1.北京中医药大学,北京市朝阳区北三环东路11号,100029
2.中日友好医院
3.中国中医科学院西苑医院
4.北京中医药大学东直门医院
5.北京中医药大学第三附属医院
6.中国中医科学院广安门医院
7.北京市丰台中西医结合医院
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收稿:2021-06-26,
修回:2021-08-31,
纸质出版:2021-12-17
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李晨浩,李得民,樊茂蓉等.明通治伤风颗粒治疗风寒感冒患者50例多中心随机对照研究[J].中医杂志,2021,62(24):2171-2175.
LI Chenhao,LI Demin,FAN Maorong,et al.Mingtong Zhishangfeng Granules (明通治伤风颗粒) in Treating 50 Cases of Common Cold with Wind-cold Type: A Multicenter Randomize-Controlled Trial[J].Journal of Traditional Chinese Medicine,2021,62(24):2171-2175.
李晨浩,李得民,樊茂蓉等.明通治伤风颗粒治疗风寒感冒患者50例多中心随机对照研究[J].中医杂志,2021,62(24):2171-2175. DOI: 10.13288/j.11-2166/r.2021.24.011.
LI Chenhao,LI Demin,FAN Maorong,et al.Mingtong Zhishangfeng Granules (明通治伤风颗粒) in Treating 50 Cases of Common Cold with Wind-cold Type: A Multicenter Randomize-Controlled Trial[J].Journal of Traditional Chinese Medicine,2021,62(24):2171-2175. DOI: 10.13288/j.11-2166/r.2021.24.011.
目的
2
初步评价明通治伤风颗粒治疗风寒感冒的临床疗效、安全性。
方法
2
将100例风寒感冒受试者按照多中心、区组随机、阳性药物平行对照研究设计原则分为治疗组和对照组各50例。治疗组给予明通治伤风颗粒治疗,每次2 g,每日3次;对照组给予感冒清热颗粒,每次12 g, 每日2次。两组疗程均为72 h。治疗前及治疗2 h、24 h、48 h、72 h进行中医证候评分;分别于治疗2 h、24 h、48 h和72 h评价中医证候疗效及单项中医症状疗效;记录两组发热患者退热起效时间和体温恢复正常时间,并观察两组安全性指标,记录不良反应。
结果
2
治疗24 h、48 h和72 h,两组患者中医证候疗效差异均有统计学意义(
P
<0.05),治疗组优于对照组。两组间单项症状头痛(24 h、48 h)、肢节酸痛(24 h)、鼻塞声重(24 h)、流涕(24 h)疗效差异有统计学意义(
P
<0.05),治疗组优于对照组。两组患者退热起效时间和体温恢复正常时间比较差异无统计学意义(
P
>0.05)。两组患者治疗前后血常规、肝功能、肾功能检查均未见异常,无不良事件发生。
结论
2
明通治伤风颗粒治疗风寒感冒中医证候疗效优于对照组,24 h即可起效,且安全性良好。
Objective
2
To evaluate the clinical effectiveness and safety of
Mingtong Zhishangfeng Granule
(明通治伤风颗粒, MZG) in the treatment of common cold with wind-cold type.
Methods
2
One hundred common cold patients with wind-cold type were randomly divided into treatment group (50 cases) and control group (50 cases) based on a multi-center, block-randomized, positive drug-controlled parallel design. The treatment group was treated with MZG, 2 g each time, three times daily, while the control group was treated with
Ganmao Qingre Granule
(感冒清热颗粒), 12 g each time, twice daily, for 72 h in both groups.The effectiveness on overall TCM syndromes and single symptom before treatment and at 2 h, 24 h, 48 h and 72 h after treatment were assessed; the time to resolution of fever and time to temperature returning to normal were evaluated; the adverse events were recorded for safety assessment.
Results
2
After 24 hours, 48 hours and 72 hours of treatment, the treatment group was superior to control group on effectiveness of TCM syndromes (
P
<0.05). In terms of single symptom, the effectiveness on headache (24 h, 48 h), limb pain (24 h), nasal congestion and deep voice (24 h) and runny nose (24 h) were better in treatment group than those in control group (
P
<0.05). There were no significant differences between groups in the time to resolution of fever and time to temperature returning to normal (
P
>0.05). There were no abnormalities in blood routine, liver function, and renal function examinations of both groups of patients before and after treatment, and no adverse events occurred.
Conclusion
2
MZG can effectively improve the TCM syndrome of common cold patients of wind-cold type and the effect initiate within 24 hours with good safety.
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