دورية أكاديمية

Efficacy and safety of Lianhua Qingwen granule in the treatment of non-influenza viral pneumonia: a randomized, double-blind, placebo-controlled, multicenter clinical study.

التفاصيل البيبلوغرافية
العنوان: Efficacy and safety of Lianhua Qingwen granule in the treatment of non-influenza viral pneumonia: a randomized, double-blind, placebo-controlled, multicenter clinical study.
المؤلفون: Ma C; Beijing Ditan Hospital Capital Medical University, Beijing, China., Chen B; Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, China., Li Y; Beijing Hospital of Ministry of Health, Beijing, China., Gu L; Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China., Dong J; Beijing Haidian Hospital, Beijing, China., Xu Z; Beijing Luhe Hospital affiliated to Capital Medical University, Beijing, China., Wei L; Beijing Sixth Hospital, Beijing, China., He Z; The First Hospital of Shijiazhuang, Shijiazhuang, China., Nie X; Xuanwu Hospital, Capital Medical University, Beijing, China., Feng S; Hebei Yiling Hospital, Shijiazhuang, China., Cao B; China-Japan Friendship Hospital, Beijing, China., Sun L; The Third Hospital of Shijiazhuang, Shijiazhuang, China., Yang L; National Key Laboratory for Innovation and Transformation of Luobing Theory, Jinan, China., Li X; Beijing Ditan Hospital Capital Medical University, Beijing, China., Jiang R; Beijing Ditan Hospital Capital Medical University, Beijing, China.
المصدر: Frontiers in medicine [Front Med (Lausanne)] 2024 Jan 17; Vol. 10, pp. 1302219. Date of Electronic Publication: 2024 Jan 17 (Print Publication: 2023).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Frontiers Media S.A Country of Publication: Switzerland NLM ID: 101648047 Publication Model: eCollection Cited Medium: Print ISSN: 2296-858X (Print) Linking ISSN: 2296858X NLM ISO Abbreviation: Front Med (Lausanne) Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Lausanne, Switzerland : Frontiers Media S.A., [2014]-
مستخلص: Objective: To observe the effectiveness and safety of Lianhua Qingwen granule in the treatment of non-influenza viral pneumonia.
Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial. Subjects who met the inclusion and exclusion criteria and were clinically diagnosed with viral pneumonia (negative for influenza virus) were randomly divided into the Lianhua Qingwen granule trial group and placebo control group. Patients in the trial group was given Lianhua Qingwen granule, 2 bags at a time, 3 times a day, and the controls were given placebo, with a treatment course of 7 days. Patients' clinical symptoms and signs, and treatment-associated adverse events were observed. Subjects should be included in the full analysis set (FAS) as long as they were all given the medication and had an effectiveness test performed after randomization. Subjects should be included in the Per Protocol Set (PPS),a subset of the total analysis set, which should contain those with strong compliance, no protocol violations, and complete baseline values for the primary indicators.
Results: A total of 169 subjects were enrolled in 12 subcenters, including 151 (76 in the trial group and 75 in the control group) in the FAS and 140 (68 in the trial group and 72 in the control group) in the PPS. After 7 days of treatment, the clinical symptom relief rates were 82.98% (FAS) and 87.12% (PPS) in the trial group, and 75.11% (FAS) and 76.02% (PPS) in the control group, respectively. The clinical symptom relief rates in the trial group were significantly higher than those in the control group ( p  < 0.001). Significant improvements in single symptoms of cough and expectoration in the trial group were observed compared with the control group ( p  < 0.05). There were no statistical differences in fever, sputum color change, chest pain, muscle pain, dyspnea, chills, and thirst between the two groups ( p > 0.05).
Safety: There were no significant differences in body weight, vital signs, blood routine, urine routine, stool routine, and blood biochemical indicators (CK, AST, ALT, Cr, and Bun) between the two groups before and after treatment ( p > 0.05). During treatment, there were no significant differences in the incidence of adverse events and serious adverse events between the two groups ( p > 0.05).
Conclusion: Lianhua Qingwen granules improved the clinical symptoms of patients with non-influenza virus pneumonia, especially ameliorating cough and expectoration. Lianhua Qingwen granules were associated with good safety.
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2024 Ma, Chen, Li, Gu, Dong, Xu, Wei, He, Nie, Feng, Cao, Sun, Yang, Li and Jiang.)
References: JAMA Netw Open. 2018 Jun 1;1(2):e180243. (PMID: 30646067)
Clin Chest Med. 2017 Mar;38(1):1-9. (PMID: 28159152)
BMC Pulm Med. 2014 Jul 29;14:123. (PMID: 25073709)
Zhongguo Zhong Yao Za Zhi. 2022 Aug;47(15):4238-4247. (PMID: 36046914)
Pediatr Clin North Am. 2022 Feb;69(1):141-152. (PMID: 34794671)
EClinicalMedicine. 2023 Mar;57:101848. (PMID: 36776504)
Front Med. 2021 Feb;15(1):139-143. (PMID: 32535730)
Arch Bronconeumol. 2015 Nov;51(11):590-7. (PMID: 25957460)
BMC Infect Dis. 2015 Feb 22;15:89. (PMID: 25812108)
Zhongguo Zhong Yao Za Zhi. 2021 Apr;46(7):1706-1710. (PMID: 33982473)
J Investig Med. 2018 Aug;66(6):957-965. (PMID: 29680828)
Altern Ther Health Med. 2014 Mar-Apr;20(2):25-30. (PMID: 24657957)
Eur Respir J. 2019 Aug 1;54(2):. (PMID: 31164430)
فهرسة مساهمة: Keywords: Chinese medicine treatment; Lianhua clear blast particles; RCT – randomized controlled trial; clinical trials; non-influenza virus pneumonia
تواريخ الأحداث: Date Created: 20240205 Latest Revision: 20240206
رمز التحديث: 20240206
مُعرف محوري في PubMed: PMC10835788
DOI: 10.3389/fmed.2023.1302219
PMID: 38314028
قاعدة البيانات: MEDLINE
الوصف
تدمد:2296-858X
DOI:10.3389/fmed.2023.1302219