Efficacy and safety of 0.18% sodium hyaluronate in patients with moderate dry eye syndrome and superficial keratitis

Background Sodium hyaluronate (SH) is used in patients with dry eye. We evaluated the efficacy and safety of SH and carboxymethylcellulose (CMC) in the treatment of dry eye syndrome with superficial keratitis.Methods A total of 22 patients with moderate dry eye and superficial keratitis were enrolled in a prospective, randomised, masked-observer, parallel-group, single-centre study. Patients were randomly assigned to a 0.18% SH or 1% CMC solution for a 2-month period. In addition to the commonly assessed parameters in patients with dry eye (among others symptoms and corneal staining with fluorescein), flow cytometry analysis of CD44, HLA DR expressions in impression cytology was investigated as a potential efficacy parameter.Results Both treatments improved the symptoms and ocular surface and were well tolerated. SH significantly (p<0.05) decreased CD44 values compared with CMC. Comfort was significantly (P<0.05) better in the SH group than that in the CMC group throughout the study. Recovery in keratitis (type, extent and depth) and symptoms were faster in the SH group than in the CMC group. Blurred vision was reported by patients in the CMC group only.Conclusions SH was well tolerated and tended to show a faster efficacy than did the CMC-based formulation in patients with moderate dry eye and superficial keratitis. SH could therefore advantageously be prescribed from the early stages of dry eye disease. This study also showed that flow cytometry in impression cytology specimens is a reliable tool for exploring the ocular surface at the epithelial level and that CD44, in addition to HLA DR, could be an interesting endpoint for future trials in dry eye syndrome with products based on SH.     

Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial

Objective

To evaluate the safety of repeated intra-articular (IA) injections of Euflexxa^® (1% sodium hyaluronate; IA--BioHA) for painful knee osteoarthritis (OA).

Design

Participants who completed the randomized, double-blind, 26-week FLEXX Trial comparing IA-BioHA to IA saline (IA-SA) for knee OA¹ received three weekly IA-BioHA injections in a 26-week Extension Study. Adverse events (AEs) were recorded and the effect of treatment on knee pain was measured immediately following a 50-foot walk test using a 100 mm visual analog scale (VAS). Responder rate, Medical Outcomes Study Short Form 36 scores, Patient’s Global Assessment, and intake of rescue medication were also evaluated.

Results

The Extension Study included 433 subjects, 219 who received IA-BioHA and 214 who received IA-SA during the FLEXX Trial. Safety results from the Extension Study indicated that 43.4% (188/433) of subjects had AEs, of which 4.8% (21/433) were deemed treatment-related AEs. Two AEs in the Extension Study led to discontinuation, and no joint effusion was reported. Patients who continued with IA-BioHA in the Extension Study maintained their improvement from baseline, with an average reduction in pain in the VAS score of −3.5 mm. Patients initially treated with IA-SA in the FLEXX Trial also had a reduction in VAS score of −9.0 mm. Secondary efficacy variables also improved during the Extension Study.

Conclusions

Repeat injections of IA-BioHA were effective, safe, well tolerated, and not associated with an increase in AEs, such as synovial effusions. Additional symptom improvements were noted for subjects who received either IA-BioHA or IA-SA in the FLEXX Trial.Clinical Trial Registration Number: NCT00379236     

Botulinum toxin injections combined with or without sodium hyaluronate in the absence of electromyography for the treatment of infantile esotropia: a pilot study

Objective

To evaluate the feasibility and safety of a revised technique of botulinum toxin type A (BTA) injections for the treatment of infantile esotropia.

Methods

Forty-seven patients with infantile esotropia were randomly divided into two groups. In group A, 23 cases were treated with a bilateral injection of 2.5–3.75 U BTA combined with sodium hyaluronate (SH) to the medial rectus muscle. In group B, 24 cases were treated with a bilateral injection of 2.5–3.75 U BTA solution alone to the medial rectus muscle. Electromyography was not used in the study. All patients received one injection and were evaluated 2 weeks, 3 months, and 6 months following injection.

Results

The measured changes between groups A and B included the frequencies of good alignment 6 months after injections (30.4% vs 37.5%), complicated ptosis (2.2% vs 20.8%), and vertical deviation (2.2% vs 2.1%).

