Üst üriner sistem taşlarında işlem öncesi furosemid ile kombine intravenöz hidrasyonun şok dalga tedavi başarısına etkisi

Abstract

Bu çalışmada ESWL tedavisi görmesi planlanan, üst üriner sistem taşı olan hastalara; ESWL işleminden 30 dakika önce intravenöz 20 mg furosemid ile birlikte ESWL işlemi süresince devam eden intravenöz 1000 cc %0,9 NaCl infüzyonu yapılmasının ESWL sonuçlarına etkisini araştırdık.Çalışmaya Haziran 2009 ile Haziran 2010 tarihleri arasında, S.B. İstanbul Eğitim ve Araştırma Hastanesi Üroloji Polikliniği'ne başvuran, ESWL tedavisine uygun, böbrekte en büyük çapı 6-20 mm arası primer, radyoopak taşı olan, ultrasonografide ve intravenöz ürografide en fazla grade 1 hidronefroz saptanan 200 hasta dahil edildi. Hastalar 2 gruba randomize edildi. Birinci gruptaki 100 hastaya standart ESWL tedavi protokolü uygulanarak kontrol grubu oluşturuldu. İkinci gruptaki 100 hastaya ise standart ESWL tedavisine ek olarak; damar yolu açıldı ve her ESWL seansından 30 dakika önce intravenöz 20 mg furosemid ile birlikte ESWL işlemi süresince devam eden intravenöz 1000 cc %0,9 NaCl infüzyonu yapıldı. Çalışma sonunda her iki grup arasında ESWL sonuçlarının karşılaştırması yapıldı.Kontrol grubu ve çalışma grubundaki hastaların yaş, taş boyutu, maksimum HÜ değeri, ortalama HÜ değeri, cilt taş mesafesi, idrar dansitesi, idrar pH'sı karşılaştırıldığında iki grup arasında istatistiksel anlamlı fark yoktu. Kontrol grubunda %69 taşsızlık ve %31 başarısızlık oranları elde edilirken, çalışma grubunda ise %71 taşsızlık ve %29 başarısızlık oranları elde edildi ve iki grup arasında istatistiksel olarak anlamlı fark saptanmadı (p=0,758). Kontrol grubunda %9, çalışma grubunda %6 oranında komplikasyon gözlendi ve iki grup arasında istatistiksel olarak anlamlı fark saptanmadı (p=0,421). Kontrol grubu ve çalışma grubundaki hastalara uygulanan ortalama toplam seans sayısı, ortalama toplam atış sayısı, ortalama kullanılan toplam enerji miktarları karşılaştırıldığında iki grup arasında istatistiksel anlamlı fark yoktu.ESWL işlemine diüretikle birlikte intravenöz hidrasyonun eklenmesi bu tedavinin başarısını artırmada; kolay uygulanabilir, ucuz ve güvenli bir ek uygulama olmakla birlikte çalışmamızda anlamlı bir fark yaratmamıştır. ESWL işlemine diüretikle birlikte intravenöz hidrasyonun eklenmesinin etkilerini daha iyi ortaya koymak için daha çok hasta içeren randomize klinik çalışmalara ihtiyaç vardır.

