Are amoxycillin and folate inhibitors as effective as other antibiotics for acute sinusitis? A meta-analysis

Objectives: To examine whether antibiotics are indicated in treating uncomplicated acute sinusitis and, if so, whether newer and more expensive antibiotics with broad spectra of antimicrobial activity are more effective than amoxycillin or folate inhibitors. Design: Meta-analysis of randomised trials. Setting: Outpatient clinics. Subjects: 2717 patients with acute sinusitis or acute exacerbation of chronic sinusitis from 27 trials. Interventions: Any antibiotic versus placebo; amoxycillin or folate inhibitors versus newer, more expensive antibiotics. Main outcome measurements: Clinical failures and cures. Results: Compared with placebo, antibiotics decreased the incidence of clinical failures by half (risk ratio 0.54 (95% confidence interval 0.37 to 0.79)). Risk of clinical failure among 1553 randomised patients was not meaningfully decreased with more expensive antibiotics as compared with amoxycillin (risk ratio 0.86 (0.62 to 1.19); risk difference 0.9 fewer failures per 100 patients (1.4 more failures to 3.1 fewer failures per 100 patients)). The results were similar for other antibiotics versus folate inhibitors (risk ratio 1.01 (0.52 to 1.97)), but data were sparse (n=410) and of low quality. Conclusions: Amoxycillin and folate inhibitors are essentially as effective as more expensive antibiotics for the initial treatment of uncomplicated acute sinusitis. Small differences in efficacy may exist, but are unlikely to be clinically important.

Key messages

• A major question in managing acute sinusitis is whether antibiotics should be used, and if so which drugs should be chosen
• In a comprehensive meta-analysis we evaluated evidence from randomised controlled trials comparing, firstly, antibiotics against placebo and, secondly, amoxycillin and folate inhibitors against newer, more expensive antibiotics
• Antibiotics were significantly more efficacious than placebo in achieving cure of clinical symptoms, but over two thirds of placebo patients showed spontaneous resolution or improvement of symptoms
• Amoxycillin and folate inhibitors had overall similar efficacy compared with newer antibiotics
• The current evidence does not justify the use of expensive, broad spectrum antibiotics in the community for treating uncomplicated acute sinusitis

     

Amoxycillin and co-trimoxazole in presumed viral respiratory infections of childhood: placebo-controlled trial.

A double-blind randomized controlled trial of amoxycillin, co-trimoxazole, and placebo was conducted on 197 children presenting with presumed viral respiratory infections. Routine throat swabs were taken to exclude streptococcal diseases. The three disease categories studied--nasopharyngitis, pharyngotonsillitis, and bronchitis (including laryngotracheobronchitis)--showed a generally similar pattern of resolution irrespective of treatment. Nevertheless, seven out of 66 children receiving placebo were withdrawn from the trial with unremitting symptoms or complications thought to require antimicrobial treatment. Only two of 56 children receiving amoxycillin and none of 75 receiving co-trimoxazole were withdrawn. Three other children receiving amoxycillin and three receiving placebo were seen during the trial but further treatment was not thought to be necessary. Thus the return consultation rate in children receiving placebo therapy was 15% compared with 4% for those receiving antimicrobial treatment. Antimicrobial treatment was associated with less nasal discharge on the eighth day of treatment. Placebo treatment allowed an earlier return to normal activity. There was a high incidence of possible side effects on all regimens including placebo. It is concluded that the benefits of antimicrobial treatment in presumed viral respiratory infections are marginal, and they should not be routinely prescribed for these conditions.     

Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial

This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis (BV) by presence of vaginal irritation, discharge and 'fishy' odor, and Nugent criteria and detection of sialidase enzyme. The subjects were treated with oral metronidazole (500 mg) twice daily from days 1 to 7, and randomized to receive oral Lactobacillus rhamnosus GR-1 (1 x 10(9)) and Lactobacillus reuteri RC-14 (1 x 10(9)) or placebo twice daily from days 1 to 30. Primary outcome was cure of BV as determined by normal Nugent score, negative sialidase test and no symptoms or signs of BV at day 30. A total of 106 subjects returned for 30-day follow-up, of which 88% were cured in the antibiotic/probiotic group compared to 40% in the antibiotic/placebo group (p<0.001). Of the remaining subjects, 30% subjects in the placebo group and none in the probiotic group had BV, while 30% in the placebo and 12% in the probiotic group fell into the intermediate category based upon Nugent score, sialidase result and clinical findings. High counts of Lactobacillus sp. (>10(5) CFU/ml) were recovered from the vagina of 96% probiotic-treated subjects compared to 53% controls at day 30. In summary, this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women.     

A double blind, placebo-controlled study of Andrographis paniculata fixed combination Kan Jang in the treatment of acute upper respiratory tract infections including sinusitis.

A double blind, placebo-controlled, parallel-group clinical study was carried out to evaluate the effect of an Andrographis paniculata (N.) extract SHA-10 fixed combination, Kan Jang, in the treatment of acute upper respiratory tract infections, including sinusitis. Ninety-five individuals in the treatment group and 90 individuals in the placebo group completed the study according to the protocol. The medication was taken for 5 days. Temperature, headache, muscle aches, throat symptoms, cough, nasal symptoms, general malaise and eye symptoms were taken as outcome measures with given scores. The total score analysis showed a highly significant improvement in the verum group versus the placebo. This result applied to the group as a whole and to the sinusitis subgroups. The individual symptoms of headache and nasal and throat symptoms together with general malaise showed the most significant improvement while cough and eye symptoms did not differ significantly between the groups. Temperature was moderately reduced in the verum group. It can be concluded that Kan Jang has a positive effect in the treatment of acute upper respiratory tract infections and also relieves the inflammatory symptoms of sinusitis. The study drug was well tolerated.     

Acute red ear in children: controlled trial of non-antibiotic treatment in general practice.

OBJECTIVE--To examine the efficacy and safety of conservative management of mild otitis media ("the acute red ear") in children. DESIGN--Double blind placebo controlled trial. SETTING--17 group general practices (48 general practitioners) in Southampton, Bristol, and Portsmouth. PATIENTS--232 children aged 3-10 years with acute earache and at least one abnormal eardrum (114 allocated to receive antibiotic, 118 placebo). INTERVENTIONS--Amoxycillin 125 mg three times a day for seven days or matching placebo; 100 ml paracetamol 120 mg/5 ml. MAIN OUTCOME MEASURES--Diary records of pain and crying, use of analgesic, eardrum signs, failure of treatment, tympanometry at one and three months, recurrence rate, and ear, nose, and throat referral rate over one year. RESULTS--Treatment failure was eight times more likely in the placebo than the antibiotic group (14.4% v 1.7%, odds ratio 8.21, 95% confidence interval 1.94 to 34.7). Children in the placebo group showed a significantly higher incidence of fever on the day after entry (20% v 8%, p less than 0.05), mean analgesic consumption (0.36 ml/h v 0.21 ml/h, difference 0.14, 95% confidence interval 0.07 to 0.23; p = 0.0022), mean duration of crying (1.44 days v 0.50 days, 0.94; 0.50 to 1.38; p less than 0.001), and mean absence from school (1.96 days v 0.52 days, 1.45; 0.46 to 2.42; p = 0.0132). Differences in recorded pain were not significant. The prevalence of middle ear effusion at one or three months, as defined by tympanometry, was not significantly different, nor was there any difference in recurrence rate or in ear, nose, and throat referral rate in the follow up year. No characteristics could be identified which predicted an adverse outcome. CONCLUSIONS--Use of antibiotic improves short term outcome substantially and therefore continues to be an appropriate management policy.     

Comparability and validity of two clinical scores in the early differential diagnosis of acute stroke.

