穴位注药埋线法干预肛门病术后疼痛临床及实验研究
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摘要
肛门病术后疼痛的西医学治疗存在诸多副作用,改良手术方法和技术的适应症、高费用限制了推广和应用,中医药治疗有一定的疗效,具备简、便、效、廉,副作用少的优势,但临床研究存在问题较多,且缺乏作用机理的客观化研究,使结论缺乏可信性,影响其进一步推广。本研究采用长强穴注药埋线法干预肛门病术后疼痛,有深厚的理论基础,且操作简便,经临床初步验证,安全有效。本课题历经文献研究、前期研究、临床研究、实验研究四个阶段,从临床及实验研究两方面来研究其临床疗效及作用机制,为其进一步推广应用提供依据。论文分为四个部分:
第一部分:文献综述
1.对传统中医关于术后疼痛的病名、病因病机、辨治方法的论述做了系统总结。
2.对疼痛的诸多影响因素包括痛觉的性别差异、年龄差异及精神因素对疼痛的影响等做了系统总结。
3.系统论述了近年来西医学对肛门病术后疼痛的研究进展,包括流行病学、术后疼痛的机理研究、动物模型及治疗方法的研究进展,为本课题的实验研究提供理论依据。
4.系统评述了中医学对肛门病手术后疼痛的研究进展,为本课题的临床研究提供理论基础和依据。
第二部分:前期研究
(1)痔术后止痛药使用情况回顾分析
目的:初步了解术后止痛药需求情况,了解术后止痛的局限性,为临床预试验提供依据。
方法:检索痔术后病历344例,初步了解痔术后止痛药使用情况,术后疼痛的影响因素,包括止痛药的初次干预时间,应用总量,应用种类,及切口数量,既往手术史,性别,年龄与止痛药需求的关系。
结果:不同年龄(以50岁为分界)、切口数量(以3个切口为界)在止痛药的需求上有明显差异(P均＜0.05),24小时内有止痛药需求的患者明显多于24小时后要求止痛的患者(P＜0.001)。344例患者中,97例(28.20%)使用过止痛药,其中,吲哚美辛缓释片97例,共156次;盐酸布桂嗪注射液22例,共25次;吗啡注射液3例共3次,初次要求止痛药干预的时间为:21.72±42.79h。中位需求时间为6.3h。。
(2)穴位注药埋线法干预痔术后疼痛临床观察
目的:观察穴位注药埋线法干预痔术后疼痛的初步疗效及安全性。
方法:入组60例,治疗组30例予术中局麻后一次性穴位埋线并注射氢溴酸高乌甲素注射液4mg,对照组30例予术后吲哚美辛栓纳肛,每日1次,连用7天,采用VAS评分评估疼痛强度,对比两组疗效、镇痛药使用情况及与干预手段相关不良反应发生情况。结果:治疗组术后6h、12h、24h及术后第7天VAS评分明显低于对照组同时段(P＜0.05)。治疗组显效5例,有效21例,无效4例,总有效率86.7%。对照组显效2例,有效17例,无效11例,总有效率63.3%(P＜0.05)。治疗组发生不良反应1例,对照组发生不良反应8例。
第三部分:临床研究
目的:1.通过采用随机对照的临床试验研究,评价穴位注药埋线法干预痔术后疼痛的临床疗效和安全性,为中医药干预痔术后疼痛,实现安全微痛化的痔手术提供临床依据。2.探讨穴位注药埋线法干预痔术后疼痛的临床疗效评价方法和临床试验方案,为中医药干预痔术后疼痛提供科学的临床试验方法。
方法:采用随机对照的临床试验方法,入组120例,治疗组60例,对照组60例。治疗组予术前局麻后于长强穴注射氢溴酸高乌甲素注射液2ml,并埋入羊肠线,对照组予吲哚美辛栓纳肛1粒/日,连用7天,采用国际通用量表SAS、SDS对比干预对精神因素的影响;并通过综合疗效评分、总有效率、不良反应发生率比较两组疗效及安全性。
结果:基础痛阈有显著的性别差异,男性痛阈高于女性。术后48小时、术后第4天,治疗组中重度疼痛明显少于对照组(P均＜0.05)。在各个访视时段,治疗组综合疗效评分总分明显低于对照组(P均＜0.05)。治疗组术后排尿困难、肛缘水肿明及合并使用镇痛药者明显少于对照组(P＜0.05)。治疗组的患者满意度明显好于对照组(P＜0.05)。两组在基线无差别的前提下,术后SDS、SAS标准分,治疗组明显低于对照组(P＜0.05)。治疗组总有效率在各时段分别为53.7%,75.9%,79.6%,96.3%,对照组总有效率在各时段分别为27.5%,58.8%,68.6%,84.3%,术后第1天,术后第7天治疗组总有效率明显高于对照组(P＜0.05)。治疗组共发生可能与药物相关的不良反应4例(7.4%),对照组发生可能与药物相关不良反应13例(16.2%),两组不良反应发生率有显著差别(P＜0.05)。
第四部分:实验研究
实验Ⅰ:实验性大鼠切口痛模型制备的研究
目的:改良尾部切口痛模型制备大鼠肛门部切口痛模型。
方法:取健康大鼠30只,常规麻醉下于肛门左侧截石位3点位距肛缘1cm向肛内方向做一放射状切口,其中6只大鼠采用vonfrey测痛仪在术前及术后不同时间点测定原发性痛敏、继发性痛敏。6只术后2小时处死,6只术后24小时处死,6只术后7天处死,6只仅麻醉,不做切口。取切口处组织做组织学观察,观察术后组织学是否与临床切口损伤进程相一致。如组织学符合,且与术前痛敏比较产生痛敏,造模成功。
结果:与术前比较,术后原发性痛敏持续5d。术后继发性痛敏持续48h。组织学观察,术后2h,组织学呈现轻度的炎性细胞浸润,主要为淋巴细胞,也有少量浆细胞。术后24小时,真皮内的中重度炎性细胞浸润。术后7天表现为中度的炎性细胞浸润伴有纤维增生,与临床切口损伤进程相一致。造模成功。
实验Ⅱ:穴位注药埋线法对术后大鼠疼痛敏感性的影响
目的:研究穴位注药埋线法对切口痛模型大鼠痛敏的影响。
方法:选择基础痛阈在10～20s之间健康小鼠48只,随机分为6组,即:A组(空白组)、B组(模型肌注盐水组)、C组(穴位高乌甲素注射)、D组(穴位注药埋线)、E组(穴位埋线)、F组(穴位盐水组),每组8只。采用热板法测定大鼠基础痛阈,麻醉成功后A组不做处理,B组于大鼠大腿外侧肌肉注射生理盐水,按2.5mg/kg给药。C组于长强穴注射氢溴酸高乌甲素注射液,按2.5mg/kg给药。D组采用自制埋线针于长强穴埋入羊肠线,按1.25cm/kg埋入,并注入氢溴酸高乌甲素注射液2.5mg/kg,E组单纯埋线,F组于长强穴注入生理盐水2.5mg/kg。干预后10分钟B、C、D、E、F组施行肛门部切口手术。采用voyfrey测痛仪测定干预后不同时间点切口局部原发性痛敏及距离切口15mm处继发性痛敏。大鼠清醒后30min将滤纸铺于小网格饲养笼中记录大鼠6小时内粪粒数。
