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Biliary lithotripsy--FDA limbo forever? 胆道碎石术,FDA永远不批准?
Pub Date : 1993-07-01
J N Macaluso
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引用次数: 0
Piezoelectric lithotripsy of radiopaque gallstones: results and six-month follow-up. 不透射线胆结石的压电碎石:结果和六个月的随访。
Pub Date : 1993-04-01
J K Han, B I Choi, Y B Yoon, Y H Park, C W Kim, M C Han

Sixty-eight patients with radiopaque gallbladder stones (38 with a single stone, 30 with multiple stones) were treated with piezoelectric extracorporeal shock wave lithotripsy (ESWL) and results were compared with those of 69 patients with radiolucent stones (28 with a single stone, 41 with multiple stones). Stones were fragmented to 4 mm or less in 76.8% after 41,466 +/- 36,504 shock waves in the radiolucent stone group and 77.9% after 54,686 +/- 51,024 shock waves in the radiopaque stone group (p = 0.876 and 0.130, respectively). In 137 patients, ten patients were lost to follow-up. Average period of follow-up was 220 +/- 198 days. Six-month clearance rate of the radiolucent stone group was 43.5% and that of the radiopaque stone group was 16.4% (p less than 0.05) Figure 1. Six-month clearance rate of patients with single stones smaller than 2 cm was also significantly higher in the radiolucent stone group than in the radiopaque stone group (69.5% vs 18.6%; p less than 0.01). However, in patients with multiple stones, the presence of calcification did not affect rates of successful fragmentation or 6-month clearance. There was no statistically significant difference in incidence of complications between the radiolucent and radiopaque stone groups. Although the number of cases are small and the follow-up period is short, our results of ESWL on radiopaque gallstones are so far not satisfactory in terms of stone clearance. Strict patient selection is needed unless there is an improvement in the lithotripsy procedure or post-lithotripsy management.

对68例胆囊结石患者(单发结石38例,多发结石30例)行压电体外冲击波碎石(ESWL)治疗,并与69例透光结石患者(单发结石28例,多发结石41例)的结果进行比较。透光石组经41,466 +/- 36,504次冲击波后,碎裂率为76.8%;不透光石组经54,686 +/- 51,024次冲击波后,碎裂率为77.9% (p分别为0.876和0.130)。137例患者中,10例患者失访。平均随访时间220±198天。透光石组6个月清除率为43.5%,不透光石组为16.4% (p < 0.05)图1。透光结石组6个月单个结石小于2 cm的清除率也显著高于不透光结石组(69.5% vs 18.6%;P < 0.01)。然而,在多发性结石患者中,钙化的存在并不影响成功碎裂率或6个月清除率。透光组和不透光组的并发症发生率无统计学差异。虽然病例数量少,随访时间短,但我们的ESWL对放射性不透明胆结石的清除效果尚不令人满意。严格的病人选择是必要的,除非有改进的碎石程序或碎石后的管理。
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引用次数: 0
Eligibility for extracorporeal shock wave lithotripsy of gallbladder stones using different entry criteria. 采用不同入路标准的体外冲击波碎石治疗胆囊结石的资格。
Pub Date : 1993-04-01
P W Plaisier, R L van der Hul, H G Nijs, R den Toom, O T Terpstra, H A Bruining

Extracorporeal shock wave lithotripsy (ESWL) was introduced as a nonsurgical treatment for uncomplicated, symptomatic gallstone disease. Due to its limited results and the possibility of stone recurrence, ESWL is mainly indicated for patients who reject or cannot tolerate cholecystectomy. For budgetary and planning purposes, it is essential to know what percentage of patients are eligible for this form of therapy. In the literature suitability is either reported variably (ranging from 10% to 53%) or not mentioned. We respectively assessed eligibility for ESWL for different entry criteria, based on the histories of 694 consecutive patients, who were referred for gallstone therapy from April 1, 1988 to October 1, 1991. Only 10.3%-46.9% of symptomatic patients were found eligible for ESWL, depending on the entry criteria used. When the overall results are compared with eligibility, there is no inverse relationship. This suggests that patient selection is not the only factor determining the results of therapy. It is concluded, therefore, that other factors, such as treatment schemes, the lithotripters used, and experience of the treating physicians, are important factors for the outcome of ESWL therapy.