OBJECTIVE--To compare two available clinical scores for the differential diagnosis of cerebral ischaemia and haemorrhage in acute stroke patients. DESIGN--Prospective, multicentre study of acute stroke patients evaluated with computed tomography and Allen and Siriraj scores; the scores were tested for comparability (kappa statistic) and validity (sensitivity, specificity, positive and negative predictive values, diagnostic gain). The effect of a policy of using Allen and Siriraj scores to determine pathological type of stroke before computed tomography was calculated. SETTING--Three hospitals in Italy, all participating in the international stroke trial, with different access facilities to computed tomography. SUBJECTS--231 consecutive patients who were screened in the three hospitals for possible inclusion in the international stroke trial from 1 November 1991 to 31 May 1993. RESULTS--The prevalence of haemorrhage (diagnosed with computed tomography) was 14.7% (95% confidence interval 10.1% to 19.3%). Allen scores were "uncertain" in 44 cases and Siriraj scores in 38 cases; in the 164 cases with both the scores in the range of "certainty" kappa was 0.72. Sensitivity, specificity, positive and negative predictive values, and diagnostic gain for haemorrhage were 0.38, 0.98, 0.71, 0.91, and 0.58 for Allen scores and 0.61, 0.94, 0.63, 0.93, and 0.48 for Siriraj scores; positive predictive values for infarction were 91% for Allen scores and 93% for Siriraj scores. According to these data, of 1000 patients with acute stroke, 680 would be correctly and 70 wrongly diagnosed as "ischaemic" with the Allen score; the figures would be 671 and 48 with Siriraj score. CONCLUSION--When computed tomography is not immediately available and the clinician wishes to start antithrombotic treatment (or randomise patients in a clinical trial), the Siriraj score (and possibly the Allen score) can be useful to identify patients at low risk of intracerebral haemorrhage.     

Comparison of Cephalexin, Penicillin V, and Ampicillin in Streptococcal Infections in Monkeys

Intravenous inoculation of a group A hemolytic streptococcus caused lethal infections in all of 11 untreated monkeys. Daily intragastric administration of either 25 or 50 mg per kg per day, given in two equal morning and afternoon doses, yielded similar results in monkeys treated with cephalexin, penicillin V, and ampicillin; all eight monkeys in each therapy group survived. At dose levels of 12.5 mg per kg per day, six of eight, four of eight, and one of eight receiving cephalexin, penicillin V, and ampicillin, respectively, died. The differences observed at the lower dose level between cephalexin and ampicillin could be attributed, in part, to differences in the minimal inhibitory concentrations (MIC) of cephalexin (MIC = 0.24 mug/ml) and ampicillin (MIC = 0.01 mug/ml). The differences in results between penicillin V, which had the same MIC as ampicillin, could perhaps be attributed, in part, to shorter duration of antibacterial activity and higher protein binding of penicillin V. These studies support previous observations that cephalexin at 25 to 50 mg/kg doses is effective in severe streptococcal sepsis in monkeys.     

Trial of three-day and ten-day courses of amoxycillin in otitis media.

A randomised double-blind controlled trial compared three-day and 10-day courses of amoxycillin (25 mg/kg daily) in children with otitis media. Seventeen doctors from five centres admitted 84 children between the ages of 2 and 10 years. Symptoms and signs were measured on admission to the trial, on day 3, and on day 15. Mother''s observations were recorded daily for 10 days. Audiograms were performed at four and 12 weeks after the end of the trial. The treatment groups showed little difference in the speed of resolution of symptoms and signs, the numbers of primary treatment failures, or the frequency of recurrent ear infections. There were no complications in either group. Most children with otitis media can probably be successfully and safely treated with no more than a three-day course of amoxycillin providing their progress is reviewed about the fifth or sixth day after treatment started. This policy could save over 1 million pounds annually in antibiotic costs.     

Trial of Phenoxymethylpenicillin,Phenethicillin, and Lincomycin in Treatment of Staphylococcal Sepsis in a Casualty Department

A comparative trial of phenoxymethylpenicillin (penicillin V), phenethicillin (Broxil), and lincomycin (Lincocin) against superficial staphylococcal infections seen in a casualty department showed no difference in the efficacy of the three agents, though half the staphylococci isolated were resistant to penicillin. Possible reasons include the fact that antibiotic treatment may not affect superficial staphylococcal infections, or that the organisms concerned may have been weak formers of penicillinase.Half the patients treated with lincomycin complained of diarrhoea and 5% of those treated with phenethicillin suffered from nausea.     

