气囊扩张与肉毒毒素注射联合治疗贲门失弛缓症的临床研究

目的：比较单纯小气囊扩张、单纯肉毒毒素(BT)注射和两者联合治疗贲门失弛缓症的疗效与副作用。方法：48例患者随机被分为3组：扩张组只用小气囊扩张治疗；注射组只注射BT治疗；联合组两种方法联合应用。分别于术前，治疗后1周、3个月和1年时比较3组患者的临床症状积分(有效率)、下食管括约肌的压力(LESP)、松弛率(LESRR)。结果：在治疗后1周、3个月和1年时，有效率及治疗前后LESP和LESRR的差值，联合组和注射组该3项指标均高于扩张组；在治疗后l周和3个月时，联合组与注射组相比无明显差异；但1年时，联合组高于注射组。3组均无并发症发生。结论：小气囊扩张术与下食管括约肌内注射BT联合治疗贲门失弛缓症，具有疗效高、持续时间长、患者痛苦小等优点。值得临床上推广应用。     

气囊扩张和肉毒毒素注射治疗贲门失弛缓食管动力变化的比较

目的 了解经内镜气囊扩张和肉毒毒素注射2种方法治疗贯门失弛缓症后食管动力的改变。方法 118例经内镜、钡餐及食管测压确诊为贲门失弛缓症患者随机分为2组:扩张组56例,注射组62例,分别采用内镜下气囊扩张和肉毒毒素注射方法。治疗前、治疗后1周内测定下食管括约肌压力(LESP)、下食管括约肌松弛压(LESRP)以及下食管括约肌松弛率(LESR)等指标,并观察患者症状缓解情况。结果 2组治疗前食管动力学3个指标无统计学差异,扩张组治疗后LESP降至(6.03±3.45)mm Hg,LESRP为(-0.11±2.34)mm Hg,LESRR升至92.50％±13.86％,与治疗前相比,差异均有显著性意义。注射组治疗后LESP降至(23.16±16.17)mm Hg,与治疗前相比,差异有显著性意义,LESRP、LESRR与治疗前相比,差异无显著性意义。临床疗效,扩张组:显效45例,改善11例;注射组:显效15例,改善38例,无效9例。结论 气囊扩张法治疗贲门失弛缓近期疗效较肉毒毒素注射法要好,临床症状的改善同LESP及LESRP的降低,特别是LESRP的降低有非常密切的对应关系。     

内镜下注射肉毒毒素治疗贲门失弛缓症的临床研究

目的探讨内镜下注射肉毒毒素治疗贲门失弛缓症的治疗效果。方法对30例贲门失弛缓症患者进行内镜下注射肉毒毒素治疗,观察其疗效。结果治疗后患者症状及LESP、LESRR均有改善。结论肉毒毒素治疗贲门失弛缓症,方法简单,疗效较好,值得临床推广应用。     

气囊扩张和肉毒毒素注射治疗贲门失弛缓症中远期疗效比较的荟萃分析

背景：一些随机对照试验比较了气囊扩张和肉毒毒素注射治疗贲门失弛缓症的中远期疗效。但结论不尽一致。目的：评价气囊扩张和肉毒毒素注射治疗贲门失弛缓症的中远期疗效。方法：通过GUT、中国生物医学文献数据库（CBMdisc）、PubMed和维普中文科技期刊全文数据库（VIP）检索有关比较气囊扩张和肉毒毒素注射治疗贲门失弛缓症中远期（6～12个月）疗效的研究，行荟萃分析。应用RevMan4．2软件，采用固定效应模型分析各研究中两组中远期症状缓解率的OR值，荟萃分析总OR值。结果：气囊扩张组贲门失弛缓症的中远期症状缓解率显著高于肉毒毒素注射组（OR：3．06，95％CI：1．82～5．14，P〈0．0001）。结论：气囊扩张治疗贲门失弛缓症的中远期疗效显著优于肉毒毒素注射疗法，临床医师可根据患者的耐受程度、治疗需达到的目的等因素选择治疗方案。     

肉毒毒素注射联合球囊扩张治疗贲门失弛缓症的临床价值

目的探讨肉毒毒素注射联合球囊扩张术在治疗贲门失弛缓症中的临床价值。方法选取贲门失弛缓症患者35例，分为两组，其中18例行球囊扩张术（扩张组），17例行肉毒毒素注射联合球囊扩张术（联合组）。随访12个月观察临床症状评分，测量食管钡餐摄片的钡柱高及宽。结果两组患者经治疗后临床症状明显改善，在术后1周、3个月两组的临床症状的缓解差异无统计学意义（P〉0．1），术后6、12个月联合治疗的临床症状缓解优于单独球囊扩张组（P〈0．05）。两组治疗后食管钡餐摄片观察均较治疗前明显好转（P〈0．05），术后1周联合组和单纯扩张组间食管排空差异无统计学意义，12个月联合组和单纯扩张组间食管排空差异有统计学意义（P〈0．05）。结论肉毒毒素注射联合球囊扩张可以有效的缓解患者症状，远期疗效优于单独球囊扩张。     

