Mielke C, Dawda V K, Anand N
Sankt-Gertraude Kraukenhaus Hospital, Berlin, Germany.
Br J Ophthalmol. 2006 Mar;90(3):310-3. doi: 10.1136/bjo.2005.079483.
To study the efficacy and safety of deep sclerectomy (DS) augmented with intraoperative low dose mitomycin C (MMC) in a west African population.
Prospective, randomised, controlled trial. Trial participants were Nigerian patients with medically uncontrolled primary open angle glaucoma undergoing primary surgery at Maja Hospital, Lagos, Nigeria. 39 eyes of 39 patients undergoing DS were randomised into receiving intraoperative MMC 0.25 mg/ml for 2 minutes at the end of procedure (DS-MMC) and a control group (DS-noMMC).
There were 21 patients in the DS-noMMC and 18 in the DS-MMC group with no difference in the preoperative characteristics of the groups. Mean follow up was 16.4 (SD 11.3) months. The probability of maintaining an intraocular pressure less than 18 mm Hg with or without additional medications (95% confidence intervals) at 1 year was 70% (47-92%, 95%) and 79% (57-100%), and at 18 months was 35% (8-62%) and 38% (7-69%) for the DS-noMMC and DS-MMC groups, respectively, with no difference in success rates (p = 0.6). An IOP of less than 18 mm Hg without additional medication was maintained in 65% (41-89%) and 73% (49-96%) at 1 year and 24% (8-48%) and 13% (13-46%) at 18 months for the DS-noMMC and DS-MMC groups, respectively (p = 0.5). There were no serious complications related to the procedure.
The success rates of DS in black west African glaucoma patients, as performed in this study, were low. The study did not achieve sufficient power to detect whether low dose intraoperative MMC application can increase success rates of DS.
研究术中低剂量丝裂霉素C（MMC）辅助深层巩膜切除术（DS）在西非人群中的疗效和安全性。
前瞻性、随机、对照试验。试验参与者为尼日利亚原发性开角型青光眼患者，这些患者在尼日利亚拉各斯的马贾医院接受初级手术，药物治疗无法控制病情。39例接受DS手术的患者的39只眼睛被随机分为两组，一组在手术结束时接受2分钟的术中MMC 0.25 mg/ml治疗（DS-MMC组），另一组为对照组（DS-noMMC组）。
DS-noMMC组有21例患者，DS-MMC组有18例患者，两组术前特征无差异。平均随访时间为16.4（标准差11.3）个月。DS-noMMC组和DS-MMC组在1年时眼压维持在18 mmHg以下（无论是否使用其他药物，95%置信区间）的概率分别为70%（47-92%，95%）和79%（57-100%），在18个月时分别为35%（8-62%）和38%（7-69%），成功率无差异（p = 0.6）。DS-noMMC组和DS-MMC组在1年时眼压在未使用其他药物的情况下维持在18 mmHg以下的比例分别为65%（41-89%）和73%（49-96%），在18个月时分别为24%（8-48%）和13%（13-46%）（p = 0.5）。未出现与手术相关的严重并发症。
本研究中，西非黑人青光眼患者接受DS手术的成功率较低。该研究没有足够的检验效能来检测术中应用低剂量MMC是否能提高DS手术的成功率。
