国产复方盐酸阿替卡因注射液在下颌阻生磨牙拔除术中的应用效果研究

Clinical evaluation of domestic compound attevacaine hydrochloride injection in extraction of impacted mandibular molar

目的研究国产复方盐酸阿替卡因注射液在下颌阻生磨牙拔除术中应用的有效性和安全性。方法选取2021年4—7月于第四军医大学口腔医院口腔外科及合作单位西安新尔美口腔诊所就诊的需拔除下颌阻生第三磨牙患者310例,采用随机数表法分为研究组(156例)和对照组(154例)。研究组采用复方盐酸阿替卡因注射液(丰源?),对照组采用阿替卡因肾上腺素注射液(必兰?),均进行下牙槽神经、舌神经、颊神经阻滞麻醉。比较两组麻醉有效性[包括麻醉有效率、麻醉起效时间、麻醉持续时间、牙拔除术中疼痛视觉模拟评分法(VAS)评分]和麻醉安全性(包括注射局麻药物后15、30、45、60 min的收缩压、舒张压及不良反应发生率)。结果研究组患者麻醉有效率(94.23%)高于对照组(90.91%),但差异无统计学意义(χ^(2)=1.185,P=0.276)。研究组舌神经麻醉起效时间显著短于对照组(t=-2.527,P=0.012),且舌神经及下牙槽神经麻醉持续时间均长于对照组(t值分别为2.166、2.260,均P<0.05)。两组患者在牙拔除术中各阶段的VAS评分变化趋势相同,不同阶段及整体VAS评分的组间比较,差异均无统计学意义(均P>0.05)。除注射局麻药物后30 min外,其他时间两组患者的收缩压、舒张压差异均无统计学意义(均P>0.05);研究组无不良反应发生,对照组有2例患者术后神经感觉异常,两组不良反应发生率比较,差异无统计学意义(P=0.498)。结论使用国产复方盐酸阿替卡因注射液(丰源?)行下牙槽神经、舌神经、颊神经阻滞麻醉后拔除下颌阻生第三磨牙的麻醉效果非劣于阿替卡因肾上腺素注射液(必兰?)。此外,丰源?具有更长的麻醉持续时间,且几乎不影响患者注射后的血压,具有作为必兰?的替代药物在临床上使用的潜力。

Objective To study the efficacy and safety of domestic compound attevacaine hydrochloride injection in extraction of impacted mandibular molars.Methods From April 2021 to July 2021,310 patients with mandibular impacted third molars needed to be extracted in the Department of Oral Surgery,Stomatological Hospital of the Fourth Military Medical University and Dental Outpatient Department of Xi′an Xinermei Medical Technology Co.Ltd were randomly divided into the study group(156 cases)and the control group(154 cases).The study group received compound attevacaine hydrochloride injection(Fengyuan?),and the control group received attevacaine adrenaline injection(Primacaine?).The inferior alveolar nerve,lingual nerve and buccal nerve block anesthesia was performed.The efficacy of anesthesia(including the effective rate of anesthesia,the onset time of anesthesia,the duration of anesthesia,the VAS score of pain during tooth extraction)and the safety of anesthesia(including the systolic blood pressure,diastolic blood pressure at 15,30,45 and 60 minutes after anesthesia and the incidence of adverse reactions)were compared between the two groups.Results The effective rate of anesthesia in the study group(94.23%)was higher than that in the control group(90.91%),but the difference was not statistically significant(χ^(2)=1.185,P=0.276).The onset time of lingual nerve anesthesia in the study group was significantly shorter than that in the control group(t=-2.527,P=0.012),and the duration of both lingual nerve and inferior alveolar nerve anesthesia was longer than that in the control group(t=2.166,2.260;P<0.05).There was no significant difference in the VAS scores between the two groups at any stage of tooth extraction(P>0.05),and the VAS scores of the two groups had the same trend(P>0.05).There was no significant difference in systolic blood pressure or diastolic blood pressure between the two groups at any time point,except for 30 minutes after anesthesia(P>0.05).There were no adverse reactions in the study group,while 2 patients in the control group had neural paresthesia.There was no significant difference in the incidence of adverse reactions between the two groups(P=0.498).Conclusion The efficacy of block anesthesia of inferior alveolar nerve,lingual nerve and buccal nerve using Fengyuan?is not inferior to Primacaine?in the extraction of mandibular impacted third molars.In addition,Fengyuan?has a longer anesthetic duration and little impact on the patient’s blood pressure after anesthesia.It has the potential for clinical use as an alternative to Primacaine?.