结果:(一):空白组与模型组vonfrey测痛值在各个时间点上比较差异均具有统计学意义(P均大于0.05),提示造模成功。术后6h、24h、48h、72h、4d切口局部vonfrey测痛值,注埋组高于单纯注药组(P均＜0.05)。术后1h、2h、6h、5d切口局部,术后1h、2h、6h、24h距切口15mm处vonfrey测痛值,注埋组均高于埋线组(P均＜0.05)。术后1h、2h、6h、24h、48h、72h、4d、5d切口局部,vonfrey测痛值在术后各时间点(不包含6d、7d,局部),术后1h、2h、6h、12h、24h、48h(15mm),注埋组均高于模型组(P均＜0.05)。说明注埋组干预后能提高切口痛大鼠对疼痛的敏感性。
(二)大鼠6h内粪粒数的比较。模型组与空白组比较,大鼠术后6h内粪粒数明显低于空白组(P=0.02);穴位注药组、注药埋线组大鼠术后6h内粪粒数明显高于模型组(P均=0.04)。提示穴位注射高乌甲素注射液、穴位注射高乌甲素注射液并埋入肠线,可能通过缓解术后疼痛改善大鼠的排便行为。
实验Ⅲ:穴位注药埋线法对切口局部、脊髓不同水平SP的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平SP的影响。
方法:造模及干预方法同实验Ⅱ,术后24小时将大鼠头部脱臼处死,取切口局部组织及脊髓组织,行免疫组化检测。
结果:与模型组比较,注药组,注埋组的SP水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平上SP的表达均高于空白组,说明SP可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低SP水平,缓解疼痛。埋线组在术后24h对外周SP水平的作用与模型组有显著差异(P＜0.05)。注埋组SP在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05);单纯注药组与埋线组比较,SP在外周和脊髓两个水平上的值没有显著差别(P＞0.05)。提示:注埋组对外周及脊髓SP的作用可能通过氢溴酸高乌甲素起主要作用,穴位埋线起到协同作用。
实验Ⅳ:穴位注药埋线法对切口局部、脊髓不同水平IL-1β的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平IL-1β的影响。
方法:同实验Ⅲ。
结果:与模型组比较,注药组,注埋组的IL-1β水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平上IL-1β均高于空白组,说明IL-1β可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低IL-1β水平,缓解疼痛。埋线组对脊髓IL-1β水平的作用与模型组有显著差异(P＜0.05)。注埋组IL-1β在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05);在脊髓水平,注埋组IL-1β明显低于单纯注药组(P＜0.05)。单纯注药组与埋线组比较,IL-1β在外周和脊髓两个水平上没有显著差别(P＞0.05)。提示:注埋组对外周及脊髓IL-1β的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
实验Ⅴ:穴位注药埋线法对脊髓p38MAPK的影响目的:研究穴位注药埋线法对脊髓p38MAPK的影响。
方法:同实验Ⅲ。
结果:与模型组比较,注药组,注埋组的脊髓p38MAPK明显低于模型组(P＜0.05);模型组脊髓p38MAPK明显高于空白组(P＜0.05),说明p38MAPK可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法能降低脊髓p38MAPK水平,缓解疼痛。注埋组脊髓p38MAPK水平明显低于单纯穴位埋线组、单纯注药组(P均＜0.05)。单纯注药组与埋线组比较,脊髓p38MAPK积分光密度没有显著差别(P＞0.05)。提示:注埋组抑制脊髓p38MAPK活性的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
实验Ⅵ:穴位注药埋线法对切口局部、脊髓不同水平NMDA受体的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平NMDA受体的影响。
方法:同实验Ⅲ。
结果:注药组,注埋组的NMDA受体水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平NMDA受体均高于空白组(P＜0.05),说明NMDA受体可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低NMDA受体水平,缓解疼痛。注埋组NMDA受体在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05),注药组局部NMDA受体水平明显低于埋线组(P＜0.05)。提示:注埋组对外周及脊髓NMDA受体的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
Therapy of western medicine on anal postoperative pain has many side-effects.Indication and high economic expense of modified operation and technique holdback its spread and application.Traditional Chinese medicine(TCM)has its advantages of convenience,validity and less side-effects,but it has some problems in its clinical studies,retard its extension.Study on injection and embedding in changqiang points for intervention on hemorrhoid post-operative pain has its advantages of easy to operate,safe and effective.This study include literature study, prophase research,experimental and clinical studies.Study mechanism of its effects from both clinical and experimental.Provide bases for extension.Study include four parts.
