目的：评估一种新型注射用透明质酸钠凝胶在鼻部整形中的临床效果及安全性能。

方法：采用多中心、前瞻性、随机、评估者设盲的平行对照设计。5家研究中心共纳入203例有鼻背和/或鼻根塑形需求的受试者，通过区组随机化方法分配至试验组（n=101）或对照组（n=102）。两组受试者在入组当天接受透明质酸钠凝胶注射，并于注射后1、3、6、9、12个月进行随访，比较两组基线资料、注射塑形后全局美容效果分级参考量表（Global Aesthetic Improvement Scale，GAIS）评分、疼痛视觉模拟量表（Visual Analogue Scale，VAS）评分及不良事件发生率。由盲态评估者测量鼻背/鼻根体积较基线的变化值，以评估该交联透明质酸钠凝胶的临床效果和安全性。

结果：本研究共纳入203名受试者，其中182人完成随访，试验组89人，对照组93人。受试者平均年龄33.6±9.1岁，女性受试者占比91.1%。均采用多点注射法，平均注射点数3.9±2.1处，平均注射剂量0.82±0.18mL。注射塑形后6个月鼻背和/或鼻根体积相对基线的变化值试验组为0.63±0.26mL，对照组为0.58±0.26mL，有效性一致（P＞0.05）。注射后6个月GAIS评分（注射研究者评价、受试者评价）试验组与对照组差异无显著性（P＞0.05）。注射后即刻和30分钟患者VAS评分试验组均优于对照组（P＜0.05）。治疗后不良反应发生率试验组为47.5%，对照组为42.2%，所有与器械相关的不良反应结局均为症状消失。

结论：该新型注射用交联透明质酸钠凝胶可有效用于鼻背和/或鼻根的塑形，且安全性较好。

Objective: To evaluate the efficacy and safety of a novel injectable sodium hyaluronate gel for nasal contouring.

Methods: This study was a multicenter, prospective, randomized, evaluator-blinded, parallel-controlled trial. A total of 203 subjects who wished to contour their nasal dorsum and/or nasal root were recruited in our center. Block randomization was used to generate a random code table for grouping, and subjects were randomly divided into the experimental group (n=101) and the control group (n=102) at a ratio of 1:1. On day 0 after randomization, the injectors administered the sodium hyaluronate gel to the subjects in both groups. Follow-ups were conducted at 1 month, 3 months, 6 months, 9 months, and 12 months after injection. The general information of the subjects, Global Aesthetic Improvement Scale (GAIS) scores, Visual Analogue Scale (VAS) scores for pain, and adverse reactions were compared and analyzed between the two groups. An independent blinded evaluator assessed the changes in the volume of the nasal dorsum and/or nasal root relative to the baseline after injection to evaluate the efficacy and safety of the cross-linked sodium hyaluronate gel for nasal contouring.

Results: A total of 203 subjects were enrolled in this study, with 182 completing the follow-up (89 in the test group and 93 in the control group). The mean age of the subjects was 33.6 ± 9.1 years, with female participants accounting for 91.1%. All subjects received multi-point injections, with an average of 3.9 ± 2.1 injection sites and a mean injection volume of 0.82 ± 0.18 mL. At 6 months post-injection, the changes in nasal dorsum and/or root volume from baseline were 0.63 ± 0.26 mL in the test group and 0.58 ± 0.26 mL in the control group, showing comparable efficacy (P > 0.05). There was no significant difference in GAIS scores (evaluated by both the injector and the subjects) between the two groups at 6 months (P > 0.05). However, the test group demonstrated significantly better VAS scores than the control group immediately after injection and at 30 minutes post-injection (P < 0.05). The incidence of adverse events was 47.5% in the test group and 42.2% in the control group, with all device-related adverse events resolving spontaneously.

Conclusion: The injectable cross-linked sodium hyaluronate gel can be effectively used for the contouring of the nasal dorsum and/or nasal root, and it has good safety.