Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double-blind, placebo-controlled trial

We wished to determine if filgrastim administration to chemotherapy/radiation therapy-naive patients receiving external-beam irradiation for head-and-neck malignancies would reduce the incidence and severity of oral/oropharyngeal mucositis. Patients were randomized to receive subcutaneous injections of either filgrastim or placebo beginning on day 1 of radiation and continuing daily throughout treatment. Study medication was titrated to keep the neutrophil count between 10 x 10(9) and 30 x 10(9)/l. The left and right buccal mucosa, hard palate, and posterior pharyngeal wall were scored weekly, by a blinded evaluator using two different scales, and the most severe score per week was used in data analysis. Fourteen of a planned 54 patients were randomized (8 filgrastim, 6 placebo), and were evaluable for a planned interim analysis. No statistically significant between-group differences were seen in mean worst scores across time using repeated measures analysis of variance (Hickey, p = 0.231; WHO, p= 0.288). At almost all timepoints, however, the worst mean scores were lower in patients treated with filgrastim compared with those in patients treated with placebo, and the number of severe (i.e., grade 3) mucositis scores was significantly lower in the filgrastim-treated group. Filgrastim may decrease the severity of radiation-induced oral/oropharyngeal mucositis.     

Oral mucositis in patients treated with chemotherapy for solid tumors: a retrospective analysis of 150 cases

 The incidence and the severity of chemotherapy-associated oral mucositis were determined in a retrospective analysis of 150 patients with various solid tumors. In addition, possible risk factors for the development of mucositis were identified. Patients were treated with chemotherapeutic regimens appropriate to tumor type and disease stage on an in- or outpatient basis. Mucositis was scored using the World Health Organization (WHO) criteria. Eighty-seven episodes of mucositis occurred in 47 (31%) patients. Twenty-six patients each experienced only one episode, whereas 21 patients had up to eight episodes of mucositis. The 1,281 chemotherapy cycles that have been analyzed included 87 cycles in which mucositis was observed. In 16 patients (11%) only slight oral mucosal changes were recorded (maximum WHO score 1), while 25 patients (17%) experienced mild to moderate mucositis (maximum WHO score 2), and in 6 patients (4%) mucositis was moderate to severe (maximum WHO score 3). No grade 4 mucositis developed. In 24 of the 47 patients with mucositis (51%) clinical features of acute pseudomembranous candidiasis were present. Leukopenia, leukopenic fever, and use of corticosteroids and central venous catheters were associated with the chemotherapy cycles with mucositis. Multivariate analysis identified the administration of paclitaxel, doxorubicin, or etoposide as independent risk factor (adjusted rate ratios 8.06, 7.35, and 6.70, respectively), whereas low body mass was associated with a slightly increased risk (adjusted rate ratio 0.92) for the development of mucositis. In conclusion, almost one-third of patients receiving chemotherapy for solid tumors experienced one or more episodes of mild to more severe oral mucositis, indicating that this is a frequent complication in such patients. Published online: 7 March 2000     

Clinical Outcome in Children with Chemotherapy-Induced Mucositis

Objectives: This study was conducted to assess the impact of oral mucositis on nutrition and performance status in pediatric cancer patients treated by chemotherapy.Data Sources: A total of 46 children were followed for mucositis episode, and their mean Oral Assessment Guide score was 20.2. Main concomitant disorders were hematological changes (86.9%), loss of appetite (60.7%), vomiting (28.3%), and diarrhea (10.9%).Conclusion: Anthropometric changes were highlighted by a decrease in body mass index (P = .03) and a decrease of Waterlow score (P = .007). Most patients had a low Lansky Play Performance Scale (LPPS) ≤40 (86.9%). High mucositis grades (P = .007) and long hospital stay (P = .005) were associated with a significant reduction in Lansky Play Performance Scale. Patient's follow-up showed need for hospitalization (84.8%), delay in chemotherapy treatment (71.7%), use of opioides (34.8%), and use of parenteral nutrition (26.1%). Death occurred in 10.9% of the cases.Implications for Nursing Practice: These findings illustrate the impact of mucositis on nutrition and performance status in children undergoing chemotherapy, which considerable affected their outcome.     

