Gelclair口服凝胶治疗经化疗和/或放疗的头颈部肿瘤患者口腔黏膜炎的疗效

Nermina Kantardži, Velda Smajlbegovi, N. Kazic, A. Cardzic
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During their oncology therapy they were treated with gelclear oral gel and checked every day for severity of their symptoms. Results: In the 13 patients significant improvement in the management of pain was observed, and 11 patients had improvement in food and fluid intakes. There were no delays in treatment, caused by severity of oral mucositis. Conclusion: Gelclear oral gel is safe and efficient agent in the treatment of oral mucositis, one of most common complication of radiotherapy and/or chemotherapy in patients with head and neck tumours. This study was supported by Pharma Swiss – department Sarajevo, Bosnia and Herzegovina. INTRODUCTION Malignant head and neck tumours represent about 4% of all malignancies. Squamous cancers of the upper aero digestive tract constitute approximately 6% of new cancer cases in men and 2% in female at all sites, except the salivary glands; there is a significant preponderance of cases in men1. It is most common between 45 to 70 years2. 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The potential impact of morbidity and mortality with oral mucositis should not be underestimated and requires active treatment. The consequences of mucositis can be mild requiring little intervention to severe that may result in fatal complications. If oral mucisitis is not treated it can cause delays in chemotherapy and/or radiotherapy treatment, or even stopping of specific oncology treatments and compromise survival. Efficacy of Gelclair oral gel in the treatment of oral mucositis in patients with head and neck tumours treated with chemotherapy and /or radiotherapy 2 of 6 Many different treatment options can be used to prevent and treat oral muciositis. Oral care protocols including dental work before starting therapy and oral cleaning during the therapy. Mouth wash products, antiseptic, antibacterial, antifungal, antiviral, and many other products were used. It is obvious that many interventions used in clinical practice have never been rigorously evaluated. There is no standard evidence based 1 protocol for treatment of oral mucisitis during radio and/or chemotherapy. 7 Gel clear oral gel was approved in 2001 by FDA, for treatment of oral mucositis. This product still is not on the positive list of medication for patients in Bosnia and Herzegovina. PATIENTS AND METHODS In the period from January to Jul 2008 15 patients were included in this study. They had pathologically proven head and neck tumor, 13 were males and 2 females. Surgery was performed in 14 patients, and all 14 had adjuvant radiotherapy, among them 9 were treated with radio and chemo therapy. One patient had just radio and chemo therapy, and 5 just adjuvant radiotherapy after surgery. Radiotherapy of the tumor and neck with two opposite field, and one anterior supraclavicular field was used technique in 14 patients; one was irradiated with two small opposed fields on larynges. 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引用次数: 0

摘要

