IMMUNE-MODULATING EFFECT OF LUGUSTRIN-RESULTS OF A DOUBLE-BLIND CLINICAL PHASE II TRIAL

The immune-modulating effect of one of the active componentsfrom ligustrum lucidum, Ligustrin (oleanolic acid) was tetsted prospe-ctively during November 1988-May 1989 through a multi-center collabora-tive study group. The patients were randomized into three groups. Thepatients in group Ⅰ and group Ⅲ (103 cases) received ligustrin tablets 40mg three times every day for 1-2 months ; while patientes in group Ⅱ(49as es) received placebo also for 1-2 months. The data revealed that the pe-rcentage of phagocytosis of macrophages was 37 .6 ±16. 2 before and 49 .0±19.0 after treatment (p=0.0072) in groups Ⅰ Ⅲ; and those weref 39.7±15 .7 and 40. 2± 18.0 (p=0 .9072) respectively in group Ⅱ. The percentageof E-Rosette formation test Showed: 42 .8 ±12 .7 before and 48. 2 ±11 .7 afterin treated groups (p=0 .0072 ) and 45.5±9.3 and 46.8±8.4 (p=0.5653 )respectively in the control group. Delayed hypersensetivity as determinedby OT. test: 55.9% of patients in the treated groups was augmented, and38.2% no change; while 24 .4% augmented and 55 .6% no change in thecontrol group. The general condition of patients was also improved in themajority of patients in the ligustrin groups, while the side-effects ofligustrin were mild. So, ligustrin in considered as a clinical useful BRM.