State Key Laboratory of Traditional Chinese Medicine Syndrome/The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, PR China; State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, PR China.
State Key Laboratory of Traditional Chinese Medicine Syndrome/The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, PR China; State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, PR China; Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, PR China.
Phytomedicine. 2024 Nov;134:155960. doi: 10.1016/j.phymed.2024.155960. Epub 2024 Aug 23.
Alleviating the sore throat caused by acute pharyngitis is a primary patient concern. However, antibiotics are not commonly recommended drugs, and abuse can lead to serious consequences such as drug resistance. Therefore, seeking alternative treatments is necessary.
To investigate the efficacy and safety of Kegan Liyan (KGLY) oral liquid for patients with acute pharyngitis.
Randomized, double-blinded, placebo-controlled, multi-center study.
Participants from 17 hospitals were randomly assigned 1:1 to receive KGLY oral liquid or placebo for five days. Assessments occurred at baseline, day 3, and day 6. The primary outcome was the recovery rate. Secondary outcomes included sore throat and cough visual analogue scale (VAS), the area under the curve (AUC) of sore throat VAS, time to sore throat relief and recovery, proportion of participants with sore throat relief and recovery, traditional Chinese medicine (TCM) syndrome score, single TCM manifestation score and use of acetaminophen.
Involving 239 participants (120 in KGLY and 119 in placebo group), the study found a significantly higher recovery rate on day 6 in the KGLY group (between-group difference, 27.20 % [15.00 % to 39.40 %], p < 0.001). On day 3 and 6, the KGLY group showed significantly larger reductions in sore throat (-3.02 vs -2.37, p = 0.001; -4.66 vs -3.64, p < 0.001) and cough VAS scores (-1.55 vs -1.05, p = 0.004; -2.28 vs -1.56, p < 0.001) from baseline. KGLY oral liquid lowered the AUC of sore throat VAS score (-2.33 [-4.10 to -0.56], p = 0.011), shortened time to sore throat recovery (hazard ratio, 0.42 [0.30 to 0.59], p < 0.001), increased sore throat recovery rate at day 6 (75.00 % vs 42.86 %, p < 0.001), decreased the TCM syndrome score (-2.03 [-2.69 to -1.37], p < 0.001), and improved individual TCM symptoms compared to placebo. No significant differences between the groups in acetaminophen usage. KGLY oral liquid was safe and tolerated.
KGLY oral liquid may be a beneficial and safe alternative treatment for acute pharyngitis, which can alleviate symptoms such as sore throat, swollen throat, cough, and phlegm production.
缓解急性咽炎引起的咽痛是患者的主要关注点。然而，抗生素并非常用药物，滥用可能导致耐药等严重后果。因此，需要寻求替代治疗方法。
探讨渴感灵口服液治疗急性咽炎的疗效和安全性。
随机、双盲、安慰剂对照、多中心研究。
将来自 17 家医院的参与者以 1:1 的比例随机分配接受渴感灵口服液或安慰剂治疗 5 天。在基线、第 3 天和第 6 天进行评估。主要结局为恢复率。次要结局包括咽痛和咳嗽视觉模拟量表（VAS）评分、咽痛 VAS 曲线下面积（AUC）、咽痛缓解和恢复时间、咽痛缓解和恢复的参与者比例、中医证候评分、单个中医症状评分和对乙酰氨基酚的使用。
共纳入 239 名参与者（渴感灵口服液组 120 名，安慰剂组 119 名），研究发现渴感灵口服液组第 6 天的恢复率显著更高（组间差异 27.20%[15.00%至 39.40%]，p<0.001）。第 3 天和第 6 天，渴感灵口服液组的咽痛（-3.02 对-2.37，p=0.001；-4.66 对-3.64，p<0.001）和咳嗽 VAS 评分（-1.55 对-1.05，p=0.004；-2.28 对-1.56，p<0.001）均显著降低。渴感灵口服液降低了咽痛 VAS 评分的 AUC（-2.33[-4.10 至-0.56]，p=0.011），缩短了咽痛恢复时间（风险比，0.42[0.30 至 0.59]，p<0.001），增加了第 6 天的咽痛恢复率（75.00%对 42.86%，p<0.001），降低了中医证候评分（-2.03[-2.69 至-1.37]，p<0.001），并改善了个别中医症状，与安慰剂相比。两组之间对乙酰氨基酚的使用无显著差异。渴感灵口服液安全且耐受良好。
渴感灵口服液可能是急性咽炎的一种有益且安全的替代治疗方法，可缓解咽痛、咽部肿胀、咳嗽和咳痰等症状。
