Antibody response of 18 month old children 1 month and 18 months following Haemophilus influenzae type b vaccine administered singly or with DTP vaccine

Seventy-six children (aged 17-19 months) received 10 micrograms of Haemophilus influenzae type b polyribosyl-ribitol phosphate (PRP) vaccine, diluted with either phosphate-buffered saline (PBS) or diphtheria-tetanus-pertussis (DTP) vaccine, in a single-blind randomized trial. There were few side effects when PRP was administered alone. Before vaccination 37 of 76 children (49%) had non-protective antibody levels (less than 0.15 micrograms/mL); 26 of these 37 (70%) achieved antibody levels of greater than 0.15 micrograms/mL 1 month after vaccination. Before vaccination 16 of 76 (21%) had antibody levels of greater than 1.0 micrograms/mL; 1 month after vaccination 39 of 76 children (51%) achieved levels of greater than 1.0 micrograms/mL. Of 12 infants who had antibody levels less than 0.15 micrograms/mL 1 month after immunization, 10 had protective levels 18 months later. Administration of PRP mixed with DTP did not affect antibody response to PRP. The potential use and limitations of PRP vaccine are discussed.     

Effect of aluminum adjuvants on safety and immunogenicity of Haemophilus influenzae type b-CRM197 conjugate vaccine

OBJECTIVE: The present study was carried out to evaluate the safety and immunogenicity of the Haemophilus influenzae type b-CRM197 (Hib-CRM197) conjugate vaccine in relation to the change of adjuvant from aluminum hydroxide to aluminum phosphate (AlPO4). METHODS: The present study was a clinical phase II, observer-blind, randomized, multicenter, controlled study. Subjects were healthy infants aged 6-12 weeks, eligible for expanded program of immunization (EPI) routine vaccination and admitted to Hacettepe University Department of Social Pediatrics and Gülveren Health Center, Ankara. A total of 520 healthy infants were randomized in a 2:2:1 ratio to receive at either Chiron Hib/AlPO4 vaccine or VaxemHib (aluminum hydroxide adjuvant) vaccine or HibTiter (no adjuvant). Vaccines were administered simultaneously with routine diphtheria, tetanus and pertussis (DTaP) and oral polio vaccine (OPV) vaccines at 2, 4 and 6 months of age. Blood samples for anti-plain polysaccharide (PRP) antibody measurement were collected before the first vaccination and 1 month after the last vaccination. After each vaccination parents filled out a diary for 7 days. RESULTS: Out of 520 subjects enrolled, 514 received three doses and were included for safety analysis. Local and systemic reactions occurred with low and similar frequencies in all groups. Only erythema was more common in Chiron Hib/AlPO4 vaccine (19, 10, 11% in Chiron Hib/AlPO4, VaxemHib and HibTiter, respectively, P < 0.05). Nine serious adverse events were reported in seven cases of which none were related to vaccines. A total of 504 subjects were included in the immunogenicity analysis. The three vaccines were highly immunogenic and equivalent in terms of percentage of acquisition of long-term protective levels. The anti-PRP geometric mean titers were 9.9, 8.3 and 5.14 micro g/mL, respectively (P < 0.05). CONCLUSIONS: The use of aluminum compounds adjuvants in Hib-CRM197 conjugate vaccines does not impact the safety profile, while it does increase the magnitude of anti-PRP antibody titers.     

Immune response to Haemophilus influenzae type b conjugate vaccine in preterm infants

Background: Haemophilus influenzae type b (Hib) vaccine became available for use in Japan in December 2008. The aim of the present study was to evaluate the immunogenicity of Hib vaccine in Japanese preterm infants. Methods: Serum samples were obtained from 54 preterm infants before the first vaccination and 1 month after the third. Anti‐polyribosylribitol phosphate (PRP) antibodies were measured using an enzyme‐linked immunosorbent assay method. Antibody positivity was defined as levels >1 µg/mL. Results: Of the 54 preterm infants, 46 (85.2%) achieved antibody levels >1 µg/mL. This compares with the 92.4% reported in full‐term infants. The antibody seroconversion rate of infants starting vaccination at 2 months of age was close to being significantly lower than when vaccination was started at 3 months of age (P= 0.060). In addition, the percentage of infants achieving a positive response in the group with a history of antenatal steroid exposure was significantly higher than in those not exposed (P= 0.046). Thus, risk factors for lower Hib antibody concentrations after three doses of vaccine were age at first vaccination and lack of use of antenatal steroids. Conclusions: There is a possibility that perinatal factors and the environment unique to preterm infants are related to their lower antibody positivity rates compared to full‐term infants. It may therefore be preferable to modify the proposed immunization schedule.     