内镜超声引导下肉毒杆菌毒素注射治疗贲门失弛缓症临床疗效观察

目的探讨超声胃镜引导下肉毒杆菌毒素注射治疗贲门失弛缓症的临床疗效。方法45例贲门失弛缓症患者，分为球囊扩张、肉毒杆菌毒素注射及Heller手术3组，观察治疗前、治疗后6个月和12个月患者临床症状计分和钡餐检查中食管宽度。结果3组患者治疗后吞咽困难、胸痛和反流症状的计分以及食管钡餐检查食管最大宽度均明显低于治疗前（P〈0．05），且3组间临床症状改善程度差异无统计学意义（P〉0．05），但扩张组和Heller手术组各有1例发生食管穿孔并发症，肉毒杆菌毒素组无并发症发生，患者耐受良好。结论超声胃镜引导下肉毒杆菌毒素注射是治疗贲门失弛缓症安全、有效的方法。     

贲门失弛缓症气囊扩张对食管动力近期和中期的影响

目的　探讨气囊扩张对贲门失弛缓症患者食管动力的影响及与扩张疗效的关系。方法　4 8例经临床、钡餐造影、内镜检查及食管测压确诊的贲门失弛缓症 ,采用上消化道动力监测系统。观察扩张前和扩张后 4周以及 12～ 2 4周时的症状计分、钡餐造影显示的食管最大宽度、下食管括约肌压力(LESP)、下食管括约肌松弛率 (LESRR)及食管体部收缩振幅。结果　①扩张后吞咽困难、胸痛和反食症状的计分以及食管的最大宽度均明显低于扩张前 (P <0 .0 5 )。②扩张后 4周、12～ 2 4周 4个方位的LESP明显降低 (P <0 .0 5 ) ,4个方位相应的LESRR扩张后较扩张前明显增加 (P <0 .0 5 )。③扩张前后LESP <2 .6 7kPa次数百分比分别为 4 5 .4 1% ,82 .4 8%和 85 .87% (与扩张前比P <0 .0 5 ) ,LESRR≥80 %的次数百分比分别占 6 .74 % ,5 5 .97%和 4 3.78% (与扩张前比P <0 .0 5 )。④ 4 8例患者中未发现食管体部恢复推进性蠕动波。食管体部收缩振幅扩张前 ,后均表现为无效收缩。结论　①气囊扩张治疗贲门失弛缓症近期、中期疗效较好 ,并有维持治疗作用。②气囊扩张不仅降低LESP且改善LESRR ,是气囊扩张缓解症状、减少食管扩张程度的重要病理生理改变的基础。提示是否再行扩张的食管动力指标除LESP外 ,还要考虑LESRR。     

贲门失弛缓症的治疗

贲门失弛缓症是一种病因尚未明确、累及食管平滑肌和下食管括约肌（LES）的动力障碍性疾病。以吞咽时食管体部蠕动消失、LES松弛障碍为特征。本病的治疗方式包括药物、注射肉毒杆菌毒素、气囊扩张术和肌切开术,旨在降低LES压力,促进食管排空,多数患者可获得较理想的结局。本文就贲门失弛缓症的治疗现状作一综述。     

内镜下气囊扩张术治疗贲门失弛缓症20例疗效观察

将40例贲门失弛缓症患者随机分为扩张组及对照组各20例,扩张组行胃镜下气囊扩张术;对照组于胃镜下注射A型肉毒素.观察两组治疗后食管括约肌压力（LESP）和症状缓解情况.结果两组治疗后LESP均较治疗前显著降低（P＜0.01）,扩张组降低较对照组明显（P＜0.01）;两组临床症状均有缓解,扩张组显效率（80%）及总有效率（100%）均显著高于对照组（25%,85%）,P＜0.05.认为气囊扩张术治疗贲门失弛缓症疗效确切,但需严格选择适应证.     