First part:Documental summary
1.Summary the name,the mechanism,dialectical and therapy of postoperative pain.
2.Summary influencing factors include sex,age,psycho-mental factors on pain.
3.Summary progress of western medicine on postoperative pain include its epidemiology,mechanism,animal model and therapy.Provide basis for experimental studies.
4.Review progress of western medicine on hemorrhoid postoperative pain,provide basis for clinical studies.
Second part:prophase research
(1)Retrospective study of analgesics on hemorrhoid postoperative pain.
Objective:Find out the limitation of analgesia on hemorrhoid postoperative pain.
Method:Analysis of 344 case history of hemorrhoid postoperative patients.Find out the service condition of analgesics,include its first intervention,total dose,type of analgesics and influencing factors.
Result:Different age and number of incision has statistical differences on use of analgesics (P＜0.05).Demand for analgesics within 24h postoperative is much more than 24h afterwards(P＜0.001).In 344 patients 97 patients(28.20%)had used analgesics.First intervention time is(21.72±42.79)h,median demand time is 6.3h.
(2)Clinical study of point injection and embedding on hemorrhoid postoperative pain.
Objective:clinical study on efficacy and safety of point injection and embedding on hemorrhoid postoperative pain.
Method:60 patients are divided into treatment group.30 patients with point injected Lappaconitine hydrobromide(LH)injection,point embedding and control group 30 patients with Indometacin Suppositories(IS).Evaluate pain intensity with VAS,compare safe and effective of groups.
Result:VAS on period of 6h、12h、24h and 7d followed operation in treatment group is significant less than control group(P＜0.05).In treatment group 5 patients had marked effect,21 patients had effect,4 patients had no effect,total effective rate is 86.7%;in control group,2 patients had marked effect,17 patients had effect,11 patients had no effect,total effective rate is 63.3%(P＜0.05).In treatment group 1 patients had adverse effect,in control group,8 patients had adverse effect.
Second part:Clinical research.
Objective:RCT study on evaluate safe and effective of point injection and embedding(PIE) on hemorrhoid postoperative pain.Provide basis for less pain hemorrhoid post-operation with intervention of TCM.
Method:120 patients are randomly divided into two groups.i.e.treatment group(n=60)and control group(n=60).The treatment group is treated by PIE.The control group is treated by IS,1 pill per day,treatment course is 7days.Compare effects of intervention methods on psycho-mental factors.Compare efficacy and safety of two groups.
Result:Basic pain threshold has significant sex differences.Threshold in male is higher than female.patients with moderate-severe pain intensity in PIE group is less than IS group on period of 48h,4d post surgery(P均＜0.05)。On all interview periods,comprehensive therapeutictotal effect score(CTES)in PIE group is less than IS group.(P＜0.05)。In PIE group, patients with dysuria,anus edema,analgesics combinations are significant less than IS group (P＜0.05)。Patient satisfaction in PIE group is better than IS group(P＜0.05)。With no difference in baseline,YSDS and YSAS in PIE group is significant less than IS group post-operation(P＜0.05)。Total effective rate of PIE group on all periods is 53.7%,75.9%, 79.6%,96.3%,respectively.Total effective rate of IS group on all periods is 27.5%,58.8%, 68.6%,84.3%,respectively.Total effective rate of PIE is significance higher than IS group on 1 d,7d post operation(P＜0.05)o 4 patients(7.4%)have side-effects in PIE group,but 13 patients(16.2%)in IS group(P＜0.05).
Third part:Experimental research
Experiment 1:Study on establishing anus incisional pain model of experimental rats.
Objective:Research on the method of making anus incisional pain model of experimental rats.
