Di Nisio Marcello, Peinemann Frank, Porreca Ettore, Rutjes Anne W S
Department of Medical, Oral and Biotechnological Sciences, University "G. D'Annunzio" of Chieti-Pescara, via dei Vestini 31, Chieti, Italy, 66013.
Cochrane Database Syst Rev. 2015 Nov 20;2015(11):CD011015. doi: 10.1002/14651858.CD011015.pub2.
Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.
To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.
The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.
RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).
We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.
We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.
AUTHORS' CONCLUSIONS: The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
尽管上肢浅静脉血栓形成是在前臂或手部外周静脉插入静脉导管后常见的并发症,但在临床实践中对于该病症的最佳治疗方法尚无共识。
总结来自随机临床试验(RCT)的证据,以探讨上肢浅静脉血栓形成(局部、口服或肠外)药物治疗的有效性和安全性。
Cochrane血管组试验检索协调员检索了专业注册库(最后检索时间为2015年4月)和Cochrane研究注册库(2015年第3期)。检索临床试验注册库至2015年4月。
RCT,比较任何(局部、口服或肠外)药物治疗与不干预或安慰剂,或比较两种不同的药物干预措施(例如,同一干预措施的不同变体方案或疗程,或不同药理类型的治疗)。
我们提取了有关方法学质量、患者特征、干预措施和结局的数据,包括体征和症状的改善作为主要有效性结局,以及经历研究治疗副作用的参与者数量作为主要安全性结局。
我们识别出13项研究(917名参与者)。评估的治疗方式包括局部治疗(11项研究)、口服治疗(2项研究)和肠外治疗(2项研究)。7项研究使用了安慰剂或无干预对照组,而其他所有研究也或仅比较了活性治疗组。没有研究评估冰或冷、热绷带应用的效果。总体而言,尽管大多数研究中报告不佳妨碍了对风险的全面评估,但个别试验中的偏倚风险为中度至高。每个结局的证据总体质量从低到中不等,主要是由于偏倚风险和不精确性所致,大多数比较仅由单个试验提供数据。由于研究间在比较、结局和测量结局的仪器类型方面存在差异,关于体征和症状改善以及研究治疗所致副作用的主要结局数据无法进行统计学合并。与安慰剂或不干预相比,一系列局部治疗,如类肝素或双氯芬酸凝胶,可改善疼痛。与安慰剂相比,口服非甾体抗炎药可降低体征和症状的强度。安全性问题报告较少,某些干预措施(如三七总皂苷乳膏、肠外低分子量肝素或去纤苷)未提供相关信息。尽管有几项试验报告了局部类肝素乳膏、Essaven凝胶或phlebolan与对照组相比的不良事件,但这些试验的效能不足以充分测量不同治疗方式之间的任何差异。在有报告处,局部治疗的不良事件主要包括局部过敏反应。仅一项纳入15名参与者的研究评估了口服非甾体抗炎药或低分子量肝素的血栓扩展和有症状的静脉血栓栓塞情况,该研究未报告任何此类病例。没有研究报告化脓性静脉炎、导管相关血流感染或生活质量的情况。
关于急性输液相关浅静脉血栓形成治疗的证据有限且质量低。数据似乎过于初步,无法评估局部治疗、全身抗凝或口服非甾体抗炎药的有效性和安全性。