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双盲、安慰剂对照随机临床试验:四物汤和验方二味饮对感冒的影响。

Effects of So-cheong-ryong-tang and Yeon-gyo-pae-dok-san on the common cold: randomized, double blind, placebo controlled trial.

机构信息

Department of Internal Medicine, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, South Korea.

出版信息

J Ethnopharmacol. 2011 Jan 27;133(2):642-6. doi: 10.1016/j.jep.2010.10.056. Epub 2010 Oct 30.

DOI:10.1016/j.jep.2010.10.056
PMID:21040773
Abstract

AIM OF THE STUDY

So-cheong-ryong-tang (SCRT) and Yeon-gyo-pae-dok-san (YPS) extracts are widely used in treatment of the common cold. The purpose of this study is to evaluate the efficacy of SCRT and YPS on the common cold.

METHODS

Four hundred eighty participants with symptoms of the common cold within 48 h were recruited for this randomized, double-blind, placebo-controlled trial. SCRT extract and YPS extract were put in gelatin capsules and orally administered 3 times a day. The pattern of participants was determined according to the Questionnaire for Common Cold Pattern Identification (QCCPI), and the severity of illness was assessed by Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) every 7 days.

RESULTS

The test and control groups were not significantly different in gender, age, smoking history, and baseline score of WURSS-21-K at the time of enrollment. SCRT treatment significantly decreased the total WURSS-21-K score on the 6th and 7th day (p<0.05) of the enrollment compared with the placebo group. YPS treatment decreased the total WURSS-21-K score on the 5th and 6th day (p<0.05 vs. the placebo group) of the enrollment. In the patients with Wind-cold pattern cold, SCRT significantly decreased the total WURSS-21-K score from 4th to 8th day (p<0.05), and YPS significantly decreased the total WURSS-21-K score from 4th to 6th day (p<0.05). For the Wind-heat pattern cold, neither SCRT nor YPS group showed significant difference from the placebo group. SCRT and YPS did not significantly decrease the time to complete resolution of the cold symptoms.

CONCLUSIONS

SCRT and YPS have beneficial, albeit limited, effects on common cold patients, especially those with the Wind-cold pattern cold.

摘要

目的

扫红汤(SCRT)和咽痛散(YPS)提取物广泛用于治疗普通感冒。本研究旨在评估 SCRT 和 YPS 对普通感冒的疗效。

方法

本随机、双盲、安慰剂对照试验招募了 480 名在 48 小时内出现普通感冒症状的患者。将 SCRT 提取物和 YPS 提取物装入明胶胶囊中,每日口服 3 次。根据感冒模式识别问卷(QCCPI)确定患者的模式,并用威斯康星州上呼吸道症状调查-21 韩国版(WURSS-21-K)每 7 天评估一次疾病严重程度。

结果

试验组和对照组在性别、年龄、吸烟史和入组时 WURSS-21-K 基线评分方面无显著差异。与安慰剂组相比,SCRT 治疗组在入组后第 6 天和第 7 天的总 WURSS-21-K 评分显著降低(p<0.05)。YPS 治疗组在入组后第 5 天和第 6 天的总 WURSS-21-K 评分显著降低(p<0.05 与安慰剂组相比)。在风寒型感冒患者中,SCRT 可显著降低第 4 天至第 8 天的总 WURSS-21-K 评分(p<0.05),YPS 可显著降低第 4 天至第 6 天的总 WURSS-21-K 评分(p<0.05)。对于风热型感冒,SCRT 和 YPS 组与安慰剂组相比均无显著差异。SCRT 和 YPS 均未显著缩短感冒症状完全缓解的时间。

结论

SCRT 和 YPS 对普通感冒患者,尤其是风寒型感冒患者有一定的有益作用,但作用有限。

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