Risk of hospitalization for neutropenic complications of chemotherapy in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis: A retrospective cohort study

Background: In a meta-analysis of data from randomized trials, the risk of febrile neutropenia during myelosuppressive chemotherapy was reported to be lower with pegfilgrastim prophylaxis than filgrastim prophylaxis. However, there is limited information on the comparative effectiveness of these agents in clinical practice.Objective: This study was undertaken to compare the risks of hospitalization for neutropenic complications of chemotherapy in US clinical practice in patients with primary solid tumors receiving pegfilgras-tim or filgrastim prophylaxis.Methods: This was a retrospective cohort study employing a US health insurance database. The source population included all patients who received chemotherapy for a primary solid tumor between January 2003 and December 2005 and who received filgrastim or pegfilgrastim during their first course of chemotherapy. All unique chemotherapy cycles were identified for each patient, and cycles in which pegfilgrastim or filgrastim was administered by cycle day 5 (considered to represent prophylaxis) were selected and pooled for analysis. The risks of hospitalization for neutro-penic complications (using both narrow and broad criteria) and for any reason were then compared between cycles in which filgrastim or pegfilgrastim prophylaxis was administered. Generalized estimating equations were used to control for potential confounding variables.Results: Filgrastim prophylaxis was used in 1193 unique chemotherapy cycles (mean [SD] number of days per cycle, 4.5 [3.3]); for pegfilgrastim prophylaxis, the number of unique chemotherapy cycles was 14,570. First-cycle use represented 16% of all cycles analyzed. The mean ages of patients receiving filgrastim and pegfilgrastim prophylaxis were 61 and 60 years, respectively. Breast cancer was the most common tumor type (52% and 51%), followed by non-Hodgkin's lymphoma (21% and 18%) and lung cancer (11% and 15%). Hospitalization for neutro-penic complications (narrow criterion) occurred during 2.1% of filgrastim cycles and 1.2% of pegfilgrastim cycles; hospitalization for neutropenic complications (broad criterion) occurred in a respective 4.8% and 3.1% of cycles; and hospitalization for all causes occurred in 8.7% and 6.3% of cycles (all, P < 0.01). The risks of hospitalization were consistently lower for chemotherapy cycles that involved pegfilgrastim prophylaxis compared with filgrastim prophylaxis (odds ratios = 0.64–0.73; P < 0.05).Conclusion: The risk of hospitalization for neutro-penic complications during cancer chemotherapy in clinical practice was approximately one third higher among patients who received filgrastim prophylaxis than among those who received pegfilgrastim prophylaxis.     

Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial

A randomized, double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of a sucralfate mouthwash in preventing and alleviating oral mucositis induced by 5-fluorouracil (5FU). A total of 81 patients with colorectal cancer were enrolled. Patients were studied during their first cycle of chemotherapy with 5FU and leucovorin (LV) daily for 5 days every 4 weeks (Mayo Clinic schedule). Patients were randomly allocated to receive either a sucralfate suspension or a placebo suspension that was identical in appearance. Patients were instructed to use the suspension as a mouthwash four times daily from the beginning of the chemotherapy cycle. All patients received oral cryotherapy. Patients graded the severity of their own symptoms on a daily basis, and this was the primary outcome measure. There was no difference in the frequency or severity of oral mucositis between the sucralfate- and the placebo-treated group. Some mucositis was reported by 79% of the patient group. Assessment of mucositis by trial staff underestimated the incidence of this problem. Results of this trial do not support the hypothesis that a sucralfate mouthwash can prevent or alleviate oral mucositis induced by 5FU. Patient reporting of mucositis is a more sensitive instrument for assessment of mucositis than review by medical staff.     

