用户名: 密码: 验证码:
毒瘀并解方治疗带状疱疹毒瘀互结证的临床研究
详细信息    本馆镜像全文|  推荐本文 |  |   获取CNKI官网全文
摘要
目的:对毒瘀并解方治疗带状疱疹毒瘀互结证进行临床研究,综合评价其疗效和安全性,并对其进行卫生经济学初步的评价。
     方法:1按纳入病例的先后顺序将患者随机分配到试验组(毒瘀并解方组)、对照组(泛昔洛韦组)。2试验组33例,口服毒瘀并解方煎剂,共服药7天。对照组32例,口服泛昔洛韦片,0.25g/次,3次/日,共服药7天。治疗期间禁止使用与研究药物效用相近的中西药物或其他相关治疗方法。请患者于治疗第4、8天复诊,观察并记录指标。治疗第8天评价综合疗效和疼痛疗效。对于疼痛未愈的患者,第30天随访,观察后遗神经痛发生情况。3观察指标:患者治疗前后的症状、体征(刻下疼痛分级、痒感、烧灼感、红斑、疱疹簇数、水疱数目、疱疹性状、溃疡、发热、淋巴结情况、皮损面积)的变化,疼痛程度的变化(视觉模拟量表法VAS法),并对60~70岁患者的综合疗效和疼痛疗效进行单独比较;时效性指标:疼痛开始减轻时间、水疱开始减少时间、红斑开始消退时间、开始结痂时间;免疫指标检查;带状疱疹后遗神经痛发生率;安全性指标(血、尿、便常规和肝肾功能,安全等级,不良反应情况);成本—效果分析等。疗效判定标准参照《中药新药临床研究指导原则》中的疗效判定标准。
     结果:1试验组与对照组两组间及两组内症状体征量化总积分比较:两组组内治疗前后比较差异均有统计学意义(P<0.01);两组组间治疗后比较差异无统计学意义(P>0.05),说明毒瘀并解方治疗带状疱疹毒瘀互结证在症状体征综合评分方面与泛昔洛韦疗效相当。2综合疗效比较:试验组与对照组比较差异无统计学意义(P>0.05),说明毒瘀并解方治疗带状疱疹毒瘀互结证在综合疗效方面与泛昔洛韦相当。其中,60~70岁患者的综合疗效比较,毒瘀并解方具有一定的优势。3试验组与对照组两组间及两组内疼痛积分比较:两组组内治疗前后比较差异均有统计学意义(P<0.01);两组组间治疗后比较差异无统计学意义(P>0.05),说明毒瘀并解方治疗带状疱疹毒瘀互结证在疼痛积分改善方面与泛昔洛韦疗效相当。4疼痛疗效比较:试验组与对照组比较差异无统计学意义(P>0.05),说明毒瘀并解方治疗带状疱疹毒瘀互结证在疼痛疗效方面与泛昔洛韦相当。其中,60~70岁患者的疼痛疗效比较,毒瘀并解方具有一定的优势。5时效性比较:试验组与对照组在疼痛开始减轻、水疱开始减少、、红斑开始消退、开始结痂的时间上比较,差异均无统计学意义(P>0.05),说明毒瘀并解方治疗带状疱疹毒瘀互结证在单项改善的时效性方面与泛昔洛韦相当。6免疫指标检查:试验组sIL-2R、T细胞亚群的变化,说明毒瘀并解方起效的机制可能为调节机体的免疫功能而达到抗病毒作用。7后遗神经痛发生率比较:试验组后遗神经痛发生1例,发生率为3%;对照组遗留后遗神经痛发生2例,发生率为6%。经检验差异无统计学意义(P>0.05)。8安全性比较:毒瘀并解方组患者用药前后血、尿、便常规,肝、肾功能检查均无异常,安全等级均为1级,说明毒瘀并解方为临床安全方药。9成本一效果分析:毒瘀并解方的一个疗程(一周)的经济费用为泛昔洛韦的1/4,说明毒瘀并解方为临床比较经济的方药。
     结论:毒瘀并解方治疗带状疱疹毒瘀互结证疗效确切,能很好的改善患者的疼痛、皮损及全身的症状体征,安全性好,成本低廉。其起效的机制可能为调节患者的免疫功能,调动机体自身抗病毒机制而杀灭病毒,尤其对老年人的症状的改善优于泛昔洛韦,这需要我们今后再进行大样本临床研究而进一步证实。
Objective: General evaluate the clinical curative effect ,security and medical economics by performing the clinical study of Duyu bingjie formula on the syndrome of toxicity and blood stasis of Herpes Zoster.
