摘要
研究目的：
尖锐湿疣是临床常见的性传播疾病,且有逐渐增长的趋势,近代研究表明HPV感染或尖锐湿疣可导致或继发生殖器恶性肿瘤如宫颈癌,外阴、肛门癌等,从而引起人类的高度重视。尖锐湿疣易于反复发作,目前中成药外用治疗尖锐湿疣的方法报道不少,但是令人满意的不多,因此寻找理想的外用中成药亦成为中医界一直关注的问题。本课题通过观察山楂核提取物为主要成份制成的消毒液-优可洛外用治疗尖锐湿疣与C02激光治疗尖锐湿疣的临床疗效比较及实验室指标比较,来探讨中成药外治尖锐湿疣的疗效,以寻找一种理想的、安全方便的尖锐湿疣外用中成药。
方法：
采用前瞻性随机对照研究方法,本课题将符合纳入标准的132例尖锐湿疣病例,按随机对照原则,分为优可洛治疗组65例,激光对照组67例,分别按照研究方案进行治疗。收集两组治疗前后的指标和数据进行观察：一般资料；临床疗效；治疗后创面愈合天数；病毒转阴率；复发率；不良反应。应用SPSS17.0软件统计分析,对治疗结果采用卡方检验分析。
结果
1.一般资料：两组在年龄、受教育程度、病程、疣体数量及积分等一般资料比较差异均无统计学意义(P>0.05)。复查时治疗组脱失6例,对照组脱失4例。
2.两组疗效比较：治疗疗程结束时优可洛治疗组65例疣体去除率为100%,无效0例。激光对照组67例,疣体去除率亦为100%。两组疗效比较差异无统计学意义(P>0.05)。
3.两组治疗后HPV-DNA-PCR比较：
(1)治疗后1个月HPV-DNA-PCR检测：优可洛治疗组59例,阴性32例,阳性27例,阴性率为54.24%；激光组63例,阴性21例,阳性42例,阴性率为33.33%。治疗后1个月两组病毒清除率比较差异有统计学意义(P<0.05)。
(2)治疗后3个月HPV-DNA-PCR检测：优可洛治疗组59例,阴性41例,阳性18例,阴性率为69.49%；激光组63例,阴性25例,阳性38例,阴性率为39.68%。治疗后3个月两组病毒清除率比较差异有统计学意义(P<0.05)。
(3)6个月HPV-DNA-PCR检测：优可洛治疗组59例,阴性46例,阳性13例,阴性率为77.97%；激光组63例,阴性28例,阳性35例,阴性率为44.44%。治疗后6个月两组病毒清除率比较差异有统计学意义(P<0.05)。
4.两组复发率比较：
(1)治疗疗程结束后1个月内复发率比较：治疗组复发4例,复发率为6.78%,对照组复发14例,复发率为22.22%,两组治疗疗程结束后1月内复发率比较差异有统计学意义(P<0.05)。
(2)治疗疗程结束后3个月内复发率比较：治疗组复发4例,复发率为6.78%,对照组复发18例,复发率为28.57%,两组治疗疗程结束后3个月内复发率比较差异有统计学意义(P<0.05)。
(3)治疗疗程结束后6个月内复发率比较：治疗组复发4例,复发率为6.78%,对照组复发20例,复发率为31.75%,两组治疗疗程结束后6月内复发率比较差异有统计学意义(P<0.05)。
结论
优可洛祛除尖锐湿疣,与激光治疗疗效相当；在HPV转阴率、复发率等方面优于激光治疗；优可洛无明显的毒副作用及不良反应,临床疗效确切。观察证实优可洛是一种很有发展前景的中药提取物外用药。
Objective:
Condyloma acuminatum(CA) is the common sexually transmitted disease in clinical, and there is a gradual upward trend, recent studies have shown that HPV infection.or genital condyloma may cause or secondary malignancies such as cervical, vulvar, anal cancer, and so on, which led to a high degree of human attention。It is very easy for CA to recurrent attacke, The method of Chinese medicine topical treatment of condyloma have been reported for many times which make little effect, it is becoming an isue to find an ideal method of chinese herbal for CA. in the professin of TCM. This research is to study the efficiency of YOUKELUO which is an chinese hebal medicine,according to observe the efficiency and laboratory indicators for comparison of youkeluo and C02 laser for CA, the aim of the study is to find an ideal, safe and convenient chinese patent medicinefor CA.
