Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial

OBJECTIVE: To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis. METHODS: Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of.84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells. RESULTS: Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66. 7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P =.810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups. CONCLUSION: A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis.     

Antimicrobial resistance associated with the treatment of bacterial vaginosis

OBJECTIVE: This study was undertaken to evaluate antimicrobial susceptibility of vaginal anaerobic bacteria before and after treatment of bacterial vaginosis. STUDY DESIGN: A randomized clinical trial of 119 nonpregnant women with bacterial vaginosis receiving either intravaginal metronidazole for 5 days or clindamycin for 3 days was performed. Women had 1 baseline and 3 follow-up visits at which quantitative vaginal cultures were performed. Anaerobic isolates underwent antimicrobial susceptibility testing. RESULTS: Complete susceptibility data was available on 95 women (47 metronidazole and 48 clindamycin). Of 1059 anaerobic bacterial isolates, less than 1% demonstrated resistance to metronidazole. In contrast, 17% demonstrated baseline clindamycin resistance, and 53% demonstrated resistance to clindamycin after therapy. Women exposed to clindamycin (but not metronidazole) had high frequencies (80%) of clindamycin-resistant anaerobic bacteria that persisted for 90 days after treatment. CONCLUSION: Treatment of bacterial vaginosis with clindamycin is associated with marked evidence of antimicrobial resistance among vaginal anaerobic bacteria. This may increase the vaginal reservoir of macrolide-resistant bacteria.     

Changes in the vaginal flora after two percent clindamycin vaginal cream in women at high risk of spontaneous preterm birth

Objective To analyse alterations in the vaginal flora after 2% clindamycin vaginal cream or placebo administered for the prevention of preterm delivery in high risk women.
Design Observational study during a randomised multicentre double-blind placebo controlled trial.
Setting Twelve city hospitals in The Netherlands.
Participants One hundred and sixty-eight women were enrolled. Alterations in the vaginal flora could be analysed in one hundred and twenty-four women by comparing the Nugent score on entry to the trial and at 31 weeks' gestation. The Nugent score was classified into normal, intermediate and bacterial vaginosis.
Interventions Two percent clindamycin vaginal cream or placebo cream administered daily for seven days at week 26 of pregnancy.
Main outcome Changes in the vaginal flora at week 31 of pregnancy.
Results The placebo group consisted of 64 women and the clindamycin group of 60 women. At week 31 the vaginal flora was similar to week 26 with placebo cream but changed from normal vaginal flora to intermediate or bacterial vaginosis with 2% clindamycin vaginal cream.
Conclusion Obstetricians should not prescribe 2% clindamycin vaginal cream to pregnant women with normal vaginal flora in order to reduce the incidence of preterm birth, because it has no beneficial effects and is actually harmful. 2% Clindamycin vaginal cream encourages the presence of bacterial vaginosis which is epidemiologically associated with preterm birth.     

Treatment options for bacterial vaginosis in patients at high risk of preterm labor and premature rupture of membranes

AIM: To estimate the efficacy of different therapeutic modalities on proven cases of bacterial vaginosis (BV) in patients at high risk of preterm labor and premature rupture of membranes. METHODS: This was a longitudinal prospective comparative study set in the antenatal outpatient clinic of the department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt. Four hundred and sixty-eight patients with a clinical picture of threatened preterm labor or at high risk of premature rupture of membranes in the third trimester were screened for BV. Positive BV was diagnosed in 156 patients. They were randomly classified into four equal groups according to the line of medical treatment. The treatments were: (i) oral metronidazole, (ii) clindamycin vaginal cream, (iii) oral clindamycin, or (iv) metronidazole vaginal suppositories. The effects of medical treatment on Amsel's criteria as well as maternal and fetal outcomes were measured. RESULTS: Based on Amsel's criteria, 156 patients (33.3%) were diagnosed with BV. There was a significant disappearance of vaginal discharge, with decreased percentages of pH > 4.5, positive amine test, and clue cells after treatment of BV in the four groups without any statistically significant difference between them. There were variable effects of the different treatments on increasing birthweight values, admission to neonatal intensive care units, and prolongation of the gestational age. Some maternal adverse effects have been recorded. There were significant improvements of the outcomes for oral metronidazole and clindamycin compared with outcomes for intravaginal metronidazole and clindamycin. CONCLUSIONS: Metronidazole and clindamycin achieve nearly equivalent cure rates when administered orally or vaginally in patients at high risk of preterm labor and premature rupture of membranes. Oral metronidazole is considered the drug of choice in treating BV due its high cure rate, better outcomes, and low cost.     

