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抗纤缓急方治疗特发性肺纤维化急性加重患者多中心随机对照研究OA北大核心CSTPCD

Kangxian Huanji Decoction for Acute Exacerbation of Idiopathic Pulmonary Fibrosis:A Multicenter Randomized Controlled Trial

中文摘要英文摘要

目的 观察抗纤缓急方治疗特发性肺纤维化急性加重(AE-IPF)患者的临床疗效及其对C反应蛋白(CRP)、单核细胞趋化蛋白-1(MCP-1)、转化生长因子-β1(TGF-β1)水平的影响.方法 将80例AE-IPF患者随机分为试验组和对照组,每组40例.在健康教育和西医常规治疗基础上,试验组给予抗纤缓急方,对照组给予抗纤缓急方安慰剂,治疗4周,随访12周.计算治疗失败率并记录住院时间,采用酶联免疫吸附法检测两组治疗前后CRP、MCP-1、TGF-β1水平.结果 试验组3例脱落,对照组4例脱落,采用全分析数据集.与对照组比较,试验组治疗失败率(5.0%vs.22.5%)、平均住院时间[(14.13±5.98)天 vs.(17.43±7.42)天]、治疗后 CRP 及 MCP-1 水平降低(P<0.05,P<0.01).两组不良事件发生率比较,差异无统计学意义(P>0.05).结论 抗纤缓急方可降低AE-IPF患者治疗失败率并缩短住院时间,其机制可能与降低患者CRP、MCP-1水平从而减轻炎症反应有关.

Objective To observe the efficacy of Kangxian Huanji Decoction(KHD)in the treatment of acute exacerbation of idiopathic pulmonary fibrosis(AE-IPF)and its effects on C-reactive protein(CRP),monocyte chemoattractant protein-1(MCP-1),and transforming growth factor(TGF)-β1.Methods Totally 80 AE-IPF patients were randomly assigned to experimental group and control group,40 patients in each group.On the basis of health education and routine treatment with Western medicine,the experimental group was given the KHD,while the control group was given the KHD placebo.The treatment lasted for 4 weeks and the follow-up was 12 weeks.The treatment failure rate was calculated and in hospital time was recorded.The levels of CRP,MCP-1 and TGF-β1 before and after treatment were measured by enzyme-linked immunosorbent assay(ELISA).Results Three cases in experimental group and 4 cases in control group dropped out.The full analysis set was used.Compared with control group,treatment failure rate(5.0%vs.22.5%),in hospital time[(14.13±5.98)d vs.(17.43±7.42)d],and levels of CRP and MCP-1 after treatment decreased in experimental group(P<0.05,P<0.01).There was no significant differences in adverse events between the 2 groups(P>0.05).Conclusion KHD could reduce the rate of treatment failure and shorten the length of in hospital time in AE-IPF patients,the mechanism may be related with relief inflammatory reactions by lowering the levels of CRP and MCP-1.

张海龙;王露;郭雯;张东;赵丽敏;周淼

河南中医药大学第一附属医院呼吸科(郑州 450003)||河南中医药大学,呼吸疾病中医药防治省部共建协同创新中心/河南省中医药防治呼吸病重点实验室(郑州 450003)河南中医药大学第一附属医院呼吸科(郑州 450003)河南省人民医院呼吸与危重症医学科(郑州 463599)河南中医药大学第三附属医院肺病科(郑州 450008)

中药复方;抗纤缓急方;特发性肺纤维化急性加重;临床疗效;C反应蛋白;单核细胞趋化蛋白-1;转化生长因子-β1;随机对照试验

Chinese herbal compound;Kangxian Huanji Decoction;acute exacerbation of idiopathic pulmonary fibrosis;clinical efficacy;C-reactive protein;monocyte chemoattractant protein-1;transforming growth factor-β1;randomized controlled trial

《中国中西医结合杂志》 2024 (002)

163-168 / 6

河南省中医药科学研究专项课题(No.2019ZY2001);河南省高等学校青年骨干教师培养计划(No.2019GGJS107);河南省特色学科中医学学科建设项目(No.STS-ZYX-2019028)

10.7661/j.cjim.20231108.251

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