     Method: 1 Divide the patients who are suffering from Herpes Zoster and sonsistent with the ingression standard into two groups randomly.2 The treatment group(Duyu bingjie formula group) includes 33 cases.Component of Duyu bingjie formula: Scetellaria Root15g, Gardenia15g, Curcuma15g, Yanhusuo10g, Umbellate Pore Fungus30g; cooked for about 200ml,taking twice a day for 7 days. The comparison group includes 32 cases, taking famciclovir(FCV) three times a day for 7 days.The Chinese herbs and Western medicine or other therapies with similar effect are forbidden during the study.3.Obsering indicatrix:the change of symptom and the physical sign(current degree of neuralgia,local itching,burning sensation, erythema, cluster number of blister,number of blister, characteristic of the blister,ulcer, fever,swollen of regional lymph node,area of the skin lesion),VAS, separatly compare the change of symptom and the physical sign and VAS of the patients 60 to 70 years of age.The time of disappear of pain,the time of disappear of incrustation and decrustation. Immune indicators inspections;the incidence of the Postherpetic neuralgia; safety indicators(blood,urine,stool,liver and kidney function, adverse reactions), Cost-effectiveness analysis,ect. Clinical criteria reference to the efficacy criteria on "Chinese medicine clinical research guidelines".
     Result : 1 There is no significant difference between the two groups of synthetic curative effect. The comparison of the patients 60 to 70 years of age indicates the treatment group is superior to comparison group.2 There is no significant difference between the two groups of pain curative effect. The comparison of the patients 60 to 70 years of age indicates the treatment group is superior to comparison group.3 There is no significant difference between the two groups of the time of disappear of pain,the time of incrustation and decrustation. 4 The result of immune indicators inspections indicates the treatment group have recovery tendency.5 There is no significant difference between the two groups of the incidence of the Postherpetic neuralgia.6 The safety indicators show the Duyu bingjie formula is safety.7 The Cost-effectiveness analysis indicates Duyu bingjie formula is economical.
     Conclusion : Duyu bingjie formula has good clinical effect on the syndrome of toxicity and blood stasisacute of herpes zoster. It can relieve the pain and improve skin and systemic symptoms and signs.It's safety and low cost. Its effect may be effective mechanism for the regulation of the immune function in patients mobilize the body's own anti-virus mechanism to destroy the virus, especially for the elderly to improve the symptoms better than famciclovir, This requires us for a large sample clinical study further confirmed in the future.
引文
1.张勇,刘爱英,张玲玲.198例带状疱疹临床分析.临床研究,2006,3(23):74-75.
    2. Whitley RJ. Changing dynamics of varicella-zoster virus Infections in the 21st century:the impact of vaccination. J Infe Dis, 2005,191:1999-2001.
    3. Nguyen HQ, Jumaan AO, SewardJF. Decline in mortality due to Varicella and implementation of varicella vaccination in the UnitedStates. N Engl J Med, 2005,352: 450-458.
    4.李学军.300例带状疱疹临床分析.中国皮肤性病学杂志,2000,14(3):171-172.
    5.任勇,路麒.带状疱疹的病因及发病机制.中国临床医生,2003,5(31):4.
    6.王开颜.带状疱疹153例临床分析.铁道医学,2000,28(4):275-276.
    7. SchmaderK, GeorgeLK, BurchettBM, etal. Racialanand sychosial risk factors for herps zoster in the elderly. J Infect Dis, 1998, 178 (Suppl. 1): S67-S70.
    8. Sercarz E, Krzych U. The distinctive specificity of antigen specific suppressor T cells. Immunol Today 1991, 12(4): 111.
    9.唐亚娟,邱国强.带状疱疹患者外周血T细胞亚群分析.苏州医学院学报,1998,18(3):239.
    10.余春艳,张盈华,张立朝,等.带状疱疹患者可溶性IL-2R和T细胞亚群的变化.细胞与分子免疫学杂志,2000,16(2):146.
    11.宋海燕,任勇.带状疱疹的临床表现.中国临床医生,2003,31(5):5-6.
    12.张勇.198例带状疱疹临床分析.临床研究,2006,3(23):74-75.
    13.林霖霖.带状疱疹的临床表现与患者年龄关系.温州医学院学报,1995,1:56-57.
    14.王芳.457例带状疱疹临床分析.中国麻风皮肤病杂志,2003,19(2):181-182.
    15.邓仰福.年龄及诱发因素在带状疱疹发病中的作用.中国皮肤性病学杂志,2000,14(2):97-98.
    16.范团起,李卫红.带状疱疹364例神经系统表现分析.中国实用神经疾病杂志,2006,9(2):28-30.