Method:Choose 60 healthy rats,under intraperitoneal anesthesia,make a radial incision with length of 1cm on the left of anus,six rats are determined primary hyperalgesia and secondary hyperalgesia with electronic vonfrey detector on all periods.6 rats are sacrificed 2h post-operation,6 rats are sacrificed 24h post-operation,6 rats are sacrificed 7d post-operation,6 rats made no incision.Local tissue were cut out-for to make histological observation,if it accord with clinical surgical process,and produce hyperalgesia,the model is successful.
Result:Compare with pre-operation,primary mechanical hyperalgesia persisted 5 days, and secondary mechanical hyperalgesia persisted 48h following incision in the anus.Two hours after incision,the tissue showed a mild inflammatory cell infiltrate containing mainly lymphocytes with a minor presence of plasma cells.Moderate inflammation was present within the underlying dermis 24 h after incision,seven days after incision,the tissues showed a mild-moderate inflammatory cell infiltrate in the dermis with overlying fibrinopurulent exudate.The control tissues showed a normal epidermis,dermis and subcutaneous tissue with no inflammatory cell infiltrate.The model is successful.
Experiment 2:Method of PIE on hyperalgesia of incisional pain rats.
Objective:Research on Method of PIE on hyperalgesia of incisional pain rats.
Method:48 healthy rats with basic pain threshold in a range of 10~20s,divided into six groups randomly.i.e.normal group(A)、model group(B)、PI(point injection)group(C)、PIE group(D)、PE(E)(point embedding)and PS(point injection saline)group(F).Followed successful anesthesia,operate intervention.10 min later,make no operationg in A group,while make operation in B,C,D,E,F groups.Determined primary hyperalgesia and secondary hyperalgesia with electronic vonfrey detector on all different periods.Record amount of fecal pellet within 6h followed conscious.
Result:(1)Vonfrey level(VF)of groupB are significant less than group A on all periods (P＞0.05).VF in group D on 6h,24h,48h,72h,4d followed operation in local tissue is higher than group C,the same as 1h、2h、6h、24h followed operation away from incision 15mm(P＜0.05).VF in group D on 1h、2h、6h、24h、48h、72h、4d、5d、6d followed operation in local tissue is higher than group B,the same as 1h、2h、6h、12h、24h、48h followed operation away from incision 15mm(P＜0.05).Number of fecal pellet(NFP)in group B is significant less than group A(P=0.02),NFP in group D and group C is significant more than group B. conclude:PIE can improve hyperalgesia,and more effective than PE and PI.
Experiment 3:Effect of PIE on SP at peripheral and spinal level
Objective:Study effect of PIE on SP at peripheral and spinal level.
Method:Followed successful intervention and operation,rats were sacrificed,cut out-for tissue of local and spinal,make immunohistochemical Detection.
Result:SP in group C and D is less than group B at both levels of peripheral and spinal (P＜0.05).SP in group B is higher than group A at both levels of peripheral and spinal (P＜0.05).SP in group E is less than group B at levels of peripheral(P＜0.05).SP in group D is less than group E both at levels of peripheral and spinal(P＜0.05);No difference of SP in group C and E at levels of peripheral and spinal(P＞0.05).
Conclude:SP may play important role in mechanism of incisional pain.PIand PIE may play its role at at levels of peripheral and spinal.
Experiment 4:Effect of PIE on IL-1βat peripheral and spinal level
Objective:Study effect of PIE on IL-1βat peripheral and spinal level.
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical detection.
Result:IL-1βin group C and D is less than group B both at levels of peripheral and spinal (P＜0.05).IL-1βin group B is higher than group A both at levels of peripheral and spinal (P＜0.05).IL-1βin group E is less than group B at levels of spinal(P＜0.05)。IL-1 pin group D is less than group E both at levels of peripheral and spinal(P＜0.05);IL-1βin group D is less than group C at levels of spinal(P＜0.05).No difference of IL-1βin group C and E at levels of peripheral and spinal(P＞0.05).
Conclude:IL-1βmay play important role in mechanism of incisional pain.PI and PIE may play its role at at levels of peripheral and spinal.
Experiment 5:Effect of PIE on p38MAPK at spinal level
Objective:Study effect of PIE on at spinal level
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical Detection.
Result:p38MAPK in group C and D is less than group B(P＜0.05).p38MAPK in group B is higher than group A(P＜0.05).p38MAPK in group D is less than group C and E(P＜0.05)。No difference of p38MAPK in group C and E(P＞0.05).
Conclude:p38MAPK may play important role in mechanism of incisional pain.Effect of PIE on p38MAPK may by synergistic effect of LH.
Experiment 6:Effect of PIE on NMDAR at peripheral and spinal level
Objective:Study of effect of PIE on NMDAR at peripheral and spinal level
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical Detection.
Result:NMDAR in group C and D is less than group B at both levels of peripheral and spinal(P＜0.05).NMDAR in group B is higher than group A both at levels of peripheral and spinal(P＜0.05).NMDAR in group D is less than group E at both levels of peripheral and spinal(P＜0.05)。NMDAR in group C is less than group E at levels of peripheral(P＜0.05)。Conclude:NMDAR may play important role in mechanism of incisional pain.Effect of PIE on p3 8MAPK may by synergistic effect of LH、embedding and point.