Adverse effects and sero-responses to an acellular pertussis/diphtheria/tetanus vaccine when combined with Haemophilus influenzae type b vaccine in an accelerated schedule

Acellular pertussis vaccines provide protection against pertussis with few adverse effects. Differences in the reactogenicity and immunogenicity of available pertussis vaccines may be influenced by the immunisation schedule employed. We assessed responses to an acellular pertussis, diphtheria, tetanus vaccine mixed with Haemophilus influenzae type b (Hib) vaccine, (PRP-T) given at age 2, 3 and 4 months. Parents kept a symptom diary for 3 days after each immunisation. Antibodies to diphtheria, tetanus, pertussis toxin and filamentous haemagglutinin were measured by enzyme immunoassay at 2 and 5 months. Results were compared with historical controls who received a combination whole-cell pertussis, diphtheria, tetanus/PRP-T vaccine in the same schedule. A total of 262 infants were recruited, of whom 251 were fully evaluated after three doses of vaccine. Systemic and most local reactions were less frequent following the acellular combination. Fever ≥38°C was reported after only 0.6% of doses. Redness or swelling ≥2.5 cm were unusual after the first two doses (2–5%), but rates rose to 13% after the third dose. Antibody responses to diphtheria and tetanus toxoids were lower, while those to pertussis antigens were higher, more uniform and less attenuated by pre-immunisation antibody than in infants who received the whole-cell combination. All infants achieved protective antibody titres of at least 0.1 IU/ml for diphtheria and 0.01 IU/ml for tetanus. Conclusion The acellular combination vaccine was immunogenic for diphtheria, tetanus and pertussis components and was associated with low rates of fever following immunisation. Received: 9 June 1998 / Accepted: 2 November 1998     

Avidity of tetanus and Hib antibodies after childhood acute lymphoblastic leukaemia - implications for vaccination strategies

AIM: To investigate the possible relationship between serum levels and avidities of antibodies against tetanus toxoid (TT) and Haemophilus influenzae type b (Hib) in children that were vaccinated after treatment for childhood acute lymphoblastic leukaemia (ALL). METHODS: The study groups were 31 paediatric patients with ALL and 18 healthy controls. All subjects were vaccinated with TT and a protein conjugated Hib vaccine. Antibody levels were analysed at three time points: At diagnosis of ALL, after cessation of treatment before vaccination and three weeks after vaccination. Avidity was measured twice, with a thiocyanate elution assay, at diagnosis of ALL and three weeks after vaccination. RESULTS: There was a correlation between level and avidity of tetanus antibodies after vaccination (r(s) = 0.59, P < 0.001). In the standard-risk and intermediate-risk ALL groups, all patients responded with protective levels of tetanus antibodies with normal avidity. In the high-risk ALL group 7/9 patients had subprotective levels of tetanus antibodies after vaccination and concomitantly the lowest avidity, implying poor protection against tetanus. No patients were found with low levels and low avidity of anti-Hib IgG, and 29/31 patients had full protection after a single dose of conjugated Hib-vaccine. CONCLUSION: The vaccination strategy after childhood ALL must be different for low-risk and high-risk ALL groups, since the high-risk group fail to elicit a recall response to tetanus.     

Immunogenicity and safety of Haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) presented in a dual-chamber syringe with DTP

