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透明质酸填充剂联合或不联合利多卡因治疗鼻唇沟皱纹的疗效和安全性:一项更新的系统评价和荟萃分析。

Efficacy and Safety of Hyaluronic Acid Fillers With or Without Lidocaine in the Treatment of Nasolabial Folds: An Updated Systematic Review and Meta-Analysis.

机构信息

Department of Burn Plastic and Cosmetic Surgery, Liaocheng People's Hospital, No. 67, Dongchang West Road, Dongchangfu District, Liaocheng, 252000, Shandong Province, China.

Department of Medical Cosmetic, Chiping District People's Hospital, Chiping District, Liaocheng, 252000, Shandong Province, China.

出版信息

Aesthetic Plast Surg. 2024 Nov;48(21):4466-4484. doi: 10.1007/s00266-024-04233-5. Epub 2024 Jul 16.

Abstract

OBJECTIVE

To update the evidence on the effectiveness and safety of hyaluronic acid gel combined with lidocaine for treating nasolabial folds.

METHODS

We searched electronic databases including PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science using subject headings and keywords associated with hyaluronic acid and lidocaine in the context of nasolabial folds. Inclusion criteria were met by randomized controlled trials (RCTs) comparing the efficacy and safety of hyaluronic acid gel with or without lidocaine. Outcomes measured included visual pain analog scale (VAS) scores, wrinkle severity scale scores, and adverse events. The quality of RCTs was evaluated using the Cochrane Randomized Controlled Trials Scale, which encompasses criteria such as randomization, allocation concealment, blinding, dropout, and withdrawal rates, and was assessed by two independent reviewers.

RESULTS

No significant difference in overall wrinkle severity rating scale scores was observed between HA with lidocaine and HA without lidocaine [MD = 0.08, 95% CI (- 0.09, 0.24), P = 0.36]. However, there was a significant reduction in pain scale scores (VAS) [SMD = -2.47, 95% CI (- 4.15, - 0.79), P = 0.004]; no significant differences were noted in the ncidence of at least one adverse event [RR = 0.97, 95% CI (0.90, 1.05), P = 0.51]; and there were no significant differences in swelling [RR =  0.99, 95% CI (0.92, 1.06), P = 0.80], erythema [RR = 1.01, 95% CI (0.91, 1.11), P = 0.91], bruising [RR = 0.99, 95% CI (0.89, 1.13), P = 0.86], itching [RR = 1.03, the 95% CI (0.88, 1.21), P = 0.74], induration [RR = 1.04, 95% CI (0.92, 1.17), P = 0.55], and papules [RR = 0.77, 95% CI (0.58, 1.02), P = 0.07]. There was a significantly lower incidence of tenderness [RR = 0.91, 95% CI (0.86, 0.97), P = 0.002] only in the control group. Sensitivity analysis confirmed the stability of results across all outcome indicators with low sensitivity and high confidence. Subgroup analysis indicated higher wrinkle severity scores among East Asians compared to Europeans and Americans.

CONCLUSIONS

HA containing lidocaine significantly reduces pain and is comparable in effectiveness and safety of HA without lidocaine. The clinical effects appear more pronounced in East Asians. Due to the limited number of related studies, further research is necessary.

LEVEL OF EVIDENCE I

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

目的

更新透明质酸凝胶联合利多卡因治疗鼻唇沟的有效性和安全性证据。

方法

我们使用与透明质酸和利多卡因在鼻唇沟背景下相关的主题词和关键词,在包括 PubMed、Embase、Cochrane 对照试验中心注册库和 Web of Science 在内的电子数据库中进行检索。纳入标准是比较透明质酸凝胶联合或不联合利多卡因的疗效和安全性的随机对照试验(RCT)。使用 Cochrane 随机对照试验量表评估 RCT 的质量,该量表涵盖了随机化、分配隐匿、盲法、脱落和退出率等标准,并由两名独立评审员进行评估。

结果

在总体皱纹严重程度评分量表评分方面,含利多卡因的透明质酸与不含利多卡因的透明质酸之间没有显著差异[MD=0.08,95%CI(-0.09,0.24),P=0.36]。然而,疼痛量表评分(VAS)显著降低[SMD=-2.47,95%CI(-4.15,-0.79),P=0.004];至少有一项不良反应的发生率无显著差异[RR=0.97,95%CI(0.90,1.05),P=0.51];肿胀[RR=0.99,95%CI(0.92,1.06),P=0.80]、红斑[RR=1.01,95%CI(0.91,1.11),P=0.91]、瘀伤[RR=0.99,95%CI(0.89,1.13),P=0.86]、瘙痒[RR=1.03,95%CI(0.88,1.21),P=0.74]、硬结[RR=1.04,95%CI(0.92,1.17),P=0.55]和丘疹[RR=0.77,95%CI(0.58,1.02),P=0.07]的发生率无显著差异。仅在对照组中,压痛的发生率显著降低[RR=0.91,95%CI(0.86,0.97),P=0.002]。敏感性分析证实了所有结局指标结果的稳定性,敏感性低,可信度高。亚组分析表明,东亚人的皱纹严重程度评分高于欧洲人和美国人。

结论

含利多卡因的透明质酸可显著减轻疼痛,且与不含利多卡因的透明质酸在疗效和安全性方面相当。在东亚人中,其临床效果似乎更为明显。由于相关研究数量有限,需要进一步研究。

证据水平 I:本杂志要求作者为每篇文章指定一个证据水平。有关这些循证医学评级的完整描述,请参考目录或在线作者指南 www.springer.com/00266。

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