Mg Of Metronidazole Research Articles

Combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis.

To compare combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis (BV). A randomized controlled trial was conducted among women diagnosed with BV using the Amsel criteria (n=90) at a university hospital in Khon Kaen, Thailand, between June 27, 2017, and April 30, 2018. The oral metronidazole group (n=44) received 400mg of metronidazole, administered three times per day. The combined vaginal tablet group (n=46) received a vaginal suppository once daily, which comprised nystatin (100000U), diiodohydroxyquin (100mg), and benzalkonium chloride (7mg). Treatment was administered for 7days in both groups. Follow-up visits at 14 and 42days assessed treatment outcomes and adverse effects. Remission of BV occurred among 41 (93%) women in the oral metronidazole group and 39 (85%) women in the combined vaginal tablet group. The adjusted relative risk was 0.92 (95% confidence interval 0.80-1.06). The rate of nausea and/or vomiting was significantly higher in the oral metronidazole group than that in the combined vaginal tablet group. Treatment efficacy of the combined vaginal tablet versus oral metronidazole was equivalent. TCTR20170627001 (www.clinicaltrials.in.th).

Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.

quadruple therapy with bismuth is recommended as a first line treatment for Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera®). a prospective, non-controlled, single center observational study was performed in a cohort of 200 consecutive patients with an untreated H. pylori infection; 58% were female. The subjects were treated for ten days with Pylera® of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera® capsule contains 140 mg of bismuth subcitrate, 125 mg of metronidazole and 125 mg of tetracycline. The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision. Eradication of infection was controlled for at least four weeks after treatment termination via the urea breath test, the stool antigen test with monoclonal antibodies or by histology. treatment compliance was observed in 96% (192/200) of the patients. Only 28.5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects. Severe adverse effects developed in only one case due to Clostridium difficile infection. The effectiveness based on intention to treat was 91.5% (183/200, 95% CI: 87.1-96.8) and per protocol was 95.2% (182/191, 95% CI: 90.9-98.9). in our experience, Pylera® is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection.

Optimal Sampling Source and Time for Wet Mount Detection ofTrichomonas vaginalis in Cervical Mucus During ART Cycle Evaluation

Objective Trichomonas vaginalis (TV) is a sexually transmitted parasitic disease with a global presence. Over a period of two years, 44 couples were assessed for cervical mucous (CM) quality/function as part of their infertility evaluation. Thirteen of 44 couples had TV present in periovulatory CM examination. In one case, TV was seen in fluid aspirated from the uterine cavity. The aim of the study was to evaluate the incidence of TV detection in asymptomatic cases during infertility workup. Design Retrospective study. All patients studied were Caucasian with the age range 29 to 39 years. Length of failure to conceive ranged from 1-9 years. Materials and Methods Cervical mucus specimens were aspirated from the external cervical os during the patients’ periovulatory period. Wet mounts were prepared for microscopic analysis. Uterine fluid specimens were collected if indicated during sonography. Results Trichomonas vaginalis trophozoites were always detected in association with white blood cells (WBC) clusters or WBC’s/epithelial cell clusters. In some cases, it would take several minutes to find trophozoites. Furthermore, trophozoites were similar in appearance as compared to WBC’s and could only be detected by the rhythmic movement of their flagella. Trichomonas vaginalis was identified in 14 of the women studied, 6 during IUI treatment, 4 as part of a post coital examination, 3 as part of a midcycle mucous examination and in 1 patient following aspiration of fluid in the fundus of the uterus. All couples testing positive were treated with 2 grams of metronidazole as a one dose treatment. This treatment rendered 13 of 14 couples TV free when CM was evaluated at ovulation in a subsequent cycle. The patient not responding to a single 2 gram dose received 500 mg of metronidazole twice daily for 7 days and subsequently tested negative for TV. Five of the 14 couples have conceived after the discovery of TV. Four patients conceived following metronidazole and one conceived in the ovulatory cycle when TV was detected. Two pregnancies have delivered healthy infants. One pregnancy is in the third trimester and one is in the first trimester. There was one first trimester spontaneous miscarriage of a tetraploid conceptus. Conclusions It is concluded that TV could be present with higher frequency in patients seeking reproductive treatment. It appears that antibiotic treatment enhances the chance for conception in couples so affected. Disclosures Nothing to disclose.

Is metronidazole a panacea for post-hemorrhoidectomy pain?

