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RESULTS | The study group had better oral hygiene than the control group at the end of treatment . | The study group had better oral hygiene than the control group at the end of treatment. |
CONCLUSIONS | The healing outcome was comparable in both groups . | The healing outcome was comparable in both groups. |
CONCLUSIONS | However , the healing time was significantly longer in the group with the short IMF period . | However, the healing time was significantly longer in the group with the short IMF period. |
CONCLUSIONS | The recovery of maximal mouth opening , oral hygiene status , and loss of weight body in the study group were significantly better than those in the control group . | The recovery of maximal mouth opening, oral hygiene status, and loss of weight body in the study group were significantly better than those in the control group. |
CONCLUSIONS | This study suggests that a short period ( 2 weeks ) of IMF in the management of minimally displaced mandibular fractures of the tooth-bearing area in young adults is a suitable alternative to the conventional method in terms of the healing outcome . | This study suggests that a short period (2 weeks) of IMF in the management of minimally displaced mandibular fractures of the tooth-bearing area in young adults is a suitable alternative to the conventional method in terms of the healing outcome. |
OBJECTIVE | To be a preliminary , prospective , randomized double blinded , placebo-controlled trial to evaluate the efficacy of Morinda citrifolia Linn or noni for the prevention of postoperative nausea and vomiting ( PONV ) in patients considered high risk for PONV after various types of surgery . | To be a preliminary, prospective, randomized double blinded, placebo-controlled trial to evaluate the efficacy of Morinda citrifolia Linn or noni for the prevention of postoperative nausea and vomiting (PONV) in patients considered high risk for PONV after various types of surgery. |
METHODS | The plant extract was prepared by boiling of dried noni fruit ( maturity stage 3-4 ) then evaporated under standard procedure and processed into capsules . | The plant extract was prepared by boiling of dried noni fruit (maturity stage 3-4) then evaporated under standard procedure and processed into capsules. |
METHODS | The doses were 150 mg , 300 mg and 600 mg which are equivalent to 5 , 10 and 20 g of dried noni fruit , respectively . | The doses were 150 mg, 300 mg and 600 mg which are equivalent to 5, 10 and 20 g of dried noni fruit, respectively. |
METHODS | One hundred patients of ASA physical status I or II , aged 18-65 years , and considered at risk for PONV , were randomized to receive 150 , 300 , 600 mg of noni extract or a placebo orally 1 hours before surgery . | One hundred patients of ASA physical status I or II, aged 18-65 years, and considered at risk for PONV, were randomized to receive 150, 300, 600 mg of noni extract or a placebo orally 1 hours before surgery. |
METHODS | Standard general anesthetic technique and postoperative analgesia were employed . | Standard general anesthetic technique and postoperative analgesia were employed. |
RESULTS | Significantly fewer patients who had received the 600 mg noni extract experienced nausea during the first 6 hours compared to the placebo group ( 48 % for the 600 mg noni group and 80 % for the placebo group , p-value = 0.04 ) . | Significantly fewer patients who had received the 600 mg noni extract experienced nausea during the first 6 hours compared to the placebo group (48 % for the 600 mg noni group and 80 % for the placebo group, p-value = 0. 04). |
RESULTS | The incidence of PONV in other time periods was not statistically different for all three noni doses compared to the placebo group . | The incidence of PONV in other time periods was not statistically different for all three noni doses compared to the placebo group. |
RESULTS | No side effects were reported in all groups . | No side effects were reported in all groups. |
CONCLUSIONS | Morinda citrifolia Linn . | Morinda citrifolia Linn. |
CONCLUSIONS | has an antiemetic property and prophylactic noni extract at 600 mg ( equivalent to 20g of dried noni fruit or scopoletin 8.712 microg ) effectively reduces the incidence of early postoperative nausea ( 0-6 hours ) . | has an antiemetic property and prophylactic noni extract at 600 mg (equivalent to 20g of dried noni fruit or scopoletin 8. 712 microg) effectively reduces the incidence of early postoperative nausea (0-6 hours). |
OBJECTIVE | To observe the efficacy and safety of Rocaltrol ( calcitriol ) and/or Caltrate D ( calicum carbonate plus vitamin D ) in elderly Chinese women with osteopenia or osteoporosis . | To observe the efficacy and safety of Rocaltrol (calcitriol) and/or Caltrate D (calicum carbonate plus vitamin D) in elderly Chinese women with osteopenia or osteoporosis. |
METHODS | One hundred fifty Chinese women aged over 65 years with osteopenia or osteoporosis from three centers were randomly divided into two groups . | One hundred fifty Chinese women aged over 65 years with osteopenia or osteoporosis from three centers were randomly divided into two groups. |
