Wanitphakdeedecha Rungsima, Ungaksornpairote Chanida, Kaewkes Arisa, Sathaworawong Angkana, Vanadurongwan Bavornrat, Lektrakul Nittaya
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
J Cosmet Dermatol. 2018 Dec;17(6):984-990. doi: 10.1111/jocd.12787. Epub 2018 Sep 10.
Enlarged, hypertrophy calf muscles are common in Asian women and can cause psychological burden. Botulinum toxin A (BTA) has been widely used in treating masseteric muscle hypertrophy and it's efficacious as a noninvasive method for calf-contouring has been reported. Food and Drug Administration has approved onabotulinumtoxin A (ONA, Botox; Allergan Inc, Irvine, CA, USA) for upper face rejuvenation and it has off-label uses for calf-contouring. A recently introduced Prabotulinumtoxin A (NABOTA , PRA; Daewoong Pharmaceutical, Seoul, Korea) demonstrated a comparable efficacy and safety to ONA for masseter reduction.
To compare the efficacy and safety of PRA and ONA gastrocnemius muscle reduction.
This is an experimental, randomized, controlled double-blind study. Twenty-two patients were randomized to receive 100 units PRA and ONA on each calf and were asked to come for follow-up visit for up to 6 months. Clinical photographic documentation, calf circumference measurement (upright position and tiptoe), isokinetic analysis, and ultrasonographic imaging were performed to evaluate the treatment result. In addition, patients' satisfaction and side effect were also recorded.
All patients completed the study without serious side effect occurred during the whole study period. The mean calf circumference of the ONA- and PRA-treated patients in upright position at baseline was 35.42 ± 1.35 cm and 36.49 ± 2.98 cm, respectively (P = 0.137). The mean calf circumference in upright position decreased significantly as early as 2 weeks after treatment, both in ONA group and in PRA group (P = 0.004 and P = 0.003, respectively), and continued to decrease until 6 months after treatment (P = 0.002 and P < 0.001, respectively). There was no statistically significant difference in mean calf circumference when comparing between ONA and PRA group at any time of follow-up period. For the tiptoe position, only in the PRA group that showed significant reduction as early as two weeks and lasted up to 6 months of follow-up (P < 0.001). The isokinetic analysis showed no significant reduction on both maximum torque and average work value in two groups. The ultrasonographic imaging revealed that the mean thickness of the lateral head of the gastrocnemius showed significant only in PRA-treated group at 2-, 3-, and 6-months of follow-up; meanwhile, the mean thickness of the medial head showed significant reduction at 2- and 6-months, with a slight increase at 3-months follow-up in two groups. The patients' satisfaction rate and doctor's evaluation also showed no statistically significant difference between both groups.
This study demonstrated that PRA and ONA provided comparable efficacy and safety in gastrocnemius muscle reduction.
小腿肌肉增大、肥厚在亚洲女性中很常见，会造成心理负担。A型肉毒毒素（BTA）已广泛用于治疗咬肌肥大，并且有报道称其作为一种无创瘦小腿方法是有效的。美国食品药品监督管理局已批准阿毒素（ONA，保妥适；美国加利福尼亚州欧文市艾尔建公司）用于面部上半部分年轻化，其在瘦小腿方面属于超适应症用药。最近推出的帕毒素（NABOTA，PRA；韩国首尔大熊制药公司）在咬肌缩小方面显示出与ONA相当的疗效和安全性。
比较PRA和ONA在腓肠肌缩小方面的疗效和安全性。
这是一项实验性、随机、对照双盲研究。22例患者被随机分为两组，每组患者每侧小腿分别注射100单位PRA和ONA，并要求进行长达6个月的随访。通过临床摄影记录、小腿围度测量（直立位和踮脚位）、等速运动分析和超声成像来评估治疗效果。此外，还记录了患者的满意度和副作用。
所有患者均完成研究，整个研究期间未发生严重副作用。基线时，ONA组和PRA组患者直立位时的平均小腿围度分别为35.42±1.35厘米和36.49±2.98厘米（P = 0.137）。治疗后2周，ONA组和PRA组直立位时的平均小腿围度均显著降低（分别为P = 0.004和P = 0.003），并持续降低至治疗后6个月（分别为P = 0.002和P < 0.001）。在随访期的任何时间，比较ONA组和PRA组时，平均小腿围度均无统计学显著差异。对于踮脚位，仅PRA组在随访2周时就显示出显著降低，并持续至6个月（P < 0.001）。等速运动分析显示两组的最大扭矩和平均功值均无显著降低。超声成像显示，仅PRA治疗组在随访2、3和6个月时腓肠肌外侧头的平均厚度显著降低；同时，两组在随访2个月和6个月时内侧头的平均厚度显著降低，在随访3个月时略有增加。两组患者的满意度和医生评价也无统计学显著差异。
本研究表明，PRA和ONA在腓肠肌缩小方面具有相当的疗效和安全性。
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