| Part1The effects of Schisandra preparations on tacrolimus blood concentrations andeffects on the protective effect of liver injury in rats.Objective：Investigate the effects of two types of Schisandra preparations，WZcapsules and bicyclol，on the plasma concentrations of immunosuppressant tacrolimusand effects on liver injury in rats.Methods：The55rats were randomly divided into four groups: control group10, theother three groups each of15,that is,FK506administered alone, FK506+WZcapsules co-administered group, FK506+bicyclol combination group. RespectivelyFK5061mg/kg*d; WZ capsules11.25mg/kg*d; bicyclol200mg/kg*d; continuousperfusion21d.And then7,14,21days after administration of the first8hours afterfasting blood test FK506concentration and the liver function.Result: Plasma concentrations of FK506monotherapy group (control group) risesslowly without Schisandra preparations, groups with the capsule and bicyclol showfunction of increasing plasma concentrations of FK506. Plasma concentrationsincreases relatively faster. Compared with the control group, one week afteradministration, the difference appears statistically significant (F=11.043, p=0.002),two(F=98.167, p=0.000) and three weeks (F=57.457, p=0.000) after administrationshow more significant differences, but bicyclol group shows no statistically differencecompared with the WZ capsules group in each time point.Conclusion:⑴The WZ capsules and high-dose of bicyclol can rapidly increaseblood density of tacrolimus;⑵FK506has a certain impairment on rat liver cells,mainly in early period of treatment, but with the going of administration, the liverfunction can restore itself;⑶Schisandra preparations can prevent ALT from elevating,especially bicyclol group shows better effect of liver protection. Part2The effects of schisandra preparations for organ transplant patients on tacrolimusblood concentrations and effects on the protective effect of liver injury.Objective：To investigate the effect of Wu Zhi capsules and bicyclol to the plasmaconcentration of tacrolimus (FK506) and the protective effect of liver damage withorgan transplant patients.Methods：Select43patients who were treated by FK506-based anti-rejection therapyafter the surgery of liver or kidney transplant were enrolled in this study. And26ofthese patients who were received liver transplant,17patients were received kidneytransplant. Divided patients who were received liver transplant into two groupsrandomly.15patients who received both Wu Zhi capsules and FK506were regardedas A-treatment group. And then11patients (as A-control group) only took FK506orally three times per day. At the same time, the kidney transplant patients were alsodivided into two groups randomly. The B-control group received combinationanti-rejection therapy which consisted of FK506, mycophenolate mofetil (MMF) andmetacortandracin. And based on the drugs of B-control group, other7patients (asB-treatment group) added bicyclol (25mg) three times per day. All these patientsroughly had the same therapy. The plasma concentration of FK506and hepatorenalfunction were detected at two time points: before therapy and10days after treatment.Results: In liver transplantation patients, the capsule can improve the blood density ofFK506, compared with pretreatment t=3.95, p=0.001; compared with control group t=2.897, p=0.008, the differences are statistically significant; In renal transplantpatients,additional bicyclol in therapeutic dose range has no significanteffect on blood FK506density, compared with pretreatment t=1.996, p=0.064;compared with control group t=1.88, p=0.081, the differences are not statisticallysignificant. Additional10days ofbicyclol in renal transplant patients with abnormalliver function turn out significantly lowALT, the difference is statistically significant(t=6.62, p=0.000) compared withpretreatment, while the treatment effect ofthe capsule in liver transplant patients is not obvious. Conclusion:⑴The capsule can increase tacrolimus blood density in livertransplantationpatients but shows weak hepatoprotective effect.⑵Therapeuticdose of Bicyclol in renal transplantation shows small effect on the blood densityof tacrolimus, but plays a significant role in liverprotection. So Bicyclol canbe more safely used in organ transplantation patients with nomal or high tacrolimusblood density and abnormal liver function. |
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