METHODS | Seventy-six participants received Caltrate D as one pill daily ; the other 74 participants received 0.25 mug Caltrate D plus Rocaltrol daily . | Seventy-six participants received Caltrate D as one pill daily ; the other 74 participants received 0. 25 mug Caltrate D plus Rocaltrol daily. |
METHODS | The changes in bone mineral density ( BMD ) served as primary end-points . | The changes in bone mineral density (BMD) served as primary end-points. |
METHODS | Height changes , the presence of new vertebral fractures , muscle strength and balance were evaluated . | Height changes, the presence of new vertebral fractures, muscle strength and balance were evaluated. |
RESULTS | The following are the mean percentage changes ( and SD ) in BMD over 12 months : at L2-L4 , 0.83 + / -3.88 in the Caltrate D group and 2.84 + / -4.04 in the Rocaltrol + Caltrate D group ( P = 0.003 , by ANCOVA ) ; at the femoral neck , 0.04 + / -3.94 in the Caltrate D group and 2.01 + / -5.45 in the Rocaltrol + Caltrate D group ( P = 0.085 , by ANCOVA ) ; and in the trochanter , 1.59 + / -4.57 in the Caltrate D group and 3.76 + / -6.25 in the Rocaltrol + Caltrate D group ( P = 0.053 , by ANCOVA ) . | The following are the mean percentage changes (and SD) in BMD over 12 months : at L2-L4, 0. 83 + / -3. 88 in the Caltrate D group and 2. 84 + / -4. 04 in the Rocaltrol + Caltrate D group (P = 0. 003, by ANCOVA) ; at the femoral neck, 0. 04 + / -3. 94 in the Caltrate D group and 2. 01 + / -5. 45 in the Rocaltrol + Caltrate D group (P = 0. 085, by ANCOVA) ; and in the trochanter, 1. 59 + / -4. 57 in the Caltrate D group and 3. 76 + / -6. 25 in the Rocaltrol + Caltrate D group (P = 0. 053, by ANCOVA). |
RESULTS | The stand and maximal forward reach test ( SMFRT ) was significantly enhanced in both groups during the 12 months of treatment , but no significant differences were found between these two groups . | The stand and maximal forward reach test (SMFRT) was significantly enhanced in both groups during the 12 months of treatment, but no significant differences were found between these two groups. |
RESULTS | No severe adverse event related to these medications occurred throughout the study . | No severe adverse event related to these medications occurred throughout the study. |
CONCLUSIONS | Treatment with Rocaltrol plus Caltrate D or Caltrate D for 12 months in elderly Chinese postmenopausal women effectively increased BMD at the lumbar spine . | Treatment with Rocaltrol plus Caltrate D or Caltrate D for 12 months in elderly Chinese postmenopausal women effectively increased BMD at the lumbar spine. |
CONCLUSIONS | Rocaltrol plus Caltrate D was more effective at the lumbar spine than Caltrate D alone . | Rocaltrol plus Caltrate D was more effective at the lumbar spine than Caltrate D alone. |
OBJECTIVE | To assess differences through grade 8 in diet , physical activity , and related health indicators of students who participated in the Child and Adolescent Trial for Cardiovascular Health ( CATCH ) school and family intervention from grades 3 through 5 . | To assess differences through grade 8 in diet, physical activity, and related health indicators of students who participated in the Child and Adolescent Trial for Cardiovascular Health (CATCH) school and family intervention from grades 3 through 5. |
METHODS | Follow-up of the 4-center , randomized , controlled field trial with 56 intervention and 40 control elementary schools . | Follow-up of the 4-center, randomized, controlled field trial with 56 intervention and 40 control elementary schools. |
METHODS | We studied 3714 ( 73 % ) of the initial CATCH cohort of 5106 students from ethnically diverse backgrounds in California , Louisiana , Minnesota , and Texas at grades 6 , 7 , and 8 . | We studied 3714 (73 %) of the initial CATCH cohort of 5106 students from ethnically diverse backgrounds in California, Louisiana, Minnesota, and Texas at grades 6, 7, and 8. |
RESULTS | Self-reported daily energy intake from fat at baseline was virtually identical in the control ( 32.7 % ) and intervention ( 32.6 % ) groups . | Self-reported daily energy intake from fat at baseline was virtually identical in the control (32. 7 %) and intervention (32. 6 %) groups. |
RESULTS | At grade 5 , the intake for controls remained at 32.2 % , while the intake for the intervention group declined to 30.3 % ( P < .001 ) . | At grade 5, the intake for controls remained at 32. 2 %, while the intake for the intervention group declined to 30. 3 % (P <. 001). |
RESULTS | At grade 8 , the between-group differential was maintained ( 31.6 % vs 30.6 % , P = .01 ) . | At grade 8, the between-group differential was maintained (31. 6 % vs 30. 6 %, P =. 01). |
RESULTS | Intervention students maintained significantly higher self-reported daily vigorous activity than control students ( P = .001 ) , although the difference declined from 13.6 minutes in grade 5 to 11.2 , 10.8 , and 8.8 minutes in grades 6 , 7 , and 8 , respectively . | Intervention students maintained significantly higher self-reported daily vigorous activity than control students (P =. 001), although the difference declined from 13. 6 minutes in grade 5 to 11. 2, 10. 8, and 8. 8 minutes in grades 6, 7, and 8, respectively. |
RESULTS | Significant differences in favor of the intervention students also persisted at grade