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硫酸钙:有何证据?

Calcium sulfates: what is the evidence?

机构信息

Division of Orthopaedic Surgery, Department of Surgery, St. Michael's Hospital and the University of Toronto, Toronto, Canada.

出版信息

J Orthop Trauma. 2010 Mar;24 Suppl 1:S46-51. doi: 10.1097/BOT.0b013e3181cec48e.

Abstract

Calcium sulphate has been used extensively as a bioabsorbable bone substitute for 90 years. Its advantages include its low cost, ready availability and unlimited supply, lack of donor site morbidity, use as a delivery vehicle for other compounds (especially antibiotics), inherent osteoconductive properties (based on a structure similar to bone), and its proven safety record. We sought to determine the evidence-based medical studies (prospective and/or randomized clinical trials) that support the use of calcium sulphate as a bioabsorbable bone substitute. At the present time, the majority of reports are basic science investigations, animal studies, and retrospective clinical reviews of varying degrees of quality. Multiple retrospective reviews reveal that calcium sulphate is an effective void-filler in contained bony defects such as metaphyseal voids after impacted fracture reduction (calcaneus, tibial plateau), simple bone cysts, or posttraumatic defects. Three case series examining the use of calcium sulphate in the treatment of bone nonunions revealed a significant failure rate, suggesting that this material, used in isolation, is not optimal to promote union in that setting. A low but consistent complication rate, specifically serous drainage from the wound as the calcium sulphate absorbs, has been reported. This complication is higher when the material is used in higher volumes (greater than 20 mL) or in subcutaneous bones (tibia, ulna). There is some Level I to II evidence (one randomized trial, one case-control study, one prospective cohort study) that antibiotic-impregnated bioabsorbable calcium sulphate has the potential to reduce the number of procedures and surgical morbidity associated with the surgical treatment of chronic osteomyelitis and infected nonunion while maintaining a high rate of infection eradication. Calcium sulphate remains an inexpensive, safe, reliable bone void filler that can also serve as a absorbable delivery vehicle for antibiotics or other compounds. Further high-quality randomized and prospective clinical trials are required to define the role of calcium sulphate in modern orthopaedics.

摘要

硫酸钙作为一种可生物吸收的骨替代物已经广泛应用了 90 年。其优点包括成本低、供应充足、来源广泛、不会引起供区并发症、可作为其他化合物(尤其是抗生素)的载体、具有固有骨诱导特性(基于与骨骼相似的结构)以及经过验证的安全性记录。我们旨在确定支持硫酸钙作为可生物吸收的骨替代物使用的基于循证医学的研究(前瞻性和/或随机临床试验)。目前,大多数报告都是基础科学研究、动物研究以及不同质量的回顾性临床研究。多项回顾性研究表明,硫酸钙是一种有效的填充材料,可用于填充有一定限制的骨缺损,如骨折复位后的干骺端缺损(跟骨、胫骨平台)、单纯性骨囊肿或创伤后缺损。三项研究硫酸钙在治疗骨不连中的应用的病例系列研究报告了较高的失败率,表明这种单独使用的材料在这种情况下并不适合促进愈合。有报道称,其并发症发生率较低但较为一致,即当硫酸钙吸收时伤口会出现浆液性引流。当材料用量较大(大于 20 毫升)或在皮下骨(胫骨、尺骨)中使用时,这种并发症的发生率更高。有一些 I 级到 II 级证据(一项随机试验、一项病例对照研究、一项前瞻性队列研究)表明,载抗生素的可生物吸收硫酸钙具有减少与慢性骨髓炎和感染性骨不连的手术治疗相关的手术次数和手术并发症的潜力,同时保持较高的感染清除率。硫酸钙仍然是一种廉价、安全、可靠的骨填充材料,也可以作为抗生素或其他化合物的可吸收载体。需要进一步开展高质量的随机和前瞻性临床试验,以确定硫酸钙在现代骨科中的作用。

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