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清咳合剂治疗小儿支原体肺炎的临床疗效:一项随机对照试验

Clinical Efficacy of Qingke Mixture in Treating Mycoplasma Pneumonia in Children: A Randomized Controlled Trial.

作者信息

Xie Xiaofei, Wang Wei, Cui ShengTao, Xie Tianlong, Song Yongfu, Wang Na, Wang Zhuang, Wang Yongji

机构信息

Department of Pediatric, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, 130000, People's Republic of China.

Changchun University of Chinese Medicine, Changchun, Jilin, 130117, People's Republic of China.

出版信息

Int J Gen Med. 2025 Sep 3;18:5073-5083. doi: 10.2147/IJGM.S531095. eCollection 2025.

Abstract

BACKGROUND

Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory infection in children, current treatments are limited by resistance and side effects. This study aims to evaluate the clinical efficacy and safety of combining Qingke Mixture with azithromycin for treating MPP in children.

METHODS

This prospective, randomized, double-blind, controlled trial included 92 children diagnosed with MPP. The treatment group received Qingke Mixture and azithromycin, while the control group received azithromycin alone. Outcomes assessed included clinical symptoms, inflammatory markers, immune response, pulmonary function, and adverse events.

RESULTS

The treatment group showed significantly higher clinical efficacy (95.65% vs 80.43%, P < 0.05). The treatment group showed faster resolution of pulmonary symptoms, shorter hospital stays, and greater improvements in pulmonary function and TCM symptom scores (P < 0.05). Inflammatory markers (WBC, CRP, IL-6, IL-8) were significantly lower, while immunoglobulin levels (IgA, IgG, IgM) and T lymphocyte subsets (CD3+, CD4+/CD8+ ratio) were higher in the treatment group compared to the control group (P < 0.05). The incidence of adverse events was low in both groups, with no statistically significant difference.

CONCLUSION

Qingke Mixture combined with azithromycin significantly improves clinical outcomes in children with MPP, enhancing efficacy while maintaining safety.

摘要

背景

支原体肺炎(MPP)是儿童常见的呼吸道感染,目前的治疗受到耐药性和副作用的限制。本研究旨在评估清咳合剂联合阿奇霉素治疗儿童MPP的临床疗效和安全性。

方法

这项前瞻性、随机、双盲、对照试验纳入了92例诊断为MPP的儿童。治疗组接受清咳合剂和阿奇霉素,而对照组仅接受阿奇霉素。评估的结果包括临床症状、炎症标志物、免疫反应、肺功能和不良事件。

结果

治疗组的临床疗效显著更高(95.65%对80.43%,P<0.05)。治疗组肺部症状缓解更快,住院时间更短,肺功能和中医症状评分改善更大(P<0.05)。与对照组相比,治疗组的炎症标志物(白细胞、C反应蛋白、白细胞介素-6、白细胞介素-8)显著更低,而免疫球蛋白水平(免疫球蛋白A、免疫球蛋白G、免疫球蛋白M)和T淋巴细胞亚群(CD3+、CD4+/CD8+比值)更高(P<0.05)。两组不良事件的发生率均较低,无统计学显著差异。

结论

清咳合剂联合阿奇霉素可显著改善儿童MPP的临床结局,提高疗效并保持安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9c9/12415112/50432d4820cf/IJGM-18-5073-g0001.jpg

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