗效的确立。通过观察皮损颜色、面积大小以及皮损厚度综合评判。疗效评判标准采用四分法[7]，即Ⅰ：无效（0～25%改善）；Ⅱ：有效（26%～50%改善）；Ⅲ：显效（51%～75%改善）；Ⅳ：基愈（76%～100%改善）。总有效率=（基愈+显效+有效例数）/总例数×100%，显效率=（基愈+显效例数）/总例数×100%。
1.4. 统计学方法
计数资料采用非参数检验（包括Kruskal-Wallis H检验和Mann-Whitney U检验），影响因素采用有序多分类logistic回归分析，P<0.05为差异有统计学意义。
2. 结果
2.1. 临床疗效
595 nm PDL治疗面颈部PWS基愈病例57例（22.0%），显效病例106例（40.9%），有效病例68例（26.3%），总有效例数231例，总有效率为89.2%。无效病例28例（10.8%）。
2.2. 单因素分析结果
见表1。不同性别患者疗效差异无统计学意义（Z=−0.271， P=0.786）；各组年龄间疗效差异无统计学意义（χ2=0.134， P=0.998）；按颜色分型疗效差异有统计学意义（χ2=24.250，P=0.000）；按皮损是否增厚疗效差异有统计学意义（Z=−2.007，P=0.045）；按面积分组疗效差异有统计学意义（Z=−3.033，P=0.002）；按皮损部位分组疗效差异有统计学意义（χ2=10.872，P=0.028）；按治疗次数分组疗效差异有统计学意义（Z=−2.889，P=0.004）。
表 1. Comparison of efficacy of PDL in treating PWS of face and neck according to different factors.
按不同因素分组PDL治疗面颈部PWS疗效分析比较
| Index | Total/case (%) | Efficacy/case (%) | P | |||
| Ⅰ | Ⅱ | Ⅲ | Ⅳ | |||
| The table shows the assessments of the treatment response. Ⅰ: Poor improvement (0-25%); Ⅱ: Moderate improvement (26%-50%); Ⅲ: Significant improvement (51%-75%); Ⅳ: Cure (76%-100%). | ||||||
| Gender | 0.786 | |||||
| Male | 82 (31.7) | 9 (11.0) | 22 (26.8) | 34 (41.5) | 17 (20.7) | |
| Female | 177 (68.3) | 19 (10.7) | 46 (26.0) | 72 (40.7) | 40 (22.6) | |
| Age | 0.988 | |||||
| 0–3 yr. | 67 (25.9) | 6 (8.9) | 18 (26.9) | 29 (43.3) | 14 (20.9) | |
| 4–10 yr. | 66 (25.5) | 8 (12.1) | 17 (25.8) | 24 (36.4) | 17 (25.8) | |
| 11–20 yr. | 79 (30.5) | 12 (15.2) | 18 (22.8) | 31 (39.2) | 18 (22.8) | |
| >20 yr. | 47 (18.1) | 2 (4.3) | 15 (31.9) | 22 (46.8) | 8 (17.0) | |
| Color | 0.000 | |||||
| Pink | 56 (21.6) | 10 (17.9) | 23 (41.1) | 16 (28.6) | 7 (12.5) | |
| Red | 158 (61.0) | 6 (3.8) | 34 (21.5) | 76 (48.1) | 42 (26.6) | |
| Purple | 45 (17.4) | 12 (26.7) | 11 (24.4) | 14 (31.1) | 8 (17.8) | |
| Proliferative or not | 0.045 | |||||
| Non-proliferative | 236 (91.1) | 20 (8.5) | 64 (27.1) | 99 (41.9) | 53 (22.5) | |
| Proliferative | 23 (8.9) | 8 (34.8) | 4 (17.4) | 7 (30.4) | 4 (17.4) | |
| Area | 0.002 | |||||