Acute otitis media: clinical course among children who received a short course of high dose antibiotic.

A prospective study was carried out in 274 children aged 3 to 10 years with acute otitis media. They were randomly allocated to one of two treatment regimens: (a) a seven day course of amoxycillin 125 mg three times a day, and (b) a two day course of amoxycillin 750 mg twice a day. They were followed up by symptom diaries and clinical examination. The findings in the 243 children who completed the trial showed that the short course of treatment was as effective as the seven day course in the speed of resolution of symptoms and signs, irrespective of previous history of otitis media or of episodes in which bulging of the eardrums was observed at presentation. A subgroup of 185 children was followed up for one year after entry to the trial. During this period no appreciable differences emerged between the two antibiotic regimens, either in recurrence rate of otitis media or in the frequency of hearing loss at one month and six months after entry to the study. Side effects of treatment were few, and those that could be attributed to antibiotic use occurred with equal frequency in the two treatment groups.     

Eradication of Helicobacter pylori in patients with duodenal ulcer following the short course of treatment with azitromycin and amoxycillin]

The efficacy of short-term treatment with azithromycin in 17 patients with acute doudenal ulcer associated with H. pylori was evaluated. Bioptats of the gastric mucosa taken at the beginning and after one month of treatment were investigated for H. pylori presence by histological, bacteriological methods, by urease test and by PCR. All the patients with positive H. pylori test were treated with Gastrozol (omeperazole, ICN Pharmaceutical) 40 mg per day for 1 week followed by 20 mg per day for 3 weeks, Sumamed (azithromycin, peira) 0.5 g once daily for 3 days and amoxycillin 0.5 mg four times a day for 10 days. Bioptats analysis before treatment revealed H. pylori in 100% for PCR methods, in 94.1% for urease test, in 88.2% for histological test. After the treatment H. pylori was revealed in 12.5% for urease and histological test, in 18.8% for bacteriological test and in 25% for PCR test. Thus the treatment efficacy was 75%. Side effects for short-term azithromycin therapy were shown in 5.9% cases.     

Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome

The glucagon-like peptide 1 (GLP-1) analog ROSE-010 reduced pain during acute exacerbations of irritable bowel syndrome (IBS). Our objective was to assess effects of ROSE-010 on several gastrointestinal (GI) motor and bowel functions in constipation-predominant IBS (IBS-C). In a single-center, randomized, parallel-group, double-blind, placebo-controlled, dose-response study, we evaluated safety, pharmacodynamics, and pharmacokinetics in female patients with IBS-C. ROSE-010 (30, 100, or 300 μg sc) or matching placebo was administered once daily for 3 consecutive days and on 1 day 2-10 days later. We measured GI and colonic transit by validated scintigraphy and gastric volumes by single-photon emission computed tomography. The primary end points were half time of gastric emptying of solids, colonic transit geometric center at 24 h, and gastric accommodation volume. Analysis included intent-to-treat principle, analysis of covariance (with body mass index as covariate), and Dunnett-Hsu test for multiple comparisons. Exposure to ROSE-010 was approximately dose-proportional across the dose range tested. Demographic data in four treatment groups of female IBS-C patients (total 46) were not different. Gastric emptying was significantly retarded by 100 and 300 μg of ROSE-010. There were no significant effects of ROSE-010 on gastric volumes, small bowel or colonic transit at 24 h, or bowel functions. The 30- and 100-μg doses accelerated colonic transit at 48 h. Adverse effects were nausea (P < 0.001 vs. placebo) and vomiting (P = 0.008 vs. placebo). Laboratory safety results were not clinically significant. In IBS-C, ROSE-010 delayed gastric emptying of solids but did not retard colonic transit or alter gastric accommodation; the accelerated colonic transit at 48 h with 30 and 100 μg of ROSE-010 suggests potential for relief of constipation in IBS-C.     

Diagnostic utility of flumazenil in coma with suspected poisoning: a double blind,randomised controlled study.

