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双氯芬酸钾凝胶在有或无超声透入情况下对运动损伤的配方及评估

Formulation and Evaluation of Diclofenac Potassium Gel in Sports Injuries with and without Phonophoresis.

作者信息

Bukhari Komal Ammar, Khan Imran Ahmad, Ishaq Shahid, Iqbal Muhammad Omer, Alqahtani Ali M, Alqahtani Taha, Menaa Farid

机构信息

Ali-Ul-Murtaza, Department of Rehabilitation Sciences, Muhammad Institute of Medical and Allied Sciences, Multan 60000, Pakistan.

Department of Pharmacology and Physiology, MNS University of Agriculture, Multan 60000, Pakistan.

出版信息

Gels. 2022 Sep 26;8(10):612. doi: 10.3390/gels8100612.

DOI:10.3390/gels8100612
PMID:36286113
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9601609/
Abstract

Pain remains a global public heath priority. , also known as sonophoresis or ultrasonophoresis, is when an ultrasound is used to maximize the effects of a topical drug. The objective of this study was to test, in patients injured in sports or accidents (N = 200), the efficacy of diclofenac potassium (DK) 6%, 4%, and 2% formulated gels with and without phonophoresis in comparison with market available standard diclofenac sodium (DS or DN) gel. The patients were enrolled after informed consent. By using the lottery method, 100 patients were randomly segregated into five groups without phonophoresis and repeated similarly with phonophoresis at a frequency of 0.8 MHz, an intensity of about 1.5 W/cm, and at continuous mode (2:1). Group-1 was treated with 6% DK gel, group-2 was treated with 4% DK gel, group-3 was treated with 2% DK gel, group-4 was treated with 4% DS gel and group-5 was given control gel three to four times a week for 4 weeks. The patients were screened by using NPRS and WOMAC scales. They were assessed on the baseline, 4th session, 8th session, 12th session, and 16th session. Significant dose-dependently relief was observed in NPRS (Numeric Pain Rating Scale) and the WOMAC (Western Ontario McMaster Osteo-Arthritis) index for pain in disability and stiffness for each group treated with DK gel compared to DS gel. Phonophoresis increased these benefits significantly when used after topical application of DK gel or DS gel, and the dose-dependent effects of DK gel plus phonophoresis were stronger than the dose-dependent effects of DS gel plus phonophoresis. The faster and profounder relief was due to phonophoresis, which allows more penetration of the DK gel into the skin as compared to the direct application of DK gel in acute, uncomplicated soft tissue injury, such as plantar fasciitis, bursitis stress injuries, and tendinitis. In addition, DK gel with phonophoresis was well tolerated. Thus, in this personalized clinical setting, according to the degree of inflammation or injured-induced pain, disability, and stiffness, DK gel 6% with phonophoresis appeared more effective and thus more recommendable than DS gel 6% alone or DS gel 6% combined to phonophoresis.

摘要

疼痛仍然是全球公共卫生的重点问题。超声药物透入疗法,也称为超声导入或超声透药疗法,是指利用超声波来增强局部药物的疗效。本研究的目的是,在因运动或意外受伤的患者(N = 200)中,测试含与不含超声药物透入疗法的6%、4%和2%双氯芬酸钾(DK)配方凝胶,与市售标准双氯芬酸钠(DS或DN)凝胶相比的疗效。患者在签署知情同意书后入组。通过抽签法,将100名患者随机分为五组,一组不接受超声药物透入疗法,另一组以0.8 MHz的频率、约1.5 W/cm的强度并采用连续模式(2:1)接受超声药物透入疗法,分组情况相同。第1组用6% DK凝胶治疗,第2组用4% DK凝胶治疗,第3组用2% DK凝胶治疗,第4组用4% DS凝胶治疗,第5组给予对照凝胶,每周治疗三至四次,共治疗4周。使用数字疼痛评分量表(NPRS)和西安大略和麦克马斯特大学骨关节炎指数(WOMAC)对患者进行筛查。在基线、第4次治疗、第8次治疗、第12次治疗和第16次治疗时对患者进行评估。与DS凝胶相比,用DK凝胶治疗的每组患者在NPRS(数字疼痛评分量表)和WOMAC(西安大略和麦克马斯特大学骨关节炎)指数的疼痛、残疾和僵硬方面均观察到显著的剂量依赖性缓解。在局部应用DK凝胶或DS凝胶后使用超声药物透入疗法可显著增强这些益处,并且DK凝胶加超声药物透入疗法的剂量依赖性效应强于DS凝胶加超声药物透入疗法的剂量依赖性效应。更快、更显著的缓解归因于超声药物透入疗法,与在急性、非复杂性软组织损伤(如足底筋膜炎、滑囊炎应激性损伤和肌腱炎)中直接应用DK凝胶相比,超声药物透入疗法可使DK凝胶更多地渗透到皮肤中。此外,含超声药物透入疗法的DK凝胶耐受性良好。因此,在这种个性化临床环境中,根据炎症程度或损伤引起的疼痛、残疾和僵硬情况,含超声药物透入疗法的6% DK凝胶似乎比单独的6% DS凝胶或6% DS凝胶联合超声药物透入疗法更有效,因此更值得推荐。

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