Interventions for infantile nystagmus syndrome: towards a randomized controlled trial?

A PubMed search for papers in the last 10 years on interventions for Infantile Nystagmus Syndrome (INS) reveals 18 papers on surgical or pharmacological interventions and 6 papers describing other interventions. There is only one randomized controlled trial (RCT), with all the other studies being uncontrolled trials/case series. To investigate the importance of RCTs, the data from the one RCT is re-analyzed as if it had been a case series. If only the group receiving the experimental treatment are considered, then the visual acuity was significantly better after than before treatment (paired t-test, p = 0.04). However, the control group who received a placebo treatment improved to a similar degree (p = 0.90). The literature on the placebo effect shows that it can influence objective variables and the outcome of surgical interventions. It is suggested that previous studies on interventions for nystagmus have laid an important foundation for future work in this field, which should involve RCTs.     

糖皮质激素类药物治疗非动脉炎性前部缺血性视神经病变有效性的系统评价

目的:评价糖皮质激素类药物治疗非动脉炎性前部缺血性视神经病变（NAION）的有效性和安全性。方法:通过计算机检索美国国立医学图书馆医学数据库PubMed、荷兰医学文摘数据库Embase、循证医学图书馆Cochrane Library、中国知网数据库、中国生物医学文献服务系统、维普中文科技期刊数据库及万方科技期刊全文数据...     

Surgical and laser interventions for pseudoexfoliation glaucoma systematic review of randomized controlled trials

To assess the comparative effectiveness and safety of different surgical and laser techniques in people with pseudoexfoliation glaucoma (PXFG). We conducted a systematic review including randomized controlled trials (RCT) that compared any pair of surgical or laser treatment versus other type of intervention in PXFG. RCT were identified by a highly sensitive search of electronic databases and two individuals independently assessed trial eligibility, abstracted data and assessed risk of bias. We performed Bayesian Meta-Analysis when outcomes were comparable. The search strategy identified 6171 records. Six studies (262 subjects) were included. Two trials analyzed the same pair of surgical interventions comparing phacoemulsification as solo procedure or combined with trabecular aspiration and we performed meta-analysis. Other RCTs compared the following interventions: trabecular aspiration associated with phacoemulsification versus phacotrabeculectomy, non-penetrating deep sclerectomy associated or not with phacoemulsification, selective versus argon laser trabeculoplasty and one-site versus two-site phacotrabeculectomy. For IOP data, none of the trials reported a difference between pairs of surgical techniques, nor changes in visual acuity or number of post-operative medications. The overall risk of bias is moderate to high. There are no apparent differences in efficacy and safety, although with large uncertainty, between surgical or laser techniques for PXFG. Based on the low-quality evidence from the six studies included in this review, it is not possible to justify the preferential use of non-penetrating surgery, MIGS or trabecular aspiration (with or without cataract surgery) in PXFG. Further research is needed to determine the optimal management of this condition.Subject terms: Glaucoma, Outcomes research     

中国大陆地区发表在SCI期刊上的眼科随机对照试验报告质量评价

背景按照循证医学（EBM）的理念对医学临床研究进行随机对照试验（RCT）能够为医疗决策提供重要证据,国际编辑组织提供的临床试验报告统一标准（CONSORT）是医学临床研究者正确撰写RCT报告的指南。目前中国临床研究人员对RCT的评价和使用方法了解的还不够。目的采用2010版CONSORT对中国大陆地区眼科研究者在SCI期刊上所发表的有关眼科疾病的RCT报告的方法学质量进行评价,为RCT报告的正确撰写提供方法学介绍。方法在PubMed平台检索中国大陆眼科研究者在SCI期刊上发表的眼科RCT研究文章,检索文献截止至2013年3月,由2位评阅者对检索的文献独立评分,统计所纳入文献对于CONSORT各项条目的符合率,根据CONSORT的发表和修订年份对文章进一步分层分析。结果共纳入60篇眼科研究相关的RCT文献,研究中的干预措施以手术类为主（34／60）,共有44篇文献设立了2个研究组,样本量的中位数为76．0。纳入的文献中,仅有22％的文章（13／60）在文题中标注了RCT。绝大多数文章在摘要和背景部分进行了合理描述,仅4篇文章提出了试验的假设,占7％。在方法部分,仅12篇文章报告了如何计算样本量,有41篇报告了资料收集的场所和地点,仅6篇文章提到了中期分析和中止原则。2010版CONSORT声明发表后,中国大陆地区所发表的RCT报告对随机化的描述并未显著改善（RR=1．06,95％CI：0．62～1．82）,对盲法进行描述的报告仅占42％（25／60）。结论中国大陆地区发表在SCI期刊上的RCT报告还存在较多问题。严格按照CONSORT声明设计并报告高质量的RCT有助于真实、客观地反映中国眼科临床研究的现状,提高中国大陆地区眼科临床试验的质量,并为眼科临床工作提供指导。     