贲门失弛缓症经胃镜球囊扩张治疗的随访研究

贲门失弛缓症是原发性食管运动障碍性疾病，临床主要表现为吞咽困难、胸骨后疼痛和反食等。我们对18例贲门失弛缓症患者经胃镜下定位进行球囊扩张治疗，并于扩张术前后测量下食管括约肌压力(LESP)、下食管括约肌松弛残余压力(LESRP)和吞咽时下食管括约肌松弛率(LESRR)，研究扩张前后下食管括约肌动力学特征及其近、远期疗效。     

Long-term follow-up of achalasia patients treated with botulinum toxin

AIMS: To evaluate long-term efficacy of intrasphincteric injection of botulinum toxin in untreated achalasia patients; to analyse whether age can be a predictor of response; and to verify whether any objective measurements correlate with symptom relief MATERIALS AND METHODS: A total of 37 patients (mean age 61.4+/-17.5 years) were enrolled, all of whom injected endoscopically with 100 U of botulinum toxin. Symptom score, oesophageal manometry and oesophageal radionuclide emptying were assessed prior to treatment and 4 weeks, 3 months and 1 year after botulinum toxin. In the case of failure or relapse (symptom score >2), treatment was repeated. RESULTS: All but 6 patients (83.7%) were in clinical remission one month after botulinum toxin. At 12 months, mean symptom score was 0.9+/-0.5 (p<0.05 vs basal); mean lower oesophageal sphincter pressure was 22.0+/-6.3 (p<0.05 vs basal), and 10-min radionuclide retention was 14.0%+/-7.2 (p<0.05 vs basal). Of the 35 patients followed, 12 (34.3%) had a relapse and were re-treated; 4 out of 12 did not respond after re-treatment. Efficacy of first injection of botulinum toxin lasted for a mean period of 15.6 months (range 2-30). Up to day 31 (83.7%) patients were still in remission. We observed a trend towards a better response to botulinum toxin treatment in patients over 50 years (p=0.053). Moreover no correlation was found between any objective achalasia measurements and symptom relief (r coefficient between 0.1 and 0.5) CONCLUSIONS: Results show that: 1) one or two intrasphincteric injections of botulinum toxin result in clinical and objective improvement in about 84% of achalasia patients and are not associated with serious side-effects; 2) patients over 50 years showed better benefit than younger patients; 3) no correlation was found between any objective measurements and symptom relief.     

Intrasphincteric botulinum toxin versus pneumatic dilatation for achalasia: a cost minimization analysis.

BACKGROUND: Pneumatic dilatation or intrasphincteric botulinum toxin injection provide effective symptom relief for patients with achalasia. Although intrasphincteric botulinum toxin injection is simple and safe, its efficacy may be short-lived. Pneumatic dilatation lasts longer, but esophageal perforation is a risk. We compared treatment costs for pneumatic dilatation and intrasphincteric botulinum toxin injection using a decision analysis model to determine whether the practical advantages of intrasphincteric botulinum toxin injection outweigh the economic impact of the need for frequent re-treatment. METHODS: Probability estimates for intrasphincteric botulinum toxin injection were derived from published reports. Probability estimates for the pneumatic dilatation strategy were obtained by retrospective review of our 10-year experience using the Rigiflex dilator. Direct, "third-party payer" costs were determined in Canadian dollars. RESULTS: Intrasphincteric botulinum toxin injection was significantly more costly at $5033 compared with $3608 for the pneumatic dilatation strategy, yielding an incremental cost of $1425 over the 10-year period considered. Sensitivity analysis showed that pneumatic dilatation is less expensive across all probable ranges of costs and probability estimates. The intrasphincteric botulinum toxin injection strategy is less costly if life-expectancy is less than 2 years. CONCLUSIONS: Intrasphincteric botulinum toxin injection is more costly than pneumatic dilatation for the treatment of achalasia. The added expense of frequent re-treatment with intrasphincteric botulinum toxin injection outweighs the potential economic benefits of the safety of the procedure, unless life-expectancy is 2 years or less.     

Controlled trial of botulinum toxin injection versus placebo and pneumatic dilation in achalasia