第一部分:文献综述
1.对传统中医关于术后疼痛的病名、病因病机、辨治方法的论述做了系统总结。
2.对疼痛的诸多影响因素包括痛觉的性别差异、年龄差异及精神因素对疼痛的影响等做了系统总结。
3.系统论述了近年来西医学对肛门病术后疼痛的研究进展,包括流行病学、术后疼痛的机理研究、动物模型及治疗方法的研究进展,为本课题的实验研究提供理论依据。
4.系统评述了中医学对肛门病手术后疼痛的研究进展,为本课题的临床研究提供理论基础和依据。
第二部分:前期研究
(1)痔术后止痛药使用情况回顾分析
目的:初步了解术后止痛药需求情况,了解术后止痛的局限性,为临床预试验提供依据。
方法:检索痔术后病历344例,初步了解痔术后止痛药使用情况,术后疼痛的影响因素,包括止痛药的初次干预时间,应用总量,应用种类,及切口数量,既往手术史,性别,年龄与止痛药需求的关系。
结果:不同年龄(以50岁为分界)、切口数量(以3个切口为界)在止痛药的需求上有明显差异(P均＜0.05),24小时内有止痛药需求的患者明显多于24小时后要求止痛的患者(P＜0.001)。344例患者中,97例(28.20%)使用过止痛药,其中,吲哚美辛缓释片97例,共156次;盐酸布桂嗪注射液22例,共25次;吗啡注射液3例共3次,初次要求止痛药干预的时间为:21.72±42.79h。中位需求时间为6.3h。。
(2)穴位注药埋线法干预痔术后疼痛临床观察
目的:观察穴位注药埋线法干预痔术后疼痛的初步疗效及安全性。
方法:入组60例,治疗组30例予术中局麻后一次性穴位埋线并注射氢溴酸高乌甲素注射液4mg,对照组30例予术后吲哚美辛栓纳肛,每日1次,连用7天,采用VAS评分评估疼痛强度,对比两组疗效、镇痛药使用情况及与干预手段相关不良反应发生情况。结果:治疗组术后6h、12h、24h及术后第7天VAS评分明显低于对照组同时段(P＜0.05)。治疗组显效5例,有效21例,无效4例,总有效率86.7%。对照组显效2例,有效17例,无效11例,总有效率63.3%(P＜0.05)。治疗组发生不良反应1例,对照组发生不良反应8例。
第三部分:临床研究
目的:1.通过采用随机对照的临床试验研究,评价穴位注药埋线法干预痔术后疼痛的临床疗效和安全性,为中医药干预痔术后疼痛,实现安全微痛化的痔手术提供临床依据。2.探讨穴位注药埋线法干预痔术后疼痛的临床疗效评价方法和临床试验方案,为中医药干预痔术后疼痛提供科学的临床试验方法。
方法:采用随机对照的临床试验方法,入组120例,治疗组60例,对照组60例。治疗组予术前局麻后于长强穴注射氢溴酸高乌甲素注射液2ml,并埋入羊肠线,对照组予吲哚美辛栓纳肛1粒/日,连用7天,采用国际通用量表SAS、SDS对比干预对精神因素的影响;并通过综合疗效评分、总有效率、不良反应发生率比较两组疗效及安全性。
结果:基础痛阈有显著的性别差异,男性痛阈高于女性。术后48小时、术后第4天,治疗组中重度疼痛明显少于对照组(P均＜0.05)。在各个访视时段,治疗组综合疗效评分总分明显低于对照组(P均＜0.05)。治疗组术后排尿困难、肛缘水肿明及合并使用镇痛药者明显少于对照组(P＜0.05)。治疗组的患者满意度明显好于对照组(P＜0.05)。两组在基线无差别的前提下,术后SDS、SAS标准分,治疗组明显低于对照组(P＜0.05)。治疗组总有效率在各时段分别为53.7%,75.9%,79.6%,96.3%,对照组总有效率在各时段分别为27.5%,58.8%,68.6%,84.3%,术后第1天,术后第7天治疗组总有效率明显高于对照组(P＜0.05)。治疗组共发生可能与药物相关的不良反应4例(7.4%),对照组发生可能与药物相关不良反应13例(16.2%),两组不良反应发生率有显著差别(P＜0.05)。
第四部分:实验研究
实验Ⅰ:实验性大鼠切口痛模型制备的研究
目的:改良尾部切口痛模型制备大鼠肛门部切口痛模型。
方法:取健康大鼠30只,常规麻醉下于肛门左侧截石位3点位距肛缘1cm向肛内方向做一放射状切口,其中6只大鼠采用vonfrey测痛仪在术前及术后不同时间点测定原发性痛敏、继发性痛敏。6只术后2小时处死,6只术后24小时处死,6只术后7天处死,6只仅麻醉,不做切口。取切口处组织做组织学观察,观察术后组织学是否与临床切口损伤进程相一致。如组织学符合,且与术前痛敏比较产生痛敏,造模成功。
结果:与术前比较,术后原发性痛敏持续5d。术后继发性痛敏持续48h。组织学观察,术后2h,组织学呈现轻度的炎性细胞浸润,主要为淋巴细胞,也有少量浆细胞。术后24小时,真皮内的中重度炎性细胞浸润。术后7天表现为中度的炎性细胞浸润伴有纤维增生,与临床切口损伤进程相一致。造模成功。
实验Ⅱ:穴位注药埋线法对术后大鼠疼痛敏感性的影响
目的:研究穴位注药埋线法对切口痛模型大鼠痛敏的影响。
方法:选择基础痛阈在10～20s之间健康小鼠48只,随机分为6组,即:A组(空白组)、B组(模型肌注盐水组)、C组(穴位高乌甲素注射)、D组(穴位注药埋线)、E组(穴位埋线)、F组(穴位盐水组),每组8只。采用热板法测定大鼠基础痛阈,麻醉成功后A组不做处理,B组于大鼠大腿外侧肌肉注射生理盐水,按2.5mg/kg给药。C组于长强穴注射氢溴酸高乌甲素注射液,按2.5mg/kg给药。D组采用自制埋线针于长强穴埋入羊肠线,按1.25cm/kg埋入,并注入氢溴酸高乌甲素注射液2.5mg/kg,E组单纯埋线,F组于长强穴注入生理盐水2.5mg/kg。干预后10分钟B、C、D、E、F组施行肛门部切口手术。采用voyfrey测痛仪测定干预后不同时间点切口局部原发性痛敏及距离切口15mm处继发性痛敏。大鼠清醒后30min将滤纸铺于小网格饲养笼中记录大鼠6小时内粪粒数。
结果:(一):空白组与模型组vonfrey测痛值在各个时间点上比较差异均具有统计学意义(P均大于0.05),提示造模成功。术后6h、24h、48h、72h、4d切口局部vonfrey测痛值,注埋组高于单纯注药组(P均＜0.05)。术后1h、2h、6h、5d切口局部,术后1h、2h、6h、24h距切口15mm处vonfrey测痛值,注埋组均高于埋线组(P均＜0.05)。术后1h、2h、6h、24h、48h、72h、4d、5d切口局部,vonfrey测痛值在术后各时间点(不包含6d、7d,局部),术后1h、2h、6h、12h、24h、48h(15mm),注埋组均高于模型组(P均＜0.05)。说明注埋组干预后能提高切口痛大鼠对疼痛的敏感性。