Background: Pain following Milligan Morgan hemorrhoidectomy is a significant cause of morbidity. The present study was carried out to find out if using metronidazole in the post-operative period of these patients results in less post-operative pain.Methods: This was a prospective randomized controlled trial which was conducted on 67 consecutive patients attending the Surgical OPD at SRN Hospital, Allahabad during the study period between August 2016 and July 2017 who underwent surgery for grade 2, grade 3 and grade 4 hemorrhoids. The patients were allocated to 3 groups-one group was the control group, the second group received oral metronidazole post-operatively for 7 days while the third group received only topical metronidazole for 7 days. All the three groups received 500 mg of metronidazole in 100 ml infusion pre-operatively. The post-operative analgesic usage was standardized for all the three groups. Appropriate tests of significance were applied to assess if the difference in the intensity of post-operative pain was significant in the immediate post-operative period and on days 1, 3 and 7 post-surgery.Results: Pain relief was significantly better in the groups using metronidazole at post-operative day 1, 3 and 7 and this was also borne in the lesser number of analgesics used by the patients of these groups.Conclusions: Use of oral or topical metronidazole in the post-operative period results in clinically significant pain relief. There is no additional benefit of one over the other and hence either can be used.

Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial

Among women, trichomoniasis is the most common non-viral sexually transmitted infection worldwide, and is associated with serious reproductive morbidity, poor birth outcomes, and amplified HIV transmission. Single-dose metronidazole is the first-line treatment for trichomoniasis. However, bacterial vaginosis can alter treatment efficacy in HIV-infected women, and single-dose metronidazole treatment might not always clear infection. We compared single-dose metronidazole with a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women and tested whether efficacy was modified by bacterial vaginosis. In this multicentre, open-label, randomised controlled trial, participants were recruited at three sexual health clinics in the USA. We included women positive for Trichomonas vaginalis infection according to clinical screening. Participants were randomly assigned (1:1) to receive either a single dose of 2 g of metronidazole (single-dose group) or 500 mg of metronidazole twice daily for 7 days (7-day-dose group). The randomisation was done by blocks of four or six for each site. Patients and investigators were aware of treatment assignment. The primary outcome was T vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment. The analysis of the primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status. This trial is registered with ClinicalTrials.gov, number NCT01018095, and with the US Food and Drug Administration, number IND118276, and is closed to accrual. Participants were recruited from Oct 6, 2014, to April 26, 2017. Of the 1028 patients assessed for eligibility, 623 women were randomly assigned to treatment groups (311 women in the single-dose group and 312 women in the 7-day-dose group; intention-to-treat population). Although planned enrolment had been 1664 women, the study was stopped early because of funding limitations. Patients in the 7-day-dose group were less likely to be T vaginalis positive at test-of-cure than those in the single-dose group (34 [11%] of 312 vs 58 [19%] of 311, relative risk 0·55, 95% CI 0·34-0·70; p<0·0001). Bacterial vaginosis status had no significant effect on relative risk (p=0·17). Self-reported adherence was 96% in the 7-day-dose group and 99% in the single-dose group. Side-effects were similar by group; the most common side-effect was nausea (124 [23%]), followed by headache (38 [7%]) and vomiting (19 [4%]). The 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women. National Institutes of Health.

Principles of demodecosis treatment

The article presents an overview of the main modern methods of treatment of demodecosis, the main antiparasitic drugs and alternative treatment regimens, their advantages and disadvantages. The aim of the study was to compare combined method of demodecosis treatment with external treatment with 7% metronidazole. 64 patients with acne and rosacea complicated demodecosis, which were divided into two groups depends on a method of treatment (250 mg of metronidazole per os 2 times a day, externally 1% metronidazole once a day for 20 days or 7% metronidazole externally, 20 days, respectively). The effectiveness of therapy in both groups was the same. It was a significant decrease in the number of morphological elements, reduction of subjective complaints of patients after the treatment. This study represents a lack of superiority in systemic therapy of demodecosis, compared to external therapy.

