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首页> 外文期刊>Plastic and reconstructive surgery >A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand
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A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand

机译：预期，多中心，随机，评估仪，分型研究，以评估大凝胶透析液与利多卡因的有效性和安全性，以便校正背部的体积缺陷

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Background: Hand rejuvenation has become increasingly popular, but there are few reports published on the use of hyaluronic acid gels for correction of volume deficits in the dorsal hand. Methods: This study evaluated the efficacy and safety of large-gel-particle hyaluronic acid with lidocaine, a 20-mg/ml hyaluronic acid gel with 0.3% lidocaine, compared to no treatment for the correction of volume deficits in the dorsal hand. This was a prospective, multicenter, split-hand study in 90 subjects who received treatment with product in one hand. The primary efficacy endpoint was based on a 1 point of improvement with treatment versus no treatment according to the Merz Hand Grading Scale at week 12. Other assessments included Central Independent Photographic Reviewers evaluations of hand photographs, Global Aesthetic Improvement Scale, subject satisfaction, and safety. Results: The mean injection volume was 2.1 ml at the first treatment. Subjects demonstrated significantly higher response rates with treatment compared to no treatment at week 12 (85.9 percent versus 21.2 percent) and at weeks 16, 20, and 24 (p = 92.8 percent) reported improvements in Global Aesthetic Improvement Scale score across all time points with treatment. Treatment-related adverse events were reported in seven subjects (7.9 percent). Most of these were mild, and none were serious. Conclusion: Hyaluronic acid with lidocaine is safe, effective, and well tolerated for the correction of volume deficits in the dorsal hand.
机译：背景：手中的恢复越来越受欢迎，但是关于透明质酸凝胶的使用很少有报道，用于校正背部手中的体积缺陷。方法：该研究评估了用Lidocaine，20mg / ml透明质酸凝胶的大凝胶颗粒透明质酸的功效和安全性，与0.3％利多卡因相比，除了校正背部手中的体积缺陷。这是在90个受试者中在一方面接受产品治疗的预期，多中心的分歧研究。初级疗效终点基于治疗的1个改善点，与第12周的Merz手分级规模没有治疗。其他评估包括中央独立摄影审查员的手拍照，全球审美改善规模，主体满足和安全性。结果：第一次治疗时平均注射体积为2.1mL。与第12周没有治疗相比，受试者的反应率明显更高（与21.2％的21.2％）和第16,20周（P = 92.8％）报告全球审美改善量表的改进治疗。七个受试者（7.9％）报告了与治疗相关的不良事件。大多数这些都是温和的，而且没有严重。结论：利多卡因的透明质酸是安全，有效的，耐受性，用于校正背部手中的体积缺陷。

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