[关键词]
[摘要]
目的:系统评价口服氯雷他定联合双氯芬酸钠滴眼液对过敏性结膜炎的临床疗效和安全性。
方法:检索Embase、Cochrane library、Pubmed、中国知网数据库、万方数据库、维普中文科技期刊数据库、中国生物医学文献服务系统中口服氯雷他定联合双氯芬酸钠滴眼液治疗过敏性结膜炎的随机对照研究,检索时间为建库至2021-07; 采用Cochrane偏倚风险评估工具对纳入研究进行质量评估,对纳入文献的发表偏倚进行Egger检验,使用RevMan 5.3统计软件对治疗总有效率、不良反应发生率、临床症状评分进行Meta分析; 对异质性较高的结果进行描述性分析。
结果:共纳入符合条件的19篇,全部为中文文献,合计患者1 931例2 044眼,对照组采用口服氯雷他定治疗,试验组在口服氯雷他定基础上联合双氯芬酸钠滴眼液; Meta分析结果表明,试验组的疗效优于对照组(OR=4.43,95%CI:3.26~6.03,P<0.00001); 试验组不良反应发生率低于对照组(OR=0.32, 95%CI:0.2~052,P<0.00001); 试验组中患者眼痒评分(MD= -0.36,95%CI:-0.39~-0.33,P<0.00001)、分泌物评分(MD= -0.24,95%CI:-0.31~-0.18,P<0.00001)均低于对照组; 试验组患者可显著降低结膜充血水肿、结膜乳头或滤泡增生、异物感症状,且差异均有统计学意义(均P<0.05); 对总有效率、不良反应发生率进行Egger检验,结果显示总有效率存在发表偏倚,但通过剪补法分析得知存在的发表偏倚未对结果造成影响。
结论:在口服氯雷他定的基础上,联合双氯芬酸钠滴眼液对于治疗过敏性结膜炎具有一定临床疗效,可改善患者眼痒、异物感、分泌物及结膜充血水肿临床症状,且不良反应发生率较低,可为今后过敏性结膜炎的药物治疗提供一定循证依据,但由于纳入的研究证据强度较低,未来需要更多的多中心、随机双盲临床试验,从而提高证据强度。
[Key word]
[Abstract]
AIM: To evaluate the clinical effects and safety of Loratadine combined with Diclofenac sodium eye drops in the treatment of allergic conjunctivitis by system review.
METHODS:Using “Loratadine” “Diclofenac sodium” and “allergic conjunctivitis” as keywords, a randomized controlled trial of Loratadine combined with diclofenac sodium in the treatment of allergic conjunctivitis was searched in Embase, Cochrane library, Pubmed, CNKI, Wanfang database, VIP and SionMed. The retrieval time is from the establishment of the database to July 2021. The risk bias tool provided by the Cochrane cooperation scale was used to assess the risk bias of included studies of RCTs. The publication bias of the included studies was assessed by the Egger's test. Meta-analysis of clinical efficiency, incidence of adverse effects, ocular itch score, and discharge score were using RevMan 5.3. Descriptive analysis were performed on the results with high heterogeneity.
RESULTS:A total of 19 articles were included, all of which were Chinese literatures, including 1 931 patients(2 044 eyes). The control group was treated with Loratadine, and the experimental group was treated with Loratadine combined with Diclofenac sodium eye drops. The Meta-analysis showed that the clinical effect of experimental group was better than control group(OR=4.43, 95%CI:3.26-6.03,P<0.00001).The incidence of adverse reaction was lower than control group(OR=0.32, 95%CI:0.2-0.52,P<0.00001). The Score of ocular itching(MD=-0.36, 95%CI:-0.39 to -0.33,P<0.00001)and discharge(MD=-0.24,95%CI: -0.31 to -0.18,P<0.00001)in experimental group was lower than control group. All the studies on hyperemia and edema of conjunctiva, conjunctival papilla or follicle proliferation and foreign body sensation in patients with allergic conjunctivitis showed that the experimental group could significantly reduce the above symptoms(all P<0.05). Egger's test was performed on the total effective rate, the incidence of adverse reaction. The results showed that there was publication bias in the total effective. Trim and fill method showed that the publication bias did not affect the results.
CONCLUSION: On the basis of the oral Loratadine, combined with Diclofenac sodium eye drops has a certain clinical efficacy in the treatment of allergic conjunctivitis, which can improve the clinical symptoms such as ocular itching, foreign body sensation, hyperemia and edema of conjunctiva, and the incidence of adverse reactions is low, which can provide evidence-based basis for the drug treatment of allergic conjunctivitis in the future. However, due to the low intensity of the included research evidence, more multicenter, randomized double-blind clinical trials are needed in the future, so that to improve the evidence intensity.
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