[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評價(jià)康柏西普治療黃斑水腫的療效和安全性,為臨床用藥提供參考。方法 計(jì)算機(jī)檢索Cochrane圖書館(The Cochrane Library)、PubMed、中國期刊全文數(shù)據(jù)庫(CNKI)和萬方醫(yī)學(xué)網(wǎng),收集康柏西普與對照組比較對黃斑水腫治療的隨機(jī)對照試驗(yàn)(RCT),提取相關(guān)資料并按照J(rèn)adad評分量表評價(jià)納入研究質(zhì)量,采用RevMan 5.3統(tǒng)計(jì)軟件進(jìn)行Meta-分析。結(jié)果 共納入21項(xiàng)RCTs,合計(jì)1 337例患者。Meta-分析結(jié)果顯示,與對照組比較,康柏西普顯著提高患者隨訪1個(gè)月[MD=0.08,95% CI(0.05,0.12),P<0.001],3個(gè)月[MD=0.09,95% CI(0.06,0.13),P<0.001]和6個(gè)月[MD=0.07,95% CI(-0.02,0.17),P=0.12]最佳矯正視力(BCVA)及治療有效率[RR=2.15,95% CI(1.29,3.57),P=0.003];顯著降低患者隨訪1個(gè)月[MD=-79.71,95% CI(-107.52,-51.91),P<0.001]、3個(gè)月[MD=-61.12,95% CI(-82.42,-39.81),P<0.001]和6個(gè)月[MD=-67.95,95% CI(-201.37,65.46),P=0.32]黃斑中心凹視網(wǎng)膜厚度(CMT);除隨訪6個(gè)月的CMT和BCVA與對照組比較沒有統(tǒng)計(jì)學(xué)差異(P=0.12、0.32),其余指標(biāo)與對照組差異具有顯著的統(tǒng)計(jì)學(xué)意義。剔除治療方案差異(單次玻璃體腔注藥)的一項(xiàng)研究再做Meta-分析后,兩組6個(gè)月CMT和BCVA與對照組比較具有統(tǒng)計(jì)學(xué)差異(P=0.01、0.001)。不良反應(yīng)方面,兩組不具有統(tǒng)計(jì)學(xué)差異。結(jié)論 對于黃斑水腫患者,康柏西普短期內(nèi)(3個(gè)月)比對照組更好的降低黃斑中心凹厚度、改善患者視力、提高治療有效率,療效可靠且耐受性好。
[Key word]
[Abstract]
Objective To evaluate the effectiveness and safety of Conbercept for macular edema (ME) systematically, in order to provide evidence-based reference for clinical use. Methods The pertinent randomized controlled trials (RCTs) about Conbercept trail group and control group in the treatment of ME were retrieved from Cochrane Library, PubMed, CNKI and Wan fang Database. The quality of included studies were evaluated after extracting data and according to modified Jadad scale. Meta-analysis was performed by using RevMan 5.3 statistical software. Results A total of 21 RCTs were included,involving 1337 patients. The results of Meta-analysis showed that best corrected visual acuity (BCVA) at 1 month[MD=0.08, 95%CI (0.05, 0.12), P<0.001], 3 month[MD=0.09, 95%CI (0.06, 0.13), P<0.001] and 6 month[MD=0.07, 95%CI (-0.02, 0.17), P=0.12] and therapeutic efficiency ratio[RR=2.15, 95%CI (1.29, 3.57), P=0.003] were significantly improved; the central macular thickness (CMT) was markedly decreased at 1 month[MD=-79.71, 95%CI(-107.52, -51.91), P<0.001], 3 months[MD=-61.12, 95%CI (-82.42, -39.81), P<0.001] and 6 months[MD=-67.95, 95% CI(-201.37, 65.46), P=0.32] after treatment; and which was statistically different to control group, but BCVA and CMT at 6 months (P=0.12 and P=0.32). when a different study in treatment regimens was eliminated, then, the BCVA and CMT at 6 months was statistically different to control group (P=0.01 and P=0.001). Conclusion Conbercept has good therapeutic efficacy and safety for ME and effectively decrease CMT, improve BCVA and therapeutic efficiency ratio at the end of 3 months.
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