Heyneman C A, Gudger C A, Beckwith J V
Idaho Drug Information Center, College of Pharmacy, Idaho State University, Pocatello 83209, USA.
Ann Pharmacother. 1997 Feb;31(2):242-4. doi: 10.1177/106002809703100218.
The evidence supporting the use of long-term IVIG therapy to induce remissions in SLE is unimpressive. The single extant clinical study used an open-label design with 12 patients, no placebo control, and questionable statistical methodology. The lack of definitive clinical studies, however, is tempered by case reports documenting significant improvement and apparent lack of toxicity in patients with SLE treated with IVIG. Standard first-line therapy of active SLE should consist of nonsteroidal antiinflammatory drugs, followed by low-dose corticosteroids and antimalarial compounds. Second-line therapeutic alternatives are the cytotoxic agents methotrexate, azathioprine, or cyclophosphamide. IVIG's primary advantage over these conventional therapies is that, unlike immunosuppressant and cytotoxic drugs, IVIG has not been reported to increase the risk of opportunistic infections. Additionally, IVIG obviates the ovarian/testicular toxicity, hemorrhagic cystitis, and carcinogenicity caused by cyclophosphamide. However, IVIG therapy is extremely expensive. (Approximate average wholesale price is $1800 per dose for a 70-kg patient). Thus, IVIG treatment consisting of 0.4 g/kg/d for 5 consecutive days on a monthly basis should be reserved for patients with active SLE resistant to the first- and second-line therapies. While IVIG-induced acute renal failure is considered rare, the serious nature of this adverse event warrants close monitoring of blood urea nitrogen and serum creatinine during and several days after treatment. Preexisting renal dysfunction should be considered a relative contradiction. Further double-blind multicenter trials are warranted to determine the long-term safety, efficacy, and cost/benefit ratio of using IVIG in SLE.
支持长期使用静脉注射免疫球蛋白(IVIG)治疗系统性红斑狼疮(SLE)以诱导病情缓解的证据并不令人信服。现有的唯一一项临床研究采用开放标签设计,有12名患者,未设安慰剂对照,统计方法也存在问题。然而,尽管缺乏确定性的临床研究,但有病例报告记录了接受IVIG治疗的SLE患者有显著改善且明显无毒性,这缓和了这种情况。活动性SLE的标准一线治疗应包括非甾体抗炎药,随后是低剂量皮质类固醇和抗疟化合物。二线治疗选择是细胞毒性药物甲氨蝶呤、硫唑嘌呤或环磷酰胺。与这些传统疗法相比,IVIG的主要优势在于,与免疫抑制剂和细胞毒性药物不同,尚未有报告称IVIG会增加机会性感染的风险。此外,IVIG可避免环磷酰胺所致的卵巢/睾丸毒性、出血性膀胱炎和致癌性。然而,IVIG治疗极其昂贵。(对于一名70公斤的患者,每剂的平均批发价约为1800美元)。因此,每月连续5天每天按0.4 g/kg给药的IVIG治疗应仅用于对一线和二线治疗耐药的活动性SLE患者。虽然IVIG引起的急性肾衰竭被认为罕见,但这种不良事件的严重性使得在治疗期间及治疗后数天需密切监测血尿素氮和血清肌酐。既往存在的肾功能不全应被视为相对禁忌证。有必要进一步开展双盲多中心试验,以确定在SLE中使用IVIG的长期安全性、疗效及成本效益比。