Parente F, Bianchi Porro G
Department of Gastroenterology, L. Sacco University Hospital, Milan, Italy.
Am J Gastroenterol. 1998 Mar;93(3):317-22. doi: 10.1111/j.1572-0241.1998.00317.x.
Although several uncontrolled studies have shown that the response rate to ganciclovir and foscarnet for all forms of cytomegalovirus (CMV) infection in immunocompromised patients is almost similar, to date, no controlled clinical trial has been specifically designed to compare these two agents in the treatment of CMV esophagitis. The aim of this study was, therefore, to compare the efficacy and safety of these two drugs in the induction therapy of CMV esophagitis in patients with acquired immunodeficiency syndrome (AIDS).
Thirty-nine of 211 (18%) consecutive AIDS patients undergoing endoscopy for esophageal symptoms had macroscopic esophagitis that proved to be sustained by CMV based on the documentation of typical intranuclear inclusions at histology; 23 were considered eligible for this study and were randomized to receive foscarnet 90 mg/kg b.i.d. or ganciclovir 5 mg/kg b.i.d. for 21 days. Twelve patients received foscarnet, whereas 11 were treated with ganciclovir. Clinical and laboratory evaluation was performed weekly, and endoscopy was repeated at the end of therapy. The two treatment groups were well balanced as to the following characteristics at entry: age, sex, absolute number of CD4 cells, duration of AIDS, Karnofsky score, frequency of concomitant Candida esophagitis (grade I or II), and severity of esophageal symptoms.
Marked endoscopic improvement (complete disappearance of macroscopic lesions or significant reduction of the endoscopic score) was observed in eight of 11 (73%) of foscarnet and seven of 10 (70%) of ganciclovir-treated patients, and inclusion bodies disappeared from follow-up biopsies in 55% and 50% of patients, respectively. The symptomatic response was also similar for both treatments: 82% of patients who received foscarnet and 80% of those treated with ganciclovir had a complete or at least a good clinical response. Frequency of adverse events was comparable with both drugs: only one patient in each group suspended treatment because of severe side effects.
Foscarnet and ganciclovir appear to be similarly effective and safe in the induction therapy of AIDS-related CMV esophagitis. Consequently, the choice of the anti-CMV agent should be tailored to the individual patient according to the different toxicity profiles of the two drugs.
尽管多项非对照研究表明，免疫功能低下患者中，更昔洛韦和膦甲酸钠对各种形式的巨细胞病毒（CMV）感染的反应率几乎相似，但迄今为止，尚无专门设计的对照临床试验来比较这两种药物治疗CMV食管炎的效果。因此，本研究的目的是比较这两种药物在获得性免疫缺陷综合征（AIDS）患者CMV食管炎诱导治疗中的疗效和安全性。
211例因食管症状接受内镜检查的连续AIDS患者中，39例（18%）有肉眼可见的食管炎，根据组织学典型核内包涵体的记录，证实由CMV引起；23例被认为符合本研究条件，随机接受膦甲酸钠90mg/kg，每日2次，或更昔洛韦5mg/kg，每日2次，共21天。12例患者接受膦甲酸钠治疗，11例接受更昔洛韦治疗。每周进行临床和实验室评估，治疗结束时重复内镜检查。两个治疗组在入组时的以下特征方面平衡良好：年龄、性别、CD4细胞绝对计数、AIDS病程、卡诺夫斯基评分、合并念珠菌食管炎（I级或II级）的频率以及食管症状的严重程度。
膦甲酸钠治疗的11例患者中有8例（73%）和更昔洛韦治疗的10例患者中有7例（70%）内镜检查有明显改善（肉眼可见病变完全消失或内镜评分显著降低），随访活检中分别有55%和50%的患者包涵体消失。两种治疗的症状反应也相似：接受膦甲酸钠治疗的患者中有82%，接受更昔洛韦治疗的患者中有80%有完全或至少良好的临床反应。两种药物不良事件的发生率相当：每组仅1例患者因严重副作用中止治疗。
膦甲酸钠和更昔洛韦在AIDS相关CMV食管炎的诱导治疗中似乎同样有效和安全。因此，应根据两种药物不同的毒性特征，为个体患者量身选择抗CMV药物。
