- 學位論文
比較阿替卡因與利多卡因於智齒拔牙手術之效果與安全性
Comparison of Efficacy and Safety of Articaine and Lidocaine in Third Molar Extraction Surgery
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摘要
簡介: Articaine(阿替卡因)是在近 50 年來發展且被廣泛使用的牙科麻醉藥 物，由於 Articaine 藥物濃度高且化學結構特殊，使其滲透組織效果佳且麻醉效果 好。至今，已有一些牙科臨床研究發現 Articaine 的麻醉效果相較傳統最常使用的 Lidocaine(利多卡因)表現更佳，同時保有與 Lidocaine 類似的安全性，尤其在浸 潤麻醉更是能凸顯其滲透能力的差異，甚至在骨質較為厚實且緻密的下顎後牙區 Articaine 的浸潤麻醉效果都能有不錯的表現。 智齒拔牙手術是牙科常見的門診手術之一，傳統認為在進行下顎智齒拔牙手 術時需要進行阻斷麻醉才能有較佳的疼痛控制效果，對於是否能夠單純使用 Articaine 之浸潤麻醉進行智齒拔牙手術仍然沒有足夠的證據，目前的文獻中仍缺 乏比較 Articaine 浸潤麻醉與 Lidocaine 阻斷麻醉在下顎智齒手術中的安全性與效 果差異。此外，臺灣國內也缺乏 Articaine 用於智齒拔牙手術的相關臨床研究。 因此，本臨床研究目的為比較 4% Articaine 含 1:100,000 腎上腺素與 2% Lidocaine 含 1:100,000 腎上腺素兩種麻醉藥物在智齒拔牙手術的麻醉效果與安全 性，其中上顎智齒手術將會比較兩種麻藥在浸潤麻醉的表現，下顎智齒手術則會比 較 Articaine 浸潤麻醉與 Lidocaine 阻斷麻醉的表現。 材料與方法: 本研究性質為前瞻性(Prospective)、隨機分派(Randomized)、 對照半口法(Split-mouth)的臨床試驗，受試者預計包含 30 位年齡介於 20 至 60 歲身體狀況大致健康的成人患者，具有雙側難度接近之上顎或/與下顎智齒，經臨 床醫師評估適用局部麻醉於門診手術切除或拔除智齒的案例。上述 30 位受試者將 會被隨機分派為左側與右側分別使用 4% Articaine 或 2% Lidocaine 進行麻醉。上 顎之智齒手術不論是何種麻醉藥皆是使用頰側-腭側浸潤麻醉(Buccal-palatal infiltration anesthesia)。下顎之智齒手術若是使用 4% Articaine 則進行頰側-舌側浸 潤麻醉(Buccal-lingual infiltration anesthesia)，若是使用 2% Lidocaine 則進行下齒槽神經、舌神經、長頰神經阻斷麻醉(Inferior alveolar nerve, lingual nerve, and long buccal nerve block anesthesia)。治療期間與治療後將會記錄受試者之心率、血壓、 血氧飽和度、麻藥使用量、拔牙手術花費時間、疼痛量表(NRS, Numerical Rating Scale, 0-10 分)、舒適度評估(1-5 分，其中 5 分為最舒適，1 分為最不舒適)、麻 醉藥物不良反應等資訊。統計上使用威爾卡森符號等級檢定(Wilcoxon signed-rank test)進行無母數的分析，以 IBM SPSS 軟體進行統計分析，取 p<0.05 為統計上顯著差異。 結果: 本研究最終共收入 30 位接受左右雙側難度接近之智齒拔牙手術的受試 者，接受上顎智齒手術的有 14 位患者(共 28 顆上顎智齒)，其中有 5 位(35.7%) 為阻生齒;接受下顎智齒手術的則有 26 位患者(共 52 顆下顎智齒)，其中有 23 位(88.5%)為阻生齒，實驗結果分為上顎與下顎進行統計與討論。 上顎智齒手術組別發現在心率、血壓、血氧飽和度與其術中最大波動量在 Articaine 組別(A)與 Lidocaine 組別(L)大致類似，除了在起始血氧飽和度 98.7±1.2%(A)vs. 99.4±0.9%(L)(p=0.02)在統計上有差異，然而並無任何患者 於術中出現血氧濃度低下之症狀。此外，上顎組別在麻藥使用量 1.1±0.2 管(A) vs. 1.2±0.2 管(L)(p=0.039)，有統計上之顯著差異。在 Articaine 組中有 71.4% (10/14)使用 1 管麻藥即可完成拔牙手術，而在 Lidocaine 組則是只有 42.9%(6/14) 使用 1 管麻藥即完成拔牙手術。然而，在手術時間(9.8±7.7 分鐘 vs. 8.6±8.3 分鐘， p=0.387)、疼痛控制(1.6±1.4分 vs.1.8±1.7分，p=0.490)與患者舒適度評估(4.0±1.1 分 vs. 4±1.0 分，p=1.000)的幾個項目兩種麻藥的表現則沒有顯著差異，且兩種麻 藥組別在上顎手術皆沒有出現不良反應。 下顎智齒手術組別發現在心率、血壓、血氧飽和度與其術中最大波動量在 Articaine 組別與 Lidocaine 組別大致類似，除了在心率的術中最大波動量 16.5±7.7 beat/min(A)大於 12.8±6.6 beat/min(L)(p=0.022)存在統計上顯著差異，然而並無任何患者於術中出現心率過速或過緩的相關症狀。此外，下顎組別在麻藥使用 量 1.5±0.4 管(A)少於 2.2±0.5 管(L)(p=0.000)，有統計上之顯著差異。在 Articaine 組中有 73.1%(19/26)使用 1.5 管麻藥以內即可完成拔牙手術，而在 Lidocaine 組則是只有 3.8%(1/26)使用 1.5 管麻藥以內即完成拔牙手術。然而， 在手術時間(16.7±10.9 分鐘 vs. 17.7±10.2 分鐘，p=0.594)、疼痛控制(2.4±1.9 分 vs. 2.4±1.4 分，p=0.986)與患者舒適度評估(3.8±1.0 分 vs. 3.8±1.0 分，p=0.985) 的幾個項目兩種麻藥的表現則沒有顯著差異，且兩種麻藥組別在下顎手術皆沒有 出現不良反應。 結論: 本臨床研究顯示在上顎智齒手術使用 4% Articaine 與 2% Lidocaine 進 行頰側-腭側浸潤麻醉之效果與安全性是接近的，使用 Articaine 能夠能夠在用量比 較小的情況下達到和 Lidocaine 相似的疼痛控制效果。而在下顎智齒手術使用 4% Articaine 頰側-舌側浸潤麻醉效果與使用 2% Lidocaine 進行阻斷麻醉可以達到相近 的疼痛控制效果，且使用 Articaine 浸潤麻醉相較於 Lidocaine 的阻斷麻醉麻醉藥物 用量可以減少將近 25%，同時保有其類似的安全性表現，且並無造成神經損傷的 案例。 因此，在智齒手術當中使用 4% Articaine 和 2% Lidocaine 的安全性與效果是 類似的，且 4% Articaine 能夠在使用量較少的情況下達到相同的疼痛控制效果，反 映出 Articaine 相較 Lidocaine 具有較高的濃度與效價的優勢。此外，在下顎智齒手 術當中，Articaine 的浸潤麻醉可作為 Lidocaine 阻斷麻醉表現接近且較低侵犯性 (Less invasive)的替代做法(Alternative)。
並列摘要