中药联合常规综合疗法治疗小儿弱视疗效的meta分析

背景 目前临床上治疗小儿弱视的常规方法主要包括验光配镜、遮盖疗法、阿托品点眼、精细目力训练、仪器治疗等或上述综合疗法,但各种疗法的效果均有一定的局限性.长期以来中药曾用于小儿弱视的治疗过程,但其疗效评价有一定争议. 目的 系统评价中药联合常规综合疗法治疗小儿弱视的疗效.方法 按照我们制定的检索策略用计算机检索2000-2015年中国期刊网全文数据库(CNKI)、万方全文数据库、美国医学文摘数据库(PubMed)中关于中药联合常规综合疗法与单纯常规综合疗法治疗小儿弱视疗效比较的随机对照试验(RCT)和临床对照试验(CCT),按照循证医学(Cochrane)系统评价的方法评价纳入研究的质量,采用改良Jadad评分量表对纳入文献的研究方法学进行评分,提取有效数据,采用RevMan 5.1统计学软件进行meta分析.采用固定效应模型分析治疗效果的合并效应量. 结果 共有33篇符合检索纳入标准的文献纳入分析,总样本量6 666例.33篇文献中共25篇描述了组间研究对象基线资料具有可比性;共29篇文献描述了所参照的诊断标准,30篇文献描述了参照的疗效标准;改良Jadad评分显示纳入研究的方法学评分为6分者1篇,3分者2篇,1～2分者30篇.Meta分析显示中药联合常规综合疗法治疗小儿弱视的总有效率合并效应量[比值比(OR)]为3.92[95％可信区间(CI):3.30 ～4.64],中药联合常规综合治疗组总疗效明显优于对照组,差异有统计学意义(Z=15.74,P＜0.01).结论 中药联合常规综合疗法治疗小儿弱视的总有效率优于单纯常规综合疗法,可以认为中药联合常规综合疗法治疗小儿弱视有效;本研究中纳入文献的总体方法学质量评价尚不令人满意,需要更多设计良好的RCT进一步证实中药在小儿弱视治疗中的作用和疗效.     

Is ophthalmology evidence based? A clinical audit of the emergency unit of a regional eye hospital

AIM: To evaluate the proportion of interventions that are evidence based in the acute care unit of a regional eye hospital. METHODS: A prospective clinical audit was carried out at Hong Kong Eye Hospital in July 2002 to investigate the extent to which ophthalmic practices were evidence based. The major diagnosis and intervention provided were identified through chart review. A corresponding literature search using Medline and the Cochrane Library was performed to assess the degree to which each intervention was based on current, best evidence. Each diagnosis intervention pair was accordingly analysed and graded. The level of best, current evidence supporting each intervention was graded and analysed. RESULTS: A total of 274 consecutive consultation episodes were examined. 22 cases were excluded since no diagnosis or intervention was made during the consultation. 108 (42.9%) patient interventions were found to be based on evidence from systematic reviews, meta-analyses, or randomised controlled trials (RCT). Evidence from prospective or retrospective observational studies supported the interventions in 86 (34.1%) patients. In 58 (23.0%) cases, no evidence or opposing evidence was found regarding the intervention. The proportion of evidence based on RCT or systematic reviews was higher for surgical interventions compared with non-surgical interventions (p=0.007). The proportion of interventions based on RCT or systematic reviews was higher for specialist ophthalmologists than trainee ophthalmologists (p=0.021). CONCLUSION: This study demonstrated that the majority of interventions in the ophthalmic unit were evidence based and comparable to the experience of other specialties.     