    17.胡韶光,叶少琼,谢裕南.带状疱疹138例分析.中国误诊学杂志,2005,5(14):2706.
    18.谭开明,刘矗,李伟权,等.带状疱疹患病现状的调查与分析.中国基层医药,2006,13(1):52-53.
    19.张春芬,冯拴安.以内脏痛为首发症状的带状疱疹48例临床分析.医学文选,2006,25(1):70-71.
    20.高秀娟,李喜哲,刘江.带状疱疹并发运动性麻痹1例.临床皮肤科杂志,1999,28(5):316.
    21.王树村,黄霞.播散性带状疱疹12例临床分析.中国皮肤性病学杂志,2004,18(5):272.
    22.李邀俤.简述抗病毒药物.海峡药学,2006,18(2):125-127.
    23.赵辨.临床皮肤病学.南京:江苏科学技术出版社,2001.112-113,301-302.
    24.张思平,赵政龙,刘金丽,等.阿昔洛韦联合甘露酣和地塞米松治疗带状疱疹的疗效观察.中国麻风皮肤病杂志,2005,21(3):233.
    25.张小亲.阿昔洛韦治疗带状疱疹疗效观察.山西医药杂志,2004,33(10):72.
    26.陈勇,陈超.阿昔洛韦治疗带状疱疹临床疗效观察.黑龙江医学,2003,11(27):873-874.
    27. Vernassiere C, Barbaud A, Trechot PH, etal. Systemic acyclovir reaction subsequent to acyclovir contact allergy: which systemic antiviral drug should then be used Contact Dermatitis, 2003, 49: 155-157.
    28. Wutzler P. Antiviral therapy of herpes simplex and varicella—zoster virus infections, lntervirology, 1997, 40: 345-356.
    29. Eisen D, Essell J, Broun BR, et al. Clinical utility of oral valacyclovir compared with oral acyclovir for the prevention of herpes simplex virus mucositis following autologous bone marrow transplantation or stem cell rescue therapy. Bone Marrow Transp 1, 2003, 31: 51-55.
    30.林靖雯,陈谦明,周红梅.抗疱疹病毒药物的研究进展.中华口腔医学杂志,2006,41 (1):60-62.
    31. Engst R, Schiewe U, Hobel W etal. Famciclovir in treatment of acute herpes zoster: results of two post2marketing surveillance studies inGermanyl Acta Derm Venereol, 2001, 81: 592-601.
    32. Humphrey RW, OBrien TR, Newcomb FM, et al. Kaposi' s sarcoma (KS) -associated herpes virus-like DNA sequences in peripheral blood mononuclear cells: association with KS and persistence in patients receiving anti— herpes virus drugs. Blood, 1996, 88: 297-301.
    33. Marcelletti iF. Synergistic inhibition of herpesvirus replication by docosanol and antiviral nucleoside analogs. Antiviral Res, 2002, 56:153-166.
    34.刘毅钧,高晖,闫小丽,等.重组人干扰素α-2b注射液治疗带状疱疹疗效观察.天津药学,2004,16(1):34-35.
    35.季素珍,郑和义,赵广,等.重组人干扰素α-2b凝胶治疗带状疱疹236例.中华皮肤科杂志,2005,38(10):648.
    36.梁敏奇.重组人白细胞介素2联合阿昔洛韦治疗老年带状疱疹疗效对比观察.华夏医学,2005(4):625.
    37.陈渝萌,刘洁如,张元花.重组人白细胞介素-2治疗老年带状疱疹的效果观察及护理.现代护理,2006,(12)12:1144.
    38.李绍刚.聚肌胞联合西咪替丁治疗带状疱疹临床效果观察.广西医学,2006,28(6):939.
    39.陈家秀,李桂明.丙种球蛋白治疗带状疱疹.中华皮肤科杂志,1998,3l(2):128.
    40.严道金,杨海平.卡介菌多糖核酸预防带状疱疹后遗神经痛疗效观察.中华皮肤科杂志,2006,39(1):53.
    41.孙维枝,信利民,田蔼萍,等.神经生长因子治疗带状疱疹疗效观察.中华皮肤科杂志,1999,32(3):197.
    42.李艳红,陈玉萍.阿司匹林外用治疗带状疱疹神经性疼痛的疗效观察.中国临床保健杂志,2004,7(2):127-128.
    43.崔红燕,刘晔.再看腺苷钴胺.中国处方药,2004,23(2):80.
    44.尹光文,何秋波,李冬芹,等.糖皮质激素治疗带状疱疹有效性及安全性观察.中华全科医师杂志,2005,4(3):187.
