Medicina Interna/enfermedades infecciosas, Hospital Clínico San Carlos, IdiSSC, Universidad Complutense, c/Martin Lagos SN, 28040, Madrid, Spain.
Centro Sanitario Sandoval, IdiSSC, C/Sandoval, 7, 28010, Madrid, Spain.
BMC Infect Dis. 2019 Oct 23;19(1):883. doi: 10.1186/s12879-019-4490-5.
Penicillin G Benzathine (PGB) is the cornerstone of syphilis treatment. However, its intramuscular (IM) administration is associated with pain at the site of injection. The dilution of PGB with local anesthetics is recommended in some guidelines, but the evidence that supports it, particularly in adults and in HIV infection, is scarce. Preliminary clinical experience also suggests that the IM administration of PGB through increased needle gauges might improve its tolerability. The aim of the study to identify less painful ways of administering IM PGB in the treatment of syphilis in adults.
Multicenter, randomized, double-blinded clinical trial in patients diagnosed with primary syphilis that required a single IM injection of PGB 2400,00 IU. Patients were randomized to receive PGB diluted with 0.5 mL mepivacaine 1% (MV) or PGB alone, and both groups either with a long 19G or short 21G IM needle. The primary objective was the effect on local pain immediately after the administration through a visual scale questionnaire on pain (0 to 10).
One hundred eight patients were included, 27 in each group. Ninety-four (94.4%) were male, and 41.7% were also HIV-infected. Mean age 36.6 years (SD 11). Significant differences in immediate pain intensity were observed when comparing the long 19G group with anesthesia (mean pain intensity, [MPI] 2.92 [CI 95% 1.08-4.07]) vs long 19G without anesthesia (MPI 5.56 [CI 95% 4.39-6.73), p < 0.001; and also between short 21G group with anesthesia (MPI 3.36 [CI 95% 2.22-4.50]) vs short 21G without anesthesia (MPI 5.06 [CI 95% 3.93-6.19]), p = 0.015). No significant differences in immediate pain were observed between 19G and 21G in the presence or absence of anesthesia (p = 1.0 in both cases). No differences were found between study arms after 6 and 24 h.
The IM administration of 1% mepivacaine-diluted PGB induces significantly less immediate local pain as compared to PGB alone. The needle gauge did not have any effect on the pain. Based on these results, we suggest anesthetic-diluted IM PGB as the standard treatment for primary syphilis.
EudraCT 2014-003969-24 (Date of registration 18/09/2014).
青霉素 G 苯甲噻唑（PGB）是治疗梅毒的基石。然而，其肌内（IM）给药与注射部位疼痛有关。一些指南建议将 PGB 与局部麻醉剂稀释，但支持这一建议的证据很少，尤其是在成人和 HIV 感染中。初步临床经验还表明，通过增加针头规格来 IM 给予 PGB 可能会提高其耐受性。本研究旨在寻找更不痛的方式来 IM 给予 PGB，以治疗成人梅毒。
多中心、随机、双盲临床试验，纳入了需要单次 IM 注射 2400000IU PGB 的原发性梅毒患者。患者随机分为接受 0.5mL 甲哌卡因 1%（MV）稀释的 PGB 或单独的 PGB 组，两组均使用长 19G 或短 21G 的 IM 针。主要目的是通过疼痛视觉量表问卷（0-10 分）评估给药后即刻局部疼痛的效果。
共纳入 108 例患者，每组 27 例。94.4%为男性，41.7%也感染了 HIV。平均年龄 36.6 岁（SD 11）。当比较长 19G 组与麻醉（平均疼痛强度 [MPI] 2.92 [95%CI 1.08-4.07]）与长 19G 无麻醉（MPI 5.56 [95%CI 4.39-6.73]）时，观察到即刻疼痛强度的显著差异，p<0.001；短 21G 组与麻醉（MPI 3.36 [95%CI 2.22-4.50]）与短 21G 无麻醉（MPI 5.06 [95%CI 3.93-6.19]）相比，也观察到即刻疼痛的显著差异，p=0.015。在有或没有麻醉的情况下，19G 和 21G 之间即刻疼痛无显著差异（p=1.0）。在 6 和 24 小时后，研究组之间未发现差异。
与单独使用 PGB 相比，1%甲哌卡因稀释的 PGB 肌内给药可显著减轻即刻局部疼痛。针规对疼痛没有影响。基于这些结果，我们建议将麻醉剂稀释的 IM PGB 作为治疗原发性梅毒的标准治疗方法。
EudraCT 2014-003969-24（注册日期 2014 年 9 月 18 日）。