体外冲击波碎石术(ESWL)是一种非手术治疗无并发症、有症状的胆结石疾病的方法。由于ESWL效果有限,且有结石复发的可能,因此主要适用于排斥或不能耐受胆囊切除术的患者。出于预算和计划的目的,了解有多少比例的患者有资格接受这种形式的治疗是至关重要的。在文献中,适用性的报告是可变的(范围从10%到53%),或者没有提到。根据1988年4月1日至1991年10月1日期间就诊的694例连续胆结石患者的病史,我们分别根据不同的入组标准评估了ESWL的资格。根据使用的入组标准,只有10.3%-46.9%的有症状患者符合ESWL。当整体结果与资格比较时,没有反比关系。这表明患者的选择并不是决定治疗结果的唯一因素。因此,其他因素,如治疗方案、使用的碎石机和治疗医生的经验,是影响体外冲击波碎石治疗结果的重要因素。
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引用次数: 0
Cost-effective shock wave hydrophones. 高性价比的冲击波水听器。
Pub Date : 1993-04-01
M E Schafer

This article presents the design of a newly developed wideband, quantitative shock wave sensor (hydrophone) made of piezoelectric material polyvinylidene difluoride (PVDF). The novel aspects of this device include a disposable sensor element to reduce the per shot costs, and a self-monitoring feature that informs the user that the sensor needs to be replaced. The development, design, and use of the sensors are presented. Results indicate that these sensors can fulfill the requirements for accurate, wideband measurement of lithotripter fields, suitable for quantitative biophysical research or Food and Drug Administration submissions. The disposable feature of the hydrophone system makes the system cost effective for research, quality assurance, and regulatory submissions.

本文介绍了一种新型的基于压电材料聚偏二氟乙烯(PVDF)的宽带定量激波传感器(水听器)的设计。该设备的新颖之处包括一个一次性传感器元件,以降低每次拍摄成本,以及一个自我监测功能,通知用户传感器需要更换。介绍了传感器的开发、设计和使用情况。结果表明,该传感器能够满足碎石机场强精确、宽带测量的要求,适用于定量生物物理研究或食品药品监督管理局申报。水听器系统的一次性特性使该系统在研究、质量保证和监管提交方面具有成本效益。
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引用次数: 0
The ability of the acoustic energy/stone burden ratio to predict gallstone clearance in biliary lithotripsy. 胆道碎石术中声能/结石负荷比预测结石清除的能力。
Pub Date : 1993-04-01
P O Moon, D E Scheeres, K Mills

The relationship between acoustic energy, stone burden, and stone clearance in biliary extracorporeal shock wave therapy (ESWL) is unclear. We hypothesized that there is a consistent relationship between these parameters that enables gallstone clearance to be predicted. Using a porcine model and various gallstone burdens, we performed biliary ESWL with varying energy levels and number of shock waves. The acoustic energy/stone burden ratio (AE/SB) was calculated that incorporated these variables. Stone clearance increased with higher energy settings and fewer stones present (p less than 0.005). The relationship between AE/SB ratio and stone clearance was logarithmic (r 2 = 0.82). The plateau of this curve showed optimal stone clearance at approximately 20 joules/g, beyond which point the benefit of further ESWL may not outweigh the risks. This relationship between AE/SB ratio and stone clearance may be able to predict the optimal energy required and probable outcome of biliary ESWL prior to the procedure.

在胆道体外冲击波治疗(ESWL)中,声能、结石负荷和结石清除之间的关系尚不清楚。我们假设这些参数之间存在一致的关系,可以预测胆结石清除。使用猪模型和不同的胆结石负荷,我们在不同的能量水平和冲击波数量下进行了胆道ESWL。结合这些变量计算了声能/石料比(AE/SB)。能量设置越高,结石清除率越高(p < 0.005)。AE/SB比值与结石清除率呈对数关系(r 2 = 0.82)。该曲线的平台显示,最佳的结石清除率约为20焦耳/克,超过这一点,进一步的ESWL的好处可能不会超过风险。AE/SB比值与结石清除率之间的关系可能能够预测手术前胆道ESWL所需的最佳能量和可能的结果。
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引用次数: 0
Results of combined electrohydraulic shock wave lithotripsy and oral litholytic therapy of gallbladder stones. 电液冲击波碎石联合口服溶石治疗胆囊结石的效果。
Pub Date : 1993-04-01
J W Maher, R W Summers, T R Dean, J Swift, D Heitshusen, G Quinn
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引用次数: 0
Electromagnetic shock wave lithotripsy of gallbladder stones in vitro: the role of different stone characteristics and treatment variables. 体外电磁冲击波碎石治疗胆囊结石:不同结石特征及治疗变量的作用。
Pub Date : 1993-04-01
H Vergunst, K Brakel, H G Nijs, E Matura, J Drexler, G Steen, F H Schröder, O T Terpstra