Порівняльне дослідження ефективності топічної терапії комбінованими препаратами змішаних вагінітів, асоційованих з цервіцитами

The objective: to increase the effectiveness of local therapy for recurrent nonspecific vaginitis associated with cervicitis in women of reproductive age on the basis of a comparative evaluation of combined drugs Terzhinan and Neo Penotran Forte. Materials and methods. A prospective, open comparative study included 56 women aged 27.5±2.8 years with recurrent nonspecific vaginitis and cervicitis who were randomized to the main group and comparison group. Patients of the main group (n=28) received the drug Terzhinan® (1 vaginal tablet in the evening, before bed, for 10 days). The comparison group included 28 patients who received Neo-Pentran Forte (1 vaginal suppository in the evening, before bedtime, for 10 days), one vaginal suppository containing 750 mg of metronidazole and 200 mg of miconazole nitrate. The complex clinical-paraclinical examination included the determination of the state of the vaginal microbiota using several methods in parallel: a bacterioscopy of vaginal smears stained by Gram, a bacteriological rapid method using AFGENITAL SYSTEM (Liofilchem®, Italy), real-time PCR (Florocenosis) with detection antigens of chlamydia, herpes simplex virus, human papillomavirus, trichomonads. Results. The main reason for the treatment of patients were abundant pathological discharge from the genital tract (73.2%), pruritus (37.5%) and burning (23.2%) in the vulva, pain during sexual intercourse (8.9%), while 33.9% of women expressed combined complaints. Attention was drawn to the significant frequency of dyshormonal pathology among women with recurrent cervico-vaginal infections. In the examined women, uterine leiomyoma was diagnosed (28.6%), genital endometriosis (19.6%), fibrocystic breast disease (37.5%), combined benign dyshormonal diseases of the genital organs (14.3%). About 21.4% of patients treatment of thyroid gland dysfunction (hypothyroidism). According to the comprehensive examination, in all patients of clinical groups, decompensated vaginal dysbiosis was diagnosed, which was manifested by a sharp decrease in the absence of Lactobacillus spp strains in 39.3% of patients and an increase in the number of isolated opportunistic and pathogenic microorganisms to 1011 CFU/ml with an increase in the number of microorganisms in microbial associations (from 2–3 to 5–6 conditionally pathogenic and pathogenic pathogens) in all the cases analyzed. When using the genital express system in vaginal contents, women of the main group identified Escherichia coli (17.9%), Pseudomonas spp. (10.7%), Gardnerella vaginalis (39.3%), Staphylococcus aureus (17 9%), Enterococcus faecalis (25.0%), Streptococcus Group B (10.7%), Candida spp. (46.4%), Mycoplasma spp./Ureaplasma ur. in the title &gt; 105 (14.0%). In the comparison group, the spectrum of detected pathogenic and conditionally pathogenic microorganisms did not differ significantly from the data of the main group. 92.6% of patients in the main group had a pronounced positive clinical effect, and a positive microbiological effect was achieved in 96.4% of cases that persisted during the next two months of follow-up. Without additional prescription of antifungal agents, a positive effect was achieved in 84.6% of patients in the main group with mixed bacterial-candidiasis vaginitis at 54.5% in the comparison group. The independent recovery of the lactobacilli pool to a titer of 107–109 CFU/ml in 17.9% of patients with a lack of detection of lactobacilli before treatment. A similar effect was not observed in the comparison group. Сonclusion. In a comparative study of the results of the use of Terzhinan and Neo-Penotran Forte in monotherapy in patients with inflammatory diseases of the lower genitalia (nonspecific recurrent vaginitis and cervicitis), the high clinical and microbiological efficacy of Terzhinan has been demonstrated. Key words: mixed vaginitis, cervicitis, Terzhinan, Neo-Penotran Forte.

Treatment of periodontitis in smokers with multiple sessions of antimicrobial photodynamic therapy or systemic antibiotics: A randomized clinical trial.

The aim of this study was to evaluate the effects of non-surgical periodontal therapies on smokers with chronic periodontitis, involving multiple adjunctive applications of antimicrobial photodynamic therapy (aPDT), and systemic metronidazole (MTZ) with amoxicillin (AMX). All participants were treated with scaling and root planing (SRP). Seventeen patients received 400 mg of MTZ and 500 mg of AMX three times per day for 7 days (MTZ + AMX). Additionally, 17 patients received a placebo, and 17 patients were treated with three applications of aPDT (immediately, 48 h and 96 h after SRP). Clinical and microbiological examinations were performed at baseline and at 90 and 180 days post-therapy. Subgingival samples were analyzed using real-time polymerase chain reaction. After 180 days, the patients in groups MTZ + AMX and aPDT had significantly lower mean probing depths, more clinical attachment level gains and less bleeding on probing. At 180 days, in the moderate pocket there was a reduction in the levels of Porphyromonas gingivalis and Prevotella nigrescens in the MTZ + AMX group, while group aPDT showed a reduction in Prevotella nigrescens. Furthermore, at 180 days, in the deep pocket a reduction in Porphyromonas gingivalis, Prevotella intermedia and Prevotella nigrescens was observed in group MTZ + AMX, as well as a reduction in the levels of Prevotella intermedia and Prevotella nigrescens in group aPDT. In smokers with periodontitis, the MTZ + AMX and aPDT treatments significantly improved the effects of SRP.

Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial.

To evaluate the clinical effects of different dosages of metronidazole (MTZ) and durations of MTZ+amoxicillin (AMX) in the treatment of generalized chronic periodontitis (GChP). Subjects with severe GChP were randomly assigned to receive scaling and root planing (SRP)-only, or combined with 250 or 400mg of MTZ+AMX (500mg) thrice a day (TID), for 7 or 14days. Subjects were monitored for 1year. One hundred and nine subjects were enrolled. At 1 year, 61.9% and 63.6% of the subjects receiving AMX+250 or 400mg of MTZ for 14days, respectively, reached the clinical endpoint for treatment (≤4 sites with probing depth ≥5mm), against 31.8% of those taking 250 or 400mg of MTZ for 7days (p<.05) and 13.6% of those receiving SRP-only (p<.05). Fourteen days of MTZ+AMX was the only significant predictor of subjects reaching the clinical endpoint at 1year (OR, 5.26; 95% CI, 2.3-12.1, p = .0000). The frequency of adverse events did not differ among treatment groups (p>.05). The adjunctive use of 400 or 250mg of MTZ plus 500mg of AMX/TID/14days offers statistically significant and clinically relevant benefits over those achieved with SRP alone in the treatment of severe GChP. The added benefits of the 7-days regimen in this population were less evident. (ClinicalTrials.gov NCT02735395).

Conjugation of metronidazole with dextran: a potential pharmaceutical strategy to control colonic distribution of the anti-amebic drug susceptible to metabolism by colonic microbes.

Metronidazole (MTDZ), the drug of choice for the treatment of protozoal infections such as luminal amebiasis, is highly susceptible to colonic metabolism, which may hinder its conversion from a colon-specific prodrug to an effective anti-amebic agent targeting the entire large intestine. Thus, in an attempt to control the colonic distribution of the drug, a polymeric colon-specific prodrug, MTDZ conjugated to dextran via a succinate linker (Dex-SA-MTDZ), was designed. Upon treatment with dextranase for 8 h, the degree of Dex-SA-MTDZ depolymerization (%) with a degree of substitution (mg of MTDZ bound in 100 mg of Dex-SA-MTDZ) of 7, 17, and 30 was 72, 38, and 8, respectively, while that of dextran was 85. Depolymerization of Dex-SA-MTDZ was found to be necessary for the release of MTDZ, because dextranase pretreatment ensures that de-esterification occurs between MTDZ and the dextran backbone. In parallel, Dex-SA-MTDZ with a degree of substitution of 17 was found not to release MTDZ upon incubation with the contents of the small intestine and stomach of rats, but it released MTDZ when incubated with rat cecal contents (including microbial dextranases). Moreover, Dex-SA-MTDZ exhibited prolonged release of MTDZ, which contrasts with drug release by small molecular colon-specific prodrugs, MTDZ sulfate and N-nicotinoyl-2-{2-(2-methyl-5-nitroimidazol-1-yl)ethyloxy}-d,l-glycine. These prodrugs were eliminated very rapidly, and no MTDZ was detected in the cecal contents. Consistent with these in vitro results, we found that oral gavage of Dex-SA-MTDZ delivered MTDZ (as MTDZ conjugated to [depolymerized] dextran) to the distal colon. However, upon oral gavage of the small molecular prodrugs, no prodrugs were detected in the distal colon. Collectively, these data suggest that dextran conjugation is a potential pharmaceutical strategy to control the colonic distribution of drugs susceptible to colonic microbial metabolism.

