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首页> 外文期刊>Annals of Surgery >Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial
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Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial

机译：全甲状旁腺切除术与常规胸腺切除术和自体移植术相比全甲状旁腺切除术单独治疗继发性甲状旁腺功能亢进：未经证实的多中心前瞻性随机对照试验结果

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Objective:This randomized controlled multicenter pilot trial was conducted to find robust estimates for the rates of recurrence of 2 surgical strategies for secondary hyperparathyroidism (SHPT) within 36 months of follow-up.Background:SHPT is a frequent consequence of chronic renal failure. Total parathyroidectomy with autotransplantation (TPTX+AT) and subtotal parathyroidectomy (SPTX) are the standard surgical procedures. Total parathyroidectomy alone (TPTX) might be a good alternative, as morbidity and recurrence rates are low according to small-scale retrospective studies.Methods:The trial was performed as a nonconfirmatory randomized controlled pilot trial with 100 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 3-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 3-year follow-up.Results:A total of 52 patients underwent TPTX and 48 TPTX+AT. Patient characteristics, preoperative baseline data, duration of surgery (02:29 vs 02:47hrs, P = 0.17) and mean hospital stay (10 7.1 vs 8 +/- 3.7 days, P = 0.11) did not differ significantly. Persistent SHPT developed in 1 TPTX and 2 TPTX+AT patients. None of the TPTX patients required delayed parathyroid AT to treat permanent hypoparathyroidism. Serum-calcium values were similar (2.1 +/- 0.3 vs 2.1 +/- 0.2, P = 0.95) whereas PTH rose by time in the TPTX+AT group and was significantly higher at the end of follow-up when compared with the TPTX group (31.7 +/- 43.6 vs 98.2 +/- 156.8, P = 0.02). Recurrent SHPT developed in 4 TPTX+AT and none of the TPTX patients.Conclusions:TPTX+AT and TPTX seem to be safe and equally effective for the treatment of otherwise uncontrollable SHPT. TPTX seems to suppress PTH more effectively and showed no recurrences after 3 years. The hypothesis that TPTX is superior to TPTX+AT referring to the rate of recurrent SHPT has to be tested in a large-scale confirmatory trial. Nevertheless, TPTX seems to be a feasible alternative therapeutic option for the surgical treatment of SHPT.
机译：目的：进行这项随机对照的多中心先导试验，以寻找对随访36个月内继发性甲状旁腺功能亢进（SHPT）的两种手术策略复发率的可靠估计。背景：SHPT是慢性肾功能衰竭的常见后果。标准的外科手术包括自体全甲状旁腺切除术（TPTX + AT）和亚全甲状旁腺切除术（SPTX）。根据小规模回顾性研究，仅进行甲状旁腺全切除术（TPTX）可能是一个很好的选择，因为其发病率和复发率较低。方法：该试验是一项非确认性随机对照试验，对100例患者进行了长期透析，否则无法控制的SHPT来生成TPTX或TPTX + AT后3年随访期内的复发率数据。在3年的随访中评估了甲状旁腺激素（PTH）和钙水平，甲状旁腺反复或持续性甲状旁腺功能亢进，甲状旁腺再手术，发病率和死亡率。结果：共有52例患者接受了TPTX和48例TPTX + AT。患者特征，术前基线数据，手术时间（02:29 vs 02：47hrs，P = 0.17）和平均住院时间（10 7.1 vs 8 +/- 3.7天，P = 0.11）没有显着差异。持续性SHPT在1例TPTX和2例TPTX + AT患者中发生。 TPTX患者均不需要延迟甲状旁腺癌治疗永久性甲状旁腺功能减退。血清钙值相似（2.1 +/- 0.3 vs 2.1 +/- 0.2，P = 0.95），而TPTX + AT组的PTH随时间增加，并且在随访结束时与TPTX相比明显升高组（31.7 +/- 43.6 vs 98.2 +/- 156.8，P = 0.02）。结论：TPTX + AT和TPTX在治疗原本无法控制的SHPT方面是安全的，同样有效。 TPTX似乎可以更有效地抑制PTH，并且3年后无复发。关于SHPT复发率，TPTX优于TPTX + AT的假设必须在大规模的验证性试验中进行检验。然而，TPTX似乎是SHPT手术治疗的可行替代治疗选择。

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