OBJECTIVE--To assess the diagnostic value and safety of the benzodiazepine antagonist flumazenil in patients with coma of unclear origin with suspected poisoning. DESIGN--Double blind, placebo controlled, randomised study. SETTING--Intensive care unit at a major teaching hospital. PATIENTS--105 Unconscious adults admitted consecutively with suspected drug overdosage during 18 months from a total of 362 cases of poisoning. Exclusion criteria were pregnancy, epilepsy, obvious poisoning with drugs identified unequivocally from information from relatives or others as other than benzodiazepines, and coma score greater than 10 on a scale graded from 4 to 20. Patients were allocated randomly to receive flumazenil (21 men and 32 women) or placebo (25 men and 27 women). INTERVENTIONS--Intravenous injection of flumazenil (10 ml, 0.1 mg/ml) or placebo (10 ml vehicle alone) given double blind over three minutes. MAIN OUTCOME MEASURES--Serum and urine concentrations of benzodiazepines, antidepressants, and several other agents; blood gas tensions; standardised evaluation on admission and five minutes after the injection by means of coma scale score and urgent diagnostic or therapeutic interventions indicated according to the history and clinical examination; standardised interview after the injection to try to ascertain further information; and adverse reactions. RESULTS--Benzodiazepines were found in the serum in 36 of the 53 patients in the flumazenil group and in 37 of the 52 who received placebo. The average coma scale score increased significantly after injection in the flumazenil group (6.4 v 12.1, p less than 0.001) but not in the placebo group. In the flumazenil group several interventions were rendered unnecessary by the injection: gastric lavage and urinary catheterisation (19 patients each), intubation (21), artificial ventilation and computed tomography of the brain (three patients each), blood culture and lumbar puncture (one patient each), and electroencephalography (two). In the placebo group the indications for these procedures did not change in any patient after injection. The 95% confidence interval for the difference in reduction of the frequency of indications for gastric lavage after injection between the two groups was 21% to 51%, that for intubation 25% to 55%, and that for urinary catheterisation 21% to 51%. In the flumazenil group 21 patients gave valuable information on their drug ingestion within 10 minutes after injection compared with only one in the placebo group (p less than 0.001). Nine adverse reactions were recorded in the flumazenil group, eight of which were graded as mild and one severe. The safety of the antagonist was acceptable, even though 60% of the patients in the flumazenil group had multiple drug poisoning including benzodiazepine. No epileptic seizures or arrhythmias were recorded. CONCLUSION--Flumazenil is a valuable and safe differential diagnostic tool in unclear cases of multiple drug poisoning.     

Evaluation of a four-drug, three-antibiotic, nonbismuth-containing "concomitant" therapy as first-line Helicobacter pylori eradication regimen in Greece

Background: The eradication rates of Helicobacter pylori (H. pylori) with standard treatments are decreasing worldwide as in Greece. Studies with new antibiotic combinations are needed to find better methods of eradication. Therefore, the aim of this study was to evaluate efficacy and tolerability of a 10‐day, four‐drug, three‐antibiotic, nonbismuth–containing concomitant regimen. Materials and Methods: This is a prospective, open‐label, multicenter study that included 131 patients infected with H. pylori. All patients were diagnosed with peptic ulcer disease or nonulcer dyspepsia by endoscopy. H. pylori infection was established by at least two positive tests among rapid urease test, gastric histology, and ¹³C‐urea breath test. For 10 days, all patients received esomeprazole 40 mg, amoxycillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all b.d. eradication was assessed with ¹³C urea breath test 8 weeks after the start of treatment. Intention‐to‐treat and per‐protocol eradication rates were determined. Results: One hundred and twenty‐seven of the 131 patients completed the study. At intention‐to‐treat analysis, the eradication rate was 91.6% (95% confidence interval (CI), 85.5–95.7%). For the per‐protocol analysis, the eradication rate was 94.5% (95% CI, 89–97.8%). Adverse events were noted in 42 of 131 (32.1%); drug compliance was excellent with 96.9% of the patients taking more than 90% of the prescribed medication. Conclusion: A 10‐day concomitant regimen appears to be an effective, safe, and well‐tolerated treatment option for first‐line H. pylori eradication in Greece.     

