The clinical respiratory journal · 2026
Efficacy and Safety of Lianhua Qingke Tablets in Children With Mycoplasma pneumoniae Pneumonia: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wang He, Dou Haiwei, Chen Guangying, Wei Yanmin, Li Hua, Xu Shuqiong, Kang Rongzhen, Liu Shanhong, Zhang Long, Li Nan, Sun Hongli, Wang Chi, Zhao Jie, Yi Jirong, Song Wentao, Li Hongrong, Ma Rong, Shen Kunling, Xin Deli, Qi Wenjie
Аннотация
BACKGROUND: Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children, with increasing macrolide resistance complicating treatment. Traditional Chinese Medicine (TCM) provides unique benefits for pediatric respiratory infections.
PURPOSE: To evaluate the safety and efficacy of Lianhua Qingke (LHQK) tablets as adjunctive therapy in children with M. pneumoniae pneumonia (MPP).
STUDY DESIGN: This prospective, multicenter, randomized, double-blind, placebo-controlled trial adhered to the Declaration of Helsinki and was registered in the Chinese Clinical Trial Registry (ChiCTR2300078209).
METHODS: A total of 160 children aged 4-14 years with mild MPP were randomized 1:1 to receive conventional therapy plus LHQK or conventional therapy plus placebo for 7 days across 13 hospitals over 4 months. Efficacy analysis included 128 participants with centrally confirmed MP infection; safety analysis included all 160. Baseline characteristics were comparable (all p > 0.05), with 98.8% medication compliance in both groups (p > 0.05). The primary outcome was the major symptom resolution rate by Day 7.
RESULTS: The LHQK group showed a significantly higher major symptom resolution rate (85.9% vs. 65.6%, p < 0.05), with a numerically shorter median time to resolution (4.5 vs. 5.0 days, p = 0.072). LHQK also significantly improved cough and expectoration relief rates (all p < 0.05). No differences were found in laboratory parameters. Adverse event incidence was lower with LHQK (2.5% vs. 8.8%, p > 0.05), with no serious events reported.
CONCLUSION: LHQK is a safe and effective adjunctive TCM therapy for mild MPP in children, offering significant benefits in respiratory symptom alleviation and a favorable safety profile, with a trend toward shorter recovery time, providing a valuable treatment option amid rising antibiotic resistance.
PURPOSE: To evaluate the safety and efficacy of Lianhua Qingke (LHQK) tablets as adjunctive therapy in children with M. pneumoniae pneumonia (MPP).
STUDY DESIGN: This prospective, multicenter, randomized, double-blind, placebo-controlled trial adhered to the Declaration of Helsinki and was registered in the Chinese Clinical Trial Registry (ChiCTR2300078209).
METHODS: A total of 160 children aged 4-14 years with mild MPP were randomized 1:1 to receive conventional therapy plus LHQK or conventional therapy plus placebo for 7 days across 13 hospitals over 4 months. Efficacy analysis included 128 participants with centrally confirmed MP infection; safety analysis included all 160. Baseline characteristics were comparable (all p > 0.05), with 98.8% medication compliance in both groups (p > 0.05). The primary outcome was the major symptom resolution rate by Day 7.
RESULTS: The LHQK group showed a significantly higher major symptom resolution rate (85.9% vs. 65.6%, p < 0.05), with a numerically shorter median time to resolution (4.5 vs. 5.0 days, p = 0.072). LHQK also significantly improved cough and expectoration relief rates (all p < 0.05). No differences were found in laboratory parameters. Adverse event incidence was lower with LHQK (2.5% vs. 8.8%, p > 0.05), with no serious events reported.
CONCLUSION: LHQK is a safe and effective adjunctive TCM therapy for mild MPP in children, offering significant benefits in respiratory symptom alleviation and a favorable safety profile, with a trend toward shorter recovery time, providing a valuable treatment option amid rising antibiotic resistance.