Liang Min, Hu Linhui, Luo Ning, Lv Hualiang, Chen Zhihua, Mo Jianping, Yang Meiyan, Lin Ying, Chen Chunbo
Department of Respiratory and Critical Care Medicine, Maoming People's Hospital, Maoming, China.
Department of Critical Care Medicine, Maoming People's Hospital, Maoming, China.
Front Pharmacol. 2022 Oct 20;13:1027901. doi: 10.3389/fphar.2022.1027901. eCollection 2022.
The timely alleviation of symptoms is essential for managing community-acquired pneumonia (CAP). Juhongtanke oral solution is a traditional marketed Chinese patent medicine believed to ease CAP symptoms. The currently available evidence is based on a few retrospective studies of patients with various types of pneumonia, whereas robust randomized controlled trials (RCTs) that support this notion are lacking. In this multi-center, prospective RCT, patients were randomly allocated to receive routine treatment alone or a combination of Juhongtanke oral solution (20 mL q8h) for 5 days and maintained for an additional 3-day safety observation period. The primary outcome was Breathlessness, Cough, and Sputum Scale (BCSS) score evaluated on day 5. Secondary outcomes included the evaluation of cough and dyspnea items in the Visual Analogue Scale (VAS) from days 1-5, remission rate in BCSS and VAS during the treatment course, and the length of hospitalization and in-hospital mortality. Of 272 patients assessed for eligibility, 240 were enrolled in the study (n =120 per group). The mean difference in BCSS evaluated on day 5 was a median 1 point [95%CI (1.00, 2.00)], significantly lower in the treatment group compared with the control group ( < 0.001). Similar results were observed in VAS on day 5, with statistics of a median 2 points [95%CI (1.40, 2.50)] in the cough item and a median 1 point [95%CI (0.50, 2.00)] in the dyspnea item, significantly lower in the treatment group compared with the control group (both < 0.001). The treatment group had a favorable outcome in BCSS and VAS remission rate assessments compared with the control group, with 99.50% vs. 89.17% in BCSS ( = 0.01), 98.33% vs. 75% in the cough item of VAS ( < 0.001), and 88.33% vs. 62.50% in the dyspnea item of VAS ( < 0.001), respectively. No notable adverse effects were observed during the study. No differences were observed in the length of hospitalization between groups (with a median of 7 days for both groups, = 0.871). Juhongtanke oral solution may be considered to alleviate the clinical symptoms of CAP.
及时缓解症状对于社区获得性肺炎(CAP)的治疗至关重要。橘红痰咳液是一种已上市的传统中成药,据信可缓解CAP症状。目前可得的证据基于对各类肺炎患者的一些回顾性研究,然而缺乏支持这一观点的有力随机对照试验(RCT)。在这项多中心、前瞻性RCT中,患者被随机分配接受单纯常规治疗或联合橘红痰咳液(20 mL,每8小时一次)治疗5天,并维持3天的安全观察期。主要结局是在第5天评估的呼吸急促、咳嗽和痰液量表(BCSS)评分。次要结局包括在第1至5天视觉模拟量表(VAS)中咳嗽和呼吸困难项目的评估、治疗过程中BCSS和VAS的缓解率,以及住院时间和院内死亡率。在评估合格的272例患者中,240例纳入研究(每组n = 120)。第5天评估的BCSS平均差异中位数为1分[95%CI(1.00,2.00)],治疗组显著低于对照组(<0.001)。在第5天的VAS中也观察到类似结果,咳嗽项目的统计中位数为2分[95%CI(1.40,2.50)],呼吸困难项目的中位数为1分[95%CI(0.50,2.00)],治疗组显著低于对照组(均<0.001)。与对照组相比,治疗组在BCSS和VAS缓解率评估中结果良好,BCSS分别为99.50%对89.17%(P = 0.01),VAS咳嗽项目为98.33%对75%(<0.001),VAS呼吸困难项目为8