A randomized clinical comparative study of cryotherapy plus photodynamic therapy vs. cryotherapy in the treatment of multiple condylomata acuminata
A randomized clinical comparative study of cryotherapy plus photodynamic therapy vs. cryotherapy in the treatment of multiple condylomata acuminata
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DOI：
10.1111/j.1600-0781.2011.00592.x
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发表时间：
2011-08-01
影响因子：
2.6
通讯作者：
Li, Jun
中科院分区：
文献类型：
--
作者：
Mi, Xia;Chai, Wangxing;Li, Jun
背景：冷冻治疗不能破坏亚临床人乳头瘤病毒感染的尖锐湿疣(CA)细胞。局部应用氨基乙酰丙酸(ALA)导致CA皮损穿透深度较浅(1)。目的：比较冷冻加ALA-光动力疗法(ALA-PDT)与冷冻治疗多发性CA的疗效和安全性。方法：80例多发性CA患者接受冷冻+ALA-PDT(n=40)或冷冻+安慰剂-PDT(n=40)。冷冻结束后，用红光(635 nm，100 mW/cm(2)，100J/cm(2))照射前3h在CA区涂抹20%丙氨酸或安慰剂溶液。如果皮损没有完全消失，在第一次治疗后7天重复治疗。结果：冷冻加ALA-PDT组和冷冻组的总有效率分别为肛门区32.4%(36/111)和32.6%(43/132)(P>；0.05)，尿道部100%(32/32)和54.5%(18/33)。外生殖器分别为94.2%(129/137)和50.5%(56/111)(P<；0.05)。联合组和冷冻组肛门部复发率分别为24.3%(27/111)和31.1%(41/132)，尿道部复发率分别为9.4%(3/32)和39.4%(13/33)，外生殖器复发率分别为3.6%(5/137)和31.5%(35/111)。两组患者均出现轻、中度疼痛、水肿、糜烂、色素沉着等不良反应，未见感染、溃疡、瘢痕形成或尿路畸形。结论：冷冻联合ALA-PDT治疗多发性尖锐湿疣较单纯冷冻治疗更为有效。
Background: Cryotherapy cannot destroy subclinical human papillomavirus-infected cells of condylomata acuminata (CA). The topical application of aminolevulinic acid (ALA) results in a shallow penetration depth in CA lesions (1).Objectives: To compare the efficacy and safety of cryotherapy plus ALA-photodynamic therapy (PDT) with cryotherapy in the treatment of multiple CA.Methods: Eighty patients with multiple CA received cryotherapy plus ALA-PDT (n = 40) or cryotherapy plus placebo-PDT (n = 40). After cryotherapy, a 20% ALA or a placebo solution was applied to the CA area 3 h before illumination with red light (635 nm, 100mW/cm(2), 100 J/cm(2)). The treatment was repeated 7 days after the first treatment if the lesions were not completely resolved. The complete response rate, recurrence rate and adverse effects in the two groups were analyzed.Results: After two treatments, the complete response rates in the combined group (cryotherapy plus ALA-PDT) and cryotherapy group were 32.4% (36/111) and 32.6% (43/132) in the anal area (P > 0.05), 100% (32/32) and 54.5% (18/33) in the urethral meatus (P < 0.05), and 94.2% (129/137) and 50.5% (56/111) in the external genitals (P < 0.05), respectively. The recurrence rates in the combined group and cryotherapy group were 24.3% (27/111) and 31.1% (41/132) in the anal area (P > 0.05), 9.4% (3/32) and 39.4% (13/33) in the urethral meatus (P < 0.05), and 3.6% (5/137) and 31.5% (35/111) in the external genitals (P < 0.05), respectively. The adverse effects in each group included mild to moderate pain, edema, erosion and hypopigmentation, without any infection, ulcers, scarring or urethral malformations.Conclusion: Cryotherapy plus ALA-PDT is a more effective regimen for the treatment of multiple CA compared with cryotherapy alone.