Method:
A prospective randomized controlled study is used in the research,132 cases of condyloma cases which meet the inclusion criteria will be divided into treatment group 65 cases of Youke Luo and laser control group,67 cases, respectively in accordance with research program for treatment. two sets of indicators and data before and after the treatment will be Collectted which including general informations, clinical effects, the days of the the surface of wound healing, the rate of the clearance of the virus, the rate of the recurrence, the safety, the untoward effect and so on。The softwareof spssl7 is used to analysis the date, Chi-square test is used to analysis the results of treatment
Results:
1.general informations:there is no statistical significance in the comparision of the age, the degree of education, the course of disease and the number of the warts.
2. Comparison of the efficacy of the two groups:in treatment group, there were 65 cases of traditional chinese medicine "Youkeluo", All the warts of which were removed, The rate of elimination was 100%; laser-control group,67 cases, the virus removal rate is also 100%. There is no significant difference between the two groups (P>0.05).
3. Comparison of HPV-DNA-PCR results of the two groups:
(1) HPV-DNA-PCR results of the inspection:excellent Luo treated 59 cases can be negative in 32 cases,27 cases were positive and negative rate was 54.24%; laser group 63 cases, negative 21 cases,42 cases of positive and negative rate was 33.33%. Using chi-square test P=0.020, difference between two groups of viral clearance rate was statistically significant (P<0.05).
(2)HPV-DNA-PCR results of the inspection:treatment groups:41 cases were negative,18 cases were positive and negative rate was 77.97%;laser group:negative 25 cases,38 cases of positive and negative rate was 39.68%. difference between two groups of viral clearance rate was statistically significant (P<0.05).
(3)HPV-DNA-PCR results of the inspection:excellent Luo treated 59 cases can be negative in 46cases,13 cases of positive and negative rate was 69.49%; laser group:negative 28 cases, positive in 35 cases, negative rate was 44.44%. Difference between two groups of viral clearance rate was statistically significant (P<0.05).
4. Comparison of relapse rate of the two groups:
(1)1 month after treatment,4 cases recurrenced in the treatment, the recurrence rate was 6.78%. in control group 1 month after treatment 14 cases of recurrence, the recurrence rate was 22.22%,,1 month after treatment two groups compared the recurrence rate, the difference was statistically significant (P<0.05).
(2) 3 months after treatment, in the treatment group 4 case recurrenced, the recurrence rate was 6.78%, in the control group18 cases recurrenced 3 months after treatment, the recurrence rate was28.57%, in the two groups 3 months after treatment, difference in recurrence rate statistically significant (P<0.05).
(3)6 months after treatment,4 cases recurrenced in the treatment group, the recurrence rate was6.78%.20 cases recurrenced 6 months after treatment in the control group, the recurrence rate was 31.75%, in the two groups 6 months after treatment, difference in recurrence rate statistically significant (P<0.05). Conclusiongs:
Youkeluo can remove the lesion of CA, which can be compared with the efficiency of the C02 laser, however the rate of the repelling the HPV, the rate of the recurrence are better than the C02 laser. The clinical efficacy of YOUKELUO is lclear, the side effect and untoward effect are slight. YOUKELUO is confirmed to be a great prospect for the development of Chinese medicine for external use.
引文
[1]王侠生,廖康煌.杨国亮皮肤病学[M].上海科学技术文献出版社,第2版,2005,7：373-375.
[2]KevinA. Ault.EpidemiologyandNaturalHistoryofHumanPapillomavirusInfe ctionsintheFemaleGenitalTract. HindawiPublishingCorporationlnfectiousD iseasesinObstetricsandGynecologyVolume2006, ArticleID40470, Pages 1-5.
