http://www.medscape.com/viewarticle/859747_3
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Safety(安全性)
The safety population included all 60 patients, who were randomized and received a safety evaluation at least one time after treatment. Both products were well tolerated, with the majority of patients reporting no or only mild injection-site reactions. The number of treatment-related adverse events was six (20.69 percent); five were injection-site pain and one was swelling/edema for Perlane-L, and one (3.45 percent) was injection-site pain for Neuramis. All adverse events were mild in intensity and resolved spontaneously without additional treatment
只有少數(6%)發生包紅腫, 疼痛等輕微不良反應, 並無嚴重併發症。
效果的部份, 無論是客觀的量表, 研究者的盲測, 與患者自身感受, 都是有效果的。
Efficacy: Independent Expert Panel Assessment (Photographic Assessment)
效果: 以量表測量
After 8 weeks, the mean Wrinkle Severity Rating Scale score decreased from 3.47 ± 0.50 at baseline to 1.69 ± 0.47 for the Neuramis-treated side, and to 1.86 ± 0.40 for the Perlane-L–treated side (p < 0.05) (Fig. 2). The mean Wrinkle Severity Rating Scale scores were 1.78 ± 0.42 and 1.83 ± 0.42 for the Neuramis-treated side at weeks 16 and 24, respectively, and were both significantly lower than scores for the Perlane-L side (1.97 ± 0.32 at week 16 and 2.02 ± 0.32 at week 24; both p < 0.05) (Fig. 2).
Figure 2.
Wrinkle Severity Rating Scale (WSRS) score of Neuramis (NDL ) and Perlane-L (PERL ) evaluated with photographic assessment by three independent expert panels. *p < 0.05, difference between Neuramis and Perlane-L.
The primary efficacy endpoint was the mean improvement in independent expert panel–assessed Wrinkle Severity Rating Scale score from baseline to week 24. At week 24, the mean improvement of the Wrinkle Severity Rating Scale score from baseline was 1.64 ± 0.74 for the Neuramis side, which was significantly greater than that of the Perlane-L side (1.45 ± 0.54; p < 0.05). The 97.5 percent confidence interval was well above the predefined margin for noninferiority, indicating that the efficacy of Neuramis was comparable to that of Perlane-L at week 24 after injection.
In both groups, 100 percent of participants had a greater than or equal to one-grade improvement of the Wrinkle Severity Rating Scale score at weeks 8 and 16. After 24 weeks, the percentage of participants who had a greater than or equal to one-grade improvement of the Wrinkle Severity Rating Scale score was 98.28 percent (57 of 58) for the side treated with Neuramis and 100 percent for the side treated with Perlane-L. Examples of clinical improvement are shown in Figures 3 and 4.
Figure 3.
Results of nasolabial fold correction in participant A. The participant received Neuramis in the participant's left nasolabial fold and Perlane-L in the participant's right nasolabial fold. Photographs shown are at baseline and at weeks 8, 16, and 24.
Figure 4.
Results of nasolabial fold correction in participant B. The participant received Neuramis in the participant's right nasolabial fold and Perlane-L in the participant's left nasolabial fold. Photographs shown are at baseline and at weeks 8, 16, and 24.
Efficacy: Blinded Investigator Assessment (Live Assessment)
效果: 研究者盲測
The mean Wrinkle Severity Rating Scale scores assessed by the blinded investigators were 1.64 ± 0.48, 1.69 ± 0.47, and 1.69 ± 0.47 for the Neuramis side at weeks 8, 16, and 24, respectively, and were all significantly lower than scores for the Perlane-L side (1.83 ± 0.42, 1.95 ± 0.35, and 2.00 ± 0.32 at weeks 8, 16, and 24, respectively; all p < 0.05) (Fig. 5).
Figure 5.
Wrinkle Severity Rating Scale (WSRS) score of Neuramis (NDL ) and Perlane-L (PERL ) evaluated with live assessment by blinded investigators. *p < 0.05, difference between Neuramis and Perlane-L.
The mean Global Aesthetic Improvement Scale scores assessed by the blinded investigators for the side treated with Neuramis were 2.62 ± 0.49, 2.50 ± 0.50, and 2.36 ± 0.55 at weeks 8, 16, and 24, respectively, and were all significantly greater than scores for the side treated with Perlane-L (2.41 ± 0.59, 2.17 ± 0.53, and 2.00 ± 0.50 at weeks 8, 16, and 24, respectively; all p < 0.05) (Fig. 6). In both groups, 100 percent of participants had a greater than or equal to one-grade improvement of the blinded investigator–assessed Global Aesthetic Improvement Scale score at all study visits.
Figure 6.
Global Aesthetic Improvement Scale (GAIS) score for Neuramis (NDL ) and Perlane-L (PERL ) evaluated with live assessment by blinded investigators. *p < 0.05, difference between Neuramis and Perlane-L.
Efficacy: Participant Self-assessment
效果: 患者自身感受
The mean Global Aesthetic Improvement Scale scores assessed by participants for the side treated with Neuramis were 2.34 ± 0.69, 2.03 ± 0.79, and 1.78 ± 0.90 at weeks 8, 16, and 24, respectively, and were all greater than scores for the side treated with Perlane-L (2.10 ± 0.77, 1.88 ± 0.80, and 1.55 ± 0.86 at weeks 8, 16, and 24, respectively; p < 0.05, p = 0.0979, and p < 0.05, respectively) (Fig. 7).
Figure 7.
Global Aesthetic Improvement Scale (GAIS) score for Neuramis (NDL ) and Perlane-L (PERL ) evaluated by participant self-assessment. *p < 0.05, difference between Neuramis and Perlane-L.
The percentages of participants who showed a greater than or equal to one-grade improvement of the participant self-assessed Global Aesthetic Improvement Scale score from baseline for the side treated with Neuramis were 100 percent, 100 percent, and 93.10 percent at weeks 8, 16, and 24, respectively; for the side treated with Perlane-L, the scores were 96.55, 96.55, and 87.93 percent at weeks 8, 16, and 24, respectively. There was no significant difference between the two groups at any of the study visits.
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