目的通过一系列单病例随机对照试验,研究清热中药在支气管扩张症稳定期的作用价值与特点。方法同一个体进行3轮次随机双盲对照试验,每1轮包括试验期和对照期2个观察期,每期服药3周,停药1周,顺序随机确定。试验期服用个体化辨证方(以下...目的通过一系列单病例随机对照试验,研究清热中药在支气管扩张症稳定期的作用价值与特点。方法同一个体进行3轮次随机双盲对照试验,每1轮包括试验期和对照期2个观察期,每期服药3周,停药1周,顺序随机确定。试验期服用个体化辨证方(以下简称个体化方),对照期服用个体化方减清热方(个体化方去除清热中药,包括清热解毒药、清热燥湿药及部分清热凉血药与清热泻火药)。主要观察指标为患者自我评价症状的likert量表(7分制),其他指标有24 h痰量等。单病例个体统计采用配对t检验,群体统计采用混合效应模型。结果21例患者中,15例完成了包含3轮随机双盲对照试验的单病例试验(占71.43%)。①各项观察指标均有不同程度的改善。从个体水平看,个体化方和个体化方减清热方的差别均无统计学意义(P>0.05)。从临床上分析,中医辨证痰热偏重的患者更倾向于个体化方,而正虚为主的患者倾向于个体化方减清热方。②21位患者作为一个群体的统计结果,两种方剂的总体症状的likert量表评分分别为(2.08±0.68 VS 1.94±0.69),其差值的均值(mean difference)及其95%可信区间为0.19(0.01,0.37),P=0.040,具有统计学差异,提示个体化方减清热方较优,但不具备临床意义(MCID<0.5)。两种方剂的CAT量表评分亦有统计学差异(P=0.040),但不具备临床意义(MCID<0.5),其他3项指标(呼吸系统症状的likert量表评分、24小时痰量及中医证候评分)均无统计学差异。结论就参加本项研究的支扩患者而言,在支扩稳定期似无必要在全程应用清热中药,可根据每个患者的痰热轻重,间断使用或减量使用清热中药,在改善症状与生活质量同时,可能降低中药费用并减少清热中药的潜在副作用。具有一定的临床上的参考价值。展开更多
OBJECTIVE:To investigate the antipyretic effect of early treatment with Traditional Chinese Medicine(TCM) on coronavirus disease 2019(COVID-19) patients.METHODS:We retrospectively analyzed 369 patients from January 26...OBJECTIVE:To investigate the antipyretic effect of early treatment with Traditional Chinese Medicine(TCM) on coronavirus disease 2019(COVID-19) patients.METHODS:We retrospectively analyzed 369 patients from January 26th,2020 to April 15th,2020,who had been diagnosed with COVID-19.Among 92 eligible cases,45 cases were identified as treatment group Ⅰ(n = 45) and 47 cases were identified as treatment group Ⅱ.Patients in the treatment group Ⅰ were treated with TCM herbal decoction within 5 d after admission.Patients in the treatment group Ⅱ were treated with TCM herbal decoction after the 6th admission day.The onset time of antipyretic effect,the antipyretic time,the time of negative oropharyngeal swab nucleic acid conversion,and the changes of cell count in blood routine test were compared.RESULTS:The treatment group Ⅰ showed shorter average antipyretic duration(4 vs 7 d;P < 0.05),and shorter average time for polymerase chain reaction(PCR) nucleic acid test results to turn negative(7 vs 11 d;P < 0.05) than the treatment group II.For patients(n = 54) with body temperature > 38 ℃,patients in the treatment group I had shorter median onset time of antipyretic effect than those in the treatment group Ⅱ(3 vs 4 d;P < 0.05).The absolute lymphocyte(LYMPH) count and absolute eosinophil(EOS) count on the 3rd day after admission and the neutrophil/lymphocyte ratio on the 6th day after admission of patients in the treatment group I were notably different from those in the treatment group Ⅱ at the same time point(P < 0.05).Based on Spearman’s rank correlation analysis,the change of body temperature on the 3rd day after admission was positively correlated with the increase of EOS count and the increase of EOS count and LYMPH counts on the 6th day after admission(P < 0.01).CONCLUSIONS:Early TCM intervention within 5 d after hospital admission shortened the onset time of antipyretic effect and fever duration of COVID-19 patients,reduced the time required for PCR test results to turn negative.Moreover,early TCM intervention also improved the results of inflammatory markers for COVID-19 patients.LYMPH and EOS counts can be used as indicators of TCM antipyretic effect.展开更多