Therapeutic regimens for treating bacterial vaginosis in pregnant women

The study comprises 128 pregnant women examined at different gestational weeks. The diagnosis of bacterial vaginosis was made using: a) the complex clinical criteria--vaginal discharge, vaginal pH, amine test and "clue cells" b) Nugent scoring system c) Spiegel criteria. Two therapeutic regimens were compared--intravaginal 2% clindamycin creme (Dalacin V) 5 g three consecutive days and intravaginal metronidazole (Flagyl) 500 mg once daily for 5 consecutive days. Control examination was carried out 5-7 days after completion of therapy using the same protocol. 28 women from the first group and 31 women from the second group had the control examination. Bacterial vaginosis was eradicated in 93% of women using intravaginal clindamycin and in 87% of women using intravaginal metronidazole. Both regimes were more effective compared to treatment with oral ampicillin for 7 days, where the cure rate was 62%.     

Clindamycin versus metronidazole in the treatment of bacterial vaginosis

One hundred forty-three women with complaints of vaginitis were assigned to receive either 500 mg of metronidazole twice daily for 7 days or clindamycin 300 mg twice daily for 7 days. There was no significant difference in the failure rate between patients treated with clindamycin (6.1%) and those treated with metronidazole (4%). Adverse reactions were infrequent and mild in both treatment groups. Three patients who received clindamycin developed non-bloody diarrhea, which was mild and did not necessitate discontinuing therapy. We conclude that clindamycin may be a safe and effective alternative to metronidazole for treating women with bacterial vaginosis.     

妊娠期细菌性阴道病的筛查与诊治

妊娠期细菌性阴道病（bacterial vaginosis,BV）可引起胎膜早破、早产、流产、绒毛膜羊膜炎、新生儿感染及产褥感染等不良妊娠结局。妊娠期BV的诊断主要依据Amsel临床诊断标准及革兰染色Nugent评分标准。需要对既往有感染相关流产、早产病史或有早产危险因素孕妇进行BV筛查,阳性者需进行治疗。妊娠期BV的治疗方案为口服克林霉素或甲硝唑。     

Clinical and cervical cytokine response to treatment with oral or vaginal metronidazole for bacterial vaginosis during pregnancy: a randomized trial

OBJECTIVE: To compare the efficacy of oral versus vaginal metronidazole treatment in pregnant women with bacterial vaginosis, and to compare cytokine profiles (interleukin-1beta, -6, and -8) in the cervical secretions of these women before and after treatment. METHODS: Pregnant women with bacterial vaginosis diagnosed both by Gram stain and clinical criteria were randomized to receive oral (n=52) or vaginal (n=50) metronidazole therapy. Cervical specimens for cytokine analysis and vaginal fluid for evaluation of bacterial vaginosis were obtained at baseline and 4 weeks after treatment. RESULTS: There was no significant difference in therapeutic cure rates (defined as a Gram stain score of 0-3 and the absence of all four clinical signs of bacterial vaginosis) between the two groups (71% and 70% for the oral and vaginal groups, respectively, P=1.0). Cervical levels of interleukin-1beta, -6, and -8 were significantly lower after treatment among the 72 women cured of bacterial vaginosis (P<.001, P=.001, and P=.02, respectively) but not among women who failed to respond to therapy. For interleukin-1beta and -6, a significant decrease in cytokine level was observed in both the oral and vaginal treatment groups. CONCLUSION: One week of oral metronidazole and 5 days of intravaginal metronidazole are equally efficacious for treatment of bacterial vaginosis during pregnancy. The decrease in cervical interleukin-1beta, -6, and -8 levels among women who established a normal flora after treatment but not among those with persistent bacterial vaginosis suggests a direct linkage between vaginal flora abnormalities and elevated cervical levels of interleukin-1beta, -6, and -8.     

Utilisation of hydrogen peroxide in the treatment of recurrent bacterial vaginosis