Protection from Radiation-Induced Oral Mucositis by Misoprostol, a Prostaglandin E(1) Analog: A Placebo-Controlled, Double-Blind Clinical Trial

Misoprostol, a prostaglandin E(1) analog, is an effective radioprotector in animal studies. Based on this evidence, a prospective, randomized, placebo-controlled, double-blind study was conducted to determine if misoprostol protected the oral and pharyngeal mucosa of irradiated head and neck cancer patients from radiation mucositis. Postsurgical patients who had no detectable cancer and who were referred for postoperative irradiation were candidates for this study. Thirty-four Hines VA and 35 Loyola University patients were accrued (69 total) over a 2-year period. A misoprostol tablet (200 &mgr;g) or an identical placebo tablet was dissolved in water and administered as an oral rinse daily about 20 min before irradiation. Conventional fractionated radiotherapy, consisting of five weekly doses of 2 Gy day(minus sign1), was delivered. The degree of mucositis was scored on a scale from 0 (no mucositis) to 4. In the 17 patients randomly assigned to the misoprostol arm at the Hines VA, no advantage was seen compared to the 17 placebo-treated patients. However, there was significantly less mucositis (p < 0.01, analysis of variance) from weeks 3--6 in the 17 patients treated with misoprostol at Loyola compared to the 18 placebo-treated patients. Several problems in the study were identified at the VA, including adherence to the protocol design. Other problems such as adequate mucositis scoring, radiation scatter from fillings, and, in particular, adequate timing between misoprostol and irradiation were identified at both locations. Absorption studies in healthy volunteers showed significant plasma levels at 10 min after an oral rinse, suggesting that initial clinical trials should be confined to topical misoprostol until more is known regarding the effect of misoprostol on tumors. The results of this pilot study suggest that misoprotol may protect the oral and pharyngeal mucosa from radiation-induced mocositis if adequate time between topical administration and radiation is allowed.     

Effects of professional oral health care on reducing the risk of chemotherapy-induced oral mucositis

Purpose

Recent years have seen remarkable progress in cancer therapy, although treatment-induced adverse reactions and complications are not uncommon. Approximately 40 % of patients undergoing chemotherapy for cancer experience adverse reactions in the oral cavity, with nearly half of them developing severe oral mucositis that necessitates postponing therapy and/or changing the drug dosage. The objective of this study was to assess the usefulness of prophylactic professional oral health care (POHC) for preventing mucositis in patients undergoing chemotherapy.

Methods

Twenty-six female patients scheduled for chemotherapy for breast cancer were included in this study and randomized to the self-care or POHC groups. Assessment parameters included oral cavity photographs, plaque control records, Saxon test scores, Oral Assessment Guide scores, and grading using the Common Terminology Criteria for Adverse Events. Beginning before surgery and continuing through the completion of chemotherapy, the POHC patient group received weekly professional oral health care, including scaling, professional cleaning of the tooth surfaces, brushing instructions, and nutritional and lifestyle guidance.

Results

More patients in the self-care group developed oral mucositis than in the POHC group. The Oral Assessment Guide score, which was used as an index of oral mucositis, was also significantly lower in the POHC group. Based on the Oral Assessment Guide and plaque control records, there was almost no deterioration of the oral environment in the POHC group, whereas deterioration was observed in the self-care group.

Conclusions

These findings demonstrate the efficacy of regular POHC in reducing the risk of oral mucositis in breast cancer patients undergoing chemotherapy.     

Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization?

