【作者】 刘佳；

【导师】 罗永芬；

【作者基本信息】 成都中医药大学 ， 针灸推拿学， 2009， 博士

【摘要】 目的：综合评价铺棉灸疗法治疗带状疱疹的临床疗效。制定铺棉灸疗法治疗带状疱疹的诊疗和操作标准,促进该法的临床推广应用。并通过该试验的设计和实施,对本次针灸临床试验设计中需要注意的问题提出讨论。方法：采用中央随机方法,由国家药品临床研究中心(成都中医药大学GCP中心)承担分配隐藏、中央随机和数据管理。成都、广州、武汉三个城市共九个研究中心承担研究任务。本次试验采用了来自成都、武汉共六个研究中心的部分数据。病例收集时间为为2008年1月4日～2008年12月31日。共纳入167例病例,脱落6例,剔除3例,无中止病例。治疗1组采用铺棉灸疗法(n=61),治疗2组采用叩刺拔罐法(n=55),对照组采用常规西药疗法(n=51)。采用综合疗效评分、疱疹指标、疼痛指标、安全性指标和耐受性指标等对三组进行疗效评价,以综合评定铺棉灸疗法治疗带状疱疹的临床应用。结果：基线情况比较：三组基线状况良好,分组均衡,具有可比性(P＞0.05)。综合疗效比较：铺棉灸疗法治疗带状疱疹有显著疗效,总有效率91.7%,但与叩刺拔罐组和西药组综合疗效比较,差异无统计学意义(P＞0.05)。铺棉灸组受试者治疗前后综合疗效评分有显著改善,但与叩刺拔罐组和西药组相比差异无统计学意义(P＞0.05)。疱疹指标比较：铺棉灸组结痂时间比叩刺拔罐组和西药组短(P＜0.05)；止疱时间及脱痂时间差异无统计学意义(P>0.05)。疼痛指标比较：①铺棉灸组治疗前后疼痛明显减轻,组间比较治疗后疼痛程度铺棉灸组低于叩刺拔罐组和西药组(P＜0.05)。铺棉灸组疼痛持续时间短于叩刺拔罐组和西药组(P＜0.05)。②在镇痛即刻效应方面,随着治疗次数的增加,铺棉灸组镇痛起效时间随之缩短,而镇痛维持时间随之增长。③三组带状疱疹后遗神经痛发生率比较,第30、60天随访铺棉灸组低于叩刺拔罐组和西药组(P＜0.05)。第90天铺棉灸组后遗神经痛发生率低于西药组,比较差异有统计学意义(P＜0.05)。指标连续动态观察比较：①铺棉灸组第8-11天和第22天随访,铺棉灸组疼痛强度低于叩刺拔罐组和西药组(P＜0.05)。②三组疼痛缓解程度前7天比较差异无统计学意义(P＞O.05)；治疗第8-11天及第22、30天随访；铺棉灸组疼痛缓解程度大于叩刺拔罐组和西药组,差异有统计学意义(P＜O.05)；第60、90天随访,三组间疼痛缓解程度差异无统计学意义(P＞0.05)。③在综合疗效评分单项指标的连续观测上,“局部痛”在第8-11天,铺棉灸组优于叩刺拔罐组和西药组,差别有统计学意义(P<0.05)；在第3天,铺棉灸组“烧灼感”大于叩刺拔罐组和西药组,差别有统计学意义(P<0.05)；“水疱数目”在治疗第8、9天,铺棉灸组优于叩刺拔罐组和西药组,差别有统计学意义(P＜0.05)；“丘疹”在第7、8、10、11天,铺棉灸组疗效不如叩刺拔罐组和西药组,差别有统计学意义(P＜O.05)。其余单项指标差别无统计学意义(P＞0.05)。安全性指标比较：三组治疗方法临床安全性均较好,差异无统计学意义(P＞O.05)。耐受性指标比较：三组耐受性评价比较,差异无统计学意义(P＞0.05)。结论：铺棉灸疗法在治疗带状疱疹中具有良好疗效,不差于叩刺拔罐疗法及常规西药疗法(口服伐昔洛韦为主)。在促进带状疱疹结痂时间、降低疼痛强度、减少疼痛持续时间、减少带状疱疹后遗神经痛发生方面优于叩刺拔罐组和对照组。铺棉灸疗法临床操作可行性好、安全性高、患者接受度好,具有良好的临床前景。更多还原

