Effectiveness of intraglandular ethanol in secondary hyperparathyroidism limited to one only hyperplastic gland

Abstract

Objective: determine the efficacy of ethanol 99.5% in intact PTH (PTHi) levels reduction when applied directly in the hyperplastic parathyroid glands of subjects with chronic kidney disease (CKD) stage 5 on dialysis with secondary hyperparathyroidism. Design: intervention study without control group. Statistical analysis: we used central tendency and dispersion tests (mean, standard deviation) and the measurement comparison was made by Student"(TM)s t test. Patients, materials and methods: over a collection period of two years, we identified subjects with CKD stage 5 on dialysis therapy (hemodialysis or peritoneal dialysis), over 18 years of age, who presented serum iPTH levels greater than 600 pg / ml, and autonomous parathyroid glands hyperplasia (volume greater than 500 mm3) confirmed by neck ultrasonography. Under ultrasound guidance ethanol was applied to each hyperplastic gland according to the glandular volume for a maximum of two applications per gland with an interval of 30 days; in case of more than 2 glands compromised, the infiltration of only 2 glands per session was allowed. 15 subjects underwent therapy. In group 1 (G1) were included 5 subjects with one only hyperplastic gland; group 5 (G5) included 10 subjects with more than one hyperplastic gland. Groups 2, 3 and 4 each one with 3, 2 and 5 subjects with two, three and four hyperplastic glands respectively. iPTH levels were assessed at 30, 60, 90 and 120 days after the last application, as well as variables like calcium, phosphorus, calcium-phosphorus product and hemoglobin. Alkaline phosphatase was assessed initially and at 3 months. Results: intraglandular ethanol administration decreased significantly iPTH values in the total population of subjects from a baseline value of 1263 ± 554 pg / ml to 1065 ± 437 pg / ml (p value: 0.08), 989 ± 568 pg / ml (p value: 0.02), 1028 ± 643 pg / ml (p value: 0.04) and 1139 ± 749 pg / ml (p value: 0.194) to the previously described intervals. In the analysis of groups, we observed that only G1 presented a significant reduction of iPTH values, with a decrease of a mean baseline value of 910 ± 508 pg / ml to 693 ± 432 (p value: 0.04), 534 ± 426 (p: 0.006), 330 ± 379 (p: 0.01) and 322 ± 75 (p = .44). In the other groups consolidated in group 5 (G5) with more than 1 hyperplastic gland, iPTH values were not significantly modified, being its initial value 1430 ± 520 pg / ml and its subsequent values 1251 ± 313 (p: 0.287), 1241 ± 482 (p: 0.255), 1378 ± 416 (p = 0.635) and 1489 ± 591 (p: 0.869). The values of calcium, phosphorus, calcium-phosphorus product and alkaline phosphatase decreased in all groups in a not significant way, probably because of the short follow-up time. The most common adverse event was pain and burning sensation that lasted for 5-10 seconds in the injected area, with presence of hypotension in one subject and dysphonia in 3 subjects, resolving with phonoaudiology therapy in the course of three months. All subjects with therapeutic failure were referred to head and neck surgery for parathyroidectomy, finding large fibrous bands during surgery in 8 patients operated to date. Conclusion: intraglandular ethanol effectively controls secondary hyperparathyroidism in patients with one impaired hyperplastic gland. Subjets with more than one hyperplastic gland should be treated surgically or with an oral calcimimetic, Cinacalcet type