THYROGEN黃宗健黃宗健黃宗健黃宗健

Thyroid Gland�The hormones secreted by the thyroid gland, thyroxine (T4,

tetraiodothyronine) and triiodothyronine (T3) are distinguished by their iodine content. Their action is to stimulate cellular metabolism.Triiodothyronine is the actual active thyroid hormone, generated by the splitting of one iodine atom from thyroxine. T3 and T4 are necessary for normal growth.

�Thyroid hormon increase basal metabolic rate(BMR)�The BMR rises due to increased synthesis use of ATP.As cells

use more oxygen to produce the ATP,more heat is given off,and body temperature.

�The thyroid hormon also stimulate protein synthesis , increasethe use of glucose and fatty acids for ATP production , increase the breakdown of triglycerides , enhance cholesterol excretion ,thus reducing blood cholesterol level.

Control of thyroid hormon secretionSecretion and release of both hormones are regulated by the action of TSH from the hypothalamopituitary system. If, for instance,a decline in blood thyroxine level is registered in the hypothalamus, the latter liberates a releasing hormone (thyrotropin-releasing hormone,TRH), which in turn induces the liberation of TSH in the anterior pituitary.TSH stimulates the thyroid, which releases thyroxine into the bloodstream.

Thyrogen • 基因重組人類甲促素(recombinanthuman TSH, rh-TSH, Thyrogen)是美國Genzyme 公司開發出來的，他們將製造TSH a 和 b 這兩個 Subunit 的基因轉染(transfect)致中國倉鼠卵巢細胞中合成生產recombinant human TSH

• ADULT DOSAGE & INDICATIONS2 dose regimen: 0.9 mg IM in buttock, followed by 2nd 0.9 mg IM

injection 24 hr later

• Adverse EffectsNausea,Headache ,Fatigue,Vomiting,Dizziness,Asthenia

Diagnostic Testing and Ablation Schedule• I-131追蹤(2MCI)或治療(30~200MCI)停藥(4週)低碘飲食(2週)

Hypothyroidism• worsening of cardiovascular conditions• difficulty walking• difficulty driving vehicles and operating machinery• fatigue• forgetfulness• difficulty concentrating• depression• dry skin and hair•low tolerance to the cold• weight gain• constipation

Thyrogen• StorageProtect from light,Refrigerate at 2-8ºC (36-46ºF)Reconstituted vialRefrigerated (2-8ºC [36-46ºF]): Use within 24 hr

• MECHANISM OF ACTIONRecombinant human TSH; binding to TSH receptors on normal thyroid

epithelial cells or on well-differentiated thyroid cancer tissuestimulates iodine uptake and organification, and synthesis and secretion of Tg, T3, and T4.

MECHANISM OF ACTION

健保給付標準

醫療服務給付項目及支付標準查詢

異動 異動診療項目代碼

26074C

中文項目名稱

碘-131癌症追蹤檢查-施打Thyrogen

英文項目名稱

健保支付點數

19475價格參考期間

094.01.01 ～迄今

附註1.適應症：(1) 甲狀腺癌復發或轉移之患者。(2)不適合停用T4之甲狀腺癌患者進行檢查或治療之準備。2.本項須個案申請事前審查。

• 研究報告顯示，比較使用 Thyrogen 與傳統的戒斷甲狀腺素:在 rh-TSH 使用之後，I131 在甲狀腺殘留組織中有效半衰期明顯地較(甲狀腺功能低下)來的長，而 48小時 I131 的攝取和殘留時間是相近的，平均的 total-body 有效半衰期和殘留時間是較短的，在大腸、胃的滯留時間較短,在大腸、胸部、卵巢、骨髓被吸收的劑量較少，接觸的輻射量亦較少，最重要的是病人的Quality of life 顯著地改善，不適的現象由平均 29 天降至 6 天，減少了戒斷甲狀腺素所產生的諸多不適。

Materials and Methods

• 254 thyroid cancer patients• 218 patients were treated after thyroid hormone

withdrawal and 36 after injections of rhTSH

• 234 patients the administered activity was 3,700 MBq (100 mCi); and for 20 patients with low-risk

cancer, the administered activity was 1,110 MBq

(30 mCi)

• The patients were hospitalized for 2.5–3 d in protected rooms

Measurement of Whole-Body Retention

• measured by a probe fixed on the ceiling of each protected room

• measurements were performed per patient after I-131 administration: at 0.5 h (before any

urinary elimination), at 2 h, and then every 12

h (i.e., at 14, 26, 38, 50, and 62 h). Results

were corrected for counting losses due to the

high initial activity

Urine Samples and Biodistribution of Radioiodine

• 19 withdrawal patients and 11 rhTSH patients and consisted of collection of urine samples and repeated whole-body scans

• For urine collection, a urine sample was collected after each miction, with the patient recording the day and hour of sampling and the urination volume. The radioactivity of each sample was measured with a calibrated γ-counter (LKB 1282 CompuGamma;Wallac).

whole-body scans

• using a calibrated dual-head γ-camera (AXIS; Philips, 19-mm-thick crystal) on days 1, 2, and

3 after radioiodine administration

Dosimetry Analysis

• Data on whole-body retention were obtained from total-body counting; data on stomach

and large intestine were obtained from

quantitative whole-body scans; data on

bladder were derived from urinary

measurements ; and data on remainder of

body were calculated by combining all these

data

RESULT

• In the 218 withdrawal patients (Table 2), the mean effective half-life was 15.7 h and was

not related to age at the time of the study (P

=0.2), serum TSH level (P=0.8), or number of

previous treatments with I131 (P = 0.9).A

longer mean effective half-life was associated

with the male sex (P = 0.02), a higher serum

creatinine level (P = 0.0001), a follicular

histology of thyroid cancer (P = 0.016),a

higher serum thyroglobulin level (P = 0.018),

and the presence of metastases (P = 0.03).

• In these 167 patients, the mean effective half-life was longer by 31% than in the 36

comparable patients who received rhTSH, at

15.2 and 10.5 h,respectively (P=0.0001).

• Among these 167 withdrawal patients, a higher serum creatinine level was associated

with a longer effective half-life (P=0.0002);

indeed, the mean creatinine clearance was

lower in withdrawal patients than in rhTSH

patients.

Residence Time

• The mean effective half life was 10.6 h for the 11 patients who received rhTSH and 16.0 h for

the 19 patients who underwent withdrawal

(P=0.0006). The whole-body residence time

was 15.2 h in rhTSH patients—significantly

shorter than the 23.0 h observed in

withdrawal patients.

In rhTSH patients, dose estimates were lower for the

stomach (P=0.009), were of borderline significance for

the upper large intestine (P=0.05) and the bone

marrow(P=0.05), and were not different for the lower

large intestine (P=0.09) or ovaries (P=0.26) (Table 4)

iodine urinary excretion was slower in

withdrawal patients than in rhTSH patients, with

an excretion of 1,800 MBq being achieved at

15.6 and 10.3 h,respectively.