急性闭角型青光眼治疗方法的循证评价

目的 从循证医学的角度对有关急性闭角型青光眼发作眼和对侧眼的治疗方法进行文献回顾和证据评价,并对今后的研究工作提出建议.方法 系统综述,检索MEDLINE、EMBASE、Cochrane组织(1966年至2006年12月)所有相关英文文献以及中国期刊全文数据库收录的中文核心刊物发表的相关文献(1979年至2006年12月),纳入文献包括随机对照临床研究(RCT)、非随机对照研究、前瞻性病例分析和病例数大于50例的回顾性病例分析,并对相关综述和入选文献的参考文献进行手工检索.入选文献按照治疗性医学文献证据级别的判定标准进行证据分级和评价.结果 共23篇英文文献和5篇中文文献入选.英文、中文文献中分别有5项和3项RCT,其余证据来自非随机临床对照研究和病例分析,涉及的治疗方法包括药物、激光和手术三大类.结论 目前已有较为有力证据的治疗方法:急性发作时即刻行激光周边虹膜成形术较传统的药物治疗方案降眼压作用起效快;急性发作缓解后行激光周边虹膜切开术(LPI)以及对侧眼的预防性LPI,具有解除瞳孔阻滞、控制眼压和预防急性发作再发或新发的效果;LPI和周边虹膜切除手术(SPI)治疗效果相当.白内障摘除术等治疗方法缺乏足够的高级别研究证据和远期随访结果证明其效果和安全性.     

The reporting quality of parallel randomised controlled trials in ophthalmic surgery in 2011: a systematic review

Purpose

Randomised controlled trials (RCTs) represent a gold standard for evaluating therapeutic interventions. However, poor reporting clarity can prevent readers from assessing potential bias that can arise from a lack of methodological rigour. The Consolidated Standards of Reporting Trials statement for non-pharmacological interventions 2008 (CONSORT NPT) was developed to aid reporting. RCTs in ophthalmic surgery pose particular challenges in study design and implementation. We aim to provide the first assessment of the compliance of RCTs in ophthalmic surgery to the CONSORT NPT statement.

Method

In August 2012, the Medline database was searched for RCTs in ophthalmic surgery reported between 1 January 2011 and 31 December 2011. Results were searched by two authors and relevant papers selected. Papers were scored against the 23-item CONSORT NPT checklist and compared against surrogate markers of paper quality. The CONSORT score was also compared between different RCT designs.

Results

In all, 186 papers were retrieved. Sixty-five RCTs, involving 5803 patients, met the inclusion criteria. The mean CONSORT score was 8.9 out of 23 (39%, range 3.0–14.7, SD 2.49). The least reported items related to the title and abstract (1.6%), reporting intervention adherence (3.1%), and interpretation of results (4.7%). No significant correlation was found between CONSORT score and journal impact factor (R=0.14, P=0.29), number of authors (R=0.01, P=0.93), or whether the RCT used paired-eye, one-eye, or two-eye designs in their randomisation (P=0.97).

Conclusions

The reporting of RCTs in ophthalmic surgery is suboptimal. Further work is needed by trial groups, funding agencies, authors, and journals to improve reporting clarity.     

Acupuncture for treating dry eye: a systematic review

Purpose: The objective of this review was to assess the effectiveness of acupuncture as a treatment option for treating the condition of dry eye. Methods: We searched the literature using 14 databases from their inceptions to 3 December 2009, without language restrictions. We included randomized clinical trials (RCTs) comparing acupuncture with conventional treatment. Their risk of bias was assessed using Cochrane criteria. Results: Six RCTs met all the inclusion criteria. Three RCTs compared the effects of acupuncture with artificial tears in patients with xerophthalmia or Sjögren syndrome. A meta‐analysis of these data showed that acupuncture improved tear break‐up times (p < 0.0001), Schirmer test scores (p < 0.00001), response rates (p = 0.002) and the region of cornea fluorescent staining (p = 0.0001) significantly more than artificial tears did. The other three RCTs compared the effects of acupuncture plus artificial tears with artificial tears alone. Two of these studies failed to show significant effects of acupuncture, while one reported significant effects. For Schirmer test scores and frequency of artificial tear usage, two RCTs reported superior effects of acupuncture plus artificial tears, while one RCT failed to do so. Conclusion: These results provide limited evidence for the effectiveness of acupuncture for treating dry eye. However, the total number of RCTs, the total sample size and the methodological quality were too low to draw firm conclusions.     

