Fakhraie Ghasem, Ghadimi Hadi, Eslami Yadollah, Zarei Reza, Mohammadi Massood, Vahedian Zakieh, Mafi Mostafa, Moghimi Sasan
Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
J Glaucoma. 2016 Mar;25(3):e182-8. doi: 10.1097/IJG.0000000000000202.
To investigate the outcome of trabeculectomy with or without adjunctive intracameral bevacizumab.
In this prospective, double-blind, randomized clinical trial, 71 patients with primary open-angle or pseudoexfoliation glaucoma were randomly assigned to receive either 1.25 mg intracameral bevacizumab (n=36) or balanced salt solution as placebo (n=35) at the end of trabeculectomy. Success was defined as at least a 30% drop in intraocular pressure (IOP) compared with baseline values and an IOP between 6 and 21 mm Hg at the last postoperative visit with (qualified) or without (complete) glaucoma medications.
Thirty-two patients in bevacizumab group and 33 in placebo group completed a mean follow-up of 10.7±2.1 and 10.5±2.5 months, respectively (P=0.731). The mean preoperative IOP was 28.25±5.64 and 29.11±4.65 mm Hg in the bevacizumab and placebo groups, respectively (P=0.485). Last visit IOP was 14.5±3.7 mm Hg in the bevacizumab group and 18.55±3.64 mm Hg in the placebo group (P<0.001). At last visit, complete success was achieved in 26 cases (81.3%) of bevacizumab group and 16 cases (48.5%) of placebo group (P<0.006). Filtering bleb leak during the first postoperative month was seen in 11 (34%) and in 3 (9%) cases of bevacizumab and placebo groups, respectively (P=0.013).
A single 1.25 mg dose of intracameral bevacizumab significantly improves the success of trabeculectomy; however, it increases the risk of early filtering bleb leakage.
研究小梁切除术联合或不联合前房内注射贝伐单抗的效果。
在这项前瞻性、双盲、随机临床试验中,71例原发性开角型或假性剥脱性青光眼患者在小梁切除术后随机分为两组,分别接受1.25mg前房内注射贝伐单抗(n = 36)或平衡盐溶液作为安慰剂(n = 35)。成功定义为与基线值相比眼压至少降低30%,且在最后一次术后随访时,使用(合格)或不使用(完全)青光眼药物的情况下眼压在6至21mmHg之间。
贝伐单抗组32例患者和安慰剂组33例患者分别完成了平均10.7±2.1个月和10.5±2.5个月的随访(P = 0.731)。贝伐单抗组和安慰剂组术前平均眼压分别为28.25±5.64mmHg和29.11±4.65mmHg(P = 0.485)。最后一次随访时,贝伐单抗组眼压为14.5±3.7mmHg,安慰剂组为18.55±3.64mmHg(P<0.001)。最后一次随访时,贝伐单抗组26例(81.3%)完全成功,安慰剂组16例(48.5%)完全成功(P<0.006)。术后第一个月,贝伐单抗组11例(34%)和安慰剂组3例(9%)出现滤过泡渗漏(P = 0.013)。
单次1.25mg前房内注射贝伐单抗可显著提高小梁切除术的成功率;然而,它会增加早期滤过泡渗漏的风险。