Introduction: Articaine is a dental anesthetic that has been developed and widely used in dentistry for nearly 50 years. Due to its higher concentration and unique chemical structure, Articaine exhibits excellent tissue penetration and anesthesia efficacy. Some dental clinical studies have found that Articaine shows better anesthetic efficacy compared to the most commonly used traditional anesthetic, Lidocaine, while maintaining similar safety to Lidocaine. Particularly, better diffusion ability of Articaine is highlighted in infiltration anesthesia, even showing good performance in the mandibular posterior teeth area with thick and dense bone. Wisdom tooth extraction surgery is one of the common outpatient procedures in dentistry. Traditionally, it is believed that inferior alveolar nerve block anesthesia is necessary for better pain control during mandibular wisdom tooth extraction. However, there is still insufficient evidence on whether Articaine infiltration anesthesia alone can be used for wisdom tooth extraction. Currently, there is a lack of comparative studies in the literature regarding the safety and effectiveness differences between infiltration anesthesia by Articaine and block anesthesia by Lidocaine for lower wisdom tooth surgery. Furthermore, there is also a lack of related clinical research on the use of Articaine for wisdom tooth extraction in Taiwan. Therefore, this study aims to compare the anesthetic efficacy and safety of 4% Articaine with 1:100,000 epinephrine and 2% Lidocaine with 1:100,000 epinephrine in maxillary and mandibular third molar extraction surgeries. In the maxillary group, we will compare two local anesthetics by infiltration anesthesia, while in the mandibular group, we will compare Articaine by infiltration anesthesia and Lidocaine by block anesthesia. Materials and Methods: This study is a prospective, randomized, split-mouth clinical trial. It is planned to include 30 adult patients aged between 20 and 60 years with generally good health status, having bilateral maxillary and/or mandibular wisdom teeth of similar difficulty that suitable for extraction under local anesthesia in the outpatient setting. These 30 participants will be randomly assigned to receive either 4% Articaine or 2% Lidocaine for anesthesia on the left and right sides, respectively. For maxillary wisdom tooth surgery, both anesthetics will be used with buccal-palatal infiltration anesthesia. For mandibular wisdom tooth surgery, Articaine will be used with buccal- lingual infiltration anesthesia, while Lidocaine will be used with inferior alveolar nerve, lingual nerve, and long buccal nerve block anesthesia. During and after the treatment, participants' heart rate, blood pressure, oxygen saturation, amount of anesthetic usage, surgery duration, pain scores (NRS, Numerical Rating Scale, 0-10), comfort evaluation (1-5, with 5 being most comfortable and 1 being least comfortable), and adverse effects to the anesthetics will be recorded. Statistical analysis will be performed using the Wilcoxon signed-rank test, with a significance level set at p<0.05, using IBM SPSS software. Results: A total of 30 subjects who underwent bilateral wisdom tooth extraction surgeries with similar difficulty were included in this study. Among them, 14 patients underwent maxillary wisdom tooth surgery (totally 28 maxillary wisdom teeth), with 5 of them (35.7%) being impacted teeth. For mandibular wisdom tooth surgery, there were 26 patients (52 mandibular wisdom teeth), with 23 of them (88.5%) being impacted teeth. The results were analyzed and discussed separately for maxillary and mandibular surgeries. In the maxillary wisdom tooth surgery group, no significant differences were observed in heart rate, blood pressure, and blood oxygen saturation, as