In Vivo Evaluation of Safety and Efficacy of Ethyl Cellulose-Ethanol Tissue Ablation in a Swine Cervix Model.
In Vivo Evaluation of Safety and Efficacy of Ethyl Cellulose-Ethanol Tissue Ablation in a Swine Cervix Model.
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DOI：
10.3390/bioengineering10111246
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发表时间：
2023-10-25
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影响因子：
--
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目前治疗宫颈发育不良的疗法在低收入和中等收入国家往往难以获得，这凸显了对可在护理点提供的新型低成本疗法的需求。乙醇消融是一种低成本的治疗局部癌症的方法，我们将其添加到乙基纤维素(EC)-乙醇凝胶配方中以提高其疗效。在这里，我们评估ec -乙醇消融是否能够安全地达到与热凝相当的消融区域，热凝是一种常用的治疗宫颈发育不良的方法。研究对象为20头雌性约克郡猪，分别在子宫颈12点钟位置单次注射500µL ec -乙醇或在100°C下单次热凝20 s。在整个ec -乙醇过程中，平均体温、心率、呼吸频率和血氧保持在正常范围内，与热凝组相似。没有观察到主要的副作用。24 h后切除生殖道检查消融区。ec -乙醇组（18.6±1.6 mm）和热凝组（19.7±4.1 mm）的坏死深度相当。单次注射ec -乙醇诱导的坏死体积（626.2±122.8µL）与热凝诱导的上半部分坏死体积（664.6±168.5µL）相当。这表明，可以进行两次ec -乙醇注射（例如，在12点和6点位置），以获得与热凝相当的总坏死体积，并安全有效地治疗中低收入国家宫颈发育不良妇女。这是第一个在大型动物模型中系统评估ec -乙醇消融的研究，并将其与热凝治疗的安全性和有效性进行比较，热凝是一种常用的治疗宫颈发育不良的消融疗法。
Current therapies for treating cervical dysplasia are often inaccessible in low and middle-income countries (LMICs), highlighting the need for novel low-cost therapies that can be delivered at the point of care. Ethanol ablation is a low-cost therapy designed to treat locoregional cancers, which we augmented into an ethyl cellulose (EC)-ethanol gel formulation to enhance its efficacy. Here, we evaluated whether EC-ethanol ablation is able to safely achieve an ablation zone comparable to thermocoagulation, a commonly used therapy for cervical dysplasia. The study was performed in 20 female Yorkshire pigs treated with either a single 500 µL injection of EC-ethanol into the 12 o’clock position of the cervix or a single application of thermocoagulation at 100 °C for 20 s. The average temperature, heart rate, respiratory rate, and blood oxygen remained within normal ranges throughout the EC-ethanol procedure and were similar to the thermocoagulation group. No major side effects were observed. The reproductive tracts were excised after 24 h to examine ablation zones. Comparable depths of necrosis were seen for EC-ethanol (18.6 ± 1.6 mm) and thermocoagulation (19.7 ± 4.1 mm). The volumes of necrosis induced by a single injection of EC-ethanol (626.2 ± 122.8 µL) were comparable to the necrotic volumes induced by thermocoagulation in the top half of the cervices (664.6 ± 168.5 µL). This suggests that two EC-ethanol injections could be performed (e.g., at the 12 and 6 o’clock positions) to achieve comparable total necrotic volumes to thermocoagulation and safely and effectively treat women with cervical dysplasia in LMICs. This is the first study to systematically evaluate EC-ethanol ablation in a large animal model and compare its safety and efficacy to thermocoagulation, a commonly used ablative therapy for cervical dysplasia.
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影响因子：
3.7
作者：
Nief C;Morhard R;Chelales E;Adrianzen Alvarez D;Bourla Bs I;Lam CT;Sag AA;Crouch BT;Mueller JL;Katz D;Dewhirst MW;Everitt JI;Ramanujam N
通讯作者：
Ramanujam N
影响因子：
4.6
作者：
Morhard R;Nief C;Barrero Castedo C;Hu F;Madonna M;Mueller JL;Dewhirst MW;Katz DF;Ramanujam N
通讯作者：
Ramanujam N
影响因子：
1.6
作者：
Chigbu, Chibuike O.;Onwudiwe, Elijah N.;Onyebuchi, Azubuike K.
通讯作者：
Onyebuchi, Azubuike K.
影响因子：
4.6
作者：
Chelales E;Morhard R;Nief C;Crouch B;Everitt JI;Sag AA;Ramanujam N
通讯作者：
Ramanujam N
影响因子：
4.4
作者：
Lorenzen E;Follmann F;Jungersen G;Agerholm JS
通讯作者：
Agerholm JS