文摘目的通过一系列单病例随机对照试验,研究清热中药在支气管扩张症稳定期的作用价值与特点。方法同一个体进行3轮次随机双盲对照试验,每1轮包括试验期和对照期2个观察期,每期服药3周,停药1周,顺序随机确定。试验期服用个体化辨证方(以下简称个体化方),对照期服用个体化方减清热方(个体化方去除清热中药,包括清热解毒药、清热燥湿药及部分清热凉血药与清热泻火药)。主要观察指标为患者自我评价症状的likert量表(7分制),其他指标有24 h痰量等。单病例个体统计采用配对t检验,群体统计采用混合效应模型。结果21例患者中,15例完成了包含3轮随机双盲对照试验的单病例试验(占71.43%)。①各项观察指标均有不同程度的改善。从个体水平看,个体化方和个体化方减清热方的差别均无统计学意义(P>0.05)。从临床上分析,中医辨证痰热偏重的患者更倾向于个体化方,而正虚为主的患者倾向于个体化方减清热方。②21位患者作为一个群体的统计结果,两种方剂的总体症状的likert量表评分分别为(2.08±0.68 VS 1.94±0.69),其差值的均值(mean difference)及其95%可信区间为0.19(0.01,0.37),P=0.040,具有统计学差异,提示个体化方减清热方较优,但不具备临床意义(MCID<0.5)。两种方剂的CAT量表评分亦有统计学差异(P=0.040),但不具备临床意义(MCID<0.5),其他3项指标(呼吸系统症状的likert量表评分、24小时痰量及中医证候评分)均无统计学差异。结论就参加本项研究的支扩患者而言,在支扩稳定期似无必要在全程应用清热中药,可根据每个患者的痰热轻重,间断使用或减量使用清热中药,在改善症状与生活质量同时,可能降低中药费用并减少清热中药的潜在副作用。具有一定的临床上的参考价值。
基金Supported by Foundation of Shanghai Science and Technology Committee,Clinical Study on the Treatment of COVID-19 with Traditional Chinese Medicine(No.2041195020002)Shanghai Infectious Disease Prevention and Treatment Ability Cultivation Project of Traditional Chinese Medicine(ZYYB-NLPY-09, ZYYBNLPY-15)+2 种基金Shanghai Key Clinical Specialty(No.shslczdzk05101)Shanghai Key Clinical Laboratory of Traditional Chinese Medicine(No.20dz2272200)Shanghai Health Commission,Shanghai Chinese Medicine Administration Emergency Scientific Research Project,Clinical Study on Prevention and Treatment of New Coronavirus Pneumonia with Integrated Chinese And Western Medicine(2020YJ01)。
文摘OBJECTIVE:To investigate the antipyretic effect of early treatment with Traditional Chinese Medicine(TCM) on coronavirus disease 2019(COVID-19) patients.METHODS:We retrospectively analyzed 369 patients from January 26th,2020 to April 15th,2020,who had been diagnosed with COVID-19.Among 92 eligible cases,45 cases were identified as treatment group Ⅰ(n = 45) and 47 cases were identified as treatment group Ⅱ.Patients in the treatment group Ⅰ were treated with TCM herbal decoction within 5 d after admission.Patients in the treatment group Ⅱ were treated with TCM herbal decoction after the 6th admission day.The onset time of antipyretic effect,the antipyretic time,the time of negative oropharyngeal swab nucleic acid conversion,and the changes of cell count in blood routine test were compared.RESULTS:The treatment group Ⅰ showed shorter average antipyretic duration(4 vs 7 d;P < 0.05),and shorter average time for polymerase chain reaction(PCR) nucleic acid test results to turn negative(7 vs 11 d;P < 0.05) than the treatment group II.For patients(n = 54) with body temperature > 38 ℃,patients in the treatment group I had shorter median onset time of antipyretic effect than those in the treatment group Ⅱ(3 vs 4 d;P < 0.05).The absolute lymphocyte(LYMPH) count and absolute eosinophil(EOS) count on the 3rd day after admission and the neutrophil/lymphocyte ratio on the 6th day after admission of patients in the treatment group I were notably different from those in the treatment group Ⅱ at the same time point(P < 0.05).Based on Spearman’s rank correlation analysis,the change of body temperature on the 3rd day after admission was positively correlated with the increase of EOS count and the increase of EOS count and LYMPH counts on the 6th day after admission(P < 0.01).CONCLUSIONS:Early TCM intervention within 5 d after hospital admission shortened the onset time of antipyretic effect and fever duration of COVID-19 patients,reduced the time required for PCR test results to turn negative.Moreover,early TCM intervention also improved the results of inflammatory markers for COVID-19 patients.LYMPH and EOS counts can be used as indicators of TCM antipyretic effect.