Separate injections of Haemophilus influenzae type b capsular polysaccharide-tetanus conjugate (PRP-T) vaccine and diphtheria-tetanus-pertussis (DTP) reconstitution of freeze-dried PRP-T vaccine with liquid DTP vaccine have been shown to be safe and immunogenic in infants. The present study was conducted to test the safety and immunogenicity of the liquid combination vaccine administered to young infants in the dual-chamber syringe. The study was a monocenter, open clinical trial of 3 month-old infants receiving PRP-T and DTP vaccines in the dual-chamber syringe reconstituted prior to injection. Healthy infants were immunized according to a 3, 4 and 5 months-of-age schedule. The vaccine was administered in a dual-chamber syringe, ready to use with two chambers. The proximal chamber contained freeze-dried PRP-T and the distal chamber contained liquid combination-vaccine DTP. The freeze-dried PRP-T vaccine was reconstituted with the liquid DTP vaccine in the same unidose dual-chamber syringe (0.5 mL) and was injected intramuscularly into the deltoid region. Blood sampling was performed prior to vaccination at 3 months of age and after the third vaccination at 6 months. The primary end-point was the serological response to PRP-T vaccine as expressed by the percentage of infants with an antibody titer greater than or equal to 1 μg/mL. The reactogenicity was expressed as the percentage of reported local and systemic reactions. A total of 108 infants were included in the study and received the dual-chamber syringe vaccine. After the third injection, all the infants had a PRP antibody titer greater than or equal to 0.15 μg/mL and 94.4% of infants had a PRP antibody titer greater than or equal to 1 μg/mL; the pertussis agglutinin titers were over the threshold 40 and 80 in all infants and 98.1% were over the threshold 320. After the third injection, all the infants had diphtheria antibody titers greater than 0.1 IU/mL and 83.3% had titers greater than 1 IU/mL; all the infants had tetanus antibody titers greater than 0.1 IU/mL and 97.2% had results over 1 IU/mL. Thirty-seven infants (34.6%) had local reactions and 64.5% had systemic reactions. The dual-chamber syringe may reduce the cost of vaccine delivery, as well as the workload, and increase the vaccine acceptability and coverage rate of vaccines.     

Invasive Haemophilus influenzae type b infections in children hospitalized in Hong Kong, 1986–1990

A 5-year territory-wide retrospective survey of invasive Haemophilus influenzae type b diseases was conducted in Hong Kong. Between 1986 and 1990, 57 cases (28 male) were recorded in children less than 12 years old (37 cases of meningitis, 9 of septicaemia and 11 of bacteraemic pneumonia). The annual incidence for children less than 5 years old was 2.7 per 10⁵ (95% confidence interval (CI) 2.0–3.5). Of the 57 cases, 39 were Chinese and 18 non-Chinese (7 Vietnamese refugees, 6 Caucasians, 5 others). The annual incidence in Vietnamese refugees less than 5 years old was 42.7 per 10⁵ (95% CI 17.2–87.9), giving a relative risk of 18.5 (95% CI 8.3–41.0). Chinese patients (68%) were under-represented as Chinese accounted for at least 94% of the population. Moreover, 14 of the 39 Chinese patients had pre-existing medical problems, compared with only 1 of the 18 non-Chinese patients (p = 0.022).     

Natural immunity to Haemophilus influenzae type B in children of Ankara, Turkey

BACKGROUND: Haemophilus influenzae type b (Hib) infection has a high morbidity and mortality rate especially in children under 5 years of age. The incidence of Hib disease in Turkey is not known, and Hib vaccine is not included in the National Immunization Program. The aim of this study was to determine the natural immunity to Hib of children 6-60 months of age living in the Park Health Center region of Ankara, Turkey. METHODS: A total of 270 children were selected by layered random sampling method, and 242 of them (89.6%) participated in the study. A questionnaire was given to the parents of the children who were included in the study and blood samples were taken from those children. Anti-Hib IgG antibody (anti-PRP) level was determined in the serum by using anti-Haemophilus influenzae IgG EIA kit and anti-PRP antibody levels of 0.15 microg/mL and over were accepted as the natural immunity. RESULTS: Natural immunity was determined in 65.3% of the children. A relationship was determined statistically between the history of disease with possible Hib agent and with natural immunity. CONCLUSIONS: The exposure rate of children with Hib was higher than expected, even in children who were just a few months old. Our data revealed that multicentric, national studies should be done to define the burden of Hib disease before making a decision for Hib vaccine to be included in the National Immunization Program.     

Immunogenicity and reactogenicity of a Haemophilus influenzae type b tetanus conjugate vaccine when administered separately or mixed with concomitant diphtheria-tetanus-toxoid and acellular pertussis vaccine for primary and for booster immunizations