Moving towards improved evidence for the effectiveness of low vision interventions

Background:  Two recently published Manchester trials have provided evidence on the effectiveness of specific low vision rehabilitation (LVR) interventions.
Methods:  In RCT 1, we compared enhanced LVR (supplementary home visits) and conventional LVR for people with AMD. In RCT 2, we evaluated the effectiveness of prism relocation spectacles in people with central scotomas due to AMD. RCT methodology was employed in each trial on large samples of subjects ( n  > 200), using a wide range of outcomes.
Results:  For RCT 1, arms did not differ significantly for any outcome. At 12 months, 94% of participants reported using at least one LVA. For RCT 2, there was no significant effect of treatment group (prism or placebo) on any of the outcomes.
Conclusions:  While these specific LVR interventions did not prove to be effective, they were not designed to address the effectiveness of LVR in general. A LVR vs no-LVR trial is proposed.
References:  Reeves, B.C., Harper, R.A. and Russell, W.B. (2004) Enhanced low vision rehabilitation for people with age-related macular degeneration: a randomised controlled trial. Br J Ophthalmol 88 , 1443–1449.
Smith, H.J., Dickinson, C.M., Cacho, I., Reeves, B.C., Harper, R.A. (2005) A randomized controlled trial to determine the effectiveness of prism spectacles for patients with age-related macular degeneration. Arch Ophthalmol 123 , 1042–1050.     

环孢素A在防止翼状胬肉术后复发中作用的meta分析

背景翼状胬肉是常见的眼表疾病，目前主要采取手术行翼状胬肉切除治疗，然而术后复发率较高。近年来有研究提出术后局部应用环孢素A（CsA）能有效降低其术后复发概率，但尚缺乏循证医学评价的证据。目的为CsA在翼状胬肉切除术中临床疗效的评价寻求循证依据。方法采用检索策略并选择关联检索词对数据库建库至2012年10月已发表有关比较翼状胬肉术后是否使用CsA滴眼剂的随机对照试验（RCT）和前瞻性队列研究（Cohort）进行检索，检索的数据库包括MEDLINE、EMBASE、Cochrane图书馆、中国期刊全文数据库（CNKI）、万方数据库和维普数据库（VIP），由2名研究者独立提取资料，对符合纳入标准的文献进行meta分析。Meta分析中纳入的关联结局指标包括术后复发率、Schirmer试验I（sIt）及术后并发症发生率。采用RevMan5．0软件进行统计分析，若纳入的各研究无异质性（P≥0．1，异质性检验，2〈50％），对计数指标的相对危险度（RR）和计量指标的加权均数差（WMD）采用固定效应模型进行分析，反之则采用随机效应模型，计算各指标95％可信区间（CI）。结果共检索到符合纳入标准的相关文献6篇，包括RCT4篇和Cohort研究2篇，1篇RCT的Jadad量表评分为5分，另3篇均为2分；2篇Cohort研究的纽卡斯尔一渥太华量表（NOS）评分为6～7分，共纳入309例366眼。6篇文献发表时间为2008--2012年。Meta分析显示，CsA组术后翼状胬肉的复发率和并发症的发生率均明显低于对照组，差异均有统计学意义（RR：0．39；95％CI：0．24～0．64，P=0．0002；RR=0．24；95％CI：0．13—0．44，P〈0．00001）。CsA组术眼术后sIt较术前的提高值明显高于对照组，差异有统计学意义（WMD=2．47，95％CI：1．59～3．35，P〈0．00001）。亚组分析结果与合并结果吻合。结论翼状胬肉切除术中使用CsA滴眼剂能有效降低术后复发率及术后并发症的发生率。     

