Faculty of Health Sciences, Bursa Uludag University, Bursa, Turkey.
Faculty of Medicine, Medical Oncology Department, Bursa Uludag University, Bursa, Turkey.
Support Care Cancer. 2023 Jun 8;31(7):385. doi: 10.1007/s00520-023-07856-7.
New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd hemostat. Ankaferd hemostat has pleiotropic effects and anti-infective characteristics in tissue healing.
The study was designed as a randomized controlled experimental study. The sample of the study comprised a total of 66 patients (33 patients in the Ankaferd hemostat group and 33 patients in the sodium bicarbonate group) with colorectal cancer who received FOLFOX combination chemotherapy treatment in the first cycle of chemotherapy to prevent mucositis. Participants who met the criteria were randomly assigned to the groups. Before the patient received chemotherapy, ECOG performance score and Oral Mucositis Grading Scale were applied on the 7th day and 15th day. The Ankaferd hemostat group brushed teeth at least twice a day for 2 min and gargled with Ankaferd hemostat twice for 2 min for 2 weeks. The sodium bicarbonate group brushed teeth at least 2 min a day and gargled with sodium bicarbonate 4 times for 2 min for 2 weeks. The Consolidated Standards of Reporting Trials diagram was used to illustrate the randomization of patients.
When the Ankaferd hemostat group is compared with the sodium bicarbonate group, there is a significant difference in favor of the Ankaferd hemostat group in the mucositis grade on the 7th day and 15th day after chemotherapy (p < 0.05). In the binary logistic regression analysis, among the factors affecting the formation of mucositis on the 7th day, only neutrophil and thyroid-stimulating hormone (TSH) were included in the model, while only the TSH variable is statistically significant.
It was determined that Ankaferd hemostat is effective in preventing oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer. In addition, it has been suggested to conduct new studies on the effectiveness of Ankaferd hemostat in the prevention of mucositis in different groups.
The study was registered at ClinicalTrials.gov (ID: NCT05438771, Date: 25.06.2022).
每天都有新的药物被引入癌症治疗中，用于预防和治疗黏膜炎。其中一种药物是 Ankaferd 止血剂。Ankaferd 止血剂在组织愈合中具有多效性和抗感染特性。
该研究设计为随机对照实验研究。研究样本包括共 66 名（33 名接受 Ankaferd 止血剂治疗的患者和 33 名接受碳酸氢钠治疗的患者）接受 FOLFOX 联合化疗治疗以预防黏膜炎的结直肠癌患者。符合条件的参与者被随机分配到各组。在患者接受化疗之前，在第 7 天和第 15 天应用 ECOG 表现评分和口腔黏膜炎分级量表。Ankaferd 止血剂组每天至少刷牙两次，每次 2 分钟，并用 Ankaferd 止血剂漱口两次，每次 2 分钟，持续 2 周。碳酸氢钠组每天至少刷牙 2 分钟，并用碳酸氢钠漱口 4 次，每次 2 分钟，持续 2 周。使用 CONSORT 图说明患者的随机分组。
与碳酸氢钠组相比，Ankaferd 止血剂组在化疗后第 7 天和第 15 天的黏膜炎分级上有显著差异（p<0.05）。在二项逻辑回归分析中，在影响第 7 天黏膜炎形成的因素中，只有中性粒细胞和促甲状腺激素（TSH）被纳入模型，而只有 TSH 变量具有统计学意义。
确定 Ankaferd 止血剂可有效预防成人结直肠癌患者因化疗引起的口腔黏膜炎。此外，建议在不同组中开展关于 Ankaferd 止血剂预防黏膜炎效果的新研究。
该研究在 ClinicalTrials.gov 注册（注册号：NCT05438771，日期：2022 年 6 月 25 日）。