BACKGROUND: In clinical trials in patients receiving myelosuppressive chemotherapy, 10-11 days of prophylaxis with filgrastim has been found to reduce the incidence of febrile neutropenia. In clinical practice, however, many patients receive shorter courses of therapy, even though the effectiveness of this regimen is unknown. OBJECTIVE: To examine the relationship between duration of filgrastim prophylaxis and risk of hospitalization in patients receiving chemotherapy for non-Hodgkin's lymphoma (NHL), breast cancer, or lung cancer. METHODS: Using a large, automated, US healthcare claims database, we identified all adults who received chemotherapy for NHL, breast cancer, or lung cancer between 1998 and 2002. For these patients, we identified their first course of chemotherapy and each unique cycle within that course. We then focused attention on all patient cycles in which filgrastim was administered on or before cycle day 5 (filgrastim prophylaxis). Pooling all such cycles, we examined the relationship between duration of filgrastim prophylaxis and risk of hospitalization for neutropenia or infection and risk of hospitalization for any reason, using generalized estimating equations. RESULTS: Mean +/- SD duration of filgrastim prophylaxis was 6.5 +/- 3.1 days across 332 cycles for 133 NHL patients, 6.1 +/- 2.9 days across 482 cycles for 205 breast cancer patients, and 4.3 +/- 3.1 days across 522 cycles for 260 lung cancer patients. In multivariate analyses, risk of hospitalization for neutropenia or infection was found to decline with each additional day of filgrastim prophylaxis for patients with NHL (OR 0.81; p = 0.003), breast cancer (OR 0.77; p = 0.001), and lung cancer (OR 0.91; p = 0.084). Risk reductions with each additional day of prophylaxis ranged from 15% to 19% for patients with NHL, 17% to 23% for those with breast cancer, and 8% to 9% for those with lung cancer. Similar reductions in risk were noted for all-cause hospitalization. CONCLUSIONS: Among patients with NHL, breast cancer, or lung cancer, shorter courses of filgrastim prophylaxis may increase the risk of hospitalization.     

老年鼻咽癌患者放疗性口腔黏膜炎的评估工具及护理进展

口腔黏膜炎是老年鼻咽癌放疗患者最为常见的不良反应,它的发生往往严重影响老年患者的治疗及生活质量。本文综述了近年来关于老年鼻咽癌患者放疗性口腔黏膜炎的相关论文,从老年鼻咽癌患者放疗性口腔黏膜炎评估以及护理的角度进行综述。本综述将为护理人员在老年鼻咽癌患者放疗性口腔黏膜炎的临床护理工作中如何选择评估工具及制定护理干预措施提供参考。     

Incidence of cancer after a first episode of idiopathic venous thromboembolism treated with 3 months or 1 year of oral anticoagulation

Summary.  Background : A prolonged treatment with oral anticoagulants has been claimed to reduce the incidence of newly diagnosed cancer in the long-term follow-up of patients with venous thromboembolism. Objectives : In a multicenter prospective study we assessed the incidence of newly diagnosed clinically overt cancer in patients with a first episode of idiopathic venous thromboembolism (VTE) treated with oral anticoagulants for 3 months or 1 year. Patients and methods : Consecutive patients with an idiopathic venous thromboembolism who had completed 3 months of oral anticoagulant therapy without having a recurrence, bleeding or newly diagnosed cancer were randomized to discontinue oral anticoagulant therapy or to continue it for nine additional months. Idiopathic venous thromboembolism was defined as thrombosis occurring in the absence of known cancer, known thrombophilia, or temporary risk factors for venous thromboembolism. All patients were followed up for at least 1 year after randomization. Results : A total of 429 patients, 265 patients with DVT and 164 with PE, were followed up for an average of 43.7 months after randomization. A newly diagnosed cancer occurred in 32 patients (7.5%), 13 (6.2%) of the 210 patients treated for 3 months and 19 (8.7%) of the 219 patients treated for 1 year (RR = 0.71, 95% confidence interval 0.36–1.41). Conclusions : The incidence of newly diagnosed clinically overt cancer is not reduced in patients with idiopathic venous thromboembolism treated with 1-year anticoagulant treatment compared with patients treated for 3 months.     

