| 引用本文:吕丽媛1，吕鹏1，段赟2，杨国旺3，李琦4，吴万垠5，侯丽1.芪胶升白胶囊防治肺癌化疗所致白细胞减少症（气血两虚证）多中心、随机对照临床研究[J].世界中医药,2021,(19):. |
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| 芪胶升白胶囊防治肺癌化疗所致白细胞减少症（气血两虚证）多中心、随机对照临床研究 |
| Multi-centers,Randomized Controlled Clinical Study on Qijiaoshengbai Capsules in Prevention and Treatment of Leukopenia(Qi and Blood Deficiency Syndrome) Caused by Chemotherapy of Lung Cancer |
| 投稿时间：2020-05-20 |
| DOI：10.3969/j.issn.1673-7202.2021.19.019 |
| 中文关键词: 芪胶升白胶囊 肺癌 化疗 白细胞减少症 气血两虚证 随机 对照 临床研究 |
| English Keywords:Qijiaoshengbai Capsules Lung cancer Chemotherapy Leukopenia Qi and blood deficiency syndrome Random Control Clinical Study |
| 基金项目:国家科技重大新药创制专项（2014ZX09301308-007） |
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| 中文摘要: |
| 目的：观察芪胶升白胶囊防治肺癌化疗所致白细胞减少症（气血两虚证）的疗效和安全性。方法：选取2015年12月至2018年1月在北京中医药大学东直门医院、甘肃省肿瘤医院、首都医科大学附属北京中医医院、上海中医药大学曙光医院、广东省中医院就这的肺癌化疗患者171例，应用随机双盲、安慰剂对照、中央随机、多中心竞争入组的方法，将符合诊断标准的患者随机分成观察组和对照组，疗程21 d。以白细胞（WBC）、中性粒细胞计数与分度为主要的疗效指标，以中医证候与症状积分为次要疗效指标，以谷草转氨酶（GOT）、谷丙转氨酶（GPT）、尿素氮（BUN）、血肌酐（CRE）、红细胞（RBC）、血红蛋白（Hb）、血小板（PLT）为安全性指标，治疗结束后统计疗效。结果：观察组患者访视点5WBC检测值与访视点1时比较，差异有统计学意义（P<0.05），表明芪胶升白胶囊、安多霖胶囊均有防治化疗后WBC减少的效果，芪胶升白胶囊具有明显的提升患者外周血WBC下降作用；2组患者访视点2外周血WBC分级比较，差异有统计学意义（P=0.018 2），表明芪胶升白胶囊具有防治化疗导致的外周血WBC分级下降效果。2组患者治疗后中性粒细胞各访视点组内、组间比较，差异无统计学意义（P>0.05），表明芪胶升白胶囊、安多霖胶囊均有防治化疗后中性粒细胞下降效果。2组患者中医证候与症状基线减访视5组内差值比较，差异有统计学意义（P<0.01）；中医证候与症状基线减访视5组间差值比较，证候总积分（P=0.017）、神疲乏力（P=0.012）、面色萎黄（P=0.004）、心悸失眠（P=0.05）等单项症状差异有统计学意义（P<0.05），表明观察组在改善中医证候总分以及神疲乏力、面色萎黄、心悸失眠等单项症状方面观察组优势明显。在临床试验过程中，2组患者未出现严重不良反应或不良事件，也未发现2组患者治疗后RBC、Hb、PLT、GOT、GPT、BUN、CRE等指标异常情况。结论：芪胶升白胶囊、安多霖胶囊均有防治化疗白细胞减少效果，并能够明显临床症状。其中，芪胶升白胶囊具有防治患者外周血WBC分级下降效果，且无不良反应，对外周血、肝肾功能等无明显影响。 |
| English Summary: |
| To observe the efficacy and safety of Qijiaoshengbai Capsules in preventing and treating leukopenia(qi and blood deficiency syndrome) caused by chemotherapy of lung cancer.Methods:A total of 171 lung cancer chemotherapy patients who were treated in Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Gansu Provincial Cancer Hospital,Beijing Chinese Medicine Hospital Affiliated to Capital Medical University,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Guangdong Provincial Hospital of Traditional Chinese Medicine from December 2015 to January 2018 were selected.Methods of randomized double-blind,placebo-controlled,central randomized,multi-center competition enrollment were used to randomize patients who met the diagnostic criteria to treatment and control groups,and they were given the treatment of a double-blind period of 21 days.The main efficacy indicators were white blood cell(WBC) and neutrophil count and indexing.TCM syndromes and symptoms scores were secondary efficacy indicators.Glutamic oxaloacetic transaminase(GOT),glutamate-pyruvate transaminase(GPT),urea nitrogen(BUN),serum creatinine(CRE),red blood cell(RBC),hemoglobin(Hb) and platelets(PLT) were used as safety indicators,the efficacy was counted after treatment.Results:The WBC detection value at visit point 5 of the treatment group was compared with that at visit point 1,and the difference was statistically significant(P<0.05),indicating that Qijiaoshengbai Capsules and Anduolin Capsule both had the effect of preventing and treating WBC reduction after chemotherapy.Qijiaoshengbai Capsules had obvious function of increasing the decrease of WBC in patients' peripheral blood.WBC grading of peripheral blood at visit point 2 of the two groups of patients were compared,the difference was statistically significant(P=0.018 2),indicating that Qijiaoshengbai Capsules had the effect of preventing and treating the decline of peripheral blood WBC grading caused by chemotherapy.After treatment,the neutrophils of the two groups were compared at each visit point within and between the groups,and there was no statistically significant difference(P>0.05),indicating that Qijiaoshengbai Capsules and Anduolin Capsules both had the effect of preventing and treating neutrophil decline after chemotherapy.The baseline of TCM syndromes and symptoms of the two groups minus the difference within the 5 visit groups were compared,and the difference was statistically significant(P<0.01).The baseline of TCM syndromes and symptoms of the two groups minus the difference between the 5 visit groups were compared,differences of the total scores of the TCM syndromes(P=0.017),Shenpi fatigue(P=0.011 7),and pale complexion(P=0.004),palpitations and insomnia(P=0.05) and other single symptoms were statistically significant(P<0.05),indicating that the treatment group had obvious advantages in improving TCM syndrome and Shenpi fatigue,pale complexion and palpitations and insomnia and other single symptoms.During the clinical trials,there were no serious adverse reactions or events in the two groups of patients,and no abnormalities in the RBC,Hb,PLT,GOT,GPT,BUN,CRE and other indicators were found in the two groups after treatment.Conclusion:Qijiaoshengbai Capsules and Anduolin Capsules both have the efficacy of preventing and treating leukopenia after chemotherapy and obviously improving the clinical syndrome.And Qijiaoshengbai Capsules has the effect of preventing and treating patients' peripheral blood WBC grading decline,and has no adverse reactions,and has no obvious effect on peripheral blood,liver and kidney functions,etc. |
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