甲状旁腺全切除加常规胸腺切除术和自体移植与单纯甲状旁腺全切除治疗继发性甲状旁腺功能亢进的比较：一项非确证性多中心前瞻性随机对照试验的结果。
Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial.
机构信息
*Department for General, Visceral, and Vascular Surgery, Agaplesion Evangelisches Krankenhaus Mittelhessen, Giessen, Germany †Department for Visceral, Thoracic, and Vascular Surgery, University Hospital of Giessen and Marburg, Marburg, Germany ‡Department for General, Visceral, and Transplantation Surgery, University Heidelberg, Heidelberg, Germany §Institute of Medical Biometry and Informatics, University Heidelberg, Heidelberg, Germany ¶Department for General and Visceral Surgery, Marienhospital Osnabrück, Osnabrück, Germany ||Department for General, Visceral, Vascular, and Thoracic Surgery, Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany **Department of Surgery, Lukaskrankenhaus Neuss, Neuss, Germany ††Department of Surgery, University Medical Center Regensburg, Regensburg, Germany ‡‡Department of Visceral, Thoracic, and Vascular Surgery, Carl Gustav Carus University Hospital, Dresden, Germany.
出版信息
Ann Surg. 2016 Nov;264(5):745-753. doi: 10.1097/SLA.0000000000001875.
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 02:47 hrs, 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.
目的
本随机对照多中心试验旨在寻找随访 36 个月内 2 种继发性甲状旁腺功能亢进症（SHPT）手术策略复发率的可靠估计值。
背景
SHPT 是慢性肾功能衰竭的常见后果。甲状旁腺全切除术伴自体移植（TPTX+AT）和甲状旁腺次全切除术（SPTX）是标准的手术方法。根据小规模回顾性研究，甲状旁腺全切除术（TPTX）可能是一种很好的替代方法，因为其发病率和复发率较低。
方法
该试验采用非确证性随机对照试验设计，纳入 100 例长期透析且甲状旁腺激素（PTH）水平不可控的 SHPT 患者，旨在生成 TPTX 或 TPTX+AT 后 3 年随访期间疾病复发率的数据。在 3 年的随访期间，评估了 PTH 和钙水平、复发性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
52 例患者接受 TPTX，48 例患者接受 TPTX+AT。患者特征、术前基线数据、手术时间（02:29 与 02:47 小时，P = 0.17）和平均住院时间（10 ± 7.1 与 8 ± 3.7 天，P = 0.11）无显著差异。1 例 TPTX 患者和 2 例 TPTX+AT 患者发生持续性 SHPT。无 TPTX 患者需要延迟甲状旁腺 AT 治疗永久性甲状旁腺功能减退症。血清钙值相似（2.1 ± 0.3 与 2.1 ± 0.2，P = 0.95），但 TPTX+AT 组的 PTH 随时间升高，在随访结束时明显高于 TPTX 组（31.7 ± 43.6 与 98.2 ± 156.8，P = 0.02）。4 例 TPTX+AT 患者和 1 例 TPTX 患者发生复发性 SHPT。
结论
TPTX+AT 和 TPTX 似乎是治疗不可控 SHPT 的安全且同样有效的方法。TPTX 似乎更有效地抑制 PTH，且 3 年后无复发。TPTX 在复发性 SHPT 发生率方面优于 TPTX+AT 的假设需要在大规模确证性试验中进行检验。然而，TPTX 似乎是治疗 SHPT 的一种可行的替代治疗选择。
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