The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: results from two prospective studies

Background  Low-energy laser (LEL) treatment has been suggested as an effective and safe method to prevent and/or treat oral mucositis induced by chemotherapy and/or radiotherapy; however, it has not gained wide acceptance so far. Materials and methods  We conducted two clinical trials testing the LEL technique: firstly, as a secondary prevention in patients with various solid tumors treated with chemotherapy who all developed severe mucositis after a previous identical chemotherapy and, secondly, as therapeutic intervention (compared to sham illumination in a randomized way) in patients with hematological tumors receiving intensive chemotherapy and having developed low-grade oral mucositis. Results  We entered 26 eligible patients in the first study and 36 were randomized in the second study. The success rate was 81% (95%CI = 61–93%) when LEL was given as a preventive treatment. In the second study, in patients with existing lesions, the therapeutic success rate was 83% (95%CI = 59–96%), which was significantly different from the success rate reached in the sham-treated patients (11%; 95%CI = 1–35%); the time to development of grade 3 mucositis was also significantly shorter in the sham-treated patients (p < 0.001). Conclusion  Our results strongly support the already available literature, suggesting that LEL is an effective and safe approach to prevent or treat oral mucositis resulting from cancer chemotherapy.     

Comparison of plain ice and flavoured ice for preventing oral mucositis associated with the use of 5 fluorouracil

Aims and objectives. The study aimed to compare the use of plain ice, flavoured ice and standard care, to evaluate the effect on mucositis and to determine patients’ perceptions of the two forms of oral cryotherapy. Background. Despite evidence that oral cryotherapy is useful in preventing mucositis in patients receiving 5‐fluorouracil, concerns have been expressed about its clinical utility, due to potential side effects and negative perceptions. Design. A randomized, controlled, crossover trial was conducted in the outpatient chemotherapy department of an acute care teaching hospital in Perth, Western Australia. Patients were randomized to receive each of three interventions across three cycles of chemotherapy: standard care alone; standard care plus plain ice; and standard care plus flavoured ice. Methods. Oral mucositis was assessed by nurses prior to each of the three chemotherapy cycles and 15 days after each intervention. Two assessment tools were used, the Oral Assessment Guide, and the Western Consortium Cancer Nursing Research Scale. Participants completed a questionnaire to determine their comfort and satisfaction with oral cryotherapy, as well as factors affecting compliance. Results. Findings from 67 patients revealed that when participants used standard care alone, they were significantly more likely to experience symptoms of mucositis than when they used either plain or flavoured ice. Odds ratios were at least threefold higher for standard care alone, varying according to the instrument used. The two main concerns reported were the taste of flavoured ice and the time required to complete the cryotherapy interventions. Side effects such as nausea, sensitivity and headache were reported more frequently for flavoured ice (n = 11) compared with plain ice (n = 5) and standard care (n = 1). Conclusions. Both forms of oral cryotherapy were effective in reducing the severity of oral mucositis after chemotherapy and were more effective than standard care alone. Flavoured ice was associated with the highest frequency of side effects. Relevance to clinical practice. The benefits of cryotherapy appear to outweigh the problems in this sample of patients. The intervention should be tailored to individual patients, based on preferences for plain versus flavoured ice and small chips vs. larger blocks. Unsweetened frozen fruit juices should be evaluated. Time constraints could be addressed by providing transportable containers of ice.     

