复方竹叶石膏颗粒防治放射性食管炎的临床研究

发布时间：2018-03-23 06:04

本文选题：放射性食管炎　切入点：复方竹叶石膏颗粒　出处：《中国人民解放军医学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的以康复新液为阳性对照药,观察和评价复方竹叶石膏颗粒防治放射性食管炎的临床疗效及安全性。方法本研究采取随机区组、对照、开放的前瞻性试验设计,拟纳入120例肺癌、食管癌患者,按随机数字表分为两组,所有患者均使用6-MVX线照射,2Gy/次,5次/周,共40-70Gy。治疗组与对照组自放疗开始日分别口服复方竹叶石膏颗粒(1袋/次)与康复新液(10ml/次),3/日,在放疗完成后停药,随访2周。比较放疗期间两组患者放射性食管炎的发生级别及其发生率、发生时间、持续时间;纪录患者放疗前后吞咽困难、口干咽干、恶心呕吐、胸背灼痛、乏力等症状积分、体重及KPS评分,1次/周;检测两组患者放疗前后血常规指标(RBC、WBC、HB、PLT)及肝肾功能指标(ALT、SCr、BUN),1次/2周,比较其放疗前后改变。结果两组患者在性别、年龄、病种、病理类型、肿瘤分期、是否化疗、照射剂量、食管受照面积方面比较无差异(P0.05)。复方竹叶石膏颗粒组放射性食管炎发生率为0级(46.6%)、1级(39.7%)、2级(13.8%),3、4级未发生,康复新液组0级(24.5%)、1级(35.1%)、2级(31.5%)、3级(8.7%),4级未发生,两组比较有统计学差异(P0.01)。复方竹叶石膏颗粒组食管炎发生于放疗后第(24.63±1.85)天较对照组(18.10±1.03)天明显推迟(P0.05),持续(15.89±2.32)天较康复新液组(26.48±1.41)天缩短(P0.05)。两组间症状积分比较,复方竹叶石膏颗粒组对吞咽困难、口干咽干、恶心呕吐的缓解较康复新液组更明显(P0.05),而两组对胸背灼痛、乏力的缓解作用无差异(P0.05)。复方竹叶石膏颗粒在维持体重方面效果优于康复新液(P0.05)。复方竹叶石膏颗粒组中RBC、HB、WBC的降低幅度小于对照组(P0.05), PLT改变及肝肾功能比较无统计学意义(P0.05),试验过程中两组均未发生严重不良事件。结论复方竹叶石膏颗粒能够有效降低2级及以上放射性食管炎发生率、推迟食管炎发生时间,缩短持续时间,有效缓解吞咽困难、口干咽干、恶心呕吐等症状,维持体重,作用优于康复新液,安全性佳,可作为预防性药物在放疗全程服用。
[Abstract]:Objective to observe and evaluate the clinical efficacy and safety of compound bamboo leaf gypsum granules in the prevention and treatment of radiation esophagitis. One hundred and twenty patients with lung cancer and esophageal carcinoma were randomly divided into two groups. All patients were treated with 6-MVX line irradiation for 2 Gy / time for 5 times a week. A total of 40-70 Gy.The treatment group and the control group were given oral compound bamboo leaf gypsum granules (1 bag / time) and Kangfeng Xin liquid (10 ml / time / day) respectively on the beginning day of radiotherapy. The drug was stopped after the completion of radiotherapy. Patients were followed up for 2 weeks. The incidence, incidence, time and duration of radiation esophagitis were compared between the two groups during radiotherapy. Dysphagia, dry throat, nausea and vomiting, chest and back burn were recorded before and after radiotherapy. The scores of symptoms such as fatigue, body weight and KPS score were measured once a week before and after radiotherapy, and the blood routine indexes before and after radiotherapy were measured, and the liver and kidney function indexes were compared before and after radiotherapy, and the changes were compared between the two groups before and after radiotherapy, and the results showed that the patients in the two groups were different in sex, age and disease. There was no difference in pathological type, tumor staging, chemotherapy, dose of radiation, and the area of esophagus irradiation. The incidence of radiation esophagitis in the compound bamboo leaf gypsum granule group was 46.6% and 39.7% respectively, and no significant difference was found in the incidence of radiation esophagitis in the compound bamboo leaf gypsum granule group. Grade 0, grade 0 and grade 1, grade 1, grade 35. 1, grade 2, grade 1, grade 3, grade 3, grade 8. 7 and grade 4 of the Kangangxin liquid group did not occur. There was significant difference between the two groups (P 0.01). The esophagitis in the compound bamboo leaf gypsum granule group was significantly delayed on the first day after radiotherapy (24.63 卤1.85) days compared with that in the control group (18.10 卤1.03) days, and the duration was 15.89 卤2.32 days, which was significantly shorter than that in the new rehabilitation solution group (26.48 卤1.41) days. The symptom score was compared between the two groups. The relief of dysphagia, dry mouth pharynx, nausea and vomiting in the compound bamboo leaf gypsum granule group was more obvious than that in the rehabilitation new solution group (P 0.05), while the pain in the chest and back of the two groups was searing. The effect of compound bamboo leaf gypsum granule on maintaining body weight was better than that of Kangfeng new solution P0.05.The decrease of PLT in compound bamboo leaf gypsum granule group was lower than that in control group (P 0.05). There was no statistical analysis on the changes of PLT and liver and kidney function in the group of compound bamboo leaf gypsum granules. There were no serious adverse events in both groups. Conclusion compound bamboo leaf gypsum granules can effectively reduce the incidence of radiation esophagitis of grade 2 or above. It can effectively relieve dysphagia, dry mouth, nausea and vomiting, maintain body weight, have better safety and can be used as prophylactic drug in the whole course of radiotherapy.
【学位授予单位】：中国人民解放军医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.55

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