BACKGROUND & AIMS: Intrasphincteric injection of botulinum toxin has been suggested as an alternative treatment modality in esophageal achalasia. A controlled trial comparing botulinum toxin, placebo, and pneumatic dilation is reported. METHODS: Sixteen patients received random intrasphincteric injections of either botulinum toxin or saline. The efficacy of treatment was assessed by symptom score, esophageal manometry, and scintigraphy. In case of failure, pneumatic dilation was performed. RESULTS: One month after injection, symptoms had improved in all patients treated with botulinum toxin (symptom score, 0.9 +/- 0.6 vs. 5.5 +/- 1.4; P < 0.02). In the placebo group, symptoms were unchanged in all patients, who were all dilated. Lower esophageal sphincter pressure decreased by 49% after treatment with botulinum toxin (P < 0.03) and by 72% after dilation (P < 0.01). Similarly, esophageal retention decreased by 47% after treatment with botulinum toxin (P < 0.02) and by 59% after dilation (P < 0.02). No significant difference in symptom score and esophageal function test results was found between patients treated with botulinum toxin injections and those undergoing dilation. However, 7 of the 8 patients in the botulinum toxin group required a second injection because of recurrent dysphagia. CONCLUSIONS: Treatment of achalasia with botulinum toxin was as effective as pneumatic dilation in relieving symptoms and improving esophageal function. The effect of the first injection was temporary, but the effect of the second injection lasted longer. (Gastroenterology 1996 Dec;111(6):1418-24)     

Intrasphincteric injection of botulinum toxin for suspected sphincter of Oddi dysfunction.

Botulinum toxin is a potent inhibitor of the release of acetylcholine from nerve endings. It has previously been shown that it can effectively reduce lower oesophageal sphincter pressures both in animals and humans with achalasia. This study examined the hypothesis that locally injected botulinum toxin could also reduce sphincter of Oddi pressure in patients with sphincter of Oddi dysfunction. Two patients with postcholecystectomy pain syndrome were diagnosed with sphincter of Oddi dysfunction (by biliary manometry in one patient and by hepatobiliary scanning criteria in the other). Botulinum toxin was injected into the sphincter of Oddi, by a sclerotherapy needle passed through a duodenoscope. In the first patient, intrasphincteric injection of botulinum toxin reduced sphincter pressure by about 50%, an effect that was sustained for at least four months. In the second patient, intrasphincteric injection caused about a 50% improvement in bile flow, with normalisation of scintigraphy. Neither patient showed any sustained improvement in pain despite these objective findings. Both patients eventually had endoscopic sphincterotomy, which also did not result in symptomatic improvement in either patient. No side effects were seen. Intrasphincteric botulinum toxin is a simple and effective means of lowering sphincter of Oddi pressure. This technique has potential for being useful clinically.     

Treatment of achalasia: the short-term response to botulinum toxin injection seems to be independent of any kind of pretreatment

Background  

It has been suggested that intrasphincteric injection of botulinum toxin (BTX) may represent an alternative therapy to balloon dilatation in achalasia. The aim of the present study was to test the effectiveness of botulinum toxin injections in achalasia patients, as assessed using lower oesophageal sphincter pressure (LOSP) and symptom scores, and to compare the response in patients with different types of pretreatment (no previous treatment, balloon dilatation, myotomy, BTX injection).     

Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomised trial

Background—Intrasphinctericinjection of botulinum toxin is a new treatment option for achalasia.
Aims—To compare the immediate andlong term efficacy of botulinum toxin with that of pneumatic dilatation.
Methods—Symptomatic patients withachalasia were randomised to botulinum toxin (22 patients, median age57 years) or pneumatic dilatation (20 patients, median age 56 years).Symptom scores were assessed initially, and at one, three, six, nine,and 12months after treatment. Objective assessment includedoesophageal manometry initially and at one month, and bariumoesophagram initially and at one, six, and 12 months post-treatment.
Results—Pneumatic dilatationresulted in a significantly (p=0.02) higher cumulative remission rate.At 12 months, 14/20 (70%) pneumatic dilatation and 7/22 (32%)botulinum toxin treated patients were in symptomatic remission(p=0.017). Failure rates were similar initially, but failure over timewas significantly (p=0.01) higher after botulinum toxin (50%) thanpneumatic dilatation (7%). Pneumatic dilatation resulted insignificant (p<0.001) reduction in symptom scores, and loweroesophageal sphincter pressure, oesophageal barium column height, andoesophageal diameter. Botulinum toxin produced significant reduction insymptom scores (p<0.001), but no reduction in objective parameters.
Conclusions—At one year pneumaticdilatation is more effective than botulinum toxin. Symptom improvementparallels objective oesophageal measurements after pneumatic dilatationbut not after botulinum toxin treatment for achalasia.

Keywords:achalasia; pneumatic dilatation; botulinum toxin; barium oesophagram

     

Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a non-randomized controlled trial

Background

Although lateral internal sphincterotomy is the gold-standard treatment for chronic anal fissure, intrasphincteric injection of botulinum toxin seems to be a reliable new option. The aim of this non-randomized study is to compare the effect of lateral internal sphincterotomy and botulinum toxin injection treatments on the outcome and reduction of anal sphincter pressures in patients with chronic anal fissure.

