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[不透射线肾结石治疗的评估:体外冲击波碎石术与Fagolitos Plus®的联合应用。初步病例对照描述。]

[Assessment of radiopaque kidney stone treatment: Combination of extracorporeal shock wave lithotripsy and Fagolitos Plus®. Preliminary case control description.].

作者信息

Morales-Martínez Ana, Melgarejo-Segura María Teresa, Cano-García María Del Carmen, Gutiérrez-Tejero Francisco, Arrabal-Martín Miguel, Arrabal-Polo Miguel Ángel

机构信息

Servicio de Urología. Hospital Universitario Clínico San Cecilio. Granada. España.

Servicio de Urología. Hospital Universitario Clínico San Cecilio. Granada. España. Instituto IBS Granada. Granada. España.

出版信息

Arch Esp Urol. 2021 Jun;74(5):489-493.

PMID:34080568
Abstract

INTRODUCTION

The nutritional supplement called Fagolitos plus® contains hydroxycitric acid as main component, in addition to zinc, magnesium, vitamin A and vitamin B6. It is necessary to study new molecules as chemolytic treatment in calcium lithiasis or that facilitate its fragmentation with the help of other instrumental treatments.

OBJECTIVE

The objective of this study is to evaluate the effectiveness of the combined treatment of Fagolitos plus® and extracorporeal lithotripsy in the fragmentation of the lithiasis.

MATERIAL AND METHODS

Retrospective case-control study includes 88 patients with lithiasis. Group 1: Treated with 1 session of extracorporeal lithotripsy and Fagoliths plus®. Group 2: Treated with 1 session of extracorporeal lithotripsy. The variables analyzed were: Age, sex, body mass index, maximum diameter of the stone, area of the stone, hounsfield units of the stone measured by axial tomography, location of the stone, result after 1 session of extracorporeal wave lithotripsy shock [complete fragmentation, partial fragmentation (presence of a fragment greater than 5 mm) and absence of fragmentation (same size of the lithiasis)], adverse effects that occurred after taking Fagolitos plus®, days of treatment with Fagolitos plus® and energy shock wave applied to lithiasis. Results were analyzed with SPSS 20.0, p≤0.05.

RESULTS

The mean age of the patients included in the study is 53.81 ± 12.62 years in group 1 compared to 56.53 ± 12.37 years in group 2, p=0.31. According to the distribution by sex, there were no statistically significant differences (p=0.5), including 24 men and 24 women in group 1 and 23 men and 17 women in group 2. The mean of body mass index of the patients in group 1 was 28.39 ± 2.27 kg/m2 in group 1 versus 28.39 ± 3.03 kg/m2 in group 2, p=0.9. The maximum diameter of the stone was 11.5 ± 3.91 mm in group 1 compared to 13.15 ± 5.49 mm in group 2, p=0.1. The area of the lithiasis measured by tomography was 104.74 ± 70.56 mm2 in group 1 compared to 141.91 ± 80.95 mm2 in group 2, p=0.3. The Hounsfield units measured by tomography of the lithiasis in group 1 was 1061.98 ± 213.68 compared to 1143.15 ± 172.24 in group 2, p=0.06. Relation to fragmentation, complete fragmentation was observed in 66.7% of group 1 patients, compared to 41% of group 2 patients (p=0.02), between 20-30 days after the first session of Extracorporeal Lithotripsy evaluated by means of a simple X-ray of the Abdomen.

CONCLUSIONS

The administration of Fagolitos plus® concomitant to extracorporeal lithotripsy could increase its effectiveness in lithiasis fragmentation, requiring clinical trials and prospective studies to confirm these findings.

摘要

引言

名为Fagolitos plus®的营养补充剂除了含有锌、镁、维生素A和维生素B6外,还以羟基柠檬酸作为主要成分。有必要研究新的分子作为钙结石的化学溶解疗法,或在其他器械治疗的辅助下促进结石碎裂。

目的

本研究的目的是评估Fagolitos plus®联合体外冲击波碎石术在结石碎裂方面的有效性。

材料与方法

回顾性病例对照研究纳入了88例结石患者。第1组:接受1次体外冲击波碎石术并服用Fagoliths plus®进行治疗。第2组:仅接受1次体外冲击波碎石术治疗。分析的变量包括:年龄、性别、体重指数、结石最大直径、结石面积、通过轴向断层扫描测量的结石亨氏单位、结石位置、1次体外冲击波碎石术后的结果[完全碎裂、部分碎裂(存在大于5mm的碎片)和未碎裂(结石大小不变)]、服用Fagolitos plus®后出现的不良反应、服用Fagolitos plus®的天数以及施加于结石的能量冲击波。结果使用SPSS 20.0进行分析,p≤0.05。

结果

第1组纳入研究患者的平均年龄为53.81±12.62岁,第2组为56.53±12.37岁,p = 0.31。按性别分布,无统计学显著差异(p = 0.5),第1组有24名男性和24名女性,第2组有23名男性和17名女性。第1组患者的平均体重指数为28.39±2.27kg/m²,第2组为28.39±3.03kg/m²,p = 0.9。第1组结石的最大直径为11.5±3.91mm,第2组为13.15±5.49mm,p = 0.1。通过断层扫描测量的结石面积,第1组为104.74±70.56mm²,第2组为141.91±80.95mm²,p = 0.3。通过断层扫描测量的第1组结石的亨氏单位为1061.98±213.68,第2组为1143.15±172.24,p = 0.06。关于碎裂情况,在通过腹部简单X线评估的首次体外冲击波碎石术后20 - 30天内,第1组66.7%的患者实现了完全碎裂,而第2组为41%(p = 0.02)。

结论

在体外冲击波碎石术的同时服用Fagolitos plus®可能会提高其在结石碎裂方面的有效性,需要进行临床试验和前瞻性研究来证实这些发现。

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引用本文的文献

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A randomized, double-blind, placebo-controlled clinical trial of the use of hydroxycitric acid adjuvant to shock wave lithotripsy therapy in patients with calcium stones. Stone fragmentation results.一项随机、双盲、安慰剂对照临床试验,评估羟基柠檬酸辅助冲击波碎石术治疗钙结石患者的效果。结石碎裂结果。
Urolithiasis. 2023 May 30;51(1):83. doi: 10.1007/s00240-023-01456-0.