With an increasing number of new vaccines available for routine childhood immunization, combination vaccines are needed in order to maintain or achieve a high compliance with recommended immunization programmes. In a prospective, randomized, comparative, multi-centre study, 822 healthy infants were enrolled to receive three doses of either a candidate or a commercially available Haemophilus influenzae type b (Hib) vaccine concomitantly with diphtheria-, tetanus- acellular pertussis (DTaP) vaccine. Study subjects were randomly allocated to one of the following groups: (1) separate, or (2) mixed injection of DTaP and candidate Hib vaccine, or (3) separate injection of DTaP and commercial Hib vaccine. One year later the first 189 study subjects received either separate or mixed injections of the same Hib and DTaP vaccines as booster doses. Evaluation of reactogenicity was based on diary cards completed by parents. Immunogenicity was documented by measuring IgG antibody concentrations in serum samples taken before and 4 weeks after primary and booster vaccination. No serious adverse events occurred and most local and systemic reactions were mild to moderate. Booster doses were more reactogenic than primary doses with all groups. Antibody concentrations against pertussis antigens were similar to those seen with DTaP alone. All but one subject had protective antibody concentrations against diphtheria and tetanus. Primary immune response to the Hib vaccine was significantly lower in the group receiving the mixed Hib-DTaP vaccine, however, ≥95% of vaccinees had anti-Hib antibody concentrations ≥0.15 μg/ml and there was a marked booster response (>100-fold) in all groups. Conclusions Mixing DTaP and Hib vaccines for primary immunization caused a decrease in anti-Hib antibody response, although after primary immunization as after booster doses, all subjects showed antibody concentrations considered to be protective for invasive Hib disease. Mixing of the vaccines did not result in increased reactogenicity. Received: 13 June 1997 / Accepted in revised form: 4 September 1997     

Safety and immunogenicity of Haemophilus influenzae type b-tetanus toxoid conjugate, presented in a dual-chamber syringe with diphtheria-tetanus-pertussis and inactivated poliomyelitis combination vaccine

The safety and immunogenicity of combining two established vaccines, polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP-T) (ActHIB, Pasteur Mérieux Connaught, Lyon, France) and diphtheria-tetanus-whole cell pertussis and inactivated poliovirus vaccine (DTP-IPV) (Tetracoq, Pasteur Mérieux Connaught, Lyon, France) were evaluated using a new dual-chamber syringe delivery system. Results were compared with those obtained when the two combination vaccines were either administered separately (two sites) or reconstituted manually and injected at a single site. A total of 487 2-month-old infants were enrolled in this study by 61 paediatricians in France. Infants were randomised to receive three immunisations of PRP-T and DTP-IPV at 2, 3 and 4 months of age, given either with the dual-chamber syringe (n = 213), as separate injections (n = 215), or as a single manually reconstituted injection (n = 59). Blood samples were taken prior to the first immunisation and 4 weeks after the third immunisation for the measurement of antibody titres. Infants were monitored by the parents for 3 days after each immunisation to detect local and systemic reactions. Local and systemic reactions occurring the 3 days following immunisation were as expected for the combination vaccines used. Safety of the vaccination using the dual-chamber syringe was as good as, if not slightly better than, that for the two vaccines administered separately. After the first immunisation, pain and unusual crying were significantly more frequent in infants who received two injections, compared to those who were immunised with the dual-chamber syringe. Serological responses were good for all antigens in the three groups and there was no evidence for any immunological interference. Almost all subjects in each group achieved levels of antibodies considered to be protective for all antigens. There were no clinically relevant differences in antibody response between any of the groups. The dual-chamber and separate injection methods of vaccination were equivalent according to a pre-defined criterion (percentage of infants with anti-PRP antibody titres ≥1.0 μg/ml). Conclusion Results from this study suggest that the two vaccines, PRP-T and DTP-IPV, may be safely and effectively administered in infants using the new dual-chamber syringe. This presentation provides an innovative strategy to combine different vaccines that are not yet available as a single formulation. Received: 20 December 1997 / Accepted: 5 January 1998     