背景:头颈部肿瘤患者在放疗或化疗过程中,口腔黏膜炎是常见的并发症。口腔黏膜炎的症状是疼痛;厌食症不适或不能忍受食物和液体粘膜炎可能很严重,并限制患者对化疗或放疗的耐受能力,造成延迟并限制癌症治疗的有效性。目的:探讨gelclair口腔凝胶治疗头颈部肿瘤患者放疗/化疗期间口腔粘膜炎的疗效。材料和方法:这是一项非随机、前瞻性研究。我们纳入了15例接受放疗和/或化疗并证实头颈部肿瘤的患者。在肿瘤治疗期间,他们接受透明口服凝胶治疗,并每天检查症状的严重程度。结果:13例患者疼痛管理有明显改善,11例患者食物和液体摄入量有改善。由于口腔黏膜炎的严重程度,没有延误治疗。结论:明胶口服凝胶是治疗头颈部肿瘤患者放化疗后最常见的并发症之一——口腔黏膜炎安全有效的药物。这项研究得到了波斯尼亚和黑塞哥维那萨拉热窝瑞士药厂的支持。头颈部恶性肿瘤约占所有恶性肿瘤的4%。除唾液腺外,上消化道鳞状癌约占男性新发癌症病例的6%,占女性新发癌症病例的2%;在男性中有明显的优势。最常见于45岁至70岁之间。在诊断时,约70%的患者处于疾病的III或IV期。治疗选择包括手术、放疗和化疗,在放疗之前、期间或之后。如果患者接受放疗和/或化疗,最常见的副作用之一是口腔黏膜炎。20-40%单独接受化疗的患者和高达50%接受放化疗联合治疗的患者,特别是头颈部肿瘤患者,会发生这种情况。口腔黏膜炎的主要症状有:红斑、味觉丧失、疼痛、口痛或口干、吞咽和进食困难。牙齿和牙龈疾病使问题进一步复杂化。减少热量摄入会导致体重减轻、肌肉力量下降和其他并发症,包括免疫力下降。口腔黏膜受损、免疫力下降的患者易发生机会性口腔感染。口腔黏膜炎的发病率和死亡率的潜在影响不应被低估,需要积极治疗。黏膜炎的后果可以是轻微的,几乎不需要干预,严重的可能导致致命的并发症。如果口腔粘膜炎得不到治疗,它可能导致化疗和/或放疗的延迟,甚至停止特定的肿瘤治疗,危及生存。Gelclair口服凝胶治疗经化疗和/或放疗的头颈部肿瘤患者口腔黏膜炎的疗效[6中的2]许多不同的治疗方案可用于预防和治疗口腔黏膜炎。口腔护理方案包括开始治疗前的牙科工作和治疗期间的口腔清洁。漱口产品,防腐,抗菌,抗真菌,抗病毒,和许多其他产品被使用。很明显,临床实践中使用的许多干预措施从未经过严格的评估。放疗和/或化疗期间口腔粘膜炎的治疗尚无标准的循证方案。凝胶透明口服凝胶于2001年被FDA批准用于治疗口腔黏膜炎。该产品仍未列入波斯尼亚和黑塞哥维那患者的积极药物清单。患者与方法2008年1月至7月共纳入15例患者。病理证实有头颈部肿瘤,男13例,女2例。14例患者行手术治疗,14例患者均行辅助放疗,其中9例患者行放化疗。术后仅放化疗1例,辅助放疗5例。14例采用双对野、一前锁骨上野的肿瘤及颈部放疗技术;其中一组在喉部用两个相对的小磁场照射。9例患者放疗前给予顺铂100mg + 5氟尿嘧啶1000mg化疗2 ~ 3个周期,5例患者放疗后第1、21、42天单独给予顺铂。在肿瘤治疗期间,我们用WHO量表评估口腔黏膜炎的等级。在放射治疗的第二周,他们开始使用凝胶透明口服凝胶标准治疗口腔黏膜炎。图1表1WHO口腔黏膜炎分级表 按年龄分患者以60岁及以上患者居多,平均年龄61岁(26-76岁)。患者的诊断以喉癌、口咽癌多见,且病情进展较晚。图4表5。患者受治疗多数患者采用联合治疗。
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Efficacy of Gelclair oral gel in the treatment of oral mucositis in patients with head and neck tumours treated with chemotherapy and /or radiotherapy
Background: During radiotherapy or chemotherapy of head and neck tumours patients commonly suffer from oral mucositis. Symptoms of oral mucositis are pain; discomfort or inability to tolerate food and fluid. Mucositis can be severe and limit the patient’s ability to tolerate chemotherapy or radiotherapy, cause delay and limit the effectiveness of cancer therapy. Aim: To examine effectiveness of gelclair oral gel in the treatment of oral mucisitis in patients with head and neck tumours during radiotherapy or/and chemotherapy. Material and method: This is nonrandomized, prospective study. We included 15 patients treated with radiotherapy and/or chemotherapy and proven head and neck tumours. During their oncology therapy they were treated with gelclear oral gel and checked every day for severity of their symptoms. Results: In the 13 patients significant improvement in the management of pain was observed, and 11 patients had improvement in food and fluid intakes. There were no delays in treatment, caused by severity of oral mucositis. Conclusion: Gelclear oral gel is safe and efficient agent in the treatment of oral mucositis, one of most common complication of radiotherapy and/or chemotherapy in patients with head and neck tumours. This study was supported by Pharma Swiss – department Sarajevo, Bosnia and Herzegovina. INTRODUCTION Malignant head and neck tumours represent about 4% of all malignancies. Squamous cancers of the upper aero digestive tract constitute approximately 6% of new cancer cases in men and 2% in female at all sites, except the salivary glands; there is a significant preponderance of cases in men1. It is most common between 45 to 70 years2. In the time of diagnosis about 70 % of patients are in III or IV stage of disease3. Treatment options include surgery, radiotherapy and chemotherapy, before, during or after radiotherapy. If the patients are treated with radio and/or chemotherapy one of the most common side effects is oral