[3]范瑞强,廖元兴.中西医结合临床皮肤性病学[M].广东世界图书出版公司,2003,3：1070-1071.
[4]蒋明军,王书崎,龚向东等.尖锐湿疣皮损中人乳头瘤病毒基因分型研究[J].中华皮肤科杂志,2005,38(5)：262-264.
[5]吕晓萍,李体远,戴勇等.尖锐湿疣皮损人乳头瘤病毒基因分型的研究[J].第三军医大学学报,2005,27(21)：2154-2156.
[6]Michelle M. Lipke, MPAS, PA-C. An Armamentarium of Wart Treatments Clinical Medicine & ResearchVolume 4, Number 4:273-293.
[7]任虹,张瑞丽,解春桃等.淋巴样增强因子1在尖锐湿疣皮损及其癌变组织中的表达[J].临床皮肤科杂志,2009,(5)：291-293.
[8]李安信,尹锐,钟白玉等.人乳头瘤病毒感染检测及其临床意义[J].中华实验和临床病毒学杂志,2006,20(3)：49-52.
[9]OSCAR SADAN.Occurrence of cervical intraepithelial neoplasia in generallyhealthyWomenwithexophyticvulvarcondylomaacuminatalnfectiousD iseasesinObstetricsandGynecology, September2005,13(3):141C14.
[10]李中伟,开长平,李娜等.尖锐湿疣患者IL－2,SIL－2R,IFN－7和IFN-a水平的检测[J].中国麻风皮肤病杂志,2004,20(5)：427-429.
[11]狄文,殷霞.人乳头瘤病毒感染和宫颈尖锐湿疣[J].实用妇产科杂志,2004,20(2)：67-68.
[12]刘源,侯安继,陆平成.复发性尖锐湿疣免疫学发病机制研究进展[J].湖北中医杂志,2006,28(6)：54-56.
[13]刘泽虎,刘贞富.国外医学皮肤性病学分册,2003,29.(1)：5-7.
[14]苗青,苗薇.尖锐湿疣患者红细胞免疫功能的初步研究[J].临床皮肤科杂志,2000,29(3)：156-157.
[15]杨义成.乳晕尖锐湿疣一例[J].皮肤与性病,2007,29(3)：60.
[16]张正中.家族慢性良天庖疮伴腋下尖锐湿疣1例[J].四川医学,2004,25(9)：946-946.
[17]常冬青.老年外耳道尖锐湿疣1例[J].中国皮肤性病学杂志,2007,21(4)： 253-254.
[18]高云.阴茎、肛周、耳廓同患尖锐湿疣1例[J].中国皮肤性病学杂志,2006,20(1)：56-57.
[19]赵辨.临床皮肤病学[M].第2版.南京：江苏科学技术出版社,2001,4(3)：536-538.
[20]范医东等.性传播疾病诊治图谱[M].山东科学技术出版社,2007,2：153-155.
[21]章易琴.孕妇尖锐湿疣11例治疗和护理[J].实用医学杂志,2008,24(18)：3173.
[22]蔡文莲.孕妇尖锐湿疣68例相关性分析[J].中华现代临床医学杂志,2008,6(7)：614-615.
[23]黄捷,赖伟珍,王太等.单味中药柴胡治疗尖锐湿疣70例[J].中医外治杂志,2006,15(4)：24-25.
[24]范瑞强,榻国维,池凤好.中药疣毒净制剂治疗尖锐湿疣的初步疗效观察[J]新中医,1997,29(9)：41.
[25]胨玲.消疣膏浩疗尖锐湿疣56僦[J].中医外治杂志,1997,3：56.
[26]池凤好,范瑞强.尖锐湿疣的中医治疗近况.深圳中西医结合杂志[J],2000,10(3)：134-136.
[27]廉翠红,陈冰,张书岭.尖锐湿疣药物及外科治疗的研究进展[J].国际皮肤性病学杂志,2008,34(1)：64-66.