Topical antiglaucoma medications and lacrimal drainage system obstruction

PURPOSE: To evaluate the effect of topical antiglaucoma medications on the lacrimal drainage system. METHODS: In a prospective controlled blind observational case series, 627 eyes of 384 patients (219 males, 165 females) were screened. Data recording (demographics and history taking), allocation in case (on topical antiglaucoma medications) and control (no glaucoma) groups, and examinations (eye examination and dye disappearance test) were performed by a senior ophthalmology resident. Exclusion criteria were epiphora prior to onset of treatment with topical antiglaucoma medication (only for case group), history of long-term use of topical medications (other than antiglaucoma medications in the case group), and previous ocular and periocular disorders. Diagnostic probing and irrigation of the lacrimal drainage system were performed by an oculoplastic surgeon masked to a patient's status as case or control. RESULTS: After exclusion, there were 130 eyes from 98 patients and 280 eyes from 178 patients in the case and control groups, respectively. Case and control groups were matched. There was significantly more lacrimal drainage system obstruction in the case group (26 of 130, 20%) than in the control group (24 of 280, 8.57%) (p = 0.002). Upper lacrimal drainage system obstruction was significantly more in the case group (p = 0.018). Increasing age was associated with significantly more obstruction in the control group only (p = 0.029). Statistically significant obstruction was found in the patients taking timolol + dorzolamide (p = 0.021) and timolol + dorzolamide + pilocarpine (p = 0.017) with a duration of 2 weeks to 156 months. CONCLUSION: Patients taking a combination of topical antiglaucoma medications showed significantly increased risk of developing lacrimal drainage system obstruction. Both total and upper obstruction was significantly more frequent in patients on topical antiglaucoma medications.     

Levocabastine eye drops in the treatment of vernal conjunctivitis

The efficacy and tolerability of levocabastine eye drops in vernal conjunctivitis (VC) were evaluated in a double-blind, placebo-controlled trial involving 46 patients over a period of 4 weeks. After 1 week of treatment, therapeutic efficacy was considered to be excellent or good for 70% of the levocabastine-treated patients compared with only 33% of patients in the placebo group (p < 0.009). Levocabastine patients experienced significantly greater relief of their individually severest symptom than placebo-treated patients both after 1 week and at the end of the trial (p < 0.04). The reduction in symptom severity was significantly greater in the levocabastine group than in the control group for photophobia (p < 0.003) after 1 week, and for photophobia (p < 0.008), irritation (p = 0.05) and itchy eyes (p = 0.05) at the end of the trial. The percentage of days on which patients were completely symptom-free was significantly higher in the levocabastine group than in the placebo group (28% versus 4%; p < 0.02). Eight placebo-treated patients withdrew from the trial due to treatment inefficacy compared with only four levocabastine-treated patients (p = 0.013). Two of the three levocabastine, and all five placebo patients who elected to continue on open-label levocabastine had an excellent or good overall response after 1 to 3 weeks of treatment. All reported adverse reactions were mild and their incidence was equal in the two treatment groups. Levocabastine eye drops are effective and well tolerated in the treatment of VC.Abbreviations AUC Area under the curve - VC Vernal conjunctivitis Address for correspondence: J. Coward, Adelphi Communications Limited, Adelphi Mill, Bollington, Macclesfield, Cheshire SK10 5JB, UK Phone: +44 625 575500; Fax: +44 625 575853     

[THIS ARTICLE HAS BEEN RETRACTED]The efficacy and safety of besifloxacin for acute bacterial conjunctivitis: a Meta-analysis

[THIS ARTICLE HAS BEEN RETRACTED] AIM: To evaluate the relative efficacy and safety of besifloxacin for treatment of acute bacterial conjunctivitis. METHODS: A comprehensive search in PubMed, EMBASE Web of Science, Cochrane Central Database and CNKI was undertaken for randomized controlled trials (RCTs) comparing besifloxacin with other treatments or placebo. The primary outcome measures were clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, and bacterial eradication rates of different kinds of pathogens. Safety outcomes were the number of adverse effects (AEs). The final search was performed on August 2018. RESULTS: Eight RCTs were included. Five studies compared the efficacy and safety of besifloxacin with placebo, 2 studies compared besifloxacin with moxifloxacin, and 1 study compared besifloxacin with gatifloxacin. A total of 3105 patients met the inclusion criteria. Besifloxacin presented higher efficacy and safety than did placebo in clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, bacterial eradication rates of different kinds of pathogens and the number of AEs. There was no significant difference between besifloxacin and moxifloxacin or gatifloxacin in the comparison items mentioned above. CONCLUSION: Besifloxacin is highly effective and safe for treatment of acute bacterial conjunctivitis. Further comparative trials regarding the effect of besifloxacin for treatment of acute bacterial conjunctivitis will aid in treatment decisions.     