Methods

Patients with chronic anal fissure were treated with either botulinum toxin injection or lateral internal sphincterotomy by their own choice. Maximal resting pressure and maximal squeeze pressure measurements were performed before and 2 weeks after treatments by anal manometry. Patients were followed for fissure relapse during 14 months.

Results

Twenty-one consecutive outpatients with posterior chronic anal fissure were enrolled. Eleven patients underwent surgery and ten patients received botulinum toxin injection treatment. Before the treatment, anal pressures were found to be similar in both groups. After the treatment, the maximal resting pressures were reduced from 104 ± 22 mmHg to 86 ± 15 mmHg in the surgery group (p < 0.05) and from 101 ± 23 mmHg to 83 ± 24 mmHg in the botulinum toxin group (p < 0.05). The mean maximal squeeze pressures were reduced from 70 ± 27 mmHg to 61 ± 32 mmHg (p > 0.05) in the surgery group, and from 117 ± 62 mmHg to 76 ± 34 (p < 0.01) in the botulinum toxin group. The fissures were healed in 70 percent of patients in the botulinum group and 82 percent in the surgery group (p > 0.05). There were no relapses during the 14 months of follow up.

Conclusion

Lateral internal sphincterotomy and botulinum toxin injection treatments both seem to be equally effective in the treatment of chronic anal fissure.

     

Therapeutic effects of different doses of botulinum toxin in chronic anal fissure

PURPOSE: The aim of this study was to evaluate the clinical and manometric results of three different doses of botulinum toxin and two methods of injection for the treatment of chronic idiopathic anal fissure. METHODS: Sixty-nine patients with chronic anal fissure were included in a non-randomized, prospective trial of intrasphincteric injection of botulinum toxin. All patients reported postdefecatory anal pain lasting more than two months. Scoring systems were developed for anal pain, bleeding, and defecatory difficulty. Maximum resting and squeeze anal pressures were determined before and one month after treatment. Twenty-three patients undergoing a 5-U injection of diluted botulinum toxin A (BOTOX) on each side of the anal sphincter (total dose, 10 U) constituted the first group. In a second group 27 patients were injected as previously described, with an additional 5-U injection below the fissure (total dose, 15 U). The 19 patients constituting the third group received a 7-U injection on each side of the anus and below the fissure (total dose, 21 U). All patients were followed up for at least six months. RESULTS: Pain relief one month after treatment was more evident in the second and the third group (48 percent of patients in the first group, 74 percent in the second group, and 100 percent in the third group). A significant reduction of the mean resting pressure was demonstrated only in Groups II and III (P < 0.05), whereas the mean squeeze pressure significantly decreased in the three groups (P < 0.01 in Group I and P < 0.001 in Groups II and III). Fifty-two percent of the patients in the first group, 30 percent in the second group, and 37 percent in the third group were reinjected during the follow-up period, because of persistence of symptomatology or early relapse. The need for surgery was similar in the first and the second group (17 and 19 percent, respectively) and clearly lower in the last group (5 percent). No serious complications or incontinence attributable to this therapeutic modality developed in any patient. CONCLUSIONS: Intrasphincteric injection of botulinum toxin is a reliable new option in the treatment of uncomplicated chronic anal fissure. The healing rate is related to the dose and probably to the number of puncture sites. No permanent damage to the continence mechanism was detected in these patients.     

不同药物治疗肠易激综合征的临床疗效

背景:肠易激综合征(IBS)是消化内科常见疾病之一,但目前所用药物尚不能对所有IBS症状有疗效。目的:分析不同药物对不同类型IBS的临床疗效。方法:136例便秘型IBS患者随机分为西沙必利或莫沙必利治疗组(A组)和西沙必利或莫沙必利+乳果糖治疗组(B组);72例腹泻型IBS患者随机分为匹维溴铵治疗组(C组)和马来酸曲美布汀治疗组(D组),分别观察治疗1周、1个月和3个月时的疗效。结果:A组1周、1个月和3个月时的总有效率分别为29.8％、25.3％和19.0％,而B组分别为69.2％、51.9％和41.2％,均显著高于A组(P<0.005、P<0.005和P<0.01)。C组1周、1个月和3个月时的总有效率分别为90.9％、67.7％和61.3％,而D组分别为79.5％、51.4％和31.4％,C组3个月时的总有效率显著高于D组(P<0.05)。各组的疗效在3个月时均有所降低,但B组和C组的总有效率仍较高。结论:单用西沙必利或莫沙必利治疗便秘型IBS疗效有限,加用乳果糖可提高疗效。匹维溴铵和马来酸曲美布汀对腹泻型IBS的近期疗效较好。