Immunogenicity and safety in infants of a DTwPHib full liquid vaccine

Aim: Combining paediatric vaccines is a rational solution to reduce the number of injections during a single clinical visit, to maintain parents' compliance and to extend vaccine coverage. Different diphtheria, tetanus and whole cell pertussis (DTwP)-containing combination vaccines are licensed and used world-wide. This study assessed the immunogenicity and safety in infants of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b-CRM₁₉₇ conjugate full liquid vaccine. Methods: The safety and efficacy of a combined ready-to-use liquid vaccine containing diphtheria and tetanus toxoids, cell suspension of Bordetella pertussis and H. influenzae type b-CRM₁₉₇ conjugate vaccine (DTwPHib) were assessed in infants eligible for the local Expanded Programme on Immunization (EPI) in Valencia, Spain. The comparative group received separate injections of reference vaccines DTwP + Hib. Results: Local and systemic reactions and adverse events were generally mild and similar in the two groups. DTwPHib elicited anti-PRP antibody titres ≥0.15 μg ml^-1 in 97% and DTwP + Hib in 94% of infants. Furthermore, 89% of DTwPHib and 78% of DTwP + Hib recipients attained anti-PRP antibody titres ≥1.0 μg ml^-1, signifying long-term protection. The anti-PRP geometric mean titre was significantly higher in the combined DTwPHib vaccine group (6.65 vs 3.57 μg ml^-1). In both groups, 99% of infants achieved protective (≥0.01 IU ml^-1) anti-diphtheria antibody levels and all children achieved protective (≥0.1 IU ml^-1) anti-tetanus antibody levels. DTwPHib caused a ≥2-fold increase in anti-pertactin antibody titres in 91% and a ≥4-fold increase in 82% of recipients. The corresponding proportions in the DTwP + Hib group were 95% and 90%. DTwPHib induced a ≥2-fold increase in anti-Aggl2 and 3 antibody levels in 79% and a ≥4-fold increase in 73% of recipients. The corresponding proportions among DTwP + Hib infants were 85 and 82%. Conclusion: Overall, the combined liquid vaccine DTwPHib is a safe and effective immunogenic vaccine for EPI use in infants.     

A double-blind placebo-controlled randomized trial on probiotics in small bowel bacterial overgrowth in children treated with omeprazole

ObjectiveTo evaluate the incidence of small bowel bacterial overgrowth (SBBO) in children treated with omeprazole, and to test whether probiotics influence the incidence.MethodsA double-blinded, placebo-controlled trial was performed in 70 children treated orally during four weeks with 20 mg omeprazole per day. Lactobacillus rhamnosus R0011 (1.9 × 10⁹ cfu) and Lactobacillus acidophillus R0052 (0.1 × 10⁹ cfu) were simultaneously given daily to 36 subjects (probiotic group), while 34 subjects received placebo (placebo group). The diagnosis of SBBO was based on the development of suggestive symptoms, in combination with a positive glucose breath test.ResultsAfter one month of proton pump inhibitor (PPI) treatment, 30% (21/70) had a positive breath test suggesting SBBO; of these 62% were symptomatic. Five children developed SBBO-like symptoms, but had a negative breath test; and 44 (63%) were symptom free and had a negative breath test. There was no difference in the incidence of positive breath tests in the probiotic versus the placebo group (33% vs 26.5%; p = 0.13).ConclusionsSince symptoms suggesting SBBO developed in 26% of PPI-treated children, and since the glucose breath test was abnormal in 72% of these, this side-effect should be more frequently considered. The probiotic tested did not decrease the risk to develop SBBO.     

A multicentre randomized placebo-controlled double-blind study on the efficacy of Ketotifen in infants with chronic cough or wheeze

The efficacy of Ketotifen was examined in the treatment of 113 infants between 6 and 36 months of age presenting with a history of cough and/or wheeze in a multicentre randomized placebo-controlled double-blind study. A 4 week no-medication baseline phase preceded the 16 week treatment phase in which infants took 2.5 mL twice daily of either placebo or Ketotifen (0.5 mg) syrup; this was followed by a 4 week wash-out phase. Diary card evaluation was performed by the parent or guardian for the duration of the study and recorded wheeze and cough twice daily as well as medication used. The percentage of symptom-free days decreased significantly in both groups (P < 0.005) with placebo-treated infants experiencing significantly more symptom-free days compared with the Ketotifen group (P < 0.01), although this difference was never more than 10% in any 4 week treatment period. Symptom severity scores and use of beta-agonist medication were also less in the placebo-treated infants but did not reach statistical significance. This study was unable to show a therapeutic advantage of Ketotifen over placebo in this group of infants with chronic cough and/or wheeze and the apparent statistical advantage of placebo is not a clinically relevant finding.     

Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine

OBJECTIVE: The safety of a booster dose of a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis-containing vaccine. STUDY DESIGN: Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria-tetanus-acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis-containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular pertussis-containing vaccine dose) versus rates in these same individuals after vaccination with their fifth DTaP dose were assessed. RESULTS: After Tdap, pain (63.6%), redness (51.7%), and swelling (41.4%) were the most frequently reported AEs. Large injection site swelling (swelling > 100 mm, arm circumference increase > 50 mm or diffuse swelling interfering with daily activities) occurred in three adolescents and resolved without sequelae. After the sixth dose of acellular pertussis-containing vaccine, adolescents reported more pain and less redness and swelling compared with incidences of these AEs reported when these same individuals received their fifth DTaP dose. CONCLUSIONS: These results suggest that Tdap is well tolerated as a sixth consecutive dose of acellular pertussis-containing vaccine.     

