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紫锥菊流浸膏对感冒和呼吸道感染发病率及严重程度影响的随机对照试验。

A randomized controlled trial of the effect of fluid extract of Echinacea purpurea on the incidence and severity of colds and respiratory infections.

作者信息

Grimm W, Müller H H

机构信息

Department of Medicine and Medical Center for Methodology and Health Research, Institute of Medical Biometry and Epidemiology, Philipps-University of Marburg, Germany.

出版信息

Am J Med. 1999 Feb;106(2):138-43. doi: 10.1016/s0002-9343(98)00406-9.

DOI:10.1016/s0002-9343(98)00406-9
PMID:10230741
Abstract

PURPOSE

Fluid extracts of Echinacea purpurea are widely used for the prevention and treatment of colds and respiratory infections, although the clinical efficacy of this agent has not been proven.

PATIENTS AND METHODS

A total of 109 patients with a history of more than 3 colds or respiratory infections in the preceding year were randomly assigned to receive 4 mL fluid extract of Echinacea purpurea or 4 mL placebo-juice twice a day in a double-blind manner. (One patient withdrew his consent before taking the first dose of the allocated medication; thus, only 108 patients were included for analysis.) The incidence and severity of colds and respiratory infections were determined during 8 weeks of follow-up, based on patient reported symptoms together with findings on physical exam. The severity of each infection was graded by the investigators. Relative risks (RR) and 95% confidence intervals (CI) were estimated.

RESULTS

During the 8-week treatment period, 35 (65%) of 54 patients in the Echinacea group and 40 (74%) of 54 patients in the placebo group had at least one cold or respiratory infection [RR = 0.88; 95% CI (0.60, 1.22)]. The average number of colds and respiratory infections per patient was 0.78 in the Echinacea group, and 0.93 in the placebo group [difference = 0.15; 95% CI (-0.12, 0.41), P = 0.33]. Median duration of colds and respiratory infections was 4.5 days in the Echinacea group and 6.5 days in the placebo group (95% CI: -1, +3 days; P = 0.45). There were no significant differences between treatment groups in the number of infections in each category of severity. Side effects were observed in 11 patients (20%) of the Echinacea group and in seven patients (13%) of the placebo group (P = 0.44).

CONCLUSION

Treatment with fluid extract of Echinacea purpurea did not significantly decrease the incidence, duration or severity of colds and respiratory infections compared to placebo.

摘要

目的

紫锥菊的流浸膏被广泛用于预防和治疗感冒及呼吸道感染,尽管该药物的临床疗效尚未得到证实。

患者与方法

共有109例在前一年患感冒或呼吸道感染超过3次的患者被随机分配,以双盲方式接受每日两次、每次4 mL紫锥菊流浸膏或4 mL安慰剂果汁。(一名患者在服用分配的药物首剂前撤回同意书;因此,仅108例患者纳入分析。)根据患者报告的症状及体格检查结果,在8周的随访期间确定感冒和呼吸道感染的发生率及严重程度。每位研究者对每种感染的严重程度进行分级。估计相对风险(RR)和95%置信区间(CI)。

结果

在8周的治疗期内,紫锥菊组54例患者中有35例(65%)、安慰剂组54例患者中有40例(74%)至少发生一次感冒或呼吸道感染[RR = 0.88;95% CI(0.60,1.22)]。紫锥菊组每位患者感冒和呼吸道感染的平均次数为0.78次,安慰剂组为0.93次[差值 = 0.15;95% CI(-0.12,0.41),P = 0.33]。紫锥菊组感冒和呼吸道感染的中位持续时间为4.5天,安慰剂组为6.5天(95% CI:-1,+3天;P = 0.45)。各严重程度类别中的感染次数在治疗组之间无显著差异。紫锥菊组11例患者(20%)和安慰剂组7例患者(13%)观察到副作用(P = 0.44)。结论:与安慰剂相比,紫锥菊流浸膏治疗并未显著降低感冒和呼吸道感染的发生率、持续时间或严重程度。

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