發(fā)布時間：2018-03-23 06:04

  本文選題：放射性食管炎　切入點(diǎn)：復(fù)方竹葉石膏顆粒　出處：《中國人民解放軍醫(yī)學(xué)院》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的以康復(fù)新液為陽性對照藥,觀察和評價復(fù)方竹葉石膏顆粒防治放射性食管炎的臨床療效及安全性。方法本研究采取隨機(jī)區(qū)組、對照、開放的前瞻性試驗(yàn)設(shè)計(jì),擬納入120例肺癌、食管癌患者,按隨機(jī)數(shù)字表分為兩組,所有患者均使用6-MVX線照射,2Gy/次,5次/周,共40-70Gy。治療組與對照組自放療開始日分別口服復(fù)方竹葉石膏顆粒(1袋/次)與康復(fù)新液(10ml/次),3/日,在放療完成后停藥,隨訪2周。比較放療期間兩組患者放射性食管炎的發(fā)生級別及其發(fā)生率、發(fā)生時間、持續(xù)時間;紀(jì)錄患者放療前后吞咽困難、口干咽干、惡心嘔吐、胸背灼痛、乏力等癥狀積分、體重及KPS評分,1次/周;檢測兩組患者放療前后血常規(guī)指標(biāo)(RBC、WBC、HB、PLT)及肝腎功能指標(biāo)(ALT、SCr、BUN),1次/2周,比較其放療前后改變。結(jié)果兩組患者在性別、年齡、病種、病理類型、腫瘤分期、是否化療、照射劑量、食管受照面積方面比較無差異(P0.05)。復(fù)方竹葉石膏顆粒組放射性食管炎發(fā)生率為0級(46.6%)、1級(39.7%)、2級(13.8%),3、4級未發(fā)生,康復(fù)新液組0級(24.5%)、1級(35.1%)、2級(31.5%)、3級(8.7%),4級未發(fā)生,兩組比較有統(tǒng)計(jì)學(xué)差異(P0.01)。復(fù)方竹葉石膏顆粒組食管炎發(fā)生于放療后第(24.63±1.85)天較對照組(18.10±1.03)天明顯推遲(P0.05),持續(xù)(15.89±2.32)天較康復(fù)新液組(26.48±1.41)天縮短(P0.05)。兩組間癥狀積分比較,復(fù)方竹葉石膏顆粒組對吞咽困難、口干咽干、惡心嘔吐的緩解較康復(fù)新液組更明顯(P0.05),而兩組對胸背灼痛、乏力的緩解作用無差異(P0.05)。復(fù)方竹葉石膏顆粒在維持體重方面效果優(yōu)于康復(fù)新液(P0.05)。復(fù)方竹葉石膏顆粒組中RBC、HB、WBC的降低幅度小于對照組(P0.05), PLT改變及肝腎功能比較無統(tǒng)計(jì)學(xué)意義(P0.05),試驗(yàn)過程中兩組均未發(fā)生嚴(yán)重不良事件。結(jié)論復(fù)方竹葉石膏顆粒能夠有效降低2級及以上放射性食管炎發(fā)生率、推遲食管炎發(fā)生時間,縮短持續(xù)時間,有效緩解吞咽困難、口干咽干、惡心嘔吐等癥狀,維持體重,作用優(yōu)于康復(fù)新液,安全性佳,可作為預(yù)防性藥物在放療全程服用。
[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 鹵1.85) days compared with that in the control group (18.10 鹵1.03) days, and the duration was 15.89 鹵2.32 days, which was significantly shorter than that in the new rehabilitation solution group (26.48 鹵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.
【學(xué)位授予單位】：中國人民解放軍醫(yī)學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R730.55

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