Rheopherese® bei altersbedingter Makuladegeneration

Background

In Austria, Rheopheresis for non-exudative age-related macular degeneration (AMD) has been proposed for inclusion into the benefit catalogue. Decisions on the inclusion of new medical interventions in reimbursement schemes or benefit catalogues are increasingly based on systematic reviews of clinical studies and their patient-relevant results.

Material and methods

A systematic literature search in five databases identified two randomised clinical trials (RCTs). A systematic analysis of the evidence based on the critical appraisal of the RCTs was carried out.

Results

Both RCTs, having a total of 238 included patients, show that to date, evidence for the effectiveness of Rheopheresis for AMD is not available, and predictions for exact indications cannot be made. The bigger RCT showed no effect at all, and the smaller one showed a small effect with questionable clinical relevance.

Conclusion

Available clinical data suggest considering Rheopheresis an experimental intervention. Its inclusion in the benefit catalogue is not recommended.     

Design characteristic of randomised controlled trials for geographic atrophy in age-related macular degeneration: selection of outcomes and sample size calculation

Purpose

The selection of suitable outcomes and sample size calculation are critical factors in the design of a randomised controlled trial (RCT). The goal of this study was to identify the range of outcomes and information on sample size calculation in RCTs on geographic atrophy (GA).

Methods

We carried out a systematic review of age-related macular degeneration (AMD) RCTs. We searched MEDLINE, EMBASE, Scopus, Cochrane Library, www.controlled-trials.com, and www.ClinicalTrials.gov. Two independent reviewers screened records. One reviewer collected data and the second reviewer appraised 10% of collected data. We scanned references lists of selected papers to include other relevant RCTs.

Results

Literature and registry search identified 3816 abstracts of journal articles and 493 records from trial registries. From a total of 177 RCTs on all types of AMD, 23 RCTs on GA were included. Eighty-one clinical outcomes were identified. Visual acuity (VA) was the most frequently used outcome, presented in 18 out of 23 RCTs and followed by the measures of lesion area. For sample size analysis, 8 GA RCTs were included. None of them provided sufficient Information on sample size calculations.

Conclusions

This systematic review illustrates a lack of standardisation in terms of outcome reporting in GA trials and issues regarding sample size calculation. These limitations significantly hamper attempts to compare outcomes across studies and also perform meta-analyses.     

Inhibition of PKC beta by oral administration of ruboxistaurin is well tolerated and ameliorates diabetes-induced retinal hemodynamic abnormalities in patients

PURPOSE: To assess ocular and systemic safety and pharmacodynamic effects of the oral PKC beta selective inhibitor ruboxistaurin (RBX; LY333531) mesylate in patients with diabetes. METHODS: This was a double-masked, placebo-controlled, parallel, randomized, single-center clinical study evaluating the effect of oral administration of RBX (8 mg twice a day, 16 mg per day, or 16 mg twice a day) or placebo for 28 days in patients with no or very mild diabetic retinopathy on mean retinal circulation time (RCT), retinal blood flow (RBF), treatment-emergent adverse events, and other safety parameters. RESULTS: Twenty-nine persons aged 18 to 65 years with type 1 or 2 diabetes were evaluated. The only treatment-emergent adverse event with a statistically significant difference among treatment groups was abdominal pain, which was more common in placebo-treated subjects (P = 0.049). Statistically significant effects of RBX were observed on several hematologic and laboratory parameters, but values were within the normal reference range and none of the changes was deemed clinically meaningful. In patients receiving 16 mg RBX twice daily, the diabetes-induced increase in RCT was ameliorated, with a baseline-to-endpoint difference of -0.84 seconds (P = 0.046) relative to placebo. Increasing RBX dose was linearly associated with greater effect on RCT (P = 0.03). Similar results were observed with RBF. CONCLUSIONS: RBX was well tolerated at doses up to 16 mg twice daily for 28 days in patients with diabetes. It ameliorated diabetes-induced RCT abnormalities. No serious safety problems were identified in this patient population. Compared with prior published data, these findings represent the first direct human evidence of both bioavailability of RBX to retinal vessels and amelioration of diabetes-induced retinal hemodynamic abnormalities by an oral PKC beta inhibitor.     