Conclusion

BTA injections combined with or without SH in the absence of electromyography demonstrated effectiveness and feasibility in the treatment of infantile esotropia. A relative decrease in the frequency of complicated ptosis resulted from injections of BTA+SH.     

玻璃酸钠滴眼液治疗干眼临床随机对照试验的Meta分析

背景 国内外有较多关于玻璃酸钠滴眼液治疗干眼疗效的报道,应用循证医学的方法对玻璃酸钠滴眼液的疗效进行评估具有重要的临床意义. 目的 运用Meta分析法评价玻璃酸钠滴眼液治疗干眼的疗效.方法 本研究为文献的二次研究设计.采用Cochrane系统综述方法,按照预先制定的检索策略,计算机检索PubMed、Medline、中国生物医学文献数据库网络版、中国知网数据库、重庆维普中文科技期刊数据库、万方数据库等电子文献数据库.检索年限从各数据库建库至2011年12月.由2名评价者共同评价所纳入研究的质量,纳入玻璃酸钠滴眼液治疗干眼的随机对照试验(RCTs),并对纳入的文献采用Jadad量表进行质量评价.对同质性研究结果进行Meta分析,采用Cochrane协作网提供的RevMan 5.0软件进行Meta分析,对异质性研究进行描述性分析,以比值比(OR)值表示效应指标. 结果 共纳入4个符合纳入标准的RCTs研究文献,Jadad量表评价结果显示,2个文献7分、1个4分、1个2分,共包括686例干眼患者,其中试验组应用玻璃酸钠点眼治疗干眼者344例,应用安慰剂、生理盐水、羟甲基纤维素、羟丙甲纤维素作为对照者342例.试验组中症状改善者183例,对照组症状改善者130例.Meta分析结果显示,试验组与对照组治疗有效率的OR为2.55,95％可信区间(CI)为0.94～6.93,试验组改善症状的有效率与对照组比较差异无统计学意义(Z=1.84,P=0.07).结论 玻璃酸钠滴眼液治疗干眼具有一定的疗效,但与对照组比较差异不明显.限于纳入研究的文献量有限,且质量参差不齐,仍然需要进行大样本、多中心RCTs分析以进一步证实玻璃酸钠治疗干眼的优越性.     

不同分子量构成的玻璃酸钠对骨关节炎治疗作用的实验研究

目的观察不同分子量构成（分子量150万Da以上相对大分子和150万Da以下相对小分子）的玻璃酸钠对骨关节炎治疗作用的特点。方法采用骨关节固定法和木瓜蛋白酶关节腔内注射两种方法造成兔膝骨关节炎模型,采用病理学研究以及镇痛实验和毛细血管通透性实验评价两种不同分子量玻璃酸钠对骨关节炎的治疗效果。结果两种玻璃酸钠对骨关节炎模型关节软骨和滑膜的病变均有不同程度的治疗作用,均能有效镇痛,并抑制毛细血管通透性。在木瓜蛋白酶注射法制作的兔膝骨关节炎模型中,分子量为150万Da以下的相对小分子量玻璃酸钠组在促进软骨组织修复和减少滑膜组织增生方面治疗效果更好。结论本研究选用的不同分子量玻璃酸钠在治疗骨关节炎方面均有确切疗效,显示玻璃酸钠治疗骨关节炎安全有效,而分子量为80～150万Da的相对小分子量玻璃酸钠在促进软骨组织修复和减少滑膜组织增生方面略显优势。     

玻璃酸钠治疗新生儿头颅血肿疗效观察

目的:探讨玻璃酸钠治疗新生儿头颅血肿的疗效.方法:将新生儿头颅血肿患儿随机分为两组,观察组50例进行玻璃酸钠血肿内注射治疗,对照组20例采用云南白药外涂.观察二种治疗方法的有效率、比较血肿消散的时间、头颅畸形的发生率.结果:玻璃酸钠治疗组有效率96%,对照组有效率55%,差异有显著性.玻璃酸钠治疗组血肿消散时间明显短于对照组(P<0.05),头颅畸形发生率明显少于对照组(P<0.05).结论:玻璃酸钠治疗新生儿头颅血肿可缩短其消散时间,减少头颅畸形及并发症的发生,值得推广应用.     