[28]徐荣春,国玉寒,宋一丽等.50%三氯醋酸治疗女性生殖器尖锐湿疣30例临床观察[J].中国性科学,2006,15(1)：22.
[29]郝延光.中西药联合治愈4例巨大型尖锐湿疣[J].中国麻风皮肤志,2008,24(8)：669.
[30]张合成.高频电刀联合重组a-2a干扰素治疗尖锐湿疣86疗效观察[J].岭南皮肤性病科杂志,2008,2：93-94.
[31]王海潮.聚肌胞疣基底注射法治疗尖锐湿疣的临床研究[J].中国热带医学,2008,8.(10)：1735.
[32]Pearson GW, Lan ey RG. Topical infiquimod[J]. J Derrnatolog Treat, 2001,12(1):37.
[33]谷东风,曾抗.应用循证医学的方法评价咪喹莫特治疗尖锐湿疣的临床疗效及流行病学特点[J].中国现代医学杂志,2008,18(15)：2190-2192,2195.
[34]钱戌春,黄月珍.二硝基氯苯(DNCB)免疫疗法治疗经验[J].新疆医科大学报,2006,9(10)：968-970.
[35]温怀学.左旋咪唑治疗复发性尖锐湿疣的临床疗效观察[J].现代保健：医学创新研究,2006,10：125-126.
[36]卢木荣,吴竞林.两种剂量平阳霉素治疗尖锐湿疣疗效观察[J].岭南皮肤性病科杂志,2008,15(2)：95-96.
[37]朱学骏,顾有守.实用皮肤性病治疗学[M].北京大学医学出版社.2007,5：510-511.
[38]郝延光.中西药联合治愈4例巨大型尖锐湿疣[J].中国麻风皮肤病杂志,2008,24(8)：669.
[39]刘洪胜,梁燕华.阿维A控制34例尖锐湿疣复发的临床疗效观察[J].皮肤病与性病,2008,30(1)：49-50.
[40]尤立平,杨顶权,王继英.阿维A联合X线放疗治疗巨大尖锐湿疣1例[J].临床皮肤科杂志,2008,37(6)：398.
[41]黄跃深.二氧化碳激光联合d－干扰素栓阴道用药治女性生殖道尖锐湿疣疗效观察[J].中国皮肤性病学杂志,2001,3(15)：109-111.
[42]王秀丽.5－氨基酮戊酸光动力治疗尿道尖锐湿疣临床与实验研究[J].应用激光,2005,25(2)：139-141,108.
[43]陈鸿超,方红,王懿娜等.盐酸氨基酮戊酸光动力疗法治疗尿道尖锐湿疣临床观察[J].临床皮肤科杂志,2009,38(3)：193-194.
[44]徐佩红,袁定芬,邬宗周等.5－氨基酮戊酸光动力疗法降低尖锐湿疣复发率的临床观察[J].临床皮肤科杂志,2009,(5)：334-335.
[45]黄国坚.光动力激光治疗尖锐湿疣20例疗效观察[J].中国麻风皮肤病杂志,2008,24(3)：235-236.
[46]朱菁,张慧国,聂凡等,HO:YAG激光治疗巨大型及腔内型尖锐湿疣13年总结[J].应用激光,2007,27(4)：351-354.
[47]秦梅香,朱菁,张美珏等HO:YAG激光治疗妊娠期尖锐湿疣49例的临床分析[J],应用激光,2007,27(4)：342-344.
[48]于千,王志芳,周卫东等.输尿管镜下钬激光治疗女性尿道尖锐湿疣[J].中国微创外科杂志,2008,8(4)：338-339.
[49]王祥林,刘成倍,徐伟等.经尿道输尿管镜下钬激光治疗尿道内尖锐湿疣12例报告[J]minimally invasive medicine,2007,2(5):478.
[50]Peter Komericki, MD,* Merve Akkilic, MD, and Daisy Kopera, MD. Pulsed Dye Laser Treatment of Genital Warts. Lasers in Surgery and Medicine, 2006,38:273-276
[51]刘忠艳.90Sr敷贴与电灼、冷冻治疗尖锐湿疣疗效观察[J].岭南皮肤性病科杂志,2008,15(1)：35-36.
