孙玮笛, 杨洁, 任艳鑫, 李晓江, 赵留芳, 张世文, 李慧宇, 崔玥. 免疫胶体金试纸法验证甲状旁腺的临床应用研究[J]. 中国肿瘤临床, 2019, 46(23): 1206-1211. DOI: 10.3969/j.issn.1000-8179.2019.23.256
引用本文: 孙玮笛, 杨洁, 任艳鑫, 李晓江, 赵留芳, 张世文, 李慧宇, 崔玥. 免疫胶体金试纸法验证甲状旁腺的临床应用研究[J]. 中国肿瘤临床, 2019, 46(23): 1206-1211. DOI: 10.3969/j.issn.1000-8179.2019.23.256
Sun Weidi, Yang Jie, Ren Yanxin, Li Xiaojiang, Zhao Liufang, Zhang Shiwen, Li Huiyu, Cui Yue. Clinical application of immune colloidal gold test strip for rapid recognition of parathyroid gland during surgery[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2019, 46(23): 1206-1211. DOI: 10.3969/j.issn.1000-8179.2019.23.256
Citation: Sun Weidi, Yang Jie, Ren Yanxin, Li Xiaojiang, Zhao Liufang, Zhang Shiwen, Li Huiyu, Cui Yue. Clinical application of immune colloidal gold test strip for rapid recognition of parathyroid gland during surgery[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2019, 46(23): 1206-1211. DOI: 10.3969/j.issn.1000-8179.2019.23.256

免疫胶体金试纸法验证甲状旁腺的临床应用研究

Clinical application of immune colloidal gold test strip for rapid recognition of parathyroid gland during surgery

  • 摘要:
      目的  研究免疫胶体金试纸法在双侧甲状腺切除手术中快速验证甲状旁腺的临床意义。
      方法  选择2017年9月至2018年12月于云南省肿瘤医院接受双侧甲状腺全切术手术患者进行前瞻性研究,共130例参与试验,随机分为试验组(免疫胶体金试纸组)74例和对照组2(常规肉眼组)56例。同时收集2015年1月至2016年1月同单位采用纳米碳技术行双侧甲状腺全切患者资料为对照组1(纳米碳组)50例,比较冰冻病理检查结果及术前、术后血钙和甲状旁腺素(PTH)值等。所有手术均由同一组医生操作完成。
      结果  76份经过病理证实的甲状旁腺,其中74份PTH值>65 pg/mL,范围(62.1~1 340.6 pg/mL),2份PTH < 65 pg/mL。其余41例非甲状旁腺均 < 65 pg/mL,差异均具有统计学意义(均P < 0.001)。免疫胶体金试纸法判断甲状旁腺真阳性率(敏感度)为97.4%,假阳性率(误诊率)为0,真阴性率(特异度)为100%,假阴性率(漏诊率)为2.63%,准确率为98.3%。试验组与对照组1术后第1天复查血钙及血PTH情况,分别为(2.073±0.167 vs.2.043±0.167)mmol/L以及(35.767±13.159 vs.34.570±11.620)pg/mL。试验组术后血钙及血PTH均值稍高于对照组1,但差异无统计学意义(P>0.05)。而术后试验组血钙及血PTH均明显高于对照组2,分别为(2.073±0.167 vs.1.982±0.234)mmol/L和(35.767±13.159 vs.26.145±11.515)pg/mL,差异具有统计学意义(P < 0.05)。
      结论  免疫胶体金试纸法可在术中高效、快速判别甲状旁腺,从而争取甲状旁腺的原位保留,避免误切,或在切除标本中有助于仔细寻找、辨认甲状旁腺,缩短手术时间,减少手术侵袭性,并减少术后低钙血症的发生。

     

    Abstract:
      Objective  To assess the usefulness of immune colloidal gold test strip for the rapid recognition of the parathyroid gland during surgery.
      Methods  This prospective study was performed from September 2017 to December 2018 in the Department of Head and Neck Surgery, Yunnan Cancer Hospital. During this period, 130 patients underwent thyroidectomy; of them, we randomly assigned 74 to the experimental group (immune colloidal gold test strip method) and 56 to control group 2 (conventional visual observation). Furthermore, we included 50 patients who underwent total thyroidectomy by the same team of doctors from January 2015 to January 2016 in control group 1. In control group 1, carbon nanotechnology was used to detect the parathyroid glands. Frozen pathological examination results and pre-and postoperative blood calcium and parathyroid hormone (PTH) levels were compared. All operations were performed by the same team of doctors.
      Results  There were 49 cases of pathologically confirmed parathyroid glands, and among them, 47 had PTH levels > 65 pg/mL (range, 62.1 to 1340.6 pg/mL) and the other 2 had PTH levels < 65 pg/mL. Another 41 cases without parathyroid gland detection had PTH levels < 65 pg/mL (P < 0.001). The difference was statistically significant. The true positive rate (sensitivity) of the immune colloidal gold test strip method in detecting the parathyroid gland was 97.4%, the false positive rate (misdiagnosis) was 0, and the accuracy was 98.3%. To compare the immune colloidal gold test strip method with carbon nanotechnology, we examined blood calcium and blood PTH levels on the first day after surgery (calcium, 2.073±0.167 vs. 2.043 ±0.167; PTH value, 35.767±13.159 vs. 34.570±11.620). The immune colloidal gold test strip method was superior to carbon nanotechnology (P>0.05), although the difference was not statistically significant. To compare the immune colloidal gold test strip method with conventional visual observation, we examined blood calcium and blood PTH levels on the first day after surgery (calcium, 2.073±0.167 vs. 1.982±0.234; PTH, 35.767±13.159 vs. 26.145±11.515). The values were much higher for the immune colloidal gold test strip method than for conventional visual observation (P < 0.05), although the difference was statistically significant.
      Conclusions  The immune colloidal gold test strip method can efficiently and quickly recognize the parathyroid glands during surgery. This ability allows us to maintain the position of the parathyroid glands, avoid their accidental removal, and examine the excised specimen. Parathyroid gland identification enables early transplantation, shortens operation time, and reduces surgical invasiveness.

     

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