凉血解毒活血汤预防放射性肺炎的随机对照试验  

Efficacy of Liangxue Jiedu Huoxue Decoction in prevention of radiation pneumonitis:a randomized controlled trial

作　　者：肖春[1] 丁慧娟[1] 冯林春[2] 曲宝林[2] 窦永起[1] 

机构地区：[1]中国人民解放军总医院中医科,北京100853 [2]中国人民解放军总医院放疗科,北京100853

出　　处：《中西医结合学报》2010年第7期624-628,共5页Journal of Chinese Integrative Medicine

基　　金：国家自然科学基金资助项目(No.30371826);军队"十一五"课题基金资助项目(No.06MA251);军队医疗成果二等奖获奖项目(No.2008-2-37)

摘　　要：背景:放射性肺炎是胸部肿瘤放射治疗中最常见的并发症之一,严重影响患者的生存质量,甚至威胁生命。目前尚无有效的中医或西医治疗方案预防放射性肺炎的发生。目的:观察凉血解毒活血汤预防放射性肺炎的临床疗效。设计、场所、对象和干预措施:前瞻性随机对照设计。将解放军总医院放疗科确定需要进行放射治疗的肺癌患者100例,随机分为治疗组和对照组,每组各50例。对照组单纯行放疗,治疗组在进行放疗的同时口服凉血解毒活血汤。治疗过程中治疗组脱落3例,剔除1例;对照组脱落6例,剔除2例。主要结局:比较放射性肺炎发生率,并用美国肿瘤放射治疗协作组(Radiation Therapy Oncology Group,RTOG)急性放射性损伤分级标准、临床影像生理评分系统(clinical-radiographic-physiologic score system,CRP)、身体机能状态量表(Karnofsky Performance Status Scale,KPS)进行评估。结果:放射性肺炎发生率,治疗组为13.04%,对照组为33.33%,两组比较,差异有统计学意义(P<0.05);按RTOG分级标准,治疗组放射性肺炎患者肺损伤程度明显低于对照组(P<0.05);治疗组CRP评分显著低于对照组(P<0.05);治疗组KPS评分显著高于对照组(P<0.05)。结论:凉血解毒活血汤可降低肺癌放疗患者的放射性肺炎发生率,减轻急性放射性肺损害程度,并可减轻患者症状,改善患者生存质量。Background：Radiation pneumonitis is one of the most common complications during radiotherapy of thoracic tumors.It impacts the quality of life of the patients and has life-threatening danger.However,there is a lack of drugs for prevention and treatment of this disease.Objective：To evaluate the efficacy of Liangxue Jiedu Huoxue Decoction,a compound traditional Chinese herbal medicine,in prevention of radiation pneumonitis.Design,setting,participants and interventions：A prospective randomized clinical study was conducted.A total of 100 patients diagnosed with lung cancer from Department of Radiotherapy,Chinese PLA General Hospital,who were planning to receive radiotherapy,were randomly assigned into treatment group and control group,with 50 patients in each group.In the treatment group 3 cases were lost to follow-up and one case was excluded,while in the control group 6 cases were lost to follow-up and 2 cases were excluded.Patients in the treatment group were treated with Liangxue Jiedu Huoxue Decoction in addition to radiotherapy,while patients in the control group were treated with radiotherapy alone.Main outcome measures：The incidence rates of radiation pneumonitis in the two groups were calculated.Acute radiation injury scoring criteria by Radiation Therapy Oncology Group （RTOG）,clinical-radiographic-physiologic （CRP） score system,and Karnofsky Performance Status Scale （KPS） were used to evaluate the status of the patients.Results：The incidence rate of radiation pneumonitis was lower in the treatment group than in the control group （13.04% versus 33.33%,P0.05）.According to the RTOG scale,the extent of lung injury was improved in the treatment group as compared with that in the control group （P0.05）.The CRP score in the treatment group was significantly lower than that in the control group （P0.05）.The KPS score in the treatment group was significantly higher than that in the control group （P0.05）.Conclusion：Liangxue Jiedu Huoxue Decoction can decrease the incidence rate o

关 键 词：放射性肺炎 中药 预防 随机对照试验 

分 类 号：R273[医药卫生—中西医结合]