| ≤10 cm2 | 163 (62.9) | 8 (4.9) | 47 (28.8) | 63 (38.7) | 45 (27.6) | |
| >10 cm 2 | 96 (37.1) | 20 (20.8) | 21 (21.9) | 43 (44.8) | 12 (12.5) | |
| Location | 0.028 | |||||
| Central face | 30 (11.6) | 2 (6.7) | 11 (36.7) | 10 (33.3) | 7 (23.3) | |
| Central&lateral face | 91 (35.1) | 16 (17.6) | 25 (27.5) | 39 (42.9) | 11 (12.1) | |
| Lateral face | 112 (43.2) | 8 (7.1) | 28 (25.0) | 45 (40.2) | 31 (27.7) | |
| Lateral face&neck | 15 (5.8) | 2 (13.3) | 1 (6.7) | 8 (53.3) | 4 (26.7) | |
| Neck | 11 (4.2) | 0 (0) | 3 (27.3) | 4 (36.4) | 4 (36.4) | |
| Treatment sessions | 0.004 | |||||
| ≤3 | 137 (52.9) | 20 (14.6) | 43 (31.4) | 48 (35.0) | 26 (19.0) | |
| >3 | 122 (47.1) | 8 (6.6) | 25 (20.5) | 58 (47.5) | 31 (25.4) | |
2.3. 有序多分类logistic回归分析结果
将表1中5个有统计学意义的因素进行有序多分类logistic回归分析（表2）。分析后发现，皮损颜色分型：红型比紫红型疗效好（OR=2.748，P<0.05），而粉红型与紫红型无显著性差异（P>0.05）。皮损面积：面积≤10 cm2者，疗效更好（OR=2.094，P<0.05）；治疗次数：治疗3次以上者疗效优于治疗1～3次者（OR=0.058，P<0.05）；皮损部位：皮损位于面中部者（OR=0.190，P<0.05）、面中及面周部者（OR=0.243，P<0.05）疗效比位于颈部者差。皮损是否增厚与疗效无关。
表 2. Ordered logistic regression analysis of influencing factors of PDL in treatment of facial and neck PWS.
影响PDL治疗面颈部PWS疗效的有序多分类logistic回归分析结果
| Influcing factor | β | SE | Wald | P | OR | 95% CI |
| β: Partial regression coefficient; SE: Standard error; OR: Odds ratio; CI: Confidence interval. | ||||||
| Color | ||||||
| Pink | −0.294 | 0.454 | 0.419 | 0.517 | 0.745 | 0.306-1.815 |
| Red | 1.011 | 0.408 | 6.138 | 0.013 | 2.748 | 1.235-6.110 |
| Purple | 1 | Ref | ||||
| Area | ||||||
| ≤10 cm2 | 0.739 | 0.296 | 6.217 | 0.013 | 2.094 | 1.171-3.743 |
| >10 cm 2 | 1 | Ref | ||||
| Location | ||||||
| Central face | −1.661 | 0.697 | 5.688 | 0.017 | 0.190 | 0.049-0.744 |
| Central & lateral face | −1.413 | 0.615 | 5.274 | 0.022 | 0.243 | 0.073-0.813 |
| Lateral face | −1.120 | 0.613 | 3.337 | 0.068 | 0.326 | 0.098-1.085 |
| Lateral face&neck | −0.365 | 0.764 | 0.228 | 0.633 | 0.694 | 0.155-3.102 |
| Neck | 1 | Ref | ||||
| Treatment sessions | ||||||
| ≤3 | −0.677 | 0.238 | 8.112 | 0.004 | 0.508 | 0.319-0.810 |
