Shome Debraj, Khare Stuti, Kapoor Rinky
J Drugs Dermatol. 2019 Mar 1;18(3):266-272.
Copy: The injectable adipocytolytic drug deoxycholic acid (DCA) is the first pharmacological intervention approved for the reduction of submental fat (SMF) and offers an alternative to invasive measures to improve the submental profile and the cervico-mental angle. DCA injection (ATX-101, Kybella [United States], Belkyra [Canada]; Kythera Biopharmaceuticals, Inc., Westlake Village, CA, acquired by Allergan, Inc.), are proprietary formulations of synthetically derived DCA that is FDA approved for improvement in the appearance of moderate to severe convexity or fullness associated with SMF. Aim: As none of the aforementioned are available in India, we undertook this study to study the efficacy of generic DCA for SMF reduction in Indian patients. Methods: 50 patients with confirmed Indian ethnicity and unwanted SMF were injected 3 mg/cm2 of generic DCA into their SMF, with a 12-week follow-up period. In each session, 5 ml of 30 mg /ml DCA was injected. The sessions were spaced approximately 2 months apart. All these patients with reductions in SMF were reported using Clinician Reported SMF Rating Scale (CR-SMFRS) and Patient Reported SMF Rating Scale (PR-SMFRS) using the Validated Rating Scale for improvement in the appearance of their chin, the neck, and the cervico-mental profile. Also, for objective assessment of improvement in SMF, caliper measurements were used. Results: One session was required in 2 patients, 12 patients needed 2 sessions, 32 patients needed 3 sessions, and 4 patients needed 4 sessions. Altogether, 90% patients showed at least a decrease of 1 point in (CR-SMFRS). Reduction in SMF as confirmed by caliper measurements was statistically significant. Conclusion: The findings show generic deoxycholic acid to be equally effective in the treatment for SMF in Indian patients. J Drugs Dermatol. 2019;18(3):266-272.
可注射的溶脂药物脱氧胆酸(DCA)是首个被批准用于减少颏下脂肪(SMF)的药物干预手段,为改善颏下外观和颈颏角提供了一种侵入性措施的替代方法。DCA注射剂(ATX - 101、Kybella[美国]、Belkyra[加拿大];Kythera生物制药公司,加利福尼亚州西湖村,已被艾尔建公司收购)是合成衍生DCA的专利配方,已获美国食品药品监督管理局(FDA)批准用于改善与SMF相关的中度至重度凸起或丰满外观。目的:由于上述产品在印度均未上市,我们开展了这项研究,以研究通用型DCA对减少印度患者SMF的疗效。方法:50名确诊为印度族裔且有多余SMF的患者,在其SMF部位注射3mg/cm²的通用型DCA,并进行为期12周的随访。每次注射时,注射5ml浓度为30mg/ml的DCA。各次注射间隔约2个月。所有这些SMF减少的患者均使用临床医生报告的SMF评分量表(CR - SMFRS)和患者报告的SMF评分量表(PR - SMFRS)进行报告,该量表使用经过验证的评分量表来评估其下巴、颈部和颈颏轮廓外观的改善情况。此外,为了客观评估SMF的改善情况,使用了卡尺测量。结果:2名患者需要1次注射,12名患者需要2次注射,32名患者需要3次注射,4名患者需要4次注射。总体而言,90%的患者在(CR - SMFRS)中至少下降了1分。经卡尺测量证实的SMF减少具有统计学意义。结论:研究结果表明,通用型脱氧胆酸在治疗印度患者的SMF方面同样有效。《药物皮肤病学杂志》。2019年;18(3):266 - 272。