| ObjectiveChemotherapy is one of the main treatments of malignant tumors and oral mucosa is extremely sensitive to chemotherapy because of its active proliferation. Oral mucositis (OM) refers to inflammations and ulcers of the oral mucosal epithelium, which manifests as erythema, decorticated ulcers, hemorrhage and errhysis. OM is one of the common toxicity in patients receiving chemotherapy. Now there are many methods to treat chemotherapy induced oral mucositis, but all the methods lacks potent evidence. From the meta analysis of the current data, there does not exist precautions that can absolutely prevent OM. In recent years, there have been a few reports on using Smecta to treat OM, but all the study is single-center, non-randomized and with small sample size. Our study focus on exploring the effectiveness of using the OAG assessment and detecting the risk factors in cancer patients with chemotherapy-induced OM.And our study focus on effectiveness of using Smecta-iodine glycerin mixed liquor in treating chemotherapy-induced OM.MethodWe analyze the factors that mainly relate to chemotherapy-induced OM, such as chemotherapy regimens, the kinds of cancers, bone marrow suppression, etc. we recruit patients by strict inclusion and exclusion criteria. The inclusion and exclusion criteria comes from published literatures related to chemotherapy-induced OM.We carry out the study at two affiliated hospitals of one university in Guangzhou City (both hospitals are three A-level hospitals and teaching hospital).From January 2009 to December 2009, One hundred and thirty patients were recruited by the inclusion criteria;not all patients completed the study. The number of patients with mild, moderate,and severe OM were 59,64,7 respectively. Ninty-four were males and twenty-six were females.48 patients were diagnosed as lymphoma,44 patients were diagnosed as breast cancer, and 38 patients were diagnosed as colon cancer.Sixty-three patients were randomized as the Smecta-iodine glycerin mixed liquor group(groupA) and 67 patients as the control group (groupB). The mean age of two groups was (53.2±1.96),(52.9±1.73). Patients were randomized into 2 groups by computer code randomization.There was no stratification data between groups.The control group use the vitamin compound gargle, which is current routine gargle to cancer patient's chemotherapy-induced OM. The vitamin compound gargle was composited of saline 400ml+gentamicin 640,000U+Vitamin B12 500mg.Patients in control group rinse their mouth four times a day, and one minute each rinse. The experimental group use vitamin compound gargle and smecta-iodine glycerin mixed liquor to rinse their mouth. We mix 3 gram Smecta powder and 10ml iodine glycerin in a bottle,then stir the mixed liquor, and stored it at the room temperature for 5 days. Patients in experimental group smear the mixed liquor to the location of OM with cotton swab, and they stop drinking water and eating for sixty minutes after each smear. They smear the location of OM four times a day. All the patients of both groups were treated for 5 consecutive days.Assessment time of OM:we assessed the situation of OM at fixed time every morning before the patient rinse the mouth or before they smear the mouth. Nurses involved in this study were allocated single blind and randomized by computer code randomization. The experimental unit consists of two nurses. one nurse carry out the treatment while the other score the patients by oral assessment guideline(OAG). The nurse in charge of scoring by OAG also makes measurements daily and records neutrophil count, body temperature accurately until the score reached at 8 points.The diagnostic criteria of oral mucositis:We assess the patients by OAG (Oral Assessment Guideline) designed by the American oncology nurse association. The OAG form consists of eight items, each item is divided into three degrees,1 point for each level, and the total were 24 points. Patients with score less than 8 points were viewed as normal, Patients with score more than 9 have oral mucositis. Patients with score 9-10 have mild OM, Patients with score 11-12 have Moderate OM, Patients with score more than 12 points have severe OM.Clinical efficacy criteria:The grade of OM was measured once the patient is recruited to the study and was recorded day by day until the fifth day. We evaluated the effectiveness of treatment at sixth day.Patients with markedly effective result:OAG score≤8 points, or mucosal hyperemia around tulcers fade away, pain and ulcers disappeared; Effective result: OAG score from 9 to 10 points,or mucosal hyperemia around tulcers fade away, the ulcer area reduced more than half of the size, the patient can take solid food; Ineffectice result:OAG score≥11 points, mucosal hyperemia around tulcers does not fade away, ulcer area does not reduce less than half of the size, the patient can not take solid food.StatisticsWe analyze the data by SPSS 13.0.The statistical analysis was carried out using descriptive statistics including mean,standard deviation,and percentiles for the variables age, and grade Of OM.while comparing the 2 groups,Chi-square test was used to compare the distribution of patients in the solid tumors and leukemia/lymphoma groups,Concordance or differences in the frequency distribution between the 2 groups were tested by Student t test.or rank test,and varivance analysis.Result1. In the group treated with Smecta-iodine glycerin mixed liquor, Number of patients with the markedly effective result, effective result and ineffective result was 54,7 and 2 respectively while in the control group the number was 4,32 and 31 respectively. Therapeutic efficacy of the two groups was 96.8% and 57.3% respectively. (H value=83.92, P value<0.001).There exists statistically significant difference in therapeutic efficacy between the Smecta-iodine glycerin mixed liquor group and the control group(P<0.0001).2. In the group treated with Smecta-iodine glycerin mixed liquor,the mean of OM duration was 4.68 days±0.96 while in the control group the mean of OM duration was 8.76 days±1.80 (t=15.89, P<0.001).The experimental group shortens the OM duration for 4.08 days±0.25 in the OM healing process. There exists statistically significant difference in the mean of OM duration between the Smecta-iodine glycerin mixed liquor group and the control group (P<0.0001).3. The OAG scores of the two group:at the first day,the OAG scores difference between the two group was 0.19±0.99 (P value=0.188),and there does not exist significant difference, that means the OAG score of the first enrolled day does not have statistical difference, and the difference of the second,third, fourth,fifth day between the two group was 1.32±0.18,2.14±0.20,2.42±0.212,15±0.18 respectively, all the P value<0.001. There exists statistically significant difference in OAG scores from second day to fifth day between the Smecta-iodine glycerin mixed liquor group and the control group(P<0.001). Conclusion1. Chemotherapy induced OM is mainly related to chemotherapy regimes, kinds of cancer, age, neutrophil count and preventive mesurements of mouth care.We should make a comprehensive assessment of OM before we take preventive mesurements.2. We can find out the risk factors of OM at early phase by using OAG scores. Carrying out the preventive mesurements of mouth care at early phase can reduce the occurrence rate of OM.3. Smering the smecta-iodine glycerin mixed liquor in the focal location fo OM can improve therapeutic efficacy of OM. It can shorten the OM duration day, alleviate the severity of chemotherapy-induced OM and reduce the risk of oral infection.It can also improve patients' quality of life and shorten the period fo hospital stay. |
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