中国临床药理学杂志

注射用透明质酸钠凝胶随机对照非劣效性研究

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李贺 ¹ , 金远方 ² , 黄芳芳 ² , 寿晓玲 ¹ , 李娜 ¹

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(18): 2645-2649

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (18) : 2645 -2649

注射用透明质酸钠凝胶随机对照非劣效性研究

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李贺¹, 金远方², 黄芳芳², 寿晓玲¹, 李娜¹

作者信息

^1.浙江医院临床试验机构，浙江杭州 310013

^2.浙江景嘉医疗科技有限公司，浙江杭州 311222

通讯作者:

寿晓玲，主任医师 Tel: （0571）87377026 E-mail: shxili5@163.com

作者简介:

李贺（1982-），女，助理研究员，主要从事临床研究工作

Randomized controlled non-inferiority study of sodium hyaluronate gel for injection

He LI¹, Yuan-fang JIN², Fang-fang HUANG², Xiao-ling SHOU¹, Na LI¹

Affiliations

^1.Department of Clinical Trial Institution, Zhejiang Hospital, Hangzhou 310013, Zhejiang Province, China

^2.Zhejiang Jingjia Medical Technology Co., Ltd., Hangzhou 311222, Zhejiang Province, China

出版时间: 2025-09-28 doi: 10.13699/j.cnki.1001-6821.2025.18.013

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摘要

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目的

比较两个不同公司生产的透明质酸钠凝胶用于纠正中重度鼻唇沟部皱纹的安全性和有效性。

方法

本研究将2019年3月至2019年8月就诊的有鼻唇沟美容意愿的健康受试者，按照1∶1比例随机分配至试验组和对照组，单次注射透明质酸钠凝胶后随访至12个月。主要评价指标为双侧鼻唇部注射前与注射后6个月皱纹改善的有效率。次要评价指标为研究者和受试者于不同时间对皱纹严重程度（WSRS）评分，及全局美容效果（GAIS）评分。

结果

符合方案集受试者共纳入137例，其中试验组和对照组分别为70例和67例。与基线相比，注射后6个月，试验组和对照组改善一个等级及以上的有效率分别为94.29%（66例/70例）和94.03%（63例/67例），两组率差为0.26%，率差（渐进正态）95%置信限[-0.08，0.08]，下限大于非劣效界值-10%，试验组有效性非劣效于对照组。注射后6个月，试验组和对照组研究者WSRS评分左侧分别为（2.13±0.64）和（2.22±0.6）分，右侧分别为（2.23±0.68）和（2.3±0.6）分；受试者WSRS评分左侧分别为（2.24±0.79）和（2.32±0.84）分，右侧分别为（2.18±0.77）和（2.29±0.76）分。试验组和对照组研究者GAIS评分认为有改善的比率分别为98.57%（69例/70例）和97.01%（65例/67例）；受试者GAIS评分认为有改善的比率分别为88.57%（62例/70例）和86.57%（58例/67例），在统计学上差异均无统计学意义（均P>0.05）。2组间不良反应及不良事件的发生率比较在统计学上差异均无统计学意义（均P>0.05）。

结论

试验组透明质酸钠凝胶用于纠正中重度鼻唇沟部皱纹的有效性不劣于对照器械。并且具有相似的安全性。

关键词

透明质酸钠凝胶 / 鼻唇沟部皱纹 / 皱纹严重程度评分 / 非劣效性研究

Abstract

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Objective

To compare the safety and efficacy of two different companies’ sodium hyaluronic acid gels for correcting moderate to severe nasolabial folds, and evaluate the non-inferiority of the test device to the control device.

Methods

This study included healthy subjects with the desire for nasolabial fold beauty who visited the hospital from March to August 2019, the subjects were randomly assigned to the test group and the control group at a ratio of 1∶1, and followed up to 12 months after a single injection sodium hyaluronic acid gel. The primary efficacy evaluation index was the effective rate of wrinkle improvement in the bilateral nasolabial area before and 6 months injection. The secondary efficacy evaluation indexes were the Wrinkles Severity Rating Scale (WSRS) scores of wrinkle improvement at different time points by the investigator and the subjects, and the Global Aesthetic Improvement Scale (GAIS) scores.

Results

A total of 137 subjects were included per protocol set, with 70 in the test group and 67 in the control group, respectively. Compared with the baseline, the effective rates of improvement of one grade or above in the test group and the control group were 94.29% (66 cases/70 cases) and 94.03% (63 cases/67 cases), respectively, with a difference of 0.26% between the two groups, and the 95% limit of the difference (asymptotic normal) was [-0.08, 0.08], with the lower limit greater the non-inferiority limit of -10%, and the efficacy of the test group was not inferior to that of the control group. At 6 months post-injection, the investigator’s WSRS scores on the left of the test and control groups were (2.13±0.64) and (2.22±0.6) points, respectively, on the right side were (2.23±0.68) and (2.3±0.6) points; the subjects’ WSRS scores on the left were (2.24±0.79) and (2.32±0.84) points, on the right side were (2.18±0.77) and (2.29±0.76) points, respectively. The investigator’s GAIS of the test and control groups that were regarded as improved were 98.57% (69 cases/70 cases) and 97.01% (65 cases/67 cases), respectively; the subjects’ GAIS that were regarded as improved were 88.5% (62 cases/70 cases) and 86.57% (58 cases/67 cases), respectively, and there was no statistically significant difference between the groups all (P>0.05). In addition, there was no significant difference in the incidence of adverse reactions/adverse events between the two groups (P>0.05).

Conclusion

The effectiveness of the test group sodium hyaluronate gel for correcting moderate to severe nasolabial folds was not inferior to that of the control. And it has similar safety.

Key words

hyaluronic acid gel / nasolabial folds / WSRS scores / non-inferiority trial

引用本文

李贺, 金远方, 黄芳芳, 寿晓玲, 李娜. 注射用透明质酸钠凝胶随机对照非劣效性研究. 中国临床药理学杂志, 2025 , 41 (18) : 2645 -2649 . DOI: 10.13699/j.cnki.1001-6821.2025.18.013

He LI, Yuan-fang JIN, Fang-fang HUANG, Xiao-ling SHOU, Na LI. Randomized controlled non-inferiority study of sodium hyaluronate gel for injection[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (18) : 2645 -2649 . DOI: 10.13699/j.cnki.1001-6821.2025.18.013

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2025年第41卷第18期

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文章信息

doi: 10.13699/j.cnki.1001-6821.2025.18.013

接收时间：2025-05-28
首发时间：2026-08-05
出版时间：2025-09-28

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收稿日期：2025-05-28

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作者信息

^1.浙江医院临床试验机构，浙江杭州 310013

^2.浙江景嘉医疗科技有限公司，浙江杭州 311222

通讯作者:

寿晓玲，主任医师 Tel: （0571）87377026 E-mail: shxili5@163.com

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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