头孢曲松治疗早期梅毒患者临床疗效的荟萃分析

Meta-analysis of randomized clinical controlled trials on effect of ceftriaxone sodium for treatment of early syphilis

目的评价头孢曲松治疗早期梅毒的疗效及安全性,为梅毒有效治疗方案制定提供临床证据。方法从建库到2012年7月初检出810篇文献,采用荟萃分析评价国内头孢曲松治疗早期梅毒的临床随机对照试验,计数资料的效应值采用相对危险度(RR),计量资料采用均数差(珚x),两者均以95%可信区间(CI)表示,P<0.05为差异有统计学意义。结果共纳入15篇文献,合计1 371例患者,头孢曲松治疗早期梅毒6个月的有效率与苄星青霉素相比(RR:1.18,95%CI:0.78~1.80)增加18.0%,12个月后有效率增加8.0%(RR:1.08,95%CI:0.89~1.30),差异均无统计学意义;在皮损消退时间上,头孢曲松的时间要短于苄星青霉素(珚x:-2.28,95%CI:-2.90^-1.66),头孢曲松与普鲁卡因青霉素相比,6个月(RR:1.14,95%CI:0.98~1.34)和12个月(RR:1.02,95%CI:0.95~1.10))有效率增加14.0%和2.0%,差异均无统计学意义;联合药物治疗1周皮损消退率是单独治疗的1.47倍(RR:1.47,95%CI:1.20~1.81);不良反应主要表现为恶心、呕吐、头晕、肌肉酸痛、短时间内局部发热症状加重,但不良反应发生率在各研究组间无差异。结论头孢曲松治疗早期梅毒疗效与苄星青霉素和普鲁卡因青霉素相当,联合苄星青霉素时比单独用苄星青霉素疗效要好,建议今后采用头孢曲松联合苄星青霉素治疗早期梅毒。

OBJECTIVE To evaluate the efficacy and safety of ceftriaxone sodium for treatment of early syphilis, so as to provide clinical evidences for valid therapeutic strategy of syphilis. METHODS 810 documents recorded from the establishment of the database to the beginning of Jul 2012, were evaluated for the randomized controlled trials of domestic ceftriaxone sodium for treating early syphilis via recta-analysis% the effec adopted relative risk （RR） rate and measurement data employed difference in means indicated by 95% confidential interval; P less than 0. 05 indicated a difference wi value of categorical data （x）; both of them were h statistical significance. RESULTS A total of 15 documents involving 1371 patients were selected. Compared with penicillin（RR： 1.18,95 % CI： 0. 78- 1. 80）, the effect rate of ceftriaxone sodium for treating early syphilis increased 18.0% within 6 months and increased 8.0% after 12 months（RR：1. 08,95% CI： 0. 89-1.30）, the difference between them had no statistical significance. In terms of skin lesion subsiding, ceftriaxone sodium took shorter time than benzathine penicilli（x：=2.28,95 %CI：- 2.90-1.66）. Compared with procaine benzathine penicillin, the effect rate of ceftriaxone sodium increased 14.0% and 2.0% after 6 months （RR：1. 14,95% CI：0. 98-1.34） and 12 months （RR ： 1.02,95 % CI：0. 95 - 1.10） respectively, indicating no difference in statistical significance. The one-week subsiding degree of skin lesion with the combination treatment grew 1.47 times （RR.. 1.47,95 %CI： 1.20- 1.81）. The adverse reaction were Jarisch-Herxheimer reaction, anaphylaxis, nausea, emesis, dizziness, muscularsoreness, increased local pyrexia in a short time, while the adverse reaction rate had no difference between each study groups. CONCLUSION The efficacy of ceftriaxone sodium on early syphilis was equivalent to that of the combination of benzathine penicillin and procaine benzathine penicillin. However, the ccombination therapy of ceftriaxone sodium and benzathine penicillin created a better effect than benzathine penicillin did alone. So the ccombination therapy of ceftriaxone sodium and benzathine penicillin on treatment of early syphilis was recommen- ded in the future.