The clinical and economic efficacies of short courses of azithromycin in acute sinusitis]

A randomized study of a 3-day course of azithromycin therapy (500 mg once daily) vs. a 10-day course of co-amoxiclav therapy (625 mg thrice daily) in patients with acute sinusitis was performed with an account of the GCP criteria. One hundred patients in 2 groups each of 50 persons were enrolled. The estimates of the patient body temperature, headache, pain on palpation in the area of the accessory nasal sinuses, nasal cavity stuffing, nasal discharge nature and the nose mucous membrane appearance were recorded prior to the treatment, in 72 hours and on the 10th-12th and 26th-30th days of the treatment. The microbiological analysis of the punctate from the accessory nasal sinuses was undertaken before the antibiotic therapy and 72 hours after its start. The economic analysis included the cost of the antibiotic therapy course, hospitalization term, medical manipulations and laboratory tests as well as the cost/efficacy index. The frequency of the relapses within 6 months after the cure was estimated in the two groups compared. In 72 hours and on the 10th-12th days after the treatment start the efficacy of azithromycin was significantly higher than that of co-amoxiclav. The cure was stated in 41 (82 per cent) and 26 (52 per cent) patients on the 10th-12th days, in 6 (12 per cent) and 21 (42 per cent) patients the improvement was stated and the fail was stated in 3 (6 per cent) and 2 (4 per cent) patients respectively. The efficacy of the drugs on the 26th-30th days after the treatment start did not differ. The isolates of Staphylococcus aureus and Streptococcus pyogenes were the main pathogens. The bacteriologic eradication was recorded in 29 (90.6 per cent) patients treated with azithromycin and only in 18 (69.2 per cent) patients treated with co-amoxiclav. Adverse reactions and relapses of the disease within 6 months after the cure were more frequent in the patients treated with co-amoxiclav. The cost of the azithromycin therapy was significantly lower. It was shown that the shortened course of the azithromycin therapy provided earlier cure of the patients with acute sinusitis, better tolerance of the drug, less frequent adverse reactions, lower cost as compared to the use of co-amoxiclav and no relapses.     

Treatment of streptococcal pharyngitis with amoxycillin once a day.

OBJECTIVE--To evaluate treatment of group A beta haemolytic streptococcal pharyngitis with amoxycillin once daily compared with phenoxymethylpenicillin three or four times a day. DESIGN--Randomised controlled study of consecutive patients presenting with symptoms suggestive of group A beta haemolytic streptococcal pharyngitis in whom culture of a throat swab yielded positive results. SETTING--Five family medicine practices. SUBJECTS--157 patients aged over 3 years who required treatment with antibiotics. MAIN OUTCOME MEASURES--Clinical response, bacteriological response, days at work and school lost, and compliance. RESULTS--During the period of the study 393 patients presented with symptoms suggesting streptococcal pharyngitis; 157 of them had throat swabs that yielded positive results on culture. Eighty two were treated with phenoxymethylpenicillin and 75 with amoxycillin. No difference was observed in the clinical response, days at work and school lost (139 days for 64 patients taking phenoxymethylpenicillin v 100 days for 57 patients taking amoxycillin; p > 0.2), or residual positive cultures after two days (6 (7.3%) v 3 (4%); p > 0.5). A significant difference in the bacteriological response was found after 14 days (5 (6.1%) v 0; p < 0.04) with no positive cultures observed in the amoxycillin group. CONCLUSIONS--These findings support the hypothesis that amoxycillin once daily is as effective as phenoxymethylpenicillin in the treatment of group A beta haemolytic streptococcal pharyngitis.     

