利用核研氯化鍶-89注射劑在前列腺癌骨轉移止痛治療后之效益評估

Clinical Trial of INER Strontium Chloride(Sr-89)Injection Palliative Therapy for Intractable Bone Pain in Prostate Cancer with Osseous Metastases

王世楨(Shyh-Jen Wang) ； 楊啟瑞(Chi-Ri Yang) ； 林萬鈺(Wan-Yu Lin) ； 羅采月(Tsai-Yueh Lo) ； 沈立漢(Lie-Hang Shen) ； 傅應凱(Yin-Kai Fu)

《核子醫學雜誌》 17卷1期 (2004/03) Pp. 7-11

https://doi.org/10.6332/ANMS.1701.002

摘要

背景：鍶-89已在臨床上被用来治療惡性腫瘤轉移性骨骼疼痛並獲得不錯的結果，本研究的目的在於測試核研氯化鍶-89注射劑在前列腺癌骨轉移止痛治療後之療效及安全性。方法：本試驗共收納45位50歲以上前列腺癌轉移骨痛之患者，依隨機序列表分別注射核研氯化鍶注射劑（23位）或愛莫生氯化鍶注射液（22位）：全部受試者（45位）皆納入安全性分析母體。療效分析之群體共計44位，其中核研氯化鍶注射劑組22位，愛莫生氯化鍶注射液22位。本試驗主要評估之療效指標為骨痛指標(Wisconsin test)於治療前後之變化。其他次要療效指標包括治療後12週之療效反應率(response rate)，以及治療後1、2、4及8週Wisconsin test最後疼痛分數的變化。安全性指標為可能出現之副作用與實驗室檢查數據之變化。結果：所有受試者其Wisconsin指數皆有所改善或至少維持藥物投與前之水準。在療效反應率上，核研組與愛莫生組分別為81.8％與77.3％：兩組間之差異為4.6％，兩組間並無顯著性之差異（P=1）。兩受試組之受試者在各項不良反應之發生率上並無統計上顯著之差異。結論：148MBq單一劑量核研氯化鍶注射劑對前列腺癌轉移骨痛患者之止痛效果具有與愛莫生氯化鍶注射液幾乎一樣之臨床反應率：在正常使用量情形，核研氯化鍶注射劑為安全之放射性藥物。

關鍵字

氯化鍶 ； 前列腺癌 ； 骨骼轉移

並列摘要

Background:Strontium-89 chloride has been used for palliative treatment of metastatic bone pain for many years. This study was undertaken to evaluate the efficacy profiles of INER Strontium Chloride(Sr-89)Injection Palliative therapy for treating intractable bone pain in prostate cancer patients with osseous metastases. Methods: This study was a single-center, double-blinded, randomized, parallel group trial to compare the efficacy and safety of INER Stronitum Chloride(Sr-89)Injection Palliative and Amersham Strontium-89 Chloride in alleviating the intractable bone pain in the in prostate cancer patients with osseous metastases. Eligible patients receivedone single dose of either INER Stronitum-89 Palliative or Amersham Strontium-89 Chloride at baseline and were followed up to 12 weeks. A total of 45 patients, aged 50 or older, were enrolled and randomized. All of them suffered from painful multiple osseous metastases resistant to chemo-,hormonal and analgesic therapies for stage C grade IV or stage D prostate cancer. Results: This study showed that both treatments resulted in significant improvement in the Wisconsin test index. No statistically significant difference was found(P=1)in response rate of these two treatments. No statistically significant difference in the incidence of adverse events was found between these two treatment groups. Conclusions: In conclusion, the study demonstrated that single dose(148MBq)of INER Stronitum Chloride(Sr-89)Injection had similar efficacy safety profiles compared with Amersham Strontium-89 Chloride. Under normal usage, INER Sr-89 is a safe and effective treatment for treating prostate cancer patients with intractable bone pain in osseous metastases

並列關鍵字

strontium chloride ； prostatic carcinoma ； osseous metastasis