well as their maximum fluctuations during the procedure, between the Articaine group (A) and Lidocaine group (L), except for the initial blood oxygen saturation of 98.7±1.2% (A) vs. 99.4±0.9% (L) (p=0.02), which showed statistical significance. However, none of the patients experienced symptoms of low blood oxygen concentration during the procedure. Moreover, there was a significant difference in the amount of anesthetic used between the two groups, with the Articaine group using 1.1±0.2 cartridges and the Lidocaine group using 1.2±0.2 cartridges (p=0.039). Specifically, 71.4% (10/14) of patients in the Articaine group required only 1 cartridge of anesthetic to complete the tooth extraction, while in the Lidocaine group, only 42.9% (6/14) needed 1 cartridge. However, there were no significant differences in several aspects, including surgical duration (9.8±7.7 minutes vs. 8.6±8.3 minutes, p=0.387), pain control (NRS pain scores of 1.6±1.4 vs. 1.8±1.7, p=0.490), and patient comfort assessment (scores of 4.0±1.1 vs. 4.0±1.0, p=1.000), and no adverse reactions were reported in either anesthetic group. In the mandibular wisdom tooth surgery group, there were no significant differences in heart rate, blood pressure, blood oxygen saturation, and their maximum fluctuations during the procedure between the Articaine and Lidocaine groups, except for the maximum heart rate fluctuation, which was 16.5±7.7 beat/min (A) and 12.8±6.6 beat/min (L) (p=0.022), showing statistical significance. However, none of the patients experienced symptoms of tachycardia or bradycardia during the procedure. Additionally, the amount of anesthetic used was significantly lower in the Articaine group (1.5±0.4 cartridges) compared to the Lidocaine group (2.2±0.5 cartridges). Specifically, 73.1% (19/26) of patients in the Articaine group required only 1.5 cartridges of anesthetic or less, while in the Lidocaine group, only 3.8% (1/26) needed 1.5 cartridges or less. Similar to the maxillary group, there were no significant differences in surgical duration (16.7±10.9 minutes vs. 17.7±10.2 minutes, p=0.594), pain control (NRS pain scores of 2.4±1.9 vs. 2.4±1.4, p=0.986), and patient comfort assessment (scores of 3.8±1.0 vs. 3.8±1.0, p=0.985) between the two anesthetic groups, and no adverse reactions were reported in either group. Conclusion: This clinical study demonstrated that using 4% Articaine and 2% Lidocaine for buccal-palatal infiltration anesthesia in maxillary wisdom tooth surgery provided similar efficacy and safety. The use of Articaine allowed for achieving similar pain control with lower dosages compared to Lidocaine. For mandibular wisdom tooth surgery, using 4% Articaine for buccal-lingual infiltration anesthesia resulted in similar pain control compared to using 2% Lidocaine for nerve block anesthesia, with Articaine requiring nearly 25% less anesthetic dosage while maintaining similar safety performance and no reported cases of nerve damage. Therefore, we would like to conclude that the safety and efficacy of using 4% Articaine and 2% Lidocaine in wisdom tooth surgery are comparable, and Articaine can achieve the same pain control with lower dosage, reflecting the higher potency and concentration of Articaine. Additionally, in mandibular wisdom tooth surgery, infiltration anesthesia by Articaine serves as a suitable, less invasive alternative to block anesthesia by Lidocaine.
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