BAY 38-4766治疗巨细胞病毒性视网膜炎的疗效评价

Evaluation of clinical efficacy of BAY 38-4766 for cytomegalovirus rentinitis

背景目前对巨细胞病毒（CMV）性视网膜炎药物治疗的研究主要聚焦于它作为获得性免疫缺陷综合征（AIDS）患者的主要眼部并发症，对于其眼部病变治疗药物的筛选尚未得到较多的关注。目的探讨AIDS眼部并发症CMV性视网膜炎首次采用BAY 38-4766药物治疗的效果。方法纳入CMV性视网膜炎患者84例154眼，在诊断为CMV性视网膜炎之前AIDS病程为4—26个月。患者就诊时154眼视力为数指／眼前～0．4，CD4^＋T细胞计数为0～30个／μl，平均为（15±9）个／μl。62例117眼患者行BAY 38-4766药物治疗，静脉诱导量为5mg／kg，每日2次，连续2周，然后给予1g维持量口服，每日3次，随访2周-18个月，观察治疗后眼底症状、视力、CD4^＋T细胞计数变化及预后。本研究经解放军第四七四医院伦理委员会批准，所有患者均签署知情同意书。结果患者存活时间为3～18个月。经过BAY 38-4766治疗者62例117眼，其中53例102眼眼底视网膜坏死灶逐渐缩小，边界清晰，视力提高至0．1—0．7。57例患者CD4^＋T细胞计数较治疗前升高了12～402个／μl，未治疗的22例患者为0—30个／μl。病变进行性恶化并在随访期内死亡。结论CMV性视网膜炎是AIDS患者的主要眼部并发症，临床上以坏死性视网膜炎伴出血及血管炎为特征，采用BAY38-4766药物治疗是目前较有效的方法。

Background At present, researches about retinitis and acquired immunodefieiency syndrome （AIDS） mainly focus on observation and analysis of the cytomegaloviius （ CMV）-induced ocular complication. To screen the effective drugs is very important for the treatment of AIDS-related CMV-indueed retinitis. Objective This study was to describe the clinical features,diagnosis and treatment outcome of CMV-indueed retinitis with BAY 38-4766 and evaluate the relationship between CMV retinitis and AIDS. Methods This was a case observational study. A total of 154 eyes of 84 patients with CMV retinitis and AIDS were enrolled in this study. Before the definitive diagnosis of CMV retinitis,the AIDS course of these patients were 4-26 months. In the initial examination,the visual acuity ranged from finger counting to 0.4, and the number of CD4^＋ T-lymphocyte was 0-30 eells/μl. The survival time in the patients ranged from 3 weeks to 18 months. BAY 38-4766 was used in 117 eyes of 62 patients,and 102 eyes of 53 patients showed the srinked of retinal lesion and improvement of vision （0. 1-0. 7）. BAY 38-4766 was used to treat the CMV retinitis in 117 eyes of 62 patients with the initial intravenous close of 5 mg/kg, twice per day for consecutive 2 weeks and followed by oral close 1 gram per day. The follow-up duration was 2 weeks to 18 months. The fundus feature,visual acuity and CD4^＋ T-lymphocyte counts were analyzed. This study proposal was approved by Ethic Committee of the 474th Hospital of PLA, and written informed consent was obtained from each patient prior to entering this study. Results The numbers of CD4^＋T-iymphoeytes increased to 12-402 cells/μl after administration of BAY 38-4766. The CMV retinitis aggravated and the vision decreased in the untreated 22 patients with the CD4^＋T-lymphocytes 0-30 cells/μl. Conclusions CMV retinitis is the most common intraocular complication in patients with AIDS.Diagnosis of CMV retinitis is based on the characteristics of necrotizing retinitis,which is typically associated with retinal hemorrhage and vasculitis. BAY 35-4766 is an effective drug for the treatment of CMV retinitis.