Clinical trial study on clindamycin palmitate hydrochloride dispersible tablets in the treatment of bacterial vaginosis

ZHANG Dai; LIU Zhao-hui

doi:10.19538/j.fk2025050115

Abstract：Objective To study the clinical significance of clindamycin palmitate hydrochloride dispersible tablets in the treatment of bacterial vaginosis(BV).Methods A prospective,randomized,double-blind,double-dummy,positive drug parallel controlled clinical trial was conducted.Totally 39 patients with bacterial vaginosis,who recevied treatment in Beijing University First Hospital from Mar.2017 to Dec.2021,were divided into the clindamycin palmitate hydrochloride dispersible tablets group(n=20)and the metronidazole group(n=19).The changes in symptoms improvement and laboratory tests of the two groups of patients on the(7±3)th day(the first follow-up)and the(28±5)th day(the second follow-up)after drug withdrawal were analyzed.The clinical efficacy was determined by improvement rate of symptom and sign scores:improvement rate=(index score before treatment-index score after treatment)/index score before treatment ×100％.The Nugent score was used for BV diagnosis and efficacy evaluation.Results There were no significant differences in pH values of vaginal secretions between the two groups of patients before treatment,at the first follow-up,and at the second follow-up(P＞0.05).At the first follow-up,there was no significant difference in the Nugent score between the clindamycin palmitate hydrochloride dispersible tablets group(5.26±2.88)and the metronidazole group(4.88±3.18)(P＞0.05).At the second follow-up,there was no significant difference in the Nugent score between the clindamycin palmitate hydrochloride dispersible tablets group(5.65±2.96)and the metronidazole group(4.71±2.92)(P＞0.05).The improvement rates of symptom and sign scores of patients was 63.12％in the clindamycin palmitate hydrochloride dispersible tablets group and 47.06％in the metronidazole group at the first follow-up,and at the second follow-up,it was 64.71％and 50.00％,respectively;there was no significant difference(P＞0.05).Before treatment,the lactobacillus grading of both groups was Ⅱ b/Ⅲ.At the first follow-up,a total of 30.6％of the patients in the two groups had their vaginal lactobacilli restored to grade Ⅰ and Ⅱ a(26.5％vs 35.3％);at the second follow-up,a total of 32.3％of the patients in the two groups had their vaginal lactobacilli restored to grade Ⅰ and Ⅱ a(29.4％vs 35.7％);there was no significant difference between the two groups(P＞0.05).Conclusions Clindamycin palmitate hydrochloride dispersible tablets are effective in the treatment of bacterial vaginosis,and the clinical efficacy is comparable to that of the metronidazole group.The recovery of vaginal lactobacilli after antibiotic treatment is not satisfactory,and therapeutic measures to assist the recovery of vaginal flora can be considered.