Clinical effects of flurbiprofen tooth patch on radiation-induced oral mucositis. A pilot study

Background Mucositis is an oral sequela of radiotherapy. In the development of mucositis several mechanisms play a role, such as inflammation and the effect of radiation on the high proliferation rate of oral basal epithelial cells. Therefore, administration of a drug with antiinflammatory and antiproliferative properties might delay the disorder and/or alleviate the severity of oral mucositis. The aim of this pilot study was to evaluate the effect of flurbiprofen in a tooth patch on the development, severity and duration of pseudomembranous mucositis in patients treated with curative head and neck radiotherapy.Methods The study group comprised 12 patients with a malignant tumor in the head and neck region to be treated with primary curative or postoperative radiotherapy. Patients applied once a day before sleep a flurbiprofen tooth patch to a natural tooth or upper denture during the full course of radiotherapy, starting 1 week before the onset of radiotherapy. Oral mucositis, pain, feeding, body weight and viability and maturation of epithelial cells were assessed. The results were compared with the findings in a historical control group.Results No differences were found for severity and duration of pseudomembranous mucositis between the two groups. The onset of pseudomembranous/ulcerative mucositis occurred later in the flurbiprofen group (14.6±3.8 days, mean±SD) than in the historical control group (11±3.5 days; P<0.05).Conclusion This study shows that the flurbiprofen 15 mg tooth patch cannot prevent the development of pseudomembranous mucositis and has no influence on the duration of oral mucositis.     

Effect of fluconazole antifungal prophylaxis on oral mucositis in head and neck cancer patients receiving radiotherapy

Goal of work The aim of the study is to evaluate the effect of fluconazole antifungal prophylaxis on the severity of mucositis in head and neck cancer patients receiving radiotherapy.Patients and methods Sixty-three patients, with malignant head and neck tumor, eligible to receive radiotherapy, entered the study. Thirty-four patients (group A) received 100 mg/day of fluconazole prophylaxis during radiotherapy and were compared with 29 patients, who received radiotherapy alone (group B). The two groups were similar in terms of patients and radiotherapy characteristics. Smear to test for Candida carriage was taken before and after radiotherapy. Oral candidiasis was diagnosed using the criteria described before. Oral mucositis was recorded according to EORTC/RTOG criteria.Main results A significant reduction of severe mucositis at the end of radiotherapy (14.7 vs 44.8%, p=0.018) and of interruptions (0 vs 17.2%, p=0.017) was observed in group A. Candidiasis was prevented (0 vs 34.5%, p=0.001), with a significant reduction of Candida carriage of 40.7% (p=0.001).Conclusion Fluconazole prophylaxis showed a significant beneficial impact on the severity of mucositis and on radiotherapy interruptions in this group of patients. The current study provides data on the build of a randomized controlled trial on the effect of fluconazole prophylaxis on treatment schedule and quality of life of the patients during head and neck radiotherapy.     

Hyperfractionated radiotherapy concomitant with cisplatin and granulocyte colony-stimulating factor (filgrastim) for laryngeal carcinoma

An open-label, non-randomized study evaluated the feasibility and efficacy of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor, r-metHuG-CSF) to prevent mucositis induced by accelerated hyperfractionated radiotherapy (1.6 Gy b.i.d., total dose 67.2 Gy in six weeks with a two-week split) and concomitant chemotherapy (cisplatin, 20 mg/m2/day, days 1-5 by continuous intravenous infusion) in patients with laryngeal carcinoma. Filgrastim 300 microg/day was administered on days 1, 3, and 5 in weeks 2-6 of radiotherapy, after the second fraction. Twenty patients (three stage II, six stage III, and eleven stage IV, according to AJCC) were enrolled in the trial. Oral mucosal toxicity was grade 2 in nine patients (45%), grade 3 in eight (40%), and grade 4 in three (15%). Severe hematological toxicity (WHO criteria) was uncommon. Nineteen patients (95%) completed the treatment in the planned time. Overall survival was 55% at three years. The administration of filgrastim with this regimen was feasible, and it appeared to reduce the severity and duration of mucositis induced by the combined treatment.     

Risk of oral and gastrointestinal mucosal injury among patients receiving selected targeted agents: a meta-analysis

Purpose

The purpose of this study was to estimate the risk and severity of oral and gastrointestinal mucosal toxicities associated with selected targeted agents.

