Ma Chao, Xie Jiawei, Chen Qingfeng, Wang Guoming, Zuo Shuyao
Department of Nuclear Medicine, Affiliated Hospital of Medical College Qingdao University, Jiangsu Road 16, Qingdao, Shandong Province, China, 266003.
Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007956. doi: 10.1002/14651858.CD007956.pub2.
Radioactive iodine treatment for differentiated thyroid cancer possibly results in xerostomia. Amifostine has been used to prevent the effects of irradiation to salivary glands. To date, the effects of amifostine on salivary glands in radioactive iodine treated differentiated thyroid cancer remain uncertain.
To assess the effects of amifostine on salivary glands in high-dose radioactive iodine treated differentiated thyroid cancer.
Studies were obtained from computerized searches of MEDLINE, EMBASE, The Cochrane Library and paper collections of conferences held in Chinese.
Randomised controlled clinical trials and quasi-randomised controlled clinical trials comparing the effects of amifostine on salivary glands after radioactive iodine treatment for differentiated thyroid cancer with placebo and a duration of follow up of at least three months.
Two authors independently assessed risk of bias and extracted data.
Two trials with 130 patients (67 and 63 patients randomised to intervention versus control) were included. Both studies had a low risk of bias. Amifostine versus placebo showed no statistically significant differences in the incidence of xerostomia (130 patients, two studies), the decrease of scintigraphically measured uptake of technetium-99m by salivary or submandibular glands at twelve months (80 patients, one study), and the reduction of blood pressure (130 patients, two studies). Two patients in one study collapsed after initiation of amifostine therapy and had to be treated by withdrawing the infusion and volume substitution. Both patients recovered without sequelae. Meta-analysis was not performed on the function of salivary glands measured by technetium-99m scintigraphy at three months after high dose radioactive iodine treatment due to the highly inconsistent findings across studies (I(2) statistic 99%). None of the included trials investigated death from any cause, morbidity, health-related quality of life or costs.
AUTHORS' CONCLUSIONS: Results from two randomised controlled clinical trials suggest that the amifostine has no significant radioprotective effects on salivary glands in high-dose radioactive iodine treated differentiated thyroid cancer patients. Moreover, no health-related quality of life and other patient-oriented outcomes were evaluated in the two included trials. Randomised controlled clinical trials with low risk of bias investigating patient-oriented outcomes are needed to guide treatment choice.
分化型甲状腺癌的放射性碘治疗可能导致口干症。氨磷汀已被用于预防辐射对唾液腺的影响。迄今为止，氨磷汀对接受放射性碘治疗的分化型甲状腺癌患者唾液腺的影响仍不明确。
评估氨磷汀对接受大剂量放射性碘治疗的分化型甲状腺癌患者唾液腺的影响。
通过计算机检索MEDLINE、EMBASE、Cochrane图书馆以及中文会议论文集获取研究。
随机对照临床试验和半随机对照临床试验，比较氨磷汀与安慰剂对分化型甲状腺癌放射性碘治疗后唾液腺的影响，随访期至少为三个月。
两位作者独立评估偏倚风险并提取数据。
纳入了两项试验，共130例患者（67例和63例患者分别随机分配至干预组和对照组）。两项研究的偏倚风险均较低。氨磷汀与安慰剂相比，在口干症发生率（130例患者，两项研究）、12个月时唾液腺或颌下腺99m锝摄取量的闪烁扫描测量值下降（80例患者，一项研究）以及血压降低（130例患者，两项研究）方面均无统计学显著差异。一项研究中有两名患者在开始氨磷汀治疗后出现虚脱，不得不通过停止输注和补液治疗。两名患者均康复且无后遗症。由于各研究结果高度不一致（I²统计量为99%），未对大剂量放射性碘治疗三个月后通过99m锝闪烁扫描测量的唾液腺功能进行Meta分析。纳入的试验均未调查任何原因导致的死亡、发病率、健康相关生活质量或费用。
两项随机对照临床试验的结果表明，氨磷汀对接受大剂量放射性碘治疗的分化型甲状腺癌患者的唾液腺没有显著的放射防护作用。此外，纳入的两项试验均未评估健康相关生活质量和其他以患者为导向的结局。需要开展偏倚风险较低的随机对照临床试验，以调查以患者为导向的结局，为治疗选择提供指导。
