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高效液相色谱法测定血浆中地塞米松,以评估翼下颌间隙注射双混剂(2%利多卡因与1:200,000肾上腺素和4mg地塞米松的混合物)后其全身吸收情况:随机对照试验。

High performance liquid chromatography determination of dexamethasone in plasma to evaluate its systemic absorption following intra-space pterygomandibular injection of twin-mix (mixture of 2 % lignocaine with 1:200,000 epinephrine and 4 mg dexamethasone): randomized control trial.

作者信息

Bhargava Darpan, Deshpande Ashwini, Thomas Shaji, Sharma Yogesh, Khare Piush, Sahu Sanjeev Kumar, Dubey Suyash, Pandey Ankit, Sreekumar K

机构信息

Department of Oral and Maxillofacial Surgery, Peoples College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, MP, India.

Oral and Maxillofacial Surgery, H-3/2, BDA Colony, Lalghati, Airport Road, Bhopal, M.P, 462032, India.

出版信息

Oral Maxillofac Surg. 2016 Sep;20(3):259-64. doi: 10.1007/s10006-016-0564-3. Epub 2016 Jun 10.

Abstract

PURPOSE

To determine systemic absorption of dexamethasone by detection of plasma concentration using high performance liquid chromatography following its administration along with local anesthetic agent as a mixture via pterygomandibular space.

METHODS

A prospective randomized double-blind clinical study was undertaken to analyze the plasma concentration of dexamethasone after intra-space pterygomandibular injection along with local anesthesia. The study was performed as per split mouth model where the mandibular quadrant allocation was done on a random basis considering each of the 30 patients is included in the two study interventions (SS and CS). For the study site (SS) procedures, dexamethasone was administered as a mixture (2 % lignocaine with 1:200,000 epinephrine and 4 mg dexamethasone) intra-space. In the control site (CS) procedures, a regular standard inferior alveolar nerve block was administered, and dexamethasone was given as intramuscular injection. The plasma dexamethasone determination was done in venous blood 30- and 60-min post injection using high performance liquid chromatography (HPLC). The clinical parameters like pain; swelling; and mouth opening on the first, third, and seventh post-operative day were analyzed and compared.

RESULTS

No significant difference was found in the clinical parameters assessed; comparative evaluation showed less swelling in the SS interventions. The plasma concentration of dexamethasone for the CS interventions was 226 ± 47 ng/ml at 30-min and 316 ± 81.6 ng/ml at 60-min post injection, and for SS, it was 221 ± 81.6 ng/ml at 30-min and 340 ± 105 ng/ml at 60-min post injection. On inter-site (CS and SS) comparison, no statistically significant difference was ascertained in dexamethasone plasma concentration at 30-min post injection (P = 0.77) and at 60-min post injection. (P = 0.32).

CONCLUSION

Intra-space (pterygomandibular space) administration of dexamethasone can achieve statistically similar plasma concentration of the drug as when the same dose is administered intramuscularly with demonstration of similar clinical effects.

摘要

目的

通过高效液相色谱法检测血浆浓度,以确定地塞米松与局部麻醉剂混合经翼下颌间隙给药后的全身吸收情况。

方法

进行一项前瞻性随机双盲临床研究,分析翼下颌间隙内注射地塞米松并联合局部麻醉后血浆中地塞米松的浓度。该研究按照双侧对照模型进行,将30例患者随机分为两组,每组患者的下颌象限分别接受两种研究干预措施(研究部位[SS]和对照部位[CS])。在研究部位(SS)的操作中,地塞米松以混合液(2%利多卡因加1:200,000肾上腺素和4毫克地塞米松)经间隙内给药。在对照部位(CS)的操作中,进行常规标准的下牙槽神经阻滞,并给予地塞米松肌肉注射。使用高效液相色谱法(HPLC)在注射后30分钟和60分钟采集静脉血测定血浆地塞米松浓度。分析并比较术后第1天、第3天和第7天的疼痛、肿胀和张口度等临床参数。

结果

在评估的临床参数方面未发现显著差异;比较评估显示SS干预组肿胀较轻。CS干预组注射后30分钟血浆地塞米松浓度为226±47纳克/毫升,60分钟时为316±81.6纳克/毫升;SS组注射后30分钟为221±81.6纳克/毫升,60分钟时为340±105纳克/毫升。在组间(CS和SS)比较中,注射后30分钟(P = 0.77)和60分钟(P = 0.32)地塞米松血浆浓度未发现统计学上的显著差异。

结论

地塞米松经翼下颌间隙内给药可达到与肌肉注射相同剂量时统计学上相似的血浆药物浓度,并显示出相似的临床效果。

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