• 1. 四川大學(xué)華西醫(yī)院核醫(yī)學(xué)科,成都,6100412. 四川大學(xué)華西醫(yī)院中國循證醫(yī)學(xué)中心,成都,610041;

目的 　評價目前131I 治療131I全身顯像陰性(131I WBS-)、甲狀腺球蛋白陽性(Tg+)的分化型甲狀腺癌臨床研究論文的方法學(xué)質(zhì)量.
方法 　計算機檢索MEDLINE(1966～2004.3)、EMBASE(1984～2003)、Cochrane圖書館臨床對照試驗資料庫(2004年第2期)、中國生物醫(yī)學(xué)文獻光盤數(shù)據(jù)庫(1978～2004.6)和中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(1994～2004),同時手檢 lt;同位素 gt;等5種放射治療和內(nèi)分泌雜志(1980.1～2003.4).采用Cochrane系統(tǒng)評價指南的質(zhì)量評價標(biāo)準(zhǔn),對收集到的所有臨床對照研究文獻的質(zhì)量進行評價.
結(jié)果 　未檢索到隨機對照試驗,檢索到非隨機對照研究3篇,其中前瞻性非隨機對照研究2篇,歷史對照研究1篇.3個研究的樣本含量分別為26、60和70例,組間樣本含量不等,均未說明所取樣本量的依據(jù);組間基線相似性不一;均未在治療實施和療效評價中采用盲法評價療效;隨訪時間2～15年,均未報道131I 治療的不良反應(yīng);未報道失訪病例.2個研究的統(tǒng)計方法使用正確,另一個研究運用的統(tǒng)計方法模糊.
結(jié)論　 131I 治療131I WBS-/Tg+ 的分化型甲狀腺癌缺乏隨機對照試驗,臨床對照研究論文的質(zhì)量在隨機、雙盲、隨訪、樣本含量等方面存在一些問題,有待進一步改進.目前迫切需要高質(zhì)量的臨床對照研究和RCT.

引用本文： 馬 超,匡安仁,吳泰相. 131I 治療131I全身顯像陰性/甲狀腺球蛋白陽性的分化型甲狀腺癌臨床研究的方法學(xué)質(zhì)量評價. 中國循證醫(yī)學(xué)雜志, 2005, 05(3): 252-236. doi: 復(fù)制

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8. Pacini F, Agate L, Elisei R, Capezzone M, Ceccarelli C, Lippi F, Molinaro E, Pinchera A. Outcome of differentiated thyroid cancer with detectable serum Tg and negative 131I whole body scan: comparison of patients treated with high 131I activities versus untreated patients[J]. J Clin Endocrinol Metab, 2001; 86(9): 4 092-4 097.
9. Liu GJ, Wang JL. Correct Choose of Statistics Methods in Clinical Research. In: Wang JL, editor in chief. Clinical epidemiology[M], 2nd ed. Shanghai: Shanghai Science and Technical Public house; 2001. p. 227.
10. Spencer CA, Takeuchi M, Kazarosyan M, Wang CC, Guttler RB, Singer PA, Fatemi S, LoPresti JS, Nicoloff JT. Serum thyroglobulin measurement and prognostic significance in patients with differentiated thyroid carcinoma[J]. J Clin Endocrinol Matab, 1998; 83(4): 1 121-1 127.
11. Ni ZZ. Non-parametric statistics. In: Ni ZZ, editor in chief, Medical Statistics[M]. 2nd ed. Beijing: People’s Heath Publishing House, 1998.p. 180.
12. Hyer S, Vini L, O’Connell M, Pratt B, Harmer C. Testicular dose and fertility in men following 131I therapy for thyroid cancer[J]. Clin Endocrinol (Oxf), 2002; 56(6): 755-758.
  1. 1. 王家良. 隨機對照試驗. 見: 王家良, 主編. 臨床流行病學(xué)[M]. 第2版. 上海: 上?？茖W(xué)技術(shù)出版社; 2001. p. 61.
  2. 2. 田蓉, 潘明志, 匡安仁. Tg升高131I顯像陰性的甲狀腺癌患者131I療效評價[J],中華核醫(yī)學(xué)雜志, 2003; 23(1): 27～28.
  3. 3. 劉關(guān)鍵, 王家良. 臨床科研中正確抉擇統(tǒng)計學(xué)方法. 見: 王家良, 主編. 臨床流行病學(xué)[M]. 第2版. 上海: 上?？茖W(xué)技術(shù)出版社; 2001. p. 227.
  4. 4. 倪宗瓚, 幾種非參數(shù)統(tǒng)計方法. 見: 倪宗瓚, 主編. 醫(yī)學(xué)統(tǒng)計學(xué)[M]. 第2版. 北京: 人民衛(wèi)生出版社, 1998.p. 180.
  5. 5. Wang JL. Randomized Controlled Trials. In: Wang JL, editor in chief. Clinical epidemiology[M]. 2nd ed. Shanghai: Shanghai Science and Technical Public house; 2001. p. 61.
  6. 6. Koh JM, Kim ES, Ryu JS, Hong SJ, Kim WB, Shong YK. Effects of therapeutic doses of 131I in thyroid papillary carcinoma patients with elevated thyroglobulin level and negative 131I whole-body scan: comparative study[J]. Clin Endocrinol (Oxf), 2003; 58(4):421-427.
  7. 7. Tian R, Pan MZ, Kuang AR. Evaluation of 131I therapy for differentiated thyroid carcinoma patients with elevated Tg and negative 131I whole body scan[J]. Chin J Nucl Med, 2003; 23(1): 27-28.
  8. 8. Pacini F, Agate L, Elisei R, Capezzone M, Ceccarelli C, Lippi F, Molinaro E, Pinchera A. Outcome of differentiated thyroid cancer with detectable serum Tg and negative 131I whole body scan: comparison of patients treated with high 131I activities versus untreated patients[J]. J Clin Endocrinol Metab, 2001; 86(9): 4 092-4 097.
  9. 9. Liu GJ, Wang JL. Correct Choose of Statistics Methods in Clinical Research. In: Wang JL, editor in chief. Clinical epidemiology[M], 2nd ed. Shanghai: Shanghai Science and Technical Public house; 2001. p. 227.
  10. 10. Spencer CA, Takeuchi M, Kazarosyan M, Wang CC, Guttler RB, Singer PA, Fatemi S, LoPresti JS, Nicoloff JT. Serum thyroglobulin measurement and prognostic significance in patients with differentiated thyroid carcinoma[J]. J Clin Endocrinol Matab, 1998; 83(4): 1 121-1 127.
  11. 11. Ni ZZ. Non-parametric statistics. In: Ni ZZ, editor in chief, Medical Statistics[M]. 2nd ed. Beijing: People’s Heath Publishing House, 1998.p. 180.
  12. 12. Hyer S, Vini L, O’Connell M, Pratt B, Harmer C. Testicular dose and fertility in men following 131I therapy for thyroid cancer[J]. Clin Endocrinol (Oxf), 2002; 56(6): 755-758.