This work was approved by our institutional review board. Between June 2009 and June 2010, 200patients aged at least 18 years who had 6–20 mm radiopaque solitary renal stones suitable for SWL therapy according to international guidelines were included in this randomised, prospective study. Informed consent was obtained from each patient before inclusion in the study group. We performed this study in accordance with the Helsinki Declaration of the World Medical Association.Patients were chosen with concern for the upper urinary system, when considering the planned treat-ment. Exclusion criteria eliminated those who had had previous renal and/or ureteral surgery, multiple stones, ureteral or ureteropelvic junction stricture, congenital ureteral and/or renal abnormalities, renal insufficiency (serum creatinine >1.8 mg/dL), a solitary kidney, or had hydronephrosis of grade II or greater, as found by intravenous urography (intravenous pyelogram). They also eliminated those who were pregnant, allergic to furosemide, or had active coagulopathy, cardiac disease (previous myocardial infarction, cardiac failure, arrhythmia, previous cardiac surgery or ischae-mic cardiac disease), known hypertension and/or were being treated with antihypertensive drugs.All patients were assessed using urine analysis, complete blood count, routine serum biochemistry, urine culture (where indicated), coagulation para-meters, plain abdominal X-ray examination (kidney, ureters and bladder), ultrasound, intravenous urog-raphy and unenhanced CT. Where urine culture was positive, appropriate antibiotherapy according to the antibiogram was given for an appropriate length of time, and SWL was started after urine cultures were negative. The patient's age and sex, and the stone's location, maximum and mean densities and distance from the skin were recorded, as were the degree of hydronephrosis, number of SWL sessions, number of pulses per session, total energy, effectiveness 3 months after the final session and complications.Patients were randomised into two groups using computer-generated numbers. The standard SWL protocol was used for the 100 patients in group 1, who formed the control group. Patients in group 2, the treatment group, received the standard SWL protocol and additionally, 40 mg furosemide 30 min before each SWL session and 1000 mL 0.9% sodium chloride infused at 16.6 mL/min during the SWL procedure. Blood pressure monitoring was performed continuously during the procedure for all patients .All SWL procedures were performed by a urolo-gist experienced in extracorporeal SWL therapy and a technician with an electromagnetic lithotripter (Modularis Vario Lithostar; Siemens Medical Systems, Elangen, Germany) with fluoroscopic focusing while the patient was in the supine position. All patients were given 75 mg diclofenac intramuscu-larly as an analgesic treatment 45 min before the procedure.SWL was started at low voltage, and after 500 pulses, with the consent of the patient, it was gradually increased to a maximum of 18 kV. In each session, pulses were applied until the stone broke up or until 5500 pulses had been given. In all cases, the pulse frequency was 90 shock waves per minute. After treat-ment, each patient was instructed to use oral analgesics for 7 days. Alterations in stone size and degree of hydronephrosis were assessed by a urologist using plain abdominal X-ray and ultrasound examinations 3 weeks after each session. Treatment was assessed as ineffective if no significant alteration in the size or fragmentation of the stone was achieved after three sessions, and other treatment modalities were recommended for these patients. Three months after the final SWL session, treatment success was assessed using urinary system X-ray and ultrasound examinations, performed by a urologist blinded to the study. The absence of stones or the presence of residual fragments no larger than 4 mm indicated successful treatment, and the pres-ence of residual fragments >4 mm indicated ineffective treatment.This study was designed to detect up to a 20% difference in success rates between the two approaches with 90% power,assuming a significance level of 0.05 (two-tailed). Relying on the results of a pilot study performed in our department, we calcu-lated the sample size needed for our study. At all stages, consul-tations with a biostatistics specialist were included. Pearson's χ2 test and Fisher's exact test were used for comparing categorical data. Student's t test and Mann–Whitney test were used for comparing quantitative data. The Spearman rank correlation coefficient was used to determine correlation, and significant relationships were tested using linear regression. A p value <0.05 was considered statistically significant.No statistically significant difference was found in demographics and stone characteristics between the groups .The success rate among the controls was statistically higher than that of the treatment group after one SWL session, but this differ-ence became insignificant after the second session. The overall stone fragmentation rates after the third session were 69% and 71% in groups 1 and 2, respectively (p=0.758;).A total of 477 SWL sessions were performed on the 200 patients. No statistically significant difference was found between the study and control groups for the average number of sessions and shocks applied or the total amount of energy used .We established a statistically significant linear correlation between stone size, maximum Hounsfield units, average Hounsfield units, total energy, total number of shocks and success of SWL in the control and study groups (p<0.01).A significant inverse correlation was obtained between urine pH and success of SWL (p=0.004) in both groups.Nine patients in group 1 developed complications: steinstrasse (multiple small ureteric stones) was seen in seven, ureteral stric-ture in one and complicated urinary system infection in another. A ureterorenoscopic balloon dilatation procedure was per-formed in a patient who developed ureteral stricture. Six patients in group 2 developed steinstrasse formations. An expul-sive treatment using an α blocker and anti-inflammatory drugs was initially recommended to all those who developed stein-strasse, and these patients were observed for a period of 3 weeks. Two such patients from the control group and one from the study group who did not pass their stone by the end of this period underwent ureterorenoscopic intervention. No statistically significant difference was found in the overall com-plication rates of the two groups (p=0.421).In conclusion, the administration of 40 mg furosemide 30 min before SWL and continuous infusion of 1000 mL 0.9% NaCl during the procedure is a safe and economical method for diuresis in patients with upper urinary tract stones, but it does not affect the successfulness of SWL as a treatment modality.