[52]孙建国,马志青,白和平.液态氮冷冻加氟尿嘧啶湿敷治疗尖锐湿疣疗效分析[J].河北医药,2008,30(9)：1286.
[53]王昕海,刘成倍,徐伟等.外科手术治疗肛周巨大尖锐湿46例临床体会[J].上海医学,2007,30(8)：622-623.[54] Wiley DJ, Douglas J, Beutner et al. External genital warts; diagnosis, treatm ent, and prevention. Clin Infect Dis,2002,35 (Suppl 2):S210-$224.
[55]李宗华.二氧化碳激光与卡介菌多糖核酸治疗尖锐湿疣86例疗效观察[J].实用医学杂志,2008,24(18)：3184-3185.
[56]董新德,付继娥.电离子加中药治疗尖锐湿疣46例[J].中医与中西医结合职业与健康,2007,23(20)：1880.
[57]李钟灵等.外用干扰素联合微波治疗尖锐湿疣临床观察[J]Chinese Medical Journal of Metallurgical Industry,2007,24 (2):218.
[58]陈慧.冷冻联合α-2b干扰素凝胶治疗肛周尖锐湿疣疗效观察[J].中国皮肤性病学杂志,2007,21(12)：749.751.
[59]周大千.浅谈尖锐湿疣的治疗[J].医学信息,2008,21(10)：1885-1887.
[60]SuzanneM, Garland, Mauricioernandez-Avila. Quadrivalent ccine against Human Papillomavirus to Prevent Anogenital Diseases[J]. THE NEW ENGLAND JOURNAL OF MEDICINE,2007,19(356):1928-1943.
[61]黄朝晖,李莉华,刘志辉等.人乳头瘤病毒6／11型E7 DNA疫苗质粒的构建与体外表达[J].临床皮肤科杂志,2005,34(3)：158-159.
[62]ROLF-MARKUS SZEIMIES, MD, PHD, Adjuvant Photodynamic Therapy Does Not Prevent Recurrence of Condylomata Acuminata After Carbon Dioxide Laser AblationFA Phase III, Prospective, Randomized, Bicentric, Double-Blind Study. DERMATOLOGIC SURGERY,2009,35(5):757-764
[63]张华,孟辉.C02激光治疗尖锐湿疣皮损的深度和范围对复发率的影响[J].临床皮肤科杂志,2005,34(7)：453.
[64]陈峰,罗海林,黄恒忠.尖锐湿疣局部治疗与整体调治的疗效分析[J].中国现代医学杂志,2006,16(19)：3037-3038.
[65]王琳,张广富.尖锐湿疣发病和复发危险因素的问卷调查[J].中国皮肤性病学杂志,2005,19(10)：615-617.
[66]吴原,章步文,平金良.尖锐湿疣患者雌激素及孕激素受体的检测[J].中国麻风皮肤病杂志,2004,20(5)：497.
[67]张黎,姜海洋,徐育娴等.女性外生殖器尖锐湿疣中雄激素、雌激素和孕激素受体的表达[J].河南医学研究,2004,13(1)：34-35.
[68]刘沐桑,刘彤.尖锐湿疣患者复发影响因素的Logistic回归分析[J].中国皮肤性病学杂志,2004,18(12)：735-737.
[69]马小萍,任健康,张美芳等,尖锐湿疣病毒载量与复发的关系探讨[J].陕西医学杂志,2007,36(3)；332-334.
[70]李文飞,信红雁,司晓青.尖锐湿疣临床治愈后原皮损区人乳头瘤病毒监测[J].中华医院感染性杂志,2005,15(10)：1144-1146.
[71]王秋艳.综合治疗女性复发性尖锐湿疣118例临床分析[J].中国妇幼保健,2007,22(23)：3265,3304.
[72]池凤好,范瑞强,褐国维等.中药疣毒净治疗尖锐湿疣随机对照研究[J]中国医药学报,1999；14(2),40-42.