mucositis. It occurs in 20-40% of patients treated with chemotherapy alone and up to 50% of patients receiving combination radiation and chemotherapy, especially those with head and neck tumors. Main symptoms of oral mucositis are: erythema, taste loss, pain, and a sore or dry mouth, swallowing and eating difficulty. Tooth and gum disease further complicate the problem. Reduction of caloric intake can lead to weight loss, loss in muscle mass strength and other complications, including a decrease in immunity. Patients with damaged oral mucosa and reduced immunity are prone to opportunistic mouth infections. The potential impact of morbidity and mortality with oral mucositis should not be underestimated and requires active treatment. The consequences of mucositis can be mild requiring little intervention to severe that may result in fatal complications. If oral mucisitis is not treated it can cause delays in chemotherapy and/or radiotherapy treatment, or even stopping of specific oncology treatments and compromise survival. Efficacy of Gelclair oral gel in the treatment of oral mucositis in patients with head and neck tumours treated with chemotherapy and /or radiotherapy 2 of 6 Many different treatment options can be used to prevent and treat oral muciositis. Oral care protocols including dental work before starting therapy and oral cleaning during the therapy. Mouth wash products, antiseptic, antibacterial, antifungal, antiviral, and many other products were used. It is obvious that many interventions used in clinical practice have never been rigorously evaluated. There is no standard evidence based 1 protocol for treatment of oral mucisitis during radio and/or chemotherapy. 7 Gel clear oral gel was approved in 2001 by FDA, for treatment of oral mucositis. This product still is not on the positive list of medication for patients in Bosnia and Herzegovina. PATIENTS AND METHODS In the period from January to Jul 2008 15 patients were included in this study. They had pathologically proven head and neck tumor, 13 were males and 2 females. Surgery was performed in 14 patients, and all 14 had adjuvant radiotherapy, among them 9 were treated with radio and chemo therapy. One patient had just radio and chemo therapy, and 5 just adjuvant radiotherapy after surgery. Radiotherapy of the tumor and neck with two opposite field, and one anterior supraclavicular field was used technique in 14 patients; one was irradiated with two small opposed fields on larynges. Two to three cycles of chemotherapy with cisplatin 100 mg and 5 fluorouracil 1000 mg was given prior to radiotherapy in 9 patients, and in 5 patients cisplatin was given alone on the day 1, 21 and 42 of radiotherapy treatment. During their oncology therapy we evaluated grade of oral mucositis by WHO scale. In the second week of radiotherapy they started with gel clear oral gel standard treatment for oral mucositis. Figure 1 Table 1. WHO scale of oral mucositis Figure 2 Table 2. Patients by the age The most of patients were 60 and older, average age 61 (26-76 years) Figure 3 Table 3 . Patients by the diagnosis The most of patients were diagnosed as carcinoma of laryngis and carcinoma of oropharingis, and with advanced disease. Figure 4 Table 5. Patients by the treatment The most of patients had combined therapy.
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