    45.杨健,黄新宇,侯捷.泼尼松预防老年人带状疱疹后神经痛的对照研究.临床皮肤科杂志,2000,29:99-100.
    46.郭洪飞,张北震,严旭,等.美能治疗带状疱疹的疗效观察.中国麻风皮肤病杂志,2006,22(9):752.
    47.涂喜汉.法莫替丁治疗带状疱疹50例临床分析.黄石理工学院学报,2006,22(4)76-77.
    48.路秀兰.微波综合治疗老年带状疱疹30例.中华理疗杂志,1999,22(4):248.
    49.宋林萍,郝秋莲,朱英北.紫外线治疗带状疱疹的临床疗效.中国康复,2003,18 (1):52.
    50.顾为光.红光治疗仪治疗84例带状疱疹疗效观察.江苏大学学报,2001,11:818.
    51.石健,滕华,李莉.激光穴位治疗带状疱疹140例临床观察.激光杂志,2004,25 (1):83.
    52.曾建玲,肖秀如.75%酒精湿敷治疗带状疱疹21例的临床效果.中国校医,2002,16(6):542.
    1.吴英,刘翠玲.中医治疗带状疱疹概况.新疆中医药,1996,4:56-58.
    2.魏文浩.带状疱疹之“五因辨治法”.河南中医,1998,18(2):25.
    3.贺芳,蔡爱萍,刘永胜.中药治疗带状疱疹86例.中国中医急症,2005,14(7):638.
    4.肖敏,艾儒棣.早期运用益气活血通络法预防老年人带状疱疹后遗神经痛.四川中医,2006,24(6):79-80.
    5.张苏恩,胡春芳.中药治疗带状疱疹60例.中国中医急症,2004,13(2):79.
    6.周继鹏.龙胆泻肝汤化裁治疗带状疱疹32例.湖南中医杂志,1994,10(4):7.
    7.史巧英.加味四妙勇安汤治疗带状疱疹127例.光明中医2006,21(9):84-85.
    8.于水永,马屏南.中药治疗带状疱疹40例.光明中医,2005,20(4):67-68.
    9.谢生根.普济消毒饮临证运用举隅.浙江中医杂志,2006,41(10):563.
    10.梁玉瑛,张淑娥.瓜蒌红花甘草汤治疗带状疱疹31例.新中医,2005,37(4):79.
    11.刘渝生.三仁汤加味治疗带状疱疹37例.中国中医急症,2004,13(9):621.
    12.梁志敏.六神丸治疗带状疱疹.浙江中医杂志,2006,41(1):51.
    13.庄建西.乌梅丸的临床运用.河南中医,2003,23(1):14-15.
    14.闵发胜,余汉中.静脉滴注双黄连联合外搽干扰素α治疗带状疱疹.中华皮肤科杂志,2004,37(9):533.
    15.苏晓杰,左文勤.黄芪注射液治疗带状疱疹疗效观察.中华皮肤科杂志,1999,32 (1):57.
    16.林秀英,白兆震.中西药合用治疗老年带状疱疹疗效观察.中国实用乡村医生杂志,2004,11(8):35.
    17.毕海军.金黄膏合鱼腥草治疗带状疱疹82例.中国中医急症,2005,14(4):329.
    18.胡旭梅.季德胜蛇药片治疗带状疱疹60例.中国民间疗法,2004,12(12):48.
    19.杨东红,朱力.紫草油治疗带状疱疹24例临床观察.长春中医学院学报,2004,20 (1):12.
    20.闫守国,陈桂华.大黄五倍子膏治疗中小学生带状疱疹21例疗效观察.中国学校卫生,2005,26(2):160.
    21.李春岚,李玉芳,项宇峰.红丹粉治疗急性带状疱疹疗效观察.时珍国医国药,2005,16(12):1290.
    22.湛先荣.“加味不二散”治疗带状疱疹60例疗效分析.中国学校卫生,2005,26 (9):749.
    23.刘世贵,徐桂萍,侯茹.拔毒涂膜剂的制备及临床观察.陕西中医学院学报,2006,29(1):59-60.
    24.谭闽英.王不留行外用治疗带状疱疹59例报告.中国乡村医药杂志,2006,13(6):51.
    25.朱玲.天花粉外用治疗皮肤感染及带状疱疹.中医杂志,2006,47(9):652.
    26.李之霞.白糖蚯蚓浸出液治疗带状疱疹.山东中医杂志,2006,25(9):616.
    27.贾爱芹,司巧莲.自拟参草散治疗带状疱疹34例.中国民间疗法,1996,5(1):43-44.