【Abstract】 OBJECTIVE:To evaluate the clinical effect of Cotton-sheet Moxibustion Therapy in patients with herpes zoster. To establish the standards of dignosis and treatment of Cotton-sheet Moxibustion Therapy for herpes zoster. To enact the criterion of Cotton-sheet Moxibustion, popularize the clinical application. And through the designing and execution of this study, put forward the discussion for design of acupuncture clinical trials.METHODS:The central-randomized, allocated and data management are assumed by the GCP center of Chengdu University of TCM. Patients are from 9 centers in cities of Chengdu, Guangzhou and Wuhan during January 4^th,2008 to December 31^th,2008.This study is a summary of 167 patients from 6 centers in cities of Chengdu and Wuhan. Treatment Group 1（Cotton-sheet Moxibustion Therapy）, n=61; treatment group 2 （Skin-needle tapping&cupping Therapy）, n=55;controlled group（Western medicine Therapy）, n=51. Adopt the guidelines of comprehensive effect, blister, pain, safety, tolerance, etc.to evaluate the comprehensive effect of Cotton-sheet Moxibustion Therapy.RESULT:Comparison of baseline:The level from baseline of the treatment groups are similar to that of the control （P＞0.05） in both intention-to-treat analysis （ITT） and pre-protocol （PP）. Comparison of comprehensive effect:The effective percentage of the Cotton-sheet Moxibustion group is 91.7%. No significant difference among the three groups. There are quite obvious diversity of the figures between the prior and posterior to the treatment in the Cotton-sheet Moxibustion group. But no significant difference from the Skin-needle tapping&cupping group and the Western medicine group（P>0.05）. Comparison of blister:Cotton-sheet Moxibustion Therapy can shorten the time of incrustation. The difference is significant between the Cotton-sheet Moxibustion group and the other groups （P＜0.05）. Comparison of Pain:①Cotton-sheet Moxibustion Therapy can release the pain caused by hepers zoster and shorten the continuance.The VAS points of Cotton-sheet Moxibustion group is significantly lower than the other groups （P＜0.05）. The continuance of pain is shorter than the others（P＜0.05）, too.②As treatment times increasing the instant analgesia time of Cotton-sheet Moxibustion Therapy short, but the time of instant analgesia become longer.③The comparison of the incidence of the postherpetic neuralgis. In the 30^th and the 60^th day of the treatment, there is significant diffenrence between the Cotton-sheet Moxibution group and the others （P＜0.05）. Comparison of Dynamic Index:①The VAS points in Cotton-sheet Moxibution group decreased obviously from the 8^th day to the 22^th. There is significant diffenrence between the Cotton-sheet Moxibution group and the other groups （P＜0.05）.②The pain relief is bigger than the others.There is significant diffenrence （P＜0.05）.③Comparison of single indexs:Partial pain released in the 8^th day to the 11^th, there is significant difference between the Cotton-sheet Moxibustion group and the others. Burning sensation of Cotton-sheet Moxibustion group is more obvious in the third day （P＜0.05）.The number of blister is less in the Cotton-sheet Moxibustion group in the day of 8^th and 9^th （P＜0.05）. Provement of pimple is not better in the Cotton-sheet Moxibustion group than the other groups （P＜0.05）.Comparison of safety:The safety of all the three groups are good（P＞0.05）. Comparison of acceptance:The acceptance of patients to all the three groups is good（P>0.05）.CONCLUSION:The comprehensive effect of the Cotton-sheet Moxibustion group is not bad’than the Skin-needle.tapping&cupping group and the Western medicine group. In the aspects of improving the incrustation and pain, releasing the incidence of the postherpetic neuralgia the Cotton-sheet Moxibustion group is better than the other two groups.The manipulation of Cotton-sheet Moxibustion Therapy in patients with herpes zoster is feasible, effective, safe, acceptable, and has promotional clinical value.更多还原