Sangthawan Duangjai, Phungrassami Temsak, Sinkitjarurnchai Wattana
Division of Radiation Oncology, Department of Radiology, Faculty ofMedicine, Prince of Songkla University, Songkhla, Thailand.
J Med Assoc Thai. 2013 Jan;96(1):69-76.
To determine the efficacy of zinc sulfate supplementation in reducing ofradiation-induced oral mucositis and pharyngitis in head and neck cancer patients.
One hundred forty four head and neck patients were enrolled in a randomized, double-blind, placebo-controlled trial. Patients who received radiation therapy alone or postoperative radiation therapy were eligible. Radiation therapy used conventional fractionation with 1.8 to 2.0 Gy perfraction, to total doses of 50 to 70 Gy over five to seven weeks. Drug and identically appearing placebo were self-administered 50 mg (10 cc) per meal, three times a day at mealtime. The zinc sulfate and placebo were administered beginning on the first day of radiation, and continued daily including weekends until radiation was completed Patients were evaluated before radiation, weekly during radiation and at the first month after completion of radiation.
The baseline characteristics of patients, tumor, and treatment were not significantly different between the two groups. There were no statistically significant differences between the two treatment groups in frequency of patients experiencing greater than or equal to grade 2 oral mucositis andpharyngitis at each week during radiation and at the first month after completion of radiation. Six patients (17%) in the zinc sulfate and ten patients (23%) in placebo group developed grade 3 oral mucositis, which was not significantly different. Twenty-two patients (32%) in the zinc sulfate and nineteen patients (27%) in the placebo group developed grade 3 pharyngitis, which was not signifiibantly different. However there was no observation of grade 4 oral mucositis and pharyngitis in either group. Nausea and vomiting were mostly of mild degree. Adverse events were not statistically significant different between the two groups.
It was concluded that zinc sulfate administered during head and neck radiation therapy produced no significant benefit in relieving radiation-induced oral mucositis and pharyngitis with acceptable side effects.
确定补充硫酸锌对降低头颈癌患者放射性口腔黏膜炎和咽炎的疗效。
144名头颈癌患者参与了一项随机、双盲、安慰剂对照试验。仅接受放射治疗或术后放射治疗的患者符合条件。放射治疗采用常规分割，每次1.8至2.0 Gy，在五至七周内总剂量达50至70 Gy。药物和外观相同的安慰剂在每餐时自行服用，每次50 mg（10 cc），每日三次。硫酸锌和安慰剂从放疗第一天开始给药，包括周末每日持续给药，直至放疗结束。患者在放疗前、放疗期间每周以及放疗结束后的第一个月进行评估。
两组患者的基线特征、肿瘤情况和治疗方式无显著差异。在放疗期间每周以及放疗结束后的第一个月，两组治疗组中出现大于或等于2级口腔黏膜炎和咽炎的患者频率无统计学显著差异。硫酸锌组有6名患者（17%）发生3级口腔黏膜炎，安慰剂组有10名患者（23%）发生3级口腔黏膜炎，差异无统计学意义。硫酸锌组有22名患者（32%）发生3级咽炎，安慰剂组有19名患者（27%）发生3级咽炎，差异无统计学意义。然而，两组均未观察到4级口腔黏膜炎和咽炎。恶心和呕吐大多为轻度。两组不良事件无统计学显著差异。
得出结论，在头颈放疗期间给予硫酸锌在缓解放射性口腔黏膜炎和咽炎方面未产生显著益处，且副作用可接受。