Solid as solvent-Novel Spectrophotometric Analytical Method for Metronidazole Tablets using Solids (Eutectic Liquid of Phenol and Niacinamide) as Solubilizing Agents (Mixed Solvency Concept)

The researchers are doing much work to give eco-friendly solutions for the pollution and toxicity caused by most of the organic solvents. Maheshwari has given a nice concept, known as mixed-solvency concept by the application of which, innumerable solvent systems can be developed. Maheshwari is of the opinion that each substance possesses solubilizing power. He has given several eco-friendly methods in the area of drug estimations and formulations precluding the use of toxic organic solvents. The present research work also provides an eco-friendly method to estimate spectrophotometrically, the metronidazole drug in tablet formulations without the help of organic solvent. The present investigation is an attempt to show that solids can also be wisely used to act as solvent precluding the use of organic solvents. The main objective of the present study is to demonstrate the solvent action of solid. Solid excipients can nicely be employed as solubilizers in the development of pharmaceutical dosage forms in solution form of poorly soluble drugs (mixed solvency concept). Present study describes the application of solvent character of eutectic liquid consisting of phenol and niacinamide in 25:10 ratio (PNM 2510) on the weight basis for spectrophotometric estimation of metronidazole tablets. Solubility of metronidazole in distilled water was found to be 7.28 mg/ml at room temperature. More than 80 mg of metronidazole dissolves in 1 ml of PNM 2510. In the present investigation, PNM 2510 was utilized to extract out (dissolve) the drug from tablet powder of metronidazole tablets. Distilled water was used for dilution purpose. Absorbance was noted at 320 nm against reagent blank to calculate the amount of drug in the tablets. Proposed method is novel, eco-friendly, rapid, free from toxicity of organic solvent, accurate and reproducible. Recovery studies and statistical data proved the accuracy, reproducibility and precision of the proposed method. The presence of phenol, niacinamide and tablet excipients did not interfere in the spectrophotometric estimation of metronidazole at 320 nm. Phenol and niacinamide do not interfere above 300 nm in spectrophotometric analysis.

Опыт применения местного комбинированного препарата, содержащего метронидазол и миконазол, для лечения бактериального вагиноза и кандидозного вульвовагинита у беременных

The problem of vaginal infections, such as bacterial vaginosis and vulvovaginal candidiasis during pregnancy is extremely relevant in connection with adverse perinatal outcomes, and an increased risk of preterm birth. Treatment of vaginal infections is a serious problem in connection with the formation of bacterial resistance, frequent recurrence, late onset of therapy due to the prolonged diagnosis and drug selection. We conducted a prospective study to evaluate the efficacy and safety of topical formulation containing 750 mg of metronidazole and 200 mg of miconazole nitrate (Neo-Penotran Forte) for the treatment of bacterial vaginosis and vulvovaginal candidiasis in pregnant women in II trimester. Methods. The study included 122 pregnant women aged 18 to 40 years (mean age 29.6±2.5 years) without concomitant extragenital pathology in 18-22 weeks gestation with a confirmed diagnosis of bacterial vaginosis (n=51) and candidiasis vulvovaginitis (n=71). The clinical and therapeutic efficacy of the drug was evaluated, as well as the speed of the onset of clinical efficacy (the day of the start of treatment), perinatal outcomes, the incidence of preterm delivery in both groups, the incidence of side effects during treatment with the drug. Results. The therapeutic efficiency of the preparation (no normalization of subjective symptoms and laboratory values) in a group of pregnant women with bacterial vaginosis at 14 and 28 days from the start of the study was 96% (n=48) and 94% (n=47), respectively. In the group with candidal vulvovaginitis - 94.2% (n=65) and 91.3% (n=63). Clinical efficacy (lack of subjective symptoms) by the end of the course of treatment achieved completely in all patients in both groups, and in many patients before the end of the full course of treatment. Conclusion. Neo-Penotran Forte is a highly effective and safe and can be recommended for the treatment of bacterial vaginosis and vulvovaginal candidiasis in pregnant women, starting with the II trimester. Effective treatment of pregnant women with bacterial vaginosis and vulvovaginal candidiasis drug Neo- Penotran Forte prevent adverse pregnancy outcomes and reduces the risk of preterm birth associated with vaginal infection, but due to the small sample size, this problem requires further investigation.

Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial.

This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance. H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040). As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.