(二)大鼠6h内粪粒数的比较。模型组与空白组比较,大鼠术后6h内粪粒数明显低于空白组(P=0.02);穴位注药组、注药埋线组大鼠术后6h内粪粒数明显高于模型组(P均=0.04)。提示穴位注射高乌甲素注射液、穴位注射高乌甲素注射液并埋入肠线,可能通过缓解术后疼痛改善大鼠的排便行为。
实验Ⅲ:穴位注药埋线法对切口局部、脊髓不同水平SP的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平SP的影响。
方法:造模及干预方法同实验Ⅱ,术后24小时将大鼠头部脱臼处死,取切口局部组织及脊髓组织,行免疫组化检测。
结果:与模型组比较,注药组,注埋组的SP水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平上SP的表达均高于空白组,说明SP可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低SP水平,缓解疼痛。埋线组在术后24h对外周SP水平的作用与模型组有显著差异(P＜0.05)。注埋组SP在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05);单纯注药组与埋线组比较,SP在外周和脊髓两个水平上的值没有显著差别(P＞0.05)。提示:注埋组对外周及脊髓SP的作用可能通过氢溴酸高乌甲素起主要作用,穴位埋线起到协同作用。
实验Ⅳ:穴位注药埋线法对切口局部、脊髓不同水平IL-1β的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平IL-1β的影响。
方法:同实验Ⅲ。
结果:与模型组比较,注药组,注埋组的IL-1β水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平上IL-1β均高于空白组,说明IL-1β可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低IL-1β水平,缓解疼痛。埋线组对脊髓IL-1β水平的作用与模型组有显著差异(P＜0.05)。注埋组IL-1β在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05);在脊髓水平,注埋组IL-1β明显低于单纯注药组(P＜0.05)。单纯注药组与埋线组比较,IL-1β在外周和脊髓两个水平上没有显著差别(P＞0.05)。提示:注埋组对外周及脊髓IL-1β的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
实验Ⅴ:穴位注药埋线法对脊髓p38MAPK的影响目的:研究穴位注药埋线法对脊髓p38MAPK的影响。
方法:同实验Ⅲ。
结果:与模型组比较,注药组,注埋组的脊髓p38MAPK明显低于模型组(P＜0.05);模型组脊髓p38MAPK明显高于空白组(P＜0.05),说明p38MAPK可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法能降低脊髓p38MAPK水平,缓解疼痛。注埋组脊髓p38MAPK水平明显低于单纯穴位埋线组、单纯注药组(P均＜0.05)。单纯注药组与埋线组比较,脊髓p38MAPK积分光密度没有显著差别(P＞0.05)。提示:注埋组抑制脊髓p38MAPK活性的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
实验Ⅵ:穴位注药埋线法对切口局部、脊髓不同水平NMDA受体的影响
目的:研究穴位注药埋线法对切口局部、脊髓不同水平NMDA受体的影响。
方法:同实验Ⅲ。
结果:注药组,注埋组的NMDA受体水平在脊髓及局部两个水平上均低于模型组(P＜0.05);模型组在脊髓及局部两个水平NMDA受体均高于空白组(P＜0.05),说明NMDA受体可能在大鼠肛门切口痛的发生中起重要作用,注药法及注药埋线法可能在外周和脊髓两个水平上发挥作用,降低NMDA受体水平,缓解疼痛。注埋组NMDA受体在脊髓及外周两个水平均低于单纯穴位埋线组(P＜0.05),注药组局部NMDA受体水平明显低于埋线组(P＜0.05)。提示:注埋组对外周及脊髓NMDA受体的作用可能通过氢溴酸高乌甲素、埋线、穴位之间的相互协同作用而实现。
Therapy of western medicine on anal postoperative pain has many side-effects.Indication and high economic expense of modified operation and technique holdback its spread and application.Traditional Chinese medicine(TCM)has its advantages of convenience,validity and less side-effects,but it has some problems in its clinical studies,retard its extension.Study on injection and embedding in changqiang points for intervention on hemorrhoid post-operative pain has its advantages of easy to operate,safe and effective.This study include literature study, prophase research,experimental and clinical studies.Study mechanism of its effects from both clinical and experimental.Provide bases for extension.Study include four parts.