    28.陈晓梅.针灸治疗带状疱疹53例疗效观察.云南中医中药杂志,2004,25(3):26.
    29.王寅.带状疱疹的针灸治疗.中国医刊,1999,34(6):46-47.
    30.李建武.头针治疗带状疱疹临床观察.针灸临床杂志,2006,22(1):32-33.
    31.王素玲.五虎群羊针法结合药物治疗带状疱疹40例疗效观察.新中医,2006,38 (2):62-63.
    32.周学林.放血拔罐加针刺夹脊穴治疗带状疱疹47例.中国全科医学,2006,9(4):338-339.
    33.刘大平.火针为主治疗带状疱疹65例.吉林中医药,2006,26(7):37.
    34.丁曦,陶昆.皮肤滚针治疗带状疱疹202例临床观察.黑龙江中医药,2006,10(5):38-40.
    35.徐慧珍,张春兰.苦参素穴位注射治疗带状疱疹.中华皮肤科杂志,2001,34(6):461.
    36.达春花,李慧莺.带状疱疹针灸辨证治疗举隅.中国临床医生,2006,34(1):39.
    37.李慧.棉花灸为主治疗带状疱疹30例.中国民族医药杂志,2006,(1)5:32.
    38.乔起敏,闫庆平.刮痧治疗带状疱疹的效果观察.齐齐哈尔医学院学报,2006,27 (13):1585.
    39.何俊安.排毒疗法治疗带状疱疹70例.中医外治杂志,2006,15(4):43.
    1.赵辨.临床皮肤病学.南京:江苏科学技术出版社,2001,4.
    2.陆德铭.中医外科学·皮肤病及性传播疾病.上海:上海科学技术出版社,1996,2.
    3.郑筱萸.中药新药临床研究指导原则(试行).中国医药科技出版社,2002,57-61.
    4. Lenert LA. The reliability and internal consistency of an Internet-capable computer program for measuring utilities. Qual Life Res, 2000, 9 (7): 811-817.
    5.张学军.皮肤性病学.北京:人民卫生出版社,2004,7.
    6.[隋]巢元方撰.丁光迪主编.诸病源候论校注.北京:人民卫生出版社,1991.
    7.[明]王肯堂辑.倪和宪,彭怀仁点校.证治准绳.北京:人民卫生出版社,2001,2版.
    8.[清]吴谦等编.御纂医宗金鉴(武英殿版排印本).北京:人民卫生出版社,1998,3版.
    9.王本祥.现代中药药理学.天津:天津科学技术出版社,1997,1.
    10.陈仁寿.国家药典中药实用手册.南京:江苏科学技术出版社,2004,10.
    11.陈介同.黄芩鱼腥草治疗病毒性角膜炎30例.中医杂志,1997,38(2):65.
    12.朱江,蔡德海,芮菁.栀子的抗炎镇痛作用研究.中草药,2000,31(3):198.
    13.聂红,马安伦,沈伯华,等.复方猪苓多糖对小鼠免疫功能的调节.细胞与分子免疫学杂志,2000,16(5):384-386.
    14.李家泰.临床药理学.北京:人民卫生出版社,1998,741-742.
    15. Cirelli R, HerneK, McCrary M, etal. Famciclovir:review of clinical efficacy and safety. Antiviral Res, 1996, 29(2-3): 141-146.
    16. Whitley RJ, Shukla S, Crooks RJ. The Identification of Risk Factor Associated with Persistent Pain following Herpes Zoster. Journal of infection disease, 1998, 178(Suppl 1): S71-S75.
    17.仓尧卿.水痘-带状疱疹疾病的研究近况.国外医学流行病学传染病分册,1998,25(6):266-269.
    18.余春艳,张盈华,张立朝,等.带状疱疹患者可溶性IL-2R和T细胞亚群的变化.细胞与分子免疫学杂志,2000,16(2):146.
    19.许冰,叶刚,张丽娟.带状疱疹患者血清可溶性白介素2受体的检测.中华皮肤科杂志,1994,27(4):235-236.
    20. Sercarz E, Krzych U. The distinctive specificity of antigen specific suppressor T cells. Immunol Today, 1991, 12(4): 111.
    21.唐亚娟,邱国强.带状疱疹患者外周血T细胞亚群分析.苏州医学院学报,1998,18(3):239.
    22.孙东信,丁采英.He-Ne激光穴位照射对带状疱疹患者T细胞亚群的影响.中国激光医学杂志,1999,8(1):19-20.
    23.夏丽英.现代中药毒理学.天津:天津科技翻译出版社,2005,10.

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700