新冠肺炎疫情爆发以来，为找寻和验证哪些中药对新冠疫情防控有效，钟南山院士团队对四十余种中成药和中药方剂进行筛选，并挑选连花清瘟胶囊进行了治疗新冠肺炎前瞻性、随机对照、多中心临床试验，证实中药对辅助治疗新冠肺炎安全有效。
近日钟南山院士、李兰娟院士、张伯礼院士等合作在著名期刊《Phytomedicine》在线发表题为“Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, inpatients with coronavirus disease : A multicenter, prospective, randomized controlled trial”的文章，公布了连花清瘟胶囊治疗COVID-19的临床试验结果。
按照研究方案,入选患者随机分为治疗组和对照组(常规治疗组),其中治疗组为常规治疗+连花清瘟胶囊每次4粒,每日3次或颗粒每次1袋,每日3次,治疗周期为14天,共收集符合研究方案的284例病例。 结果显示:经过连花清瘟胶囊治疗组治疗14天后,主要临床症状(发热、乏力、咳嗽)治愈率较对照组显著提高,在治疗第7天达57.7%,治疗第10天达80.3%,治疗第14天达到91.5%,发热、乏力、咳嗽单项症状持续的时间也有所缩短。从降低转重型患者的比例方面分析,连花清瘟胶囊治疗组与对照组明显更低(连花清瘟治疗组:2.1%,对照组:4.2%)。 在本临床试验中,连花清瘟胶囊在提高新冠肺炎核酸转阴率和缩短转阴时间方面与对照组(常规治疗组)对比虽然显示出一定的优势,但差异尚未达到统计学意义;研究中未出现与研究药物相关的严重不良事件。
上述系列发现表明,在常规治疗基础上联合应用连花清瘟胶囊口服14天可提高新冠肺炎发热、乏力、咳嗽等临床症状的改善率,改善肺部影像学病变,缩短症状的持续时间,提高临床治愈率。
广州呼吸健康研究院称,此次研究证实以连花清瘟胶囊为代表的中医药对辅助治疗新冠肺炎有效,该研究结果被国际植物医学领域影响因子较高的杂志《Phytomedicine》(《植物医学》)收录发表,也是国际对中国中药防控新冠肺炎的认可和肯定,对中医药国际化具有重要的促进意义。
Abstract
Coronavirus disease (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.To determine the safety and efficacy of LH capsule in patients with Covid-19.We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5%vs. 82.4%,p= 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7vs. 10 days,p 0.001). Time to recovery of fever (2vs. 3 days), fatigue (3vs. 6 days) and coughing (7vs. 10 days) was also significantly shorter in treatment group (allp 0.001). The rate of improvement in chest computed tomographic manifestations (83.8%vs. 64.1%,p 0.001) and clinical cure (78.9%vs. 66.2%,p =0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (bothp 0.05). No serious adverse events were reported.In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
本期来源：BioArt、中国经济网