First part:Documental summary
1.Summary the name,the mechanism,dialectical and therapy of postoperative pain.
2.Summary influencing factors include sex,age,psycho-mental factors on pain.
3.Summary progress of western medicine on postoperative pain include its epidemiology,mechanism,animal model and therapy.Provide basis for experimental studies.
4.Review progress of western medicine on hemorrhoid postoperative pain,provide basis for clinical studies.
Second part:prophase research
(1)Retrospective study of analgesics on hemorrhoid postoperative pain.
Objective:Find out the limitation of analgesia on hemorrhoid postoperative pain.
Method:Analysis of 344 case history of hemorrhoid postoperative patients.Find out the service condition of analgesics,include its first intervention,total dose,type of analgesics and influencing factors.
Result:Different age and number of incision has statistical differences on use of analgesics (P＜0.05).Demand for analgesics within 24h postoperative is much more than 24h afterwards(P＜0.001).In 344 patients 97 patients(28.20%)had used analgesics.First intervention time is(21.72±42.79)h,median demand time is 6.3h.
(2)Clinical study of point injection and embedding on hemorrhoid postoperative pain.
Objective:clinical study on efficacy and safety of point injection and embedding on hemorrhoid postoperative pain.
Method:60 patients are divided into treatment group.30 patients with point injected Lappaconitine hydrobromide(LH)injection,point embedding and control group 30 patients with Indometacin Suppositories(IS).Evaluate pain intensity with VAS,compare safe and effective of groups.
Result:VAS on period of 6h、12h、24h and 7d followed operation in treatment group is significant less than control group(P＜0.05).In treatment group 5 patients had marked effect,21 patients had effect,4 patients had no effect,total effective rate is 86.7%;in control group,2 patients had marked effect,17 patients had effect,11 patients had no effect,total effective rate is 63.3%(P＜0.05).In treatment group 1 patients had adverse effect,in control group,8 patients had adverse effect.
Second part:Clinical research.
Objective:RCT study on evaluate safe and effective of point injection and embedding(PIE) on hemorrhoid postoperative pain.Provide basis for less pain hemorrhoid post-operation with intervention of TCM.
Method:120 patients are randomly divided into two groups.i.e.treatment group(n=60)and control group(n=60).The treatment group is treated by PIE.The control group is treated by IS,1 pill per day,treatment course is 7days.Compare effects of intervention methods on psycho-mental factors.Compare efficacy and safety of two groups.
Result:Basic pain threshold has significant sex differences.Threshold in male is higher than female.patients with moderate-severe pain intensity in PIE group is less than IS group on period of 48h,4d post surgery(P均＜0.05)。On all interview periods,comprehensive therapeutictotal effect score(CTES)in PIE group is less than IS group.(P＜0.05)。In PIE group, patients with dysuria,anus edema,analgesics combinations are significant less than IS group (P＜0.05)。Patient satisfaction in PIE group is better than IS group(P＜0.05)。With no difference in baseline,YSDS and YSAS in PIE group is significant less than IS group post-operation(P＜0.05)。Total effective rate of PIE group on all periods is 53.7%,75.9%, 79.6%,96.3%,respectively.Total effective rate of IS group on all periods is 27.5%,58.8%, 68.6%,84.3%,respectively.Total effective rate of PIE is significance higher than IS group on 1 d,7d post operation(P＜0.05)o 4 patients(7.4%)have side-effects in PIE group,but 13 patients(16.2%)in IS group(P＜0.05).
Third part:Experimental research
Experiment 1:Study on establishing anus incisional pain model of experimental rats.
Objective:Research on the method of making anus incisional pain model of experimental rats.