Methods

We searched the English-language literature in February 2011 for reports of randomized clinical trials comparing a FDA-approved targeted agent to a standard of care regimens. Long-term follow-up and secondary reports of trials were excluded, leaving 85 studies for analysis. Using meta-analytic methods, we calculated the relative risks of oral and gastrointestinal toxicities, adjusting for sample size using the inverse variance technique. For each targeted agent and each side effect, we calculated the number needed to harm, the number of patients that, if treated with the more toxic regimen, would produce one additional episode of the toxicity.

Results

Oral mucositis was significantly more frequent among patients treated with bevacizumab, erlotinib, sorafenib, or sunitinib, although this difference was confined to low-grade mucositis. The clinical significance of these findings is unclear given its low incidence and mild severity. In contrast, diarrhea was significantly more frequent with most of the targeted agents studied, with adjusted relative risks between 1.5 and 4.5. An additional patient with diarrhea will be observed for every three to five patients treated with these targeted agents, compared with conventional regimens.

Conclusions

Oral mucosal toxicities occasionally complicate treatment with these targeted agents, but the clinical significance of this finding is not clear. Diarrhea is a hallmark of treatment with these targeted agents; this side effect should be carefully ascertained to permit early intervention and control.     

头颈部肿瘤放疗中口腔黏膜反应的治疗

目的探讨2种漱口液治疗肿瘤患者在放射治疗过程中急性上口腔黏膜炎的疗效。方法将87例头颈部肿瘤患者按随机数字表法分为2组,自制漱口液组（n=43例）和口泰漱口液组（n=44例）。2组在放疗过程中分别采用自制漱口液和口泰漱口液含漱,每次10mL,4～5次.d-1,自放射治疗开始后1周内使用,连续使用7周。根据RTOG/EORTC急性放射性黏膜炎分级标准对2组患者的疗效及口腔黏膜损伤情况进行比较。结果自制漱口液组有效率高于口泰漱口液组、Ⅲ级急性放射性黏膜炎发生率低于口泰漱口液组（均P〈0.05）。结论头颈部肿瘤患者在放疗过程中口腔黏膜反应是不可避免的,自制漱口液配制简单、价格便宜、疗效确定,在头颈部肿瘤患者放射治疗过程中可作为预防和治疗用药。     

Methylene Blue for the Treatment of Intractable Pain Associated with Oral Mucositis

Oral mucositis is a common and often debilitating complication among cancer patients receiving radiation therapy to the head and neck or chemotherapy agents, or undergoing hematopoietic stem cell transplantation. Pain and decreased oral function associated with oral mucositis may persist long after the conclusion of therapy. Although most patients respond to conservative management, a subset of patients develops intractable pain with severe consequences. For some, the use of total parenteral nutrition with insertion of percutaneous endoscopic gastrostomy feeding tubes is the only alternative. Current recommendations to treat mucositis and its related pain include basic oral care, bland oral rinses, topical anesthetics, and systemic analgesics. We believe that chemical neurolysis of the affected areas with methylene blue used as an oral rinse is a noninvasive, efficient, safe, and cost‐effective alternative that can provide prolonged analgesia in patients with intractable pain of oral mucositis. The benefits of this therapy are reflected in its improvement of patients’ quality of life by enabling oral feeding and controlling pain. We report a series of 5 consecutive patients with intractable oral mucositis‐related pain despite conventional treatment with systemic opiates. All 5 patients responded well to the use of 0.05% methylene blue as mouth rinse, demonstrating sustained analgesia over 3 weeks. The treatment was tolerated well, and overall patient satisfaction was very high. We also observed that methylene blue rinse significantly reduced the total opioid requirement, as demonstrated by reductions in the patients’ morphine equivalent daily dose scores after its use. Our case series suggests that 0.5% methylene blue oral rinse therapy is an effective and inexpensive modality that can be used safely to palliate intractable oral pain in patients with mucositis associated with cancer treatment. To our knowledge, this is the first report using this therapy to treat pain from oral mucositis.