背景:临床研究证实,清肺大源颗粒(QFDY)可有效治疗由肺热毒综合征(PHTS)引起的流感和上呼吸道感染(URTIs)。中药颗粒剂已成为临床上广泛使用的剂型。随着提取工艺的不断优化,中药颗粒的优势已逐渐显现,但中药颗粒的价格普遍高于中药传统剂型,我们支持对这些患者合理使用适当剂量的QFDY。因此,我们将常规剂量的一半设置为低剂量组,并设计了三臂研究以严格比较低剂量QFDY的疗效差异,QFDY和安慰剂组,以期为临床合理选择剂量和安全有效使用该药提供科学支持。
方法:我们招募了108例临床诊断为由PHTS引起的流感和URTI的患者,在湖北六家医院接受治疗。中国。使用集中式随机化系统,患者以1:1:1的比例随机分配给QFDY,低剂量QFDY,或安慰剂对照组接受相应的药物,和研究医生,主题,结果评估员,统计学家不知道分组。主要结果是完成发烧缓解的时间。次要结果包括中药在缓解体征和症状方面的疗效以及单个症状的消失率。在整个试验期间监测不良事件。
结果:共招募了108名患者。总共106名患者被纳入完整分析集(FAS)。在FAS分析中,3组治疗前基线比较差异无统计学意义(P>0.05)。1.关于完成退烧的中位时间,QFDY,低剂量QFDY和安慰剂组的中位时间为26小时,40小时和48小时,分别。QFDY组比安慰剂组有更短的时间来完成发烧缓解,差异有统计学意义(P<0.05),而低剂量QFDY组比安慰剂组有更短的时间,但差异无统计学意义(P>0.05)。2.以中医在治疗满三天后缓解症状的总疗效来看,以及红肿和喉咙痛的治愈率,鼻塞流鼻涕,打喷嚏,QFDY和低剂量QFDY优于安慰剂,差异有统计学意义(P<0.01)。QFDY组与低剂量QFDY组比拟无统计学意义(P>0.05)。3.就治疗三天后的头痛治愈率而言,QFDY优于安慰剂,差异有统计学意义(P<0.05),低剂量QFDY无明显疗效。4.安全性比较显示无严重不良事件和30次轻微不良事件。临床上认为与药物无关,也没有统计学意义。
结论:在治疗由PHTS引起的流感和URTIs患者时,主要表现为临床症状,如红肿和喉咙痛,鼻塞流鼻涕,打喷嚏,当发烧不明显或出现低烧时,建议和首选使用低剂量QFDY来缓解临床症状.此外,凭借其良好的安全性,QFDY可用于治疗由PHTS引起的流感和URTI患者,能有效缩短发热时间,显着增加中药在治疗3天后缓解症状的总疗效,加速红肿和喉咙痛等症状的恢复,鼻塞流鼻涕,打喷嚏,头痛,等。临床试验注册:http://www。chictr.org.cn.
背景:ChiCTR2100043449。2021年2月18日注册
Clinical studies have confirmed that Qingfei Dayuan (QFDY) granules are effective in the treatment of influenza and upper respiratory tract infections (URTIs) caused by pulmonary heat-toxin syndrome (PHTS). Granules of Chinese medicine formulations have become a widely used dosage form in clinical practice. With the continuous optimization of extraction technology, the advantages of Chinese medicine granules have been gradually demonstrated, but the price of Chinese medicine granules is generally higher than that of traditional dosage forms of Chinese medicine, and we support the rational use of the appropriate dosage of QFDY for patients with these conditions. Therefore, we set up half of the conventional dose as the low dose group, and designed the three-arm study to rigorously compare the efficacy difference of low-dose QFDY, QFDY and the placebo group, with the expectation of providing scientific support for the rational selection of the dose and the safe and effective use of the medicine in clinical practice.
We recruited 108 patients with clinical diagnoses of influenza and URTIs caused by PHTS to receive treatment at six hospitals in Hubei, China. Using a centralized randomization system, patients were randomly assigned at a 1:1:1 ratio to the QFDY, low-dose QFDY, or placebo control groups to receive the corresponding drug, and the study physicians, subjects, outcome assessors, and statisticians were unaware of group assignments. The primary outcome was the time to complete fever relief. Secondary outcomes included the efficacy of Chinese medicine in alleviating signs and symptoms and the disappearance rate of individual symptoms. Adverse events were monitored throughout the trial.
A total of 108 patients were recruited. A total of 106 patients were included in the full analysis set (FAS). In the FAS analysis, there was no statistically significant difference in baseline of the three groups before treatment (P > 0.05). 1. Regarding the median time to complete fever relief, the QFDY, low-dose QFDY and placebo groups had median times of 26 h, 40 h and 48 h, respectively. The QFDY group had a shorter time to complete fever relief than the placebo group, and the difference was statistically significant (P < 0.05), while the low-dose QFDY group had a shorter time than the placebo group, but the difference was not statistically significant (P > 0.05). 2. In terms of the total efficacy of Chinese medicine in alleviating symptoms at the end of three full days of treatment, as well as the cure rate of red and sore throat, stuffy and runny nose, and
sneezing, QFDY and low-dose QFDY were superior to the placebo, and the differences were statistically significant (P < 0.01). There was no statistical significance in the comparison between the QFDY group and the low-dose QFDY group (P > 0.05). 3. In terms of the headache cure rate after three full days of treatment, QFDY was superior to the placebo, with a statistically significant difference (P < 0.05), and there was no significant efficacy of low-dose QFDY. 4. Safety comparisons showed no serious adverse events and 30 minor adverse events, which were not clinically considered to be related to the drug and were not statistically significant.
In the treatment of patients with influenza and URTIs caused by PHTS, which are mainly characterized by clinical symptoms such as red and sore throat, stuffy and runny nose, and
sneezing, when fever is not obvious or low-grade fever is present, the use of low-dose QFDY to simply alleviate the clinical symptoms is recommended and preferred. Moreover, with its good safety profile, QFDY can be used in the treatment of patients with influenza and URTIs caused by PHTS, which can effectively shorten the duration of fever, significantly increase the total efficacy of Chinese medicine in alleviating symptoms after 3 days of treatment, and accelerate the recovery of symptoms such as red and sore throat, stuffy and runny nose,
sneezing, and headache, etc. Clinical Trial Registration: http://www.chictr.org.cn.
ChiCTR2100043449. Registered on 18 February 2021.