AIM: The authors have evaluated the real efficacy of using hydrogen peroxide for previously treated recurrent bacterial vaginosis that is resistant to other forms of treatment. METHODS: The study included 58 women aged between 18 and 42 years old. Vaginal irrigations with 30 ml of hydrogen peroxide (3%) were prescribed in the evening for a week. The follow-up was carried out 3 months after the end of treatment. RESULTS: The results clearly show that the use of hydrogen peroxide in vagina can eliminate the main symptoms of bacterial vaginosis, and in particular the malodorous leucoxanthorrhea in 89% of cases at 3 months after the end of treatment, a result that is comparable to that obtained using metronidazole or clindamycin as a vaginal cream. Moreover, hydrogen peroxide facilitates the restoration of normal vaginal bacterial flora (represented by H202-producing lactobacillus) in 100% of cases and normal acid pH (pH<4.5) in 98% of cases; it also fosters the disappearance of clue cells from vaginal smears and anaerobic pathogenic flora from vaginal secretions in 100% of cases. The amine test became negative in 97.8% of cases. All results underwent statistical analysis and were found to be statistically significant. CONCLUSION: Hydrogen peroxide represents a valid alternative to conventional treatments for recurrent bacterial vaginosis, and associates the absence of collateral effects with low costs, excellent tolerability and real therapeutic efficacy.     

Anal sphincter disruption at vaginal delivery: is recurrence predictable?

Objectives: To evaluate the efficacy of clindamycin vaginal cream 2% once daily for 7 days in prolonging pregnancy. Study design: Randomised clinical trial of 112 women between 14 and 25 weeks of gestation with diagnosis of asymptomatic bacterial vaginosis were enrolled in a multicenter randomised trial and assigned to active or no treatment. A total of 55 women were assigned to clindamycin and 57 to no treatment. Main outcome measure: frequency of pre-term delivery. Results: The rates of pre-term delivery was 12.2% in the clindamycin group and 15.7% in the no treatment group (P=0.78). Birth weight was <2500 g in three and seven babies, respectively, in the two groups (P=0.32). Mean gestational ages at birth were 38.9 and 39.2 (P=0.52), respectively, in the clindamycin and no treatment groups. Conclusions: The results of this study suggest that treating asymptomatic bacterial vaginosis does neither markedly prolong pregnancy nor increase birthweight.     

Efficacy of clindamycin vaginal ovule (3-day treatment) vs. clindamycin vaginal cream (7-day treatment) in bacterial vaginosis

OBJECTIVE: To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV). METHODS: Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second. RESULTS: Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI -4.1-16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups. CONCLUSIONS: A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV.     

Metronidazole.

Metronidazole has proven to be a useful and inexpensive antibiotic for the treatment of T. vaginalis and bacterial vaginosis. Few alternatives exist for these two specific indications, and metronidazole will continue to play a primary role in therapy. Oral metronidazole continues to be a very inexpensive alternative to oral vancomycin for the treatment of C. difficile-induced pseudomembranous colitis. For the treatment of moderate to severe mixed aerobic/anaerobic pelvic infections, metronidazole should be considered secondarily in patients who have failed other multiple- or single-drug regimens or in patients who are infected. with anaerobic organisms resistant to other commonly used agents including clindamycin, cefoxitin, cefotetan, or ampicillin/sulbactam. Metronidazole is not a first line drug of choice for antibiotic prophylaxis in obstetric and gynecologic patients.     

Comparison of oral and vaginal metronidazole therapy for nonspecific bacterial vaginosis

A prospective, randomized, nonblind study was performed to compare the efficacy of a 7-day vaginal regimen with 500 mg metronidazole (Flagyl) once a day and that of oral treatment with 400 mg metronidazole twice daily for 7 days in the treatment of nonspecific bacterial vaginosis. No treatment was given to the sexual partners and there was no restriction of sexual intercourse. 38 women completed the study and at follow-up after 4 weeks, women receiving vaginal therapy had a cure rate of 79% compared with 74% in the women on oral therapy. Cure rates were lower among users of an intrauterine contraceptive device (57 versus 88% among nonusers). The occurrence of lactate-producing bacteria (lactobacilli and aerobic streptococci) in the vagina was significantly higher in women after vaginal compared with oral therapy. Gardnerella vaginalis was isolated in 58% of the women after vaginal and in 44% of the women after oral treatment. It is concluded that vaginal application of 500 mg metronidazole daily for 7 days is equally effective as oral administration in the treatment of bacterial vaginosis.     

Randomised treatment trial of bacterial vaginosis to prevent post-abortion complication

