重连口服液治疗新型冠状病毒感染患者的临床疗效  

Clinical Efficacy of Chonglian Oral Liquid on COVID-19 Patients

作　　者：周童 张西安 田玉丽 慈慧敏 王新汝 朱彩云 李泽庚[2,3] 童佳兵 ZHOU Tong;ZHANG Xi'an;TIAN Yuli;CI Huimin;WANG Xinru;ZHU Caiyun;LI Zegeng;TONG Jiabing(Anhui University of Chinese Medicine,Hefei 230012,China;First Affiliated Hospital,Anhui University of Chinese Medicine,Hefei 230031,China;Key Laboratory of Traditional Chinese Medicine for Prevention and Treatment of Lung Diseases,Key Laboratory of Anhui Provincial Department of Education,Hefei 230031,China;Center for Xin'an Medicine and Modernization of Traditional Chinese Medicine,Institute of Health and Medicine,Hefei Comprehensive National Science Center,Hefei 230012,China)

机构地区：[1]安徽中医药大学,合肥230012 [2]安徽中医药大学第一附属医院,合肥230031 [3]安徽省教育厅重点实验室中医药防治肺系重大疾病重点实验室,合肥230031 [4]合肥综合性国家科学中心大健康研究院新安医学与中医药现代化研究所,合肥230012

出　　处：《中国实验方剂学杂志》2023年第17期142-149,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：安徽省卫生健康科研项目(AHWJ2022a025);安徽省中医药传承创新科研项目(2020ccyb18)。

摘　　要：目的:观察重连口服液对轻型及中型新型冠状病毒肺炎(COVID-19)患者炎症免疫指标及病情转归的影响,综合评价其有效性及安全性。方法:采用随机对照临床研究方法,收取轻型/中型确诊患者120例,对其进行随机分组,最终观察组55例,对照组56例。根据新版诊疗方案,给予对照组西医基础治疗,观察组在西医基础治疗上加服重连口服液,两组均连续治疗10 d,比较观察两组患者中医证候积分、证候疗效、退热时间、核酸转阴时间、炎症免疫指标、影像学疗效改善情况、转归及不良事件发生情况。结果:与本组治疗前比较,两组患者中医证候积分均显著降低(P<0.01),与对照组治疗后比较,观察组患者咳嗽、咽干、咽痛、乏力和肌肉酸痛的改善更为明显(P<0.05)。观察组患者总有效率为100%(55/55),对照组患者总有效率为98.21%(55/56),观察组患者总有效率显著高于对照组(Z=3.707,P<0.01)。与对照组治疗后比较,观察组患者退热及核酸转阴时间明显缩短(P<0.05)。与本组治疗前比较,两组患者淋巴细胞计数(LYM)、淋巴细胞百分比(LYM%)、成熟T淋巴细胞(CD3^(+))、辅助/诱导性T淋巴细胞(CD4^(+))水平显著升高(P<0.01);与对照组治疗后比较,观察组改善更明显(P<0.05)。与本组治疗前比较,两组患者的炎症指标均显著降低(P<0.01);与对照组治疗后比较,观察组超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6)、降钙素原(PCT)水平明显降低(P<0.05)。两组影像学疗效评价及转归差异无统计学意义;治疗期间两组均未发生不良反应事件。结论:重连口服液联合西医治疗可显著改善轻、中型新型冠状病毒感染患者临床症状,缩短退热和核酸转阴时间,调节患者免疫功能,抑制炎症反应,从而提高临床疗效。Objective:To observe the effect of Chonglian oral liquid on inflammatory and immune markers as well as the clinical outcomes of patients with mild-to-moderate corona virus disease 2019(COVID-19)and comprehensively evaluate its efficacy and safety.Method:A clinical randomized controlled trial(RCT)was conducted,involving 120 confirmed cases of mild-to-moderate COVID-19.The patients were randomly divided into two groups,with 55 cases in the observation group and 56 cases in the control group.According to the updated diagnosis and treatment protocol,the control group received standard western medical treatment,while the observation group received Chonglian oral liquid in addition to standard western medical treatment.Both groups were treated continuously for 10 days.The traditional Chinese medicine(TCM)syndrome scores,syndrome efficacy,fever abatement time,nucleic acid negative conversion time,inflammatory and immune markers,improvement in imaging findings,clinical outcomes,and occurrence of adverse events were compared between the two groups.Result:Both groups showed a significant decrease in TCM syndrome scores after treatment(P<0.01).Compared with the control group after treatment,the observation group exhibited a more significant improvement in cough,dry throat,sore throat,fatigue,and muscle pain(P<0.05).The total effective rate in the observation group was 100%(55/55),significantly higher than 98.21%(55/56)in the control group(Z=3.707,P<0.01).The observation group also showed a significantly shorter duration of fever abatement and nucleic acid negative conversion compared with the control group after treatment(P<0.05).Both groups had a significant increase in lymphocyte count(LYM),lymphocyte percentage(LYM%),mature T lymphocytes(CD3^(+)),and helper/inducer T lymphocytes(CD4^(+))after treatment(P<0.01).Compared with the control group after treatment,the observation group showed greater improvement in these markers(P<0.05).In terms of inflammatory markers,both groups had a significant decrease compared with those

关 键 词：重连口服液 新型冠状病毒(SARS-CoV-2) 临床疗效 免疫 炎症 蚤休散 

分 类 号：R2-0[医药卫生—中医学] R22R285.5R2-031R259R563.1