The Protective Effects of Turmeric on Liver Enzymes of Metronidazole-Treated Adult Male Wistar Rats

Over the years, research works on the different liver enzymes has proven to be very helpful to man. This study evaluates the protective effects of turmeric on the liver enzymes of metronidazole-treated adult male wistar rats. With previous researches, metronidazole has been found to exert some negative effects on some organs of the body like the testis, kidney etc but the turmeric on its own part, has been found to have no side effects with a host of beneficial functions such as its anti-oxidant and antimicrobial effect amongst a host of other functions. In this study, twenty wistar rats with weight range of between 165-180g were assigned into four groups A, B, C and D of 5 each. The experimental groups A, B and C were orally administered 200mg of metronidazole, 400mg of metronidazole and 400mg of metronidazole as well as 400mg of turmeric respectively for duration of twenty-eight days while the group D served as control and were orally administered water and feed only. Twenty four hours after the last administration, the animals were anaesthetized under chloroform inhalation and dissected for organ collection. Blood for serum preparation was collected into sterile plain tubes and stored in the refrigerator for analysis. Serum samples from the bloods were analyzed for liver enzymes activities using randox kit method. The study revealed that turmeric helped reduced the effects of metronidazole on the serum activities of ALT, AST and ALP on the liver. This present study suggests that metronidazole could have negative effects on the liver and so advises that turmeric be added when on metronidazole administration.

Pharmacokinetics/pharmacodinamic (PK/PD) evaluation of a short course of oral administration of metronidazole for the management of infections caused by Bacteroides fragilis

Metronidazole is the antibiotic of choice for the management of infections caused by anaerobes. Its administration requires multiple daily doses causing increased medication errors. Due to its high post-antibiotic effect and rapid concentration-dependent bactericidal activity, administration of this antibiotic in an extended dosing interval would achieve PK/PD parameters effectively. To assess the probability of achieving effective PK/PD relationship with the administration of 1,000 mg every 24 hours of metronidazole for Bacteroides fragilis infections. A clinical trial was conducted in a group of volunteers who received a single oral dose of 500 or 1,000 mg of metronidazole. Determinations of values of Cmax, t max, and AUCC0-24 h. determined using the trapezoidal method, were obtained for a Markov simulation that would allow for determining the likelihood of achieving a AUC0-24 h/MIC ratio above 70 for infections caused by susceptible B. fragilis. Cmax (24,03 ± 6,89 mg/L) and t max (1,20 ± 0.80 hrs) and the value of AUC0-24 h (241.91 ± 48.14 mg * h/L) were determined. The probability of obtaining a AUC0-24 h/MIC ratio greater than 70 was greater than 99%. From a pharmacokinetic perspective, with the administration of a daily dose of 1,000 mg of metronidazole, it is possible to achieve a therapeutic goal of AUC0-24 h/MIC ratio above 70 for the treatment of anaerobic infections.

Population pharmacokinetic models for cefuroxime and metronidazole used in combination as prophylactic agents in colorectal surgery: Model-based evaluation of standard dosing regimens

The antibiotics used for prophylaxis in colorectal surgery must maintain appropriate plasma concentrations during the entire surgery to avoid surgical site infections caused by aerobes and anaerobes; cefuroxime plus metronidazole is one of the combinations used. The aim of this study was to evaluate the adequacy of cefuroxime plus metronidazole administration as prophylaxis in colorectal surgery. In total, 63 patients electively undergoing rectal or colon surgery were administered 1500mg of cefuroxime and 1500mg of metronidazole in 15-min and 1-h infusions, respectively, prior to surgery. Blood samples were withdrawn during and after surgery for determination of plasma concentrations by high-performance liquid chromatography. Population pharmacokinetic models were developed using NONMEM 7.2.0. Pharmacokinetic/pharmacodynamic (PK/PD) simulations were performed to explore the ability of different dosage regimens to achieve the pharmacodynamic targets. Pharmacokinetics for both antibiotics were best described by a two-compartment model. Elimination of cefuroxime was conditioned by creatinine clearance (CLCr). The half-life of cefuroxime was 1.5h for patients with normal renal function and 4.9h in patients with renal impairment. Elimination and distribution of metronidazole were affected by patient body weight (BW). PK/PD analysis revealed that a single-dose protocol of 1500mg of cefuroxime and metronidazole is adequate in short surgeries (≤2h). However, for longer surgeries, recommendations are suggested depending on the patient's CLCr and BW. Additional doses of cefuroxime are needed for patients with moderate renal impairment or those presenting normal renal function. For metronidazole, an additional dose is needed for patients with a BW of 90kg.

Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study.

Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients. Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344. Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)]. Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated.