From 40 sets of five human gallstones obtained at cholecystectomy, four stones were subjected to either 125/250 (maximum generator output) or 250/500 (half maximum generator output) electromagnetic shock waves (treatments I/II and III/IV, respectively); the fifth stone was used for computed tomography (CT) and chemical analysis. Overall, 130 (81%) of 160 stones fragmented, including 72 (45%) adequately (fragments less than or equal to 5 mm). For the treatments I, II, III, and IV the overall fragmentation rates were 80%, 95%, 70%, and 80%, respectively. The corresponding percentages of adequate fragmentation ( less than or equal to 5 mm) were 38%, 70%, 30%, and 42%, respectively. The best results were thus obtained after application of 250 shock waves (maximum generator output; treatment II). Pure cholesterol stones (p less than 0.01), stones with a mean CT density less than or equal to 110 HU (p less than 0.001), and stones with a calcified rim (p < 0.05) fragmented significantly better, but adequate fragmentation ( less than or equal to 5 mm) was significantly determined by stone weight and diameter (p less than 0.001), bilirubin content (p less than 0.02), and calcium content (p less than 0.05). A weight greater than 500 mg and a diameter > 10 mm could be defined as stone characteristics with significant negative predictors of adequate fragmentation. However, because the experimental conditions in this in vitro study did not completely simulate clinical settings for various reasons, these observations must be interpreted accordingly.(ABSTRACT TRUNCATED AT 250 WORDS)

从胆囊切除术获得的40组5个人类胆结石中,有4个结石受到125/250(最大发电机输出)或250/500(最大发电机输出的一半)电磁冲击波(分别为治疗I/II和III/IV);第五颗结石用于计算机断层扫描(CT)和化学分析。总体而言,160块石头中有130块(81%)破碎,其中72块(45%)充分破碎(碎片小于或等于5毫米)。处理1、处理2、处理3和处理4的总体破碎率分别为80%、95%、70%和80%。相应的适当破碎度(小于或等于5 mm)比例分别为38%、70%、30%和42%。因此,在250个激波(最大发电机输出;纯胆固醇结石(p < 0.01)、CT平均密度小于或等于110 HU的结石(p < 0.001)、边缘钙化的结石(p < 0.05)碎裂明显更好,但碎裂程度(小于或等于5 mm)由结石重量和直径(p < 0.001)、胆红素含量(p < 0.02)和钙含量(p < 0.05)显著决定。重量大于500mg且直径大于10mm可被定义为具有充分破碎性的显著负预测因子的石头特征。然而,由于各种原因,本体外研究的实验条件并不能完全模拟临床环境,因此必须对这些观察结果进行相应的解释。(摘要删节250字)
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引用次数: 0
Sonographic classification of gallstones and outcome of extracorporeal shock wave lithotripsy. 胆囊结石的超声分类及体外冲击波碎石的疗效。
Pub Date : 1993-04-01
A Andriulli, L Gremo, G Limerutti, A Bianchi, E Berti, A Arrigoni, G Napolitano, R Cirillo

