Scaglione F, Cattaneo G, Alessandria M, Cogo R
Department of Pharmacology, University of Milan, Italy.
Drugs Exp Clin Res. 1996;22(2):65-72.
The aim of the study was to determine the properties of a standardized extract of ginseng root in inducing a higher immune response in vaccination against influenza. Attention was also paid to the common cold in this multicentre, two-arm, randomized, placebo-controlled, double-blind investigation. A total of 227 volunteers who visited 3 private practices in Milan received daily oral capsule doses of either placebo (113) or 100 mg of standardized ginseng extract Ginsana G 115 (114) for a period of 12 weeks within which they received an anti-influenza polyvalent vaccination at week 4. As a result, while the frequency of influenza or common cold between weeks 4 and 12 was 42 cases in the placebo group, it was only 15 cases in the G115 group, the difference being statistically highly significant (p < 0.001). Whereas antibody titres by week 8 rose to an average of 171 units in the placebo group, they rose to an average of 272 units in the G115 group (p < 0.0001). Natural killer (NK) activity levels at weeks 8 and 12 were nearly twice as high in the G115 group as compared to the placebo group (p < 0.0001). In all the volunteers, laboratory values of 24 safety parameters showed no significant differences between the end and the beginning of the 12-week study in either of the groups. There were only 9 adverse events in the study, the principal one being insomnia.
该研究的目的是确定人参根标准化提取物在流感疫苗接种中诱导更高免疫反应的特性。在这项多中心、双臂、随机、安慰剂对照、双盲研究中，还关注了普通感冒。共有227名在米兰3家私人诊所就诊的志愿者，在12周内每天口服胶囊剂量的安慰剂（113人）或100毫克标准化人参提取物 Ginsana G 115（114人），并在第4周接受了多价流感疫苗接种。结果，在第4周和第12周之间，安慰剂组流感或普通感冒的发生频率为42例，而G115组仅为15例，差异具有高度统计学意义（p < 0.001）。到第8周时，安慰剂组的抗体滴度平均升至171单位，而G115组则升至272单位（p < 0.0001）。在第8周和第12周时，G115组的自然杀伤（NK）活性水平几乎是安慰剂组的两倍（p < 0.0001）。在所有志愿者中，两组在12周研究结束时与开始时相比，24项安全参数的实验室值均无显著差异。该研究中仅有9例不良事件，主要为失眠。
