龙胆泻肝丸干预防治放射性分泌性中耳炎的临床研究

摘要

Objective To investigate the efficacy of the intervention and treatment for the patients with NPC who received radiotherapy were taked by Chinese medicine LongDan XieGan pill or placebo. Methods Select 120 NPC patients with radiotherapy who meet the standard randomly and divide them into groups to have a comparison and each group with 30 patients. Experimental group: At the beginning of radiotherapy, these patients should have a placebo till doses up to 20Gy/30Gy/50Gy to six months after the end of the radiotherapy, these patients should have drugs to do intervention and prevention. Control group have the placebo till doses up to 70-80Gy. Observe the drug throughout the observation period of RSOM in patients with intervention treatment group, and different period of time related data for statistical analysis, summed up the drugs on radioactive otitis media with effusion in intervention treatment. Results With the radiotherapy going on, the earliest time of the RSOM appearing in every group is when the radiation dose reaches to 30Gy, the most frequent time of the RSOM appearing is that three months after the end of the radiotherapy and six months after the end of the radiotherapy, and the RSOM appearing will not end with the end of the radiotherapy. Conclusion The earliest time of the RSOM appearing in every group is when the radiation dose reaches to 30Gy, the most frequent time of the RSOM appearing is that three months after the end of the radiotherapy and six months after the end of the radiotherapy. If an early intervention is done, the incidence of the RSOM could be reduced, and the life quality of the NPC patients is improved. Longdan Xiegan pill can evidently decrease the incidence of the RSOM of the NPC patients during the whole observation period, and the clinical control rate was higher significantly the control group.%　　目的探讨(中药)龙胆泻肝丸干预防治鼻咽癌(NPC)患者放射治疗并发分泌性中耳炎的临床意义及疗效.方法随机抽取120例NPC放射治疗患者，分实验组、对照组各30例，实验组从放疗开始时服用安慰剂.当各组放疗剂量达到20Gy、30Gy和50Gy直到放疗结束后6个月，服用药物龙胆泻肝丸干预治疗.对照组服用安慰剂，放疗总剂量为70-78Gy.动态观察药物在整个观察期内对放射性分泌性中耳炎(RSOM)患者的干预治疗作用，并将各组不同时段的相关数据进行统计分析，总结出药物对放射性分泌性中耳炎的干预治疗效果.结果随着放疗时间的推移，各组出现RSOM的最早时间点为放疗剂量达30Gy时，放疗结束后3个月和放疗结束后6个月是RSOM的高发期，并且RSOM的发生并不随着放疗的结束而终止.结论NPC患者在整个观察期内，出现SOM的最早时间点为放疗剂量达30Gy时，而最明显的时间点为放疗结束后3个月和6个月时.如能尽早进行干预，可降低SOM的发病率，改善NPC患者放疗中及放疗后的听力损害，提高其生活质量.龙胆泻肝丸能明显降低NPC患者在整个观察期内RSOM的发病率，其对RSOM的临床控制率明显优于对照组率.