The success of extracorporeal shock wave lithotripsy (ESWL) for gallstone elimination is dependent on the lithotripter's ability to reduce the stone to fragments less than 5 mm in diameter, but wide variation in successful fragmentation rates have been reported even with the same instrument. This variation is probably due in part to differences in stone composition. Tsuchiya et al. have recently related the pre-operative ultrasound properties of gallstones to their chemical compositions. In the present study, 138 patients with cholecystolithiasis were treated with ESWL and results were evaluated in light of the pre-treatment sonogram patterns as classified by the aforementioned authors. Complete fragmentation (CF), i.e., fragments less than 5 mm, was achieved in 90% of patients with type I a patterns (pure cholesterol stones); stone number, diameter, and volume had no effects on fragmentation. Significantly lower CF rates were obtained with I b and I c (mixed cholesterol), and type II (combination) stones (p less than 0.0003). No fragmentation at all was achieved in the six stones with type III (bilirubinate) patterns. Twelve months after treatment, 45%, 25%, and 9% of the patients with type 1 a, type I b, and types I c or II (the latter two combined), respectively, were stone-free. Pure and mixed cholesterol gallstones without calcification seem to respond best to ESWL; effective treatment can be expected even when stones are numerous (4-10) or large ( greater than 35 mm). We recommend the inclusion of ultrasound properties of gallstones in the selection criteria for candidates for ESWL.

体外冲击波碎石术(ESWL)清除胆结石的成功取决于碎石者将结石减少到直径小于5mm的碎片的能力,但即使使用相同的仪器,成功的碎裂率也有很大差异。这种变化可能部分是由于石头成分的不同。Tsuchiya等人最近将胆结石的术前超声特性与其化学成分联系起来。在本研究中,138例胆囊结石患者接受了ESWL治疗,并根据上述作者分类的治疗前超声图模式对结果进行了评估。完全碎裂(CF),即碎片小于5mm,在90%的I型a型(纯胆固醇结石)患者中实现;石粒数、直径和体积对碎裂没有影响。b型和c型(混合胆固醇)和II型(混合型)结石的CF率显著降低(p < 0.0003)。6例III型(胆红素)结石均未出现碎裂。治疗12个月后,45%、25%和9%的1型a、I型b和I型c或II型(后两者合并)患者无结石。无钙化的纯胆固醇和混合胆固醇胆结石似乎对ESWL反应最好;即使结石数量众多(4-10)或较大(大于35毫米),也可预期有效治疗。我们建议将胆结石的超声特征纳入ESWL候选者的选择标准。
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引用次数: 0
Flashlamp exited pulsed dye laser and electrohydraulic lithotripsy: in vitro study on tissue effects. 闪光灯脉冲染料激光与电液碎石术:体外组织效应的研究。
Pub Date : 1993-04-01
T Lingenfelser, A Routschka, T Grossmann, S Dette, A Distler, W Renn

Intracorporal lithotripsy has gathered momentum in the management of gallstone disease due to the increasing sophistication of technical equipment for the percutaneous, as well as the retrograde-endoscopic route. Laser-induced shock wave lithotripsy (LISL) and electrohydraulic lithotripsy (EHL) have proved feasible by allowing reliable fragmentation of biliary calculi. Evaluation of therapeutic risks, e.g., effects of accidental irradiation of the gallbladder wall, has been performed in small sample sizes only. We investigated the effects of LISL and EHL on multiple sets of human and porcine gallbladders under in vitro conditions. Gallbladders were freshly harvested, mounted, and immersed in different mediums (normal saline, blood, bile). They were swiftly exposed to LISL (Pulsolith¿) and EHL (Lithotron EL 23¿) under differing experimental conditions (energy setting, pulse mode, exposition time, medium, probe pressure) and subjected to standard procedures for morphometric evaluation (Bioquant¿). Tissue effects were described by the depth (d) and width (w) of the cratered lesions, as well as the extension of the damage in the surrounding tissue(s). Serial cuts of the exposed areas yielded 894 section for morphometric analysis. Multivariate analysis of variance (MANOVA) revealed a significant effect of laser energy (p[d] less than 0.002, p[w] < 0.05, p[s] < 0.05), medium (p[d] less than 0.03, p[w] < 0.001, p[s] < 0.04, and exposition time (p[d] less than 0.001, p[s] < 0.001) on the degree of tissue lesion.(ABSTRACT TRUNCATED AT 250 WORDS)