OBJECTIVE: To evaluate the efficacy of metronidazole to reduce post-abortion complications among women with bacterial vaginosis. DESIGN: A randomised, double-blind placebo-controlled trial. SETTING: An American outpatient abortion facility between April 1999 and June 2000. SAMPLE: Women presenting for surgical abortion were screened for bacterial vaginosis using a pH and amines card test. METHODS: Women positive for elevated pH and amines on a self-collected vaginal discharge sample were randomised to 1000 mg oral metronidazole before abortion followed by 500 mg twice daily or placebo. All randomised women were also dispensed 100 mg doxycycline to take twice daily for seven days. MAIN OUTCOME MEASURES: Data were collected by phone, daily diary or visit and scored from 0 to 7 for post-abortion complications. Intention-to-treat analyses were completed prior to unblinding. RESULTS: Of 1764 women screened by card test, 638 (36%) were positive. Of these, 393 were randomised. Follow up data were available for 253 (64%) of these women. A complication score of 3 or more occurred in 21% of women assigned to metronidazole, compared with 19% in those assigned placebo (RR 1.1, 95% CI 0.7-1.9). Among 153 women with Gram stain confirmation for bacterial vaginosis, there was a similar lack of benefit with treatment (RR 1.6, 95% CI 0.9-3.0). No individual symptom or sign was statistically different between groups even for second trimester procedures. CONCLUSION: Among women undergoing abortion and diagnosed with bacterial vaginosis, oral metronidazole, in conjunction with doxycycline, did not reduce post-abortion complications.     

Oral metronidazole vs. Metrogel Vaginal for treating bacterial vaginosis. Cost-effectiveness evaluation.

OBJECTIVE: To compare the cost-effectiveness of metronidazole versus Metrogel Vaginal in the treatment of bacterial vaginosis. STUDY DESIGN: Sixty consecutive patients with a clinical diagnosis of bacterial vaginosis were randomly assigned prospectively into either the metronidazole, 500 mg (twice daily for seven days by mouth) or Metrogel Vaginal (one applicator twice daily for five days) treatment group. The study patients were aged 18-30 years, without other medical problems. The patients proceeded with outpatient therapy and returned 7-10 days after the completion of treatment for reevaluation. During the study, patients refrained from sexual relations, avoided alcohol and drugs, and avoided all medication. The physician evaluated the patients for bacterial vaginosis through standard wet preparation, whiff test and pH testing prior to and after treatment. The patients were randomized by a nurse and were blinded for study purposes to the evaluating physician. RESULTS: Successful treatment outcomes for bacterial vaginosis occurred in 27 and 28 patients for Metrogel Vaginal and metronidazole, respectively, out of the original 30 patients in each study group. All patients introduced into the study completed the study without difficulty. No significant complications were found in either treatment group. Three patients treated with metronidazole experienced nausea during the treatment interval. The entire cost of treatment was $19.71 and $1.51 for Metrogel Vaginal and metronidazole, respectively. CONCLUSION: The most cost-effective treatment for bacterial vaginosis was generic metronidazole. While the use of the more expensive Metrogel Vaginal may be reasonable for patients experiencing side effects of oral metronidazole, most patients should be treated with the less expensive generic metronidazole.     

Comparative study of intravaginal metronidazole and triple-sulfa therapy for bacterial vaginosis

Objective: We sought to compare the efficacy of metronidazole gel vs. triple-sulfa cream in the treatment of bacterial vaginosis (BV).Methods: In a double-blinded study, 247 women with symptomatic BV were randomly assigned to receive either 5 g of 0.75% metronidazole gel twice daily for 5 days or triple-sulfa cream twice daily for 5 days. There were 205 (96 treated with metronidazole and 109 treated with triple-sulfa) evaluable patients to compare efficacy at the final visit. Approximately 60% of these patients had been previously treated for BV, reflecting the recurrent nature of the disease in this patient population.Results: At the first (12-16 days) return visit, 81/103 (79%) patients in the metronidazole group were cured compared with 80/113 (71%) patients in the triple-sulfa cream group (P = 0.333). At the final (28-35 days) return visit, 63/96 (66%) in the 96 metronidazole group remained cured compared with only 51/109 (47%) in the triple-sulfa group (P = 0.02). An intent-to-treat analysis similarly showed that the cure rate with metronidazole was superior to triple-sulfa (P 相似文献   

Assessment of office-based care of sexually transmitted diseases and vaginitis and antibiotic decision-making by obstetrician-gynecologists.