透明质酸钠原料病毒灭活/去除工艺的研究

目的对鸡冠来源的透明质酸钠病毒灭活/去除工艺进行验证。方法根据生产所用鸡冠确定其可能携带的病毒种类,选择呼肠孤病毒Ⅲ型、伪狂犬病毒、水泡性口炎病毒和猴空泡病毒40作为相关的指示病毒。对透明质酸钠原料的制备工艺进行分析,确定透明质酸钠原料制备工艺中加热灭活工艺作为可能灭活/去除病毒的工艺,并进行病毒灭活/去除效果的验证。结果呼肠孤病毒Ⅲ型、伪狂犬病毒、水泡性口炎病毒和猴空泡病毒40经加热灭活处理的平均灭活对数值分别为≥5.688,≥5.375,≥6.542,≥7.125。透明质酸钠加热灭活工艺可有效灭活病毒。结论透明质酸钠加热灭活工艺可作为透明质酸钠制备过程中灭活病毒工艺,能有效保证产品的安全性。     

输液式关节腔冲洗加玻璃酸钠注射治疗膝关节骨性关节炎60例疗效分析

目的探讨采用关节腔冲洗加玻璃酸钠注射治疗膝关节骨性关节炎的临床疗效。方法选择我院治疗的膝关节骨性关节炎120例患者进行研究,按照治疗方法不同分为治疗组和对照组各60例,两组患者的性别、年龄、疾病类型均无统计学意义（P〉0．05）,所有患者均签署知情同意书,愿意参加本研究。采用SPSS13．0统计软件进行统计描述与分析。结果对两组人群进行治疗效果分析显示,两组患者的治疗效果存在统计学差异（P〈0．05）,治疗组优良率为93．75％,对照组为61．25％,差异有统计学意义（P〈0．05）。结论采用关节腔冲洗加玻璃酸钠注射治疗膝关节骨性关节炎的临床疗效较好,应加强临床推广。     

应用透明质酸钠并球囊子宫支架在预防宫腔镜电切术后宫腔粘连中的疗效观察

目的探讨透明质酸钠联合球囊子宫支架在预防宫腔镜电切术后发生宫腔粘连的效果研究。方法将120例官腔镜电切术患者平均分为观察组和对照组各60例。观察组患者术后在宫腔内注射透明质酸钠并放置球囊子宫支架：对照组患者单纯置入宫内节育器1枚。记录术后1、3个月两组患者的出血量、宫腔粘连情况,并观察两组患者术后有无感染、子宫穿孔、大出血等并发症发生。结果术后1个月和3个月,观察组的宫腔粘连发生情况、术后子宫出血量和并发症发生情况优于对照组,差异有统计学意义。结论官腔镜电切术后应用透明质酸钠配合球囊子宫支架可有效预防宫腔粘连,减少子宫出血。且安全简便,值得临床广泛推广应用。     

医用透明质酸钠预防甲状腺术后切口粘连的有效性和安全性分析

目的分析医用透明质酸钠在预防甲状腺术后切口粘连方面的作用,并观察患者并发症的发生情况。方法在我院进行各类颈部甲状腺手术的患者中选择68例进行研究,其中切口应用医用透明质酸钠的患者34例组成干预组,切口不做任何处理的患者34例组成对照组,对照组和干预组的患者的年龄、性别、病情及手术情况等基本临床资料之间的差异无统计学意义(P>0.05)。对照组患者颈前肌群深面、颈阔肌深面及皮肤切口缝合后不做任何处理,干预组患者颈前肌群深面、颈阔肌深面及皮肤切口缝合后涂抹透明质酸钠,比较两组患者手术半年后患者的切口粘连情况,及切口感染等并发症的发生率。结果对照组患者半年后切口粘连的发生率为5.88%,干预组患者切口粘连的发生率为29.41%,两组之间的差异明显且有统计学意义。对照组出现皮下积液的患者4人,切口感染者1人,患者均未出现过敏性反应或者排异反应;干预组出现皮下积液的患者3人,切口感染1人,患者均未出现过敏和排异反应,二者之间的差异不大,无统计学意义。结论医用透明质酸钠可以有效的预防甲状腺术后切口的粘连,同时不会增加患者的并发症的发生率。既保证了伤口愈合的有效性,同时又保证了患者的安全,在我们临床实践中可以广泛应用。