Milani Massimo, Barcellona Eliana, Agnello Antonella
R&D Mipharm, Via B. Quaranta 12, 20141 Milan, Italy.
Eur J Obstet Gynecol Reprod Biol. 2003 Jul 1;109(1):67-71. doi: 10.1016/s0301-2115(02)00478-5.
To evaluate the efficacy of tinidazole (T) (Trimonase, Mipharm, Italy) and an acidic vaginal gel (Miphil) (M) in comparison with vaginal clindamycin (CL) (Cleocin Pharmacia Upjohn) in BV.
A multicentre, randomised, investigator-blinded, controlled trial.
64 women with BV were enrolled. Thirty-two were allocated to receive oral T 2g, single dose, and 32 were assigned to CL 2% for 7 consecutive days. After week 1, T group were treated with an acidic vaginal gel, 2g every 3 days, for additional 3 weeks, whereas CL group did not received any additional treatment. Patients were evaluated at week 1 and 4. Vaginal pH, the BV-blue test (Gryphus Diagnostics, USA) and the whiff test were performed at baseline and at week 4.
Clinical cure rate; normalisation of vaginal pH (pH<4.5); and laboratory cure rate (defined as a clinical cure rate and a negative results of BV-blue and whiff test).
At baseline, vaginal pH values were (mean+/-S.D.) 5.4+/-0.7 and 5.3+/-0.5 in T and CL groups, respectively. Six patients (2 in T group and 4 in CL group) withdrew from the study due to side effects. At week 1, the clinical cure rates were 84% in both T and CL treated group (P=N.S.). At week 4, clinical cure rates were 94% in T+M group and 77% in CL group (P=N.S.). The laboratory cure rates were 81% in T+M group and 59% in CL group (P<0.04). Vaginal pH normalisation (i.e. pH <4.5) was achieved in 78% and in 38% of T+M and CL groups, respectively (P<0.0007).
In the short term, 2g single oral dose tinidazole was at least as effective as 7-day of vaginal clindamycin. The sequential treatment of tinidazole and acidic vaginal gel was superior to vaginal clindamycin in lowering vaginal pH and achieving a higher laboratory tests normalization rate at 1-month follow-up.
评估替硝唑（T）（Trimonase，意大利米法姆制药公司）和酸性阴道凝胶（Miphil）（M）与阴道用克林霉素（CL）（Cleocin Pharmacia Upjohn）治疗细菌性阴道病（BV）的疗效。
一项多中心、随机、研究者盲法、对照试验。
招募64例BV患者。32例分配接受单次口服2g替硝唑，32例分配接受连续7天使用2%克林霉素。第1周后，替硝唑组每3天使用2g酸性阴道凝胶再治疗3周，而克林霉素组未接受任何额外治疗。在第1周和第4周对患者进行评估。在基线和第4周进行阴道pH值、BV-蓝试验（美国Gryphus诊断公司）和嗅试验。
临床治愈率；阴道pH值正常化（pH<4.5）；实验室治愈率（定义为临床治愈率以及BV-蓝试验和嗅试验结果阴性）。
基线时，替硝唑组和克林霉素组的阴道pH值分别为（均值±标准差）5.4±0.7和5.3±0.5。6例患者（替硝唑组2例，克林霉素组4例）因副作用退出研究。第1周时，替硝唑治疗组和克林霉素治疗组的临床治愈率均为84%（P=无显著性差异）。第4周时，替硝唑+酸性阴道凝胶组的临床治愈率为94%，克林霉素组为77%（P=无显著性差异）。替硝唑+酸性阴道凝胶组的实验室治愈率为81%，克林霉素组为59%（P<0.04）。替硝唑+酸性阴道凝胶组和克林霉素组分别有78%和38%的患者实现阴道pH值正常化（即pH<4.5）（P<0.0007）。
短期内，单次口服2g替硝唑至少与7天阴道用克林霉素效果相当。在1个月随访时，替硝唑与酸性阴道凝胶序贯治疗在降低阴道pH值和实现更高的实验室检查正常化率方面优于阴道用克林霉素。