| >3 | 1 | Ref | ||||
| Proliferative or not | ||||||
| Non-proliferative | 0.334 | 0.519 | 0.414 | 0.520 | 1.397 | 0.505-3.865 |
| Proliferative | 1 | Ref | ||||
2.4. 不良反应
PDL治疗终点为轻度紫癜，17.8%的患者出现轻度肿胀，3 d左右消退。1例患者出现色素沉着，术后半年基本恢复正常肤色。未发生水疱、溃疡、萎缩性瘢痕及增生性瘢痕等较严重不良反应。
3. 讨论
经过30余年的临床探究和验证，PDL已广泛用于治疗鲜红斑痣。本研究显示，应用595 nm PDL治疗259例面颈部鲜红斑痣患者，总有效率为89.2%，显效率为62.9%，基愈率为22.0%。目前多数研究主要通过单因素分析评价其疗效及影响因素[7-9]，本研究首次对临床疗效进行有序多分类logistic回归分析，综合分析和评价可能对疗效具有较大影响的因素，结果显示影响疗效的主要因素包括皮损类型、皮损面积、皮损部位及治疗次数。
本研究采用自身前后对照的方式，对PDL治疗鲜红斑痣治疗前及治疗后的照片进行疗效评价。本组病例单因素分析与有序logistic回归分析均显示红型疗效显著优于粉红型和紫红型，而粉红型与紫红型疗效无显著性差异（P>0.05），此结果与LIN等报道的结果一致[10]。这可能是由于粉红型鲜红斑痣血管深度较红型浅，血管管腔直径较小；而紫红型血管位置可能相对更深，血管管腔直径较大，因此粉红型和紫红型鲜红斑痣临床治疗效果与红型相比相对较差。此外，皮损颜色加深是由于受累区域的血管扩张引起的血红蛋白含量升高，而粉红型鲜红斑痣血红蛋白含量相对较低，对PDL治疗敏感性较低；紫红型鲜红斑痣往往伴有一定程度的增厚，因此临床治疗效果与红型相比相对较差。本研究单因素分析结果显示非增厚型皮损疗效优于增厚型，与KHANDPUR等报道的结果相类似[11]，而本研究有序多分类logistic回归分析显示非增厚型皮损与增厚型皮损疗效并无统计学差异，否定了单因素分析的结果，提示皮损增厚不是疗效的影响因素。
本研究的单因素及多因素分析结果均显示皮损面积越小，疗效越好，与既往报道结果一致[7]。分析原因可能有面积越小者往往需要更少的治疗次数，就能达到较好的疗效。而本研究中，皮损位于面周部、颈部者较其他部位疗效更佳，推测原因可能是由于面中部血管丰富且血管较粗，血红蛋白受热凝固后易被血流冲开，同时血管深达皮下组织，结构复杂，因此达不到满意的治疗效果[12]。本研究中，3次以上治疗者疗效明显优于3次以下者，与既往报道结果一致[9]。同一类型的皮损，随着治疗次数增加，疗效也相应增加，但通常在治疗7次之后，疗效增加不明显，可能是由于纤维样结构形成，影响激光束的穿透。
值得注意的是，本研究显示疗效与年龄无显著相关性，与既往研究类似[10]，但也有多个研究显示，年龄越小，治疗效果越好[7-9]，分析原因可能是就鲜红斑痣皮损本身而言，年龄可能不是影响疗效的关键性因素。
本研究中10.2%的患者对治疗无效，这部分病例皮损面积较大、皮损多分布于面中及面周部、治疗次数偏少，与既往研究治疗抵抗的病例特征类似[13]。对于这部分病例，宜采取联合治疗，提高治疗效果。近年来不断有学者尝试采用联合或其他治疗方式以提高疗效：BAE等[14]采用PDL联合射频治疗难治性PWS，结果显示联合治疗的区域取得了明显改善。研究显示PDL联合局部使用咪喹莫特和雷帕霉素等药物治疗面部PWS，疗效显著提高[15]。多项研究结果表明光动力治疗（photodynamic therapy, PDT）与PDL相比，一次清除率更高，且在紫红型皮损中PDT疗效更佳[16-17]。但也有一些方式并未显著提高疗效：WANG等[18]联合采用双波长激光（595 nm PDL联合1064 nm Nd: YAG）治疗鲜红斑痣，疗效并未显著增加，且增加了瘢痕等严重不良反应的发生率。
综上所述，595 nm PDL治疗面颈部鲜红斑痣可达到较好疗效，不良反应发生率低，是目前治疗面颈部鲜红斑痣的较好选择。同时，对于面积较大、皮损位于颜面中部、紫红型的患者，可酌情选择其他治疗方式，如光动力治疗，595 nmPDL联合其他激光、药物，射频治疗等。此外，本文属回顾性研究，资料有限，样本量偏低，后期会继续优化。
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利益冲突 所有作者均声明不存在利益冲突
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