A randomised clinical trial of 10-day concomitant therapy and standard triple therapy for Helicobacter pylori eradication

BackgroundAs a result of increased resistance to antibiotics, Helicobacter pylori eradication rates using standard triple therapy have been declining. AimTo validate the efficacy and tolerability of a concomitant regimen as a first-line treatment for H. pylori infection. MethodsA total of 348 naïve H. pylori-infected patients from six hospitals in Korea were randomly assigned to concomitant therapy and standard triple therapy groups. The concomitant regimen consisted of 30mg of lansoprazole, 1g of amoxicillin, 500mg of clarithromycin, and 500mg of metronidazole, twice daily for 10 days. The standard triple regimen consisted of 30mg of lansoprazole, 1g of amoxicillin, and 500mg of clarithromycin, twice daily for 10 days. ResultsConcomitant and standard eradication rates were 78.7% (137/174) vs. 70.7% (123/174) by intention-to-treat (p=0.084) and 88.7% (133/150) vs. 78.4% (120/153) by per-protocol (p=0.016), respectively. The two groups were similar with regard to the incidence of adverse events. ConclusionsAlthough 10-day concomitant therapy was validated as a suboptimal treatment option for the treatment of H. pylori infection, this regimen is expected to be a promising starting point in the development of an optimal treatment regimen for H. pylori infection.

High-Dose Vaginal Metronidazole for Recurrent Bacterial Vaginosis—A Pilot Study

The purpose of this study was to evaluate high-dose intravaginal metronidazole, with or without miconazole, in enhancing cure rates in women with recurrent BV. A total of 43 women with symptomatic recurrent BV were enrolled in a 4-arm study comparing 500 mg versus 750 mg of metronidazole, with or without miconazole, intravaginally for 7 days. Test of cure by saline wet mount and 10% potassium chloride microscopy, pH, Gram stain for Nugent score, and yeast culture were performed 3 times after treatment: 3 to 7 days, 30 to 35 days, and 60 to 70 days. Overall cure rate for the entire group was 92.6% at visit 2, 62.1% at visit 3, and 51.4% at visit 4. At visit 2, there was no difference in cure rates among patients who received metronidazole 750 mg ± miconazole daily (90.5%) compared with metronidazole 500 mg ± miconazole daily (85%). At visit 3, there was a significant improvement in cure rates among patients who received metronidazole 750 mg ± miconazole daily (78.9%) compared with metronidazole 500 mg ± miconazole daily (44.4%) (p < .05). At visit 4, a significant difference in clinical cure rates persisted among patients who received metronidazole 750 mg ± miconazole daily (68.4%) compared with of metronidazole 500 mg ± miconazole daily (33.3%; p < .05). Poor responses (Nugent score > 4 or pH > 4.4) at the first visit alter treatment-predicted recurrence. The addition of miconazole did not enhance BV response rates. Cure rates for BV were high in this refractory cohort and seemed dose dependent.

Metronidazole and Hydroxymetronidazole Central Nervous System Distribution: 1. Microdialysis Assessment of Brain Extracellular Fluid Concentrations in Patients with Acute Brain Injury

The distribution of metronidazole in the central nervous system has only been described based on cerebrospinal fluid data. However, extracellular fluid (ECF) concentrations may better predict its antimicrobial effect and/or side effects. We sought to explore by microdialysis brain ECF metronidazole distribution in patients with acute brain injury. Four brain-injured patients monitored by cerebral microdialysis received 500 mg of metronidazole over 0.5 h every 8 h. Brain dialysates and blood samples were collected at steady state over 8 h. Probe recoveries were evaluated by in vivo retrodialysis in each patient for metronidazole. Metronidazole and OH-metronidazole were assayed by high-pressure liquid chromatography, and a noncompartmental pharmacokinetic analysis was performed. Probe recovery was equal to 78.8% ± 1.3% for metronidazole in patients. Unbound brain metronidazole concentration-time curves were delayed compared to unbound plasma concentration-time curves but with a mean metronidazole unbound brain/plasma AUC0-τ ratio equal to 102% ± 19% (ranging from 87 to 124%). The unbound plasma concentration-time profiles for OH-metronidazole were flat, with mean average steady-state concentrations equal to 4.0 ± 0.7 μg ml(-1). This microdialysis study describes the steady-state brain distribution of metronidazole in patients and confirms its extensive distribution.