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低剂量辛伐他汀在接受环孢素治疗的心脏移植受者中的安全性和有效性。

Safety and efficacy of low dose simvastatin in cardiac transplant recipients treated with cyclosporine.

作者信息

Vanhaecke J, Van Cleemput J, Van Lierde J, Daenen W, De Geest H

机构信息

Department of Cardiology, University Hospital Gasthuisberg, University of Leuven, Belgium.

出版信息

Transplantation. 1994 Jul 15;58(1):42-5.

PMID:8036706
Abstract

Hyperlipidemia is common in heart transplant patients. Lipid-lowering therapy poses special problems, yet may be important because accelerated graft atherosclerosis is the major factor limiting long-term survival. Simvastatin 5 mg/day was started > 6 months after surgery in 26 consecutive cardiac transplant recipients with a total serum cholesterol level of > 250 mg/dl. The dose of simvastatin was increased in 5-mg increments until total serum cholesterol fell below 220 mg/dl or until side effects developed or up to a maximal dose of 20 mg/day. The final average daily dose was 10 mg. Changes in serum lipid levels after 6 months of therapy were compared with data from a matched and concurrent control group of heart transplant patients not taking simvastatin. Immunosuppression for both groups consisted of CsA, AZA, and corticosteroids. In the simvastatin-treated group, the serum level of total cholesterol decreased by 27% from 315 +/- 53 to 230 +/- 38 mg/dl (P < 0.0001), low density lipoprotein cholesterol decreased by 40% from 205 +/- 30 to 123 +/- 32 mg/dl (P < 0.0001), and triglycerides decreased by 21% from 177 +/- 89 to 140 +/- 49 mg/dl (P < 0.01). There was no significant change in high density lipoprotein cholesterol level. Body weight and CsA blood levels remained stable. Steroid intake decreased during the study period to a similar extent in both the treated and the control groups. In the control group, no significant changes in serum lipid levels were observed. Two patients experienced a mild form of myotoxicity. In one other patient simvastatin treatment was stopped after an acute pancreatitis of uncertain etiology developed. Low dose simvastatin effectively lowers total serum cholesterol, low density lipoprotein cholesterol, and triglycerides in heart transplant patients. With due precautions, the safety profile of the drug in this patient population seems reasonable.

摘要

高脂血症在心脏移植患者中很常见。降脂治疗存在特殊问题,但可能很重要,因为加速性移植血管动脉粥样硬化是限制长期生存的主要因素。26例连续心脏移植受者术后6个月以上开始服用辛伐他汀,初始剂量为5mg/天,其总血清胆固醇水平>250mg/dl。辛伐他汀剂量以5mg的增量增加,直至总血清胆固醇降至220mg/dl以下,或出现副作用,或达到最大剂量20mg/天。最终平均每日剂量为10mg。将治疗6个月后的血脂水平变化与同期未服用辛伐他汀的心脏移植患者匹配对照组的数据进行比较。两组的免疫抑制方案均包括环孢素(CsA)、硫唑嘌呤(AZA)和皮质类固醇。在辛伐他汀治疗组中,总胆固醇水平从315±53mg/dl降至230±38mg/dl,下降了27%(P<0.0001);低密度脂蛋白胆固醇从205±30mg/dl降至123±32mg/dl,下降了40%(P<0.0001);甘油三酯从177±89mg/dl降至140±49mg/dl,下降了21%(P<0.01)。高密度脂蛋白胆固醇水平无显著变化。体重和环孢素血药浓度保持稳定。在研究期间,治疗组和对照组的类固醇摄入量均有相似程度的下降。在对照组中,未观察到血脂水平有显著变化。两名患者出现轻度肌毒性。另有一名患者在发生病因不明的急性胰腺炎后停止了辛伐他汀治疗。低剂量辛伐他汀可有效降低心脏移植患者的总血清胆固醇、低密度脂蛋白胆固醇和甘油三酯。采取适当预防措施后,该药在该患者群体中的安全性似乎是合理的。

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Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial.洛伐他汀对未接受高效抗逆转录病毒治疗的HIV-1感染者的抗逆转录病毒作用(LIVE研究):一项II期随机临床试验。
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