机构地区:[1]西藏自治区藏医院,拉萨850000
出 处:《西藏科技》2024年第1期58-63,75,共7页Xizang Science And Technology
基 金:国家中医药管理局2022年第九批新型冠状病毒感染肺炎中医药应急专项课题(2022ZYLCYJ09-1);西藏自治区卫生健康委藏医药管理局2023年度局级科研课题(JJKT2023002)。
摘 要:目的观察藏药治疗新型冠状病毒感染核酸转阴率和改善临床症状的初步临床疗效。方法研究分初步观察和进一步确证两个阶段。初步观察阶段总样本量为1000例,按照随机、开放、平行、对照原则,通过随机数字表随机分为4组治疗方案,最终剔除连花清瘟胶囊和金嗓子等联合用药的患者后,共738例患者完成疗效评价;其观察主要指标为核酸阳性指标转阴时间周期,次要指标为核酸CT值的变化和临床症状改善情况。进一步确证阶段,总样本量为631例,按照随机、开放、平行、对照原则,通过随机数字表分为2组治疗方案,最终剔除依从性较差或者临床资料不全的患者后,共603例患者完成疗效评价,其观察主要指标为核酸阳性指标转阴时间周期,次要指标为核酸CT值的变化次要指标为核酸CT值的变化和临床症状改善情况。。结果初步观察阶段的四组治疗方案的核酸转阴时间中位数分别为6天、7天、6天、7天。7天内的核酸转阴率分别为64.32%、67.98%、64.21%、68.11%,组间无统计学意义(P>0.05);四组藏药均能明显改善临床症状,但组间无统计学意义(P>0.05)。进一步确证阶段的2个治疗方案核酸转阴时间中位数均为3天。7天内的核酸转阴率分别为75.84%和82.95%,第二组治疗方案在7天内的累计核酸转阴率显著高于第一组治疗方案(P<0.05)。结论藏药治疗新型冠状病毒感染可以缩短核算转阴时间,减少无症状和轻症患者的转重率,临床疗效显著,不良反应少,值得推广使用。Objective To observe the preliminary clinical efficacy of Tibetan medicine in the treatment of nucleic acid conversion rate and improvement of clinical symptoms of novel coronavirus infection.Methods This study is divided into two phases,namely preliminary observation and further confirmation.The total sample size in the preliminary observation stage was 1,000 cases.According to the principles of randomization,openness,parallelism,and control,the patients were randomly divided into 4 groups of treatment regimens through a random number table,and finally 738 patients completed the efficacy evaluation after a group of patients who took the combination of Lianhua Qingwen Capsule and Golden Throat was exclueded.The main indicators of observation were the time period of negative conversion of nucleic acid positive indicators,and the secondary indicators were the changes in nucleic acid CT values and the improvement of clinical symptoms.In the further confirmation stage,the total sample size was 631 cases,which were divided into two groups of treatment regimens according to the principles of randomization,openness,parallelism,and control.In the end after eliminating the patients with poor compliance or incomplete clinical data,a total of 603 patients completed the efficacy evaluation,with the main indicators of observation that were the time period of the positive nucleic acid index turning negative,and the secondary indicators that were the change in the nucleic acid CT value and the improvement of clinical symptoms.Results The median nucleic acid conversion time of the four groups in the initial observation stage was 6 days,7 days,6 days,and 7 days respectively.The rates of nucleic acid conversion within 7 days were 64.32%,67.98%,64.21%,and 68.11%respectively,with no statistical significance between groups(P>0.05).Tibetan medicine could significantly improve clinical symptoms of the four groups,but there was no statistical significance between the groups(P>0.05).The median time to negative nucleic acid conversion of
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