由于经皮和逆行内窥镜的技术设备越来越先进,体内碎石术在胆结石疾病的治疗中得到了越来越多的应用。激光诱导冲击波碎石术(LISL)和电液碎石术(EHL)已被证明是可行的,可以可靠地粉碎胆道结石。治疗风险的评估,例如,意外照射胆囊壁的影响,仅在小样本量中进行。我们在体外条件下研究了LISL和EHL对人、猪多组胆囊的影响。新鲜采集胆囊,装上,浸泡在不同的培养基中(生理盐水、血液、胆汁)。在不同的实验条件下(能量设置、脉冲模式、暴露时间、介质、探针压力),他们迅速暴露于LISL (Pulsolith¿)和EHL (Lithotron EL 23¿)中,并进行标准的形态测量评估程序(Bioquant¿)。组织效应由凹坑病变的深度(d)和宽度(w)以及周围组织损伤的扩展程度(s)来描述。对暴露区域进行连续切割,得到894切片,用于形态计量学分析。多因素方差分析(MANOVA)显示激光能量(p[d] < 0.002, p[w] < 0.05, p[s] < 0.05)、介质(p[d] < 0.03, p[w] < 0.001, p[s] < 0.04)和暴露时间(p[d] < 0.001, p[s] < 0.001)对组织病变程度有显著影响。(摘要删节250字)
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引用次数: 0
Extracorporeal shock wave lithotripsy and percutaneous nephrostolithotomy for urinary calculi: comparison of immediate and long-term effects. 体外冲击波碎石术与经皮肾取石术治疗尿路结石的近期与远期效果比较。
Pub Date : 1993-01-01
K J Carlson, S P Dretler, R A Roth, E Hatziandreu, K Gladstone, A G Mulley

Extracorporeal shock wave lithotripsy and percutaneous nephrostolithotomy have become widely used technologies for removal of urinary calculi, despite a lack of adequate evaluative studies. The possibility of long-term adverse effects of these treatments has been raised, particularly an increase in stone recurrence and development of hypertension following extracorporeal shock wave lithotripsy. We conducted a retrospective study of 1,000 patients treated with extracorporeal shock wave lithotripsy or percutaneous nephrostolithotomy for upper tract stone disease to assess immediate effectiveness and complications, with prospective follow-up to assess stone recurrence and development of hypertension. The effectiveness of each treatment (defined in terms of patients rendered stone-free or having only fragments at discharge) was similar for most stone types. While stone recurrence rates in the first 2 years after treatment were similar in the two groups, cumulative recurrence at 3 years was higher following extracorporeal shock wave lithotripsy compared to percutaneous nephrostolithotomy (39% vs. 23%, p = 0.04). However, logistic regression and Kaplan-Meier analyses showed no significant difference in clinically evident recurrence for patients treated with extracorporeal shock wave lithotripsy. Cumulative incidence of clinically evident stone recurrence did not differ significantly between patients with fragments at discharge (20%) and patients rendered stone-free (15%) (p = 0.24). There was no difference in the development of new hypertension requiring medical treatment. Our findings indicate that extracorporeal shock wave lithotripsy is effective and associated with lower short-term morbidity than percutaneous nephrostolithotomy. Stone fragments left behind by lithotripsy do not appear to confer significant risk of early stone recurrence. Further study is necessary to define long-term risk of recurrence following extracorporeal shock wave lithotripsy.

体外冲击波碎石术和经皮肾结石取石术已成为广泛应用的尿路结石清除技术,尽管缺乏充分的评估研究。这些治疗的长期不良反应的可能性已经提高,特别是体外冲击波碎石术后结石复发和高血压发展的增加。我们对1000名接受体外冲击波碎石术或经皮肾取石术治疗上尿路结石的患者进行了回顾性研究,以评估其即时疗效和并发症,并进行了前瞻性随访,以评估结石复发和高血压的发展。对于大多数结石类型,每种治疗方法的有效性(根据患者无结石或出院时只有碎片来定义)是相似的。虽然两组治疗后2年的结石复发率相似,但体外冲击波碎石术3年的累积复发率高于经皮肾取石术(39% vs. 23%, p = 0.04)。然而,logistic回归和Kaplan-Meier分析显示,体外冲击波碎石患者的临床明显复发率无显著差异。临床明显结石复发的累积发生率在出院时有结石碎片的患者(20%)和无结石患者(15%)之间没有显著差异(p = 0.24)。在需要药物治疗的新高血压的发展方面没有差异。我们的研究结果表明体外冲击波碎石术比经皮肾取石术更有效,短期发病率更低。碎石术留下的结石碎片似乎不会产生早期结石复发的显著风险。需要进一步的研究来确定体外冲击波碎石术后复发的长期风险。
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引用次数: 0
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The Journal of stone disease
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