摘要
目的 对注射用甲哌卡因在口腔临床局部麻醉应用中的有效性及安全性进行评价。方法 采取平行组设计、分层随机、双盲、多中心临床试验方法。对照剂为含肾上腺素2％利多卡因,纳入病倒包括上颌全部及下颌前牙区牙齿中牙髓炎或需要拔除牙齿的患者。结果 除17例外,127例符合纳入标准,试验组66、对照组61例;口腔内科60、口腔外科67例,男性55、女性72例,年龄20～65岁,平均38.84±12.06岁。在唇颊侧根尖区牙槽局部粘膜下浸润1.5毫升甲哌卡因,起效中位时间与对照组一样都是60秒钟,麻醉持续时间146.7分钟,中位时间125分钟。可成功进行牙髓治疗及拔牙操作。试验组81.82％病例术中完全无痛,15.15％微痛但能顺利完成操作,优良率达到96.97％。甲哌卡因组9例(13.64％)注射后收缩压短暂升至145～162mm汞柱,5例(8.33％)舒张压短暂升至91～93mm汞柱。心率略有升高,1例注射甲哌卡因后半分钟至一分钟心悸,不需处理。上述反应多与药物中所含肾上腺素有关。无过敏反应发生。结论 甲哌卡因是一种安全可靠、麻醉效果好的口腔用局部麻醉剂。
Objective To assess efficacy of mepivacaine on local anesthesia in dentistry and oral surgery and its safety. Methods parallel group, stratified randomization, double blinded, muti-center clinical trail was designed. Two percent lidocaine with adrenaline in same cartridge was as control. Healthy patients with deep decay, pulpitis needed operative dentistry, or indication for extraction of the teeth, which located in the maxilla or front part of the mandible were included. Results Except 17 cases, 127 patients fulfilled inclusion criteria: 66 in treatment group and 61 in control group, dental filling for 60 and extraction for 67 cases, male 55 and female 72,average at 38.84 ± 12.06 years. Submucous infiltration of 1.5 ml mepivacaine at labial or buccal side of the alveolar process produced onset of anesthesia in the median of 60 seconds which was same as that of lidocaine, anesthesia duration for 146.7 minutes with the median of 125 minutes, permitting painless filling or extractions. In the treatment group 81. 82% freed of pain, while 15.15% had slight pain but received no extra local anesthetic for implementation of the treatment procedures, making the successful rate of 96. 97%. In the mepivacaine group, 13.64% of the cases had transient elevation of the systolic pressure to the level of 145 - 162mm Hg, 8. 33% diastolic pressure to the level of 91~93 mm Hg. Only one case had transient palpitation in half minute after one minute injection of the drug with no medical care needed. All the cardiovascular reactions might result from adrenaline containing in the injections. Conclusion Mepivacaine is an effective, safe and reliable anesthetic agent for dentistry and oral surgery.
关键词
甲哌卡因
局部麻醉
安全性
随机双盲临床试验
Mepivacaine
local anesthesia
safety
randomization
double blinded
clinical trial
