M E D I C U S - Shoqata e Mjekëve Shqiptarë të Maqedonisë-Hipokrati
M E D I C U S - Shoqata e Mjekëve Shqiptarë të Maqedonisë-Hipokrati M E D I C U S - Shoqata e Mjekëve Shqiptarë të Maqedonisë-Hipokrati
efficacy of pharmacologic therapies in increasing ureteral stone expulsion and reducing total analgesic use (15,19). AIM To perform a study to evaluate the clinical role of 1A- 1D-specific antagonists in the medical expulsive therapy of symptomatic lower third ureteral stones. MATERIAL AND METHODS This prospective study was performed at the University Clinic of Urology in Skopje for a period of twelve months, from 01.01 to 31.12.2008. Fifty patients were enrolled in the study. The inclusive parameters were: stone diameter less than 10 mm, radiopaque stone visualized in the distal ureter on a plain x-ray of the kidney, ureters and bladder (KUB), beginning of first renal colic within 6 hours. Exclusive parameters were any previous surgical or conservative therapy for renal and ureteral stones as well as any previous pelvic surgery or irradiation, presence of urinary system infection, radiolucency stones, hypotension. Before the treatment all patients were evaluated with KUB and a urinary tract ultrasonography. Stone size was recorded for each patient. The treatment was fully explained to patients. Biochemical and hematological evaluation of the patients were obtained before the treatment. Also, complete urine analyses were performed before, during and after treatment. Patients were randomly divided into 2 groups. The 25 patients in the Group 1 received tamsulosin (0.4 mg daily) while the 25 patients in group 2 received placebo. Tamsulosin was recommended to be taken after breakfast in the morning with a lot of fluid. The medication was given for up to 30 days. All patients were given symptomatic therapy with injections of 100 mg ketoprofenum and trospium chloride 20 mg, twice a day. Every additional need for analgesics was noted. There were no differences between the groups with respect to age, sex distribution, or stone size (Table 1). They were required to consume a minimum of 2 liters of water daily. For more adequate detection of the spontaneous passage of the stones, patients were directed to filter their urine, and those who had passed their stones were asked to stop all the medications. Every patient was controlled with KUB plus urinary ultrasonography every week. The number of pain episodes, total ketoprofenum and trospium dosage, time of the spontaneous passage of the calculi and side effects of the medications were also noted. In patients who could not experience spontaneous passage of the calculi ureteroscopy and extracorporeal shock wave lithotripsy (ESWL) treatments were started. Statistical analysis were performed with ANOVA, the Pearson chi-square test using the parameters of stone size, expulsion rate, time to expulsion, amount of analgesic compound and pain episodes. RESULTS The stone expulsion rate was 72% (18 of 25 patients) in group 1 and 48% (12 of 25) in group 2 with a mean expulsion time of 5.9±1.8 and 10.2 ± 3.1 days, respectively (Fig. 1). Group 1 showed a statistically advantage in respect of both expulsion rate
(P=0.01) and expulsion time (P=0.005). There was not any significant difference in the mean stone size found in either group between patients who were and those who where not stone free (6.1±1.3 and 6.3±1.4 mm, respectively; P>0.05). No difference was observed in the distribution of expulsion by sex (P>0.05). The need for additional analgesics and the number of colic episodes rate was as twice as higher in the group 2 than in group 1 (fig 2). Tramadol 50 mg was administered when there was additional need for analgesics. The only adverse effect from the tamsulosin therapy was transient hypotension and was seen in 1 patient in group 1 (4%). However it did not resulted in treatment discontinuation. Due to recurrent colic, 3 patients in the group 2 (12%) were submitted to ureteral stenting. The patients from the whole study (7 in group 1 and 13 in group 2) who were not stone free after the 30 days of follow-up were treated successfully with ureteroscopy. Table 1. Demographic data of the two groups Group 1 (n=25) Group 2 (n=25) Mean age±SD (years) 42.2±11.1 43.1±9.9 male:female ratio 14:11 15:10 Mean stone size±SD (mm) 6.1±1.3 6.3±1.4 Fig. 1: 90 80 70 60 50 40 30 20 10 0 Expulsion rate and mean expulsion time colic episodes (n) additional analgesics (mg x 100) Group 1 Group 2
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- Page 125 and 126: REFERENCAT Gjendja emocionale e fë
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- Page 157 and 158: DISCUSSION Spontaneous passage of u
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(P=0.01) and expulsion time (P=0.005). There was not any significant difference in the<br />
mean stone size found in either group between patients who were and those who where<br />
not stone free (6.1±1.3 and 6.3±1.4 mm, respectively; P>0.05). No difference was<br />
observed in the distribution of expulsion by sex (P>0.05). The need for additional<br />
analgesics and the number of colic episodes rate was as twice as higher in the group 2<br />
than in group 1 (fig 2). Tramadol 50 mg was administered when there was additional<br />
need for analgesics.<br />
The only adverse effect from the tamsulosin therapy was transient hypotension<br />
and was seen in 1 patient in group 1 (4%). However it did not resulted in treatment<br />
discontinuation. Due to recurrent colic, 3 patients in the group 2 (12%) were submitted to<br />
ureteral stenting. The patients from the whole study (7 in group 1 and 13 in group 2) who<br />
were not stone free after the 30 days of follow-up were treated successfully with<br />
ureteroscopy.<br />
Table 1.<br />
Demographic data of the two groups<br />
Group 1 (n=25) Group 2 (n=25)<br />
Mean age±SD (years) 42.2±11.1 43.1±9.9<br />
male:female ratio 14:11 15:10<br />
Mean stone size±SD (mm) 6.1±1.3 6.3±1.4<br />
Fig. 1:<br />
90<br />
80<br />
70<br />
60<br />
50<br />
40<br />
30<br />
20<br />
10<br />
0<br />
Expulsion rate and mean expulsion time<br />
colic episodes (n) additional analgesics (mg x 100)<br />
Group 1 Group 2