Slow versus rapid enteral feeding advancement in preterm newborn infants 1000–1499 g: a randomized controlled trial

Aim:  To evaluate whether preterm neonates weighing 1000–1499 g at birth receiving rapid enteral feeding advancement at 30 mL/kg/day attain full feedings (180 mL/kg/day) earlier than those receiving slow enteral feeding advancement at 20 mL/kg/day without increase in the incidence of feeding intolerance or necrotizing enterocolitis.
Methods:  A total of 100 stable intramural neonates weighing between 1000 and 1499 g and gestational age less than 34 weeks were randomly allocated to enteral feeding (expressed human milk or formula) advancement of 20 mL/kg/day (n   = 50) or 30 mL/kg/day (n   = 50).
Results:  Neonates in the rapid feeding advancement group achieved full volume feedings before the slow advancement group (median 7 days vs. 9 days) (p < 0.001), had significantly fewer days of intravenous fluids (median 2 days vs. 3.4 days) (p < 0.001), shorter length of stay in hospital (median 9.5 days vs. 11 days) (p = 0.003) and regained birth weight earlier (median 16 days vs. 22 days) (p < 0.001). There were no statistical differences in the proportion of infants with apnea, feed interruption or feed intolerance.
Conclusion:  Rapid enteral feeding advancements of 30 mL/kg/day are well tolerated by stable preterm neonates weighing 1000–1499 g.     

地塞米松溶液预处理外周静脉置入中心静脉导管预防早产儿静脉炎随机双盲对照试验

目的 探讨地塞米松溶液预处理导管在预防早产儿经外周静脉置入中心静脉导管（PICC）所致静脉炎中的可行性及安全性。方法 186例需行PICC置管术的低出生体重儿随机分为两组。两组均采用标准操作规范置入PICC,地塞米松组92例置管前使用地塞米松0.08 mg·mL-1稀释液50 mL浸泡PICC导管,生理盐水组94例使用生理盐水50 mL浸泡PICC导管,浸泡时间均为5 min。比较两组患儿置管术后静脉炎的发生率、出现时间、严重程度及其他导管相关并发症发生情况。结果 地塞米松组静脉炎发生率14.1%（13/92）,平均出现时间为（4.4±1.0）d,生理盐水组分别为33.0%(31/94)和(2.8±0.8)d,地塞米松组静脉炎严重程度低于生理盐水组,两组间差异均有统计学意义（P<0.05）。两组其他置管相关并发症发生率差异无统计学意义（P>0.05）。结论 在早产儿PICC置管前,使用地塞米松溶液预处理导管,能降低PICC所致静脉炎发生率及其严重程度,且能延缓静脉炎出现时间,未增加其他导管相关并发症。     

Effect of diosmectite on intestinal permeability changes in acute diarrhea: a double-blind placebo-controlled trial.

The effect of diosmectite on intestinal permeability changes in acute diarrhea was measured during a double-blind placebo-controlled trial carried out in 59 Gabonese children aged 5-35 months. Intestinal permeability tests (IPTs), measuring the urinary elimination of orally administered lactulose and mannitol at a dosage of 1 g/10 kg each, were performed during the morning following admission and repeated 2 days later after treatment by diosmectite or placebo. During the first IPT, urine volume and lactulose and mannitol urinary recoveries were comparable in the diosmectite and in the placebo groups: 50 vs. 35.5 ml (median; p = 0.21), 1.01 vs. 1.27% (p = 0.35), and 2.20 vs. 2.87% (p = 0.12). As a result, the lactulose/mannitol (L/M) ratio was similar in the two groups: 44.44 vs. 35.33% (p = 0.98). During the second IPT, the urinary lactulose recovery decreased similarly in both groups (-0.18 vs. -0.29%; p = 0.76), whereas the urinary mannitol recovery exhibited opposite variations, the increase in the diosmectite group (+ 1.43%) contrasting significantly with the decrease in the placebo group (-0.47%; p = 0.01). When comparing the first and the second IPT, the decrease of the L/M ratio was significant in the diosmectite group (44.44 vs. 28.32%; p = 0.02) and not in the placebo group (35.33 vs. 48.23%; p = 0.91). During gastroenteritis, diosmectite appears to enhance absorption of mannitol, a marker of intestinal absorptive area.