OBJECTIVE: Survey office-based obstetric-gynecologic practitioners regarding their knowledge of infectious disease care and antibiotic use. METHODS: A survey questionnaire of multiple-choice questions was mailed to Fellows of the American College of Obstetricians and Gynecologists about clinical entities for which recommendations have undergone recent changes or about which there was a lack of consensus in a prior similar survey (Gibbs RS, McGregor JA, Mead PB, et al.: Obstet Gynecol 83:631-636, 1994). RESULTS: Respondents indicated that oral metronidazole was their most frequent choice to treat bacterial vaginosis. Ampicillin (57%) was used more often than penicillin (39%) for intrapartum group B streptococcus prophylaxis. Azithromycin was preferred (61%) over erythromycin-base (38%) for chlamydia treatment during pregnancy. There were several modes of practice that deviated from accepted care: 27% and 29% did not screen for chlamydia and gonorrhea, respectively, in pregnancy; 17% used cultures for Gardnerella vaginalis to diagnose bacterial vaginosis; 25% considered quinolones to be safe in pregnancy; 93% felt metronidazole should never be used in pregnancy; and the majority (66%) would send a patient treated successfully for pelvic cellulitis home with an oral antibiotic. CONCLUSION: Respondents' infectious disease knowledge and practices in obstetrics and gynecology is appropriate in treating sexually transmitted diseases, bacterial vaginosis, and group B streptococcus. Numerous deficiencies still exist in screening for sexually transmitted diseases in pregnancy and diagnosing bacterial vaginosis, as well as in the choice of antibiotics to use or avoid for certain infections.     

乳酸杆菌治疗妊娠合并细菌性阴道病临床观察

目的观察乳酸杆菌活菌制剂对妊娠期合并细菌性阴道病的治疗作用，评价其疗效。方法107例妊娠合并细菌性阴道病的患者随机分为两组，分别应用乳酸杆菌活菌胶囊及甲硝唑栓阴道上药，每晚1次，连续用药10天，停药3天回院复查。结果乳酸杆菌活菌胶囊能迅速缓解临床症状，实验室检查转阴有效率高，总有效率85．1％，甲硝唑栓有效率81．4％，两者相比差异无显著性。结论乳酸杆菌活菌胶囊是目前安全、有效、无毒副作用的治疗妊娠期细菌性阴道病的药物。     

Cost of bacterial vaginosis in pregnancy. Decision analysis and cost evaluation of a clinical study in Germany.

OBJECTIVE: To estimate the economic impact of screening for and treatment of bacterial vaginosis during early pregnancy. STUDY DESIGN: Data from a clinical study that aligned two screening and treatment strategies and a no-screening or treatment strategy with three gynecologic practices in Berlin were used in decision tree analysis. Costs applied to the clinical outcomes were determined from standard German references and the charges from university clinics. RESULTS: Practices A and B screened all 600 patients in the early second trimester and treated the positive cases with clindamycin 2% vaginal cream (A) or a Lactobacillus preparation (B), which incurred lower total costs, $493,159 and $497,619, as compared to practice C (total costs, $534,926), which did not screen or treat for bacterial vaginosis. Including costs of screening and treatment, the net savings of practice A as compared to practice C was estimated to be $47,316. CONCLUSION: The presence of more preterm, premature and low-birth-weight infants added costs for practice C. The estimated cost savings lend support to the value of screening and treatment for bacterial vaginosis in early pregnancy.     

Treatment with 2% clindamycin vaginal cream prior to first trimester surgical abortion to reduce signs of postoperative infection: a prospective, double-blinded, placebo-controlled, multicenter study

BACKGROUND: Bacterial vaginosis (BV) and intermediate flora is known risk-factor for postoperative infection after surgical termination of pregnancy. Vaginal application of 2% clindamycin cream is an efficacious treatment for BV, but it is not known whether preoperative administration of clindamycin cream might reduce the signs of post-abortion infection after surgical termination of pregnancy. AIM: To evaluate whether preoperative treatment with clindamycin cream might reduce the signs of post-abortion infection after legal abortion. DESIGN: Prospective, double-blinded, placebo-controlled, multicenter study. MATERIAL AND METHODS: Consecutive women attending for surgical termination prior to 11+4 gestational weeks were approached. We randomized participants to preoperative vaginal treatment with 2% clindamycin cream or placebo cream in a double-blinded fashion. At all visits vaginal smears were air dried on microscopy slides to be stored. The rate of postoperative pelvic infection according to our definition was the main outcome variable, the cure rates of BV and of intermediate flora were secondary outcome variables. RESULTS: Of 1655 enrolled women, 1102 were evaluable for analyses. Fifty-eight women developed signs of post-abortion infection. Preoperative treatment with clindamycin cream significantly (RR: 4.2, 95% C.I. 1.2-15.9) reduced the risk of post-abortion infection among women with abnormal vaginal flora (BV and intermediate flora). Treatment with clindamycin cream in women with normal lactobacilli flora did not demonstrate any difference compared to the non-treatment group. CONCLUSION: Preoperative treatment for at least three days with clindamycin cream significantly reduced the risk for developing signs of post-abortion infection only among women with preoperative abnormal vaginal flora (BV and intermediate flora).