岗藿抗感汤联合达菲治疗病毒性肺炎的临床疗效观察  

Clinical Observation of Gang Huo Kanggan Decoction Combined with Oseltamivir Phosphate for Treatment of Viral Pneumonia

作　　者：吕肖肖 刘小虹[2] 刘建博[3] 李耿[4] 

机构地区：[1]广州中医药大学第一临床医学院,广东广州510405 [2]广州中医药大学,广东广州510006 [3]广州中医药大学第一附属医院,广东广州510405 [4]广州中医药大学中药学院,广东广州510006

出　　处：《广州中医药大学学报》2017年第1期16-21,共6页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省自然科学基金资助项目(编号:201230006598);广东省科技攻关项目(编号:2013B020224005)

摘　　要：【目的】探讨岗藿抗感汤治疗病毒性肺炎的有效性和安全性,为岗藿抗感汤Ⅲ期临床试验给药剂量和疗程提供依据。【方法】采用单一中心、随机、单盲、平行对照设计,按照随机数字表法将符合条件的30例病毒性肺炎(非重症)患者随机分为治疗组17例和对照组13例。2组均给予补液、营养支持、西药退热及必要时化痰等对症治疗,治疗组在对症治疗基础上,给予岗藿抗感汤(由银翘散加岗梅根、藿香、羌活等组成)联合奥司他韦(达菲)治疗,对照组在对症治疗基础上单用奥司他韦治疗。2组均服药5 d。观察2组在退热时间、肺炎吸收情况、中医证候积分改善情况等方面的差异,检测2组血中炎症因子白细胞介素-2(IL-2)、白细胞介素-4(IL-4)、白细胞介素-6(IL-6)、白细胞介素-10(IL-10)、肿瘤坏死因子-α(TNF-α)、干扰素-γ(IFN-γ)等指标的变化情况,评价其临床证候疗效和药物的安全性。【结果】(1)治疗组的退热时间低于对照组,差异有统计学意义(P<0.05)。(2)治疗后,2组的中医证候积分均较治疗前显著下降(P<0.01),但治疗后组间比较,差异无统计学意义(P>0.05)。(3)治疗后,2组肺炎吸收情况评分比较,差异无统计学意义(P>0.05)。(4)治疗后,治疗组IL-6、TNF-α水平较治疗前有所下降(P<0.01),IL-10、IFN-γ水平较治疗前有所上升(P<0.01);而对照组治疗后仅IL-10、IFN-γ水平较治疗前有所上升(P<0.05)。组间比较,治疗组在改善IL-10、IFN-γ水平方面优于对照组(P<0.05或P<0.01)。(5)治疗后,治疗组和对照组的总有效率均为100.00%,2组临床证候疗效比较,差异无统计学意义(P>0.05)。(6)治疗期间,治疗组出现1例不良事件,该患者服药后出现腹泻、溏便,经对症治疗后好转。该患者的其余相关安全性指标,包括三大常规(血、尿、大便常规)、心电图、肝肾功能等在治疗后均未发现明显异常。【结论】岗藿抗感汤联合奥司Objective To investigate the effectiveness and safety of Gang Huo Kanggan Decoction（GHKD）combined with Oseltamivir Phosphate for viral pneumonia, thus to supply evidence for the medication dosage and treatment course for clinical trial Ⅲ of GHKD. Methods Single-center,randomized,single-blinded,and parallel-controlled design was adopted. By using random number table,30 non-severe viral pneumonia patients were randomized into treatment group（17 cases）and control group（13 cases）. Both groups were given symptomatic treatment of fluid infusion, nutrient supplement, and subsiding fever with western medicine as well as expectorant agents if necessary. And additionally, the treatment group was given oral use of GHKD mainly composed of Yinqiao San,Radix Ilicis Asprellae,Herba Agastaches,and Rhizoma et Radix Notopterygii combined with Oseltamivir Phosphate,and the control group was given Oseltamivir Phosphate orally. The medication of the two groups lasted for 5 days. The clinical efficiency and safety of the two groups were evaluated with the clinical outcomes of time for subsiding fever, pneumonia absorption and traditional Chinese medical syndrome scores,and laboratory indexes of serum interleukin-2（IL-2）,interleukin-4（IL-4）,interleukin-6（IL-6）,interleukin-10（IL-10）,tumor necrosis factor alpha（TNF-α）and interferon gamma（IFN-γ）. Results（1）The time for subsiding fever in the treatment group was shorter than that of the control group,the difference being significant（P 0.05）.（2）The traditional Chinese medical syndrome scores of both groups were decreased obviously as compared with those before treatment（P 0.01）,but the differences were insignificant between the two groups after treatment（P 0.05）.（3）After treatment,the differences of scores of pneumonia absorption in both groups were insignificant（P 0.05）.（4）After treatment,serum levels of IL-6 and TNF-α of the treatment group were lower（P 0.01）, while IL- 10 and IFN- γ levels of both groups were h

关 键 词：岗藿抗感汤 病毒性肺炎 奥司他韦 岗梅根 藿香 羌活 银翘散 

分 类 号：R259.631[医药卫生—中西医结合]