Method:Choose 60 healthy rats,under intraperitoneal anesthesia,make a radial incision with length of 1cm on the left of anus,six rats are determined primary hyperalgesia and secondary hyperalgesia with electronic vonfrey detector on all periods.6 rats are sacrificed 2h post-operation,6 rats are sacrificed 24h post-operation,6 rats are sacrificed 7d post-operation,6 rats made no incision.Local tissue were cut out-for to make histological observation,if it accord with clinical surgical process,and produce hyperalgesia,the model is successful.
Result:Compare with pre-operation,primary mechanical hyperalgesia persisted 5 days, and secondary mechanical hyperalgesia persisted 48h following incision in the anus.Two hours after incision,the tissue showed a mild inflammatory cell infiltrate containing mainly lymphocytes with a minor presence of plasma cells.Moderate inflammation was present within the underlying dermis 24 h after incision,seven days after incision,the tissues showed a mild-moderate inflammatory cell infiltrate in the dermis with overlying fibrinopurulent exudate.The control tissues showed a normal epidermis,dermis and subcutaneous tissue with no inflammatory cell infiltrate.The model is successful.
Experiment 2:Method of PIE on hyperalgesia of incisional pain rats.
Objective:Research on Method of PIE on hyperalgesia of incisional pain rats.
Method:48 healthy rats with basic pain threshold in a range of 10~20s,divided into six groups randomly.i.e.normal group(A)、model group(B)、PI(point injection)group(C)、PIE group(D)、PE(E)(point embedding)and PS(point injection saline)group(F).Followed successful anesthesia,operate intervention.10 min later,make no operationg in A group,while make operation in B,C,D,E,F groups.Determined primary hyperalgesia and secondary hyperalgesia with electronic vonfrey detector on all different periods.Record amount of fecal pellet within 6h followed conscious.
Result:(1)Vonfrey level(VF)of groupB are significant less than group A on all periods (P＞0.05).VF in group D on 6h,24h,48h,72h,4d followed operation in local tissue is higher than group C,the same as 1h、2h、6h、24h followed operation away from incision 15mm(P＜0.05).VF in group D on 1h、2h、6h、24h、48h、72h、4d、5d、6d followed operation in local tissue is higher than group B,the same as 1h、2h、6h、12h、24h、48h followed operation away from incision 15mm(P＜0.05).Number of fecal pellet(NFP)in group B is significant less than group A(P=0.02),NFP in group D and group C is significant more than group B. conclude:PIE can improve hyperalgesia,and more effective than PE and PI.
Experiment 3:Effect of PIE on SP at peripheral and spinal level
Objective:Study effect of PIE on SP at peripheral and spinal level.
Method:Followed successful intervention and operation,rats were sacrificed,cut out-for tissue of local and spinal,make immunohistochemical Detection.
Result:SP in group C and D is less than group B at both levels of peripheral and spinal (P＜0.05).SP in group B is higher than group A at both levels of peripheral and spinal (P＜0.05).SP in group E is less than group B at levels of peripheral(P＜0.05).SP in group D is less than group E both at levels of peripheral and spinal(P＜0.05);No difference of SP in group C and E at levels of peripheral and spinal(P＞0.05).
Conclude:SP may play important role in mechanism of incisional pain.PIand PIE may play its role at at levels of peripheral and spinal.
Experiment 4:Effect of PIE on IL-1βat peripheral and spinal level
Objective:Study effect of PIE on IL-1βat peripheral and spinal level.
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical detection.
Result:IL-1βin group C and D is less than group B both at levels of peripheral and spinal (P＜0.05).IL-1βin group B is higher than group A both at levels of peripheral and spinal (P＜0.05).IL-1βin group E is less than group B at levels of spinal(P＜0.05)。IL-1 pin group D is less than group E both at levels of peripheral and spinal(P＜0.05);IL-1βin group D is less than group C at levels of spinal(P＜0.05).No difference of IL-1βin group C and E at levels of peripheral and spinal(P＞0.05).
Conclude:IL-1βmay play important role in mechanism of incisional pain.PI and PIE may play its role at at levels of peripheral and spinal.
Experiment 5:Effect of PIE on p38MAPK at spinal level
Objective:Study effect of PIE on at spinal level
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical Detection.
Result:p38MAPK in group C and D is less than group B(P＜0.05).p38MAPK in group B is higher than group A(P＜0.05).p38MAPK in group D is less than group C and E(P＜0.05)。No difference of p38MAPK in group C and E(P＞0.05).
Conclude:p38MAPK may play important role in mechanism of incisional pain.Effect of PIE on p38MAPK may by synergistic effect of LH.
Experiment 6:Effect of PIE on NMDAR at peripheral and spinal level
Objective:Study of effect of PIE on NMDAR at peripheral and spinal level
Method:Followed successful intervention and operation,rats were sacrificed,cut outfor tissue of local and spinal,make immunohistochemical Detection.
Result:NMDAR in group C and D is less than group B at both levels of peripheral and spinal(P＜0.05).NMDAR in group B is higher than group A both at levels of peripheral and spinal(P＜0.05).NMDAR in group D is less than group E at both levels of peripheral and spinal(P＜0.05)。NMDAR in group C is less than group E at levels of peripheral(P＜0.05)。Conclude:NMDAR may play important role in mechanism of incisional pain.Effect of PIE on p3 8MAPK may by synergistic effect of LH、embedding and point.
引文
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