Penicillin induced Haemolytic Anaemia

The case histories of two patients with penicillin-induced haemolytic anaemia are presented. One had received 20 mega units a day for 18 days, the other had received 20 mega units a day for two days and then 12 mega units a day for 25 days, before the haemolytic anaemia was diagnosed. Both had previously had courses of penicillin. A strongly positive direct antiglobulin reaction which appeared to be mainly due to IgG antibody was one of the main diagnostic features, and free IgG antipenicillin antibody was found in the serum of both patients. The haemolysis appeared to Lessen as soon as the drug was stopped, and the direct antiglobulin test became negative in 66–77 days.Twelve additional reported cases are reviewed. All had received high doses of penicillin and all had had penicillin previously. The lowest dose recorded was 10 mega units a day for 26 days. The incidence of anti-penicillin antibodies in a hospital population is given, and the mechanism of this type of haemolytic anaemia is discussed. Penicillin-induced haemolytic anaemia should be suspected in any patient receiving penicillin in high doses in whom there is a fall in the haemoglobin level.     

Impact of Chisan (ADAPT-232) on the quality-of-life and its efficacy as an adjuvant in the treatment of acute non-specific pneumonia

A double-blind, placebo-controlled, randomized (simple randomisation), pilot (phase III) study of Chisan^® (ADAPT-232; a standardised fixed combination of extracts of Rhodiola rosea L., Schisandra chinensis Turcz. Baill., and Eleutherococcus senticosus Maxim) was carried out on two parallel groups of patients suffering from acute non-specific pneumonia. Sixty patients (males and females; 18–65 years old) received a standard treatment with cephazoline, bromhexine, and theophylline: in addition, one group of 30 patients was given Chisan mixture, whilst the second group of 30 patients received a placebo, each medication being taken twice daily from the beginning of the study for 10–15 days. The primary outcome measurements were the duration of antibiotic therapy associated with the clinical manifestations of the acute phase of the disease, together with an evaluation of mental performance in a psychometric test and the self-evaluation of quality-of-life (QOL) (WHOQOL-Bref questionnaires) before treatment and on the first and fifth days after clinical convalescence. The mean duration of treatment with antibiotics required to bring about recovery from the acute phase of the disease was 2 days shorter in patients treated with Chisan compared with those in the placebo group. With respect to all QOL domains (physical, psychological, social and ecological), patients in the Chisan group scored higher at the beginning of the rehabilitation period, and significantly higher on the fifth day after clinical convalescence, than patients in the control group. Clearly, adjuvant therapy with ADAPT-232 has a positive effect on the recovery of patients by decreasing the duration of the acute phase of the illness, by increasing mental performance of patients in the rehabilitation period, and by improving their QOL. Both the clinical and laboratory results of the present study suggest that Chisan (ADAPT-232) can be recommended in the standard treatment of patients with acute non-specific pneumonia as an adjuvant to increase the QOL and to expedite the recovery of patients.     

20例葡萄球菌感染所致化脓性脊柱炎的临床特征分析

为探讨葡萄球菌感染所致化脓性脊柱炎(pyogenic vertebral osteomyelitis,PVO)的临床及影像学特征,本研究回顾性分析了2009年1月-12月上海交通大学附属第六人民医院感染病科收治的20例葡萄球菌感染所致PVO患者的临床特征、实验室检查指标、影像学资料及治疗效果。结果显示,20例PVO患者中金黄色葡萄球菌感染较为多见,85%患者病变在腰椎,50%患者白细胞计数升高,13例发热(65%),12例(60%)出现椎旁脓肿,所有患者C反应蛋白、红细胞沉降率、铁蛋白均升高。计算机断层扫描(computed tomography,CT)平扫示感染椎体骨质破坏;磁共振成像(magnetic resonance imaging,MRI)示病变椎体及椎间盘破坏区异常信号灶,增强后可见明显强化;单光子发射计算机断层扫描(emission computed tomography,ECT)示病变椎体不均匀放射性摄取增高。金黄色葡萄球菌对青霉素耐药率达77.8%。12例椎旁脓肿患者经CT引导下穿刺置管引流加敏感抗生素治疗,临床结局良好。结果提示,金黄色葡萄球菌是葡萄球菌感染所致PVO的主要致病菌,其对青霉素普遍耐药,炎症指标和影像学检查可用于疗效评估及随访,内科保守治疗对PVO有效。