Treating with besifloxacin for acute bacterial conjunctivitis: a Meta-analysis

AIM: To evaluate the relative efficacy and safety of besifloxacin for treatment of acute bacterial conjunctivitis. METHODS: A comprehensive search in PubMed, EMBASE Web of Science, Cochrane Central Database and CNKI was undertaken for randomized controlled trials (RCTs) comparing besifloxacin with other treatments or placebo. The primary outcome measures were clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, and bacterial eradication rates of different kinds of pathogens. Safety outcomes were the number of adverse effects (AEs). The final search was performed on August 2018. RESULTS: Six RCTs were included. Four studies compared the efficacy and safety of besifloxacin with placebo, 1 study compared besifloxacin with moxifloxacin, and 1 study compared besifloxacin with gatifloxacin. A total of 2780 patients met the inclusion criteria. Besifloxacin presented higher efficacy and safety than did placebo in clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, bacterial eradication rates of different kinds of pathogens and the number of AEs. There was no significant difference between besifloxacin and moxifloxacin or gatifloxacin in the comparison items mentioned above. CONCLUSION: Besifloxacin is highly effective and safe for treatment of acute bacterial conjunctivitis. Further comparative trials regarding the effect of besifloxacin for treatment of acute bacterial conjunctivitis will aid in treatment decisions.     

抗VEGF药物治疗视网膜中央静脉阻塞并发黄斑水肿的Meta分析

背景视网膜中央静脉阻塞（CRVO）可导致黄斑水肿,影响视力,且治疗方法有限,近年虽有随机对照临床试验（RCTs）研究抗血管内皮生长因子（VEGF）对CRVO的疗效,但还缺乏循证评价。目的对VEGF玻璃体腔内注射治疗CRVO并发黄斑水肿进行循证医学评价。方法采用Meta分析的方法和Coehrane系统评价方法,检索有关抗VEGF玻璃体腔内注射治疗CRVO合并黄斑水肿的RCTs文献进行二次分析,检索文献范围包括Cochrane Library、Pubmed、Embase、万方数据库、会议记录等,文献不限定发表语言及时间,由2位作者独立决定入选文献,对纳入文献进行质量评价,分析指标为治疗前后最佳矫正视力（BCVA）提高≥15个字母的人数比例、BCVA LogMAR提高值及光学相干断层扫描（OCT）测得的视网膜中心凹厚度（CFT）变化值。使用Cochrane协作网Review Manager 5．1软件对连续变量进行合并效应量的检测,6篇文献间经,检验无显著异质性,故采用固定效应模型对治疗后不同时间抗VEGF治疗组与假治疗组间的BCVA、BCVA LogMAR视力和CFT进行分析。结果共纳入RCTs文献6篇,总样本量为948眼,纳入的文献中包括5个多中心研究和1个单中心研究。其中1篇文献用哌加他尼钠（pegaptanib）作为治疗组,2篇文献用雷珠单抗（ranibizumab）作为治疗组,1篇文献采用贝伐单抗（bevacizumab）作为治疗组,2篇文献采用VEGF Trap—Eye作为治疗组。1年随访时间中抗VEGF药物治疗组BCVA提高≥15个字母的人数比例明显高于假治疗组,6个月时差值最明显（Z=8．43,P〈0．00001）;6个月随访时间中BCVA LogMAR提高均大于假治疗组,第6个月时差值最大（Z=28．27,P〈0．00001）。6个月随访时间中抗VEGF治疗组患眼CFT下降值明显大于假治疗组,其中第3个月时差值最明显（Z=35．38,P〈0．00001）。抗VEGF治疗组玻璃体腔内注射后偶发眼部并发症,主要为玻璃体出血19眼、白内障16眼、眼内炎8眼、虹膜新生血管2眼等,而用药后全身不良事件罕见。结论抗VEGF药物治疗CRVO并发黄斑水肿效果明显,不良反应较少,但疗效维持时间较短。发病早期及时注射抗VEGF药物对患者更有益,但晚期注射仍能取得一定疗效。