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雷翔,袁利超,王勇,徐志伟,许东风,武蕾,黄燕,梁丹,翟付明,张洪春.感冒灵颗粒治疗普通感冒有效性和安全性的前瞻性真实世界研究[J].湖南中医药大学学报英文版,2022,42(10):1767-1771.[Click to copy
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| 感冒灵颗粒治疗普通感冒有效性和安全性的前瞻性真实世界研究 |
| 雷翔,袁利超,王勇,徐志伟,许东风,武蕾,黄燕,梁丹,翟付明,张洪春 |
| (北京岐黄科技有限公司, 北京 100055;中日友好医院, 北京 100029;华润三九医药股份有限公司, 广东 深圳 518110;河南省人民医院, 河南 郑州 450003;南阳医学高等专科学校第一附属医院, 河南 南阳 473007;河北省中医院, 河北 石家庄 050013;内蒙古自治区中医医院, 内蒙古自治区, 呼和浩特 010021;保定市第一中医院, 河北 保定 071066) |
| 摘要: |
| 目的 评价广泛人群中999感冒灵颗粒治疗普通感冒的有效性和安全性，为临床合理用药提供真实世界证据。方法 本研究采用多中心、前瞻性、大样本、医院集中监测方法，在全国31家医疗机构中开展研究，共入组患者8007例，其中有效性和安全性数据完整的单用其他抗感冒药的患者1007例，设为对照组，通过倾向性评分，在单用感冒灵颗粒的患者中配对1007例，设为试验组；比较两组患者一般信息、用药信息、感冒临床症状信息及不良事件信息。结果 治疗后第2天，试验组发热、鼻塞、咳嗽症状消失率均明显高于对照组（P<0.05）。治疗后第3天，试验组流涕、鼻塞症状消失率均明显高于对照组（P<0.05）。治疗后第2天和第3天，试验组临床症状总评分较基线变化值、总有效率均明显高于对照组（P<0.05）。试验组9例患者发生相关不良事件10例次，发生率0.13%，不良事件特征为嗜睡、头晕、消化不良、恶心、反酸、困乏和眼睛酸痛等。结论 中西药复方制剂999感冒灵颗粒用于普通感冒疗效确切，在流涕、鼻塞、发热和咳嗽等症状改善方面具有临床优势，没有发现新的或严重的不良反应，临床应用值得推广。 |
| 关键词: 普通感冒 感冒灵颗粒 有效性 安全性 真实世界研究 医院集中监测 倾向性匹配法 中西药复方 |
| DOI：10.3969/j.issn.1674-070X.2022.10.029 |
| Received:August 29, 2022 |
| 基金项目:华润三九医药股份有限公司资助课题（2019110050000552）。 |
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| Prospective real-world study of the efficacy and safety of Ganmaoling Granules in treating common cold |
| LEI Xiang,YUAN Lichao,WANG Yong,XU Zhiwei,XU Dongfeng,WU Lei,HUANG Yan,LIANG Dan,ZHAI Fuming,ZHANG Hongchun |
| (Beijing Qi-Huang Technology Co. Ltd., Beijing 100055, China;China-Japan Friendship Hospital, Beijing 100029, China;China Resources Sanjiu Medical & Pharmaceutical Co. Ltd., Shenzhen, Guangdong 518110, China;Henan Provincial People's Hospital, Zhengzhou, Henan 450003, China;The First Hospital of Nanyang Medical College, Nanyang, Henan 473007, China;Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang, Hebei 050013, China;Inner Mongolia Autonomous Regional Hospital of Chinese Medicine, Hohhot Inner Mongolia Autonomous Region, 010021, China;The First Hospital of Chinese Medicine in Baoding, Baoding, Hebei 071066, China) |
| Abstract: |
| Objective To evaluate the efficacy and safety of 999 Ganmaoling Granules in the treatment of common cold in a wide range of population, and to provide real-world evidence for rational clinical drug use. Methods We adopted the multi-center, prospective, large-sample and hospital centralized monitoring method in the study. A total of 8007 patients were included from 31 hospitals. Among them, 1007 patients who took other anti cold drugs with complete efficacy and safety data were set as the control group. Another 1007 patients who only used Ganmaoling Granules were paired as the experimental group by propensity score matching. We compared the general information, medication information, clinical symptom information of cold and adverse event information of two groups. Results On the second day after treatment, the disappearance rate of fever, nasal obstruction and cough symptoms in experimental group was significantly higher than that in control group (P<0.05). On the third day after treatment, the disappearance rate of runny nose and nasal obstruction in experimental group was significantly higher than that in control group (P<0.05). On the second and third days after treatment, the total score of clinical symptoms in experimental group was significantly higher than that in control group (P<0.05). In the experimental group, there were 9 cases and 10 times of related adverse events, with an incidence rate of 0.13%. The adverse events were characterized by somnolence, dizziness, dyspepsia, nausea, acid regurgitation, fatigue and eye soreness. Conclusion The compound preparations of Chinese and western medicine, 999 Ganmaoling Granules, has a definite effect on common cold. It has clinical advantages in improving symptoms such as runny nose, nasal obstruction, fever and cough. No new or serious adverse reactions has been found. The clinical application of 999 Ganmaoling Granules is worth popularizing. |
| Key words: common cold Ganmaoling Granules efficacy safety real-world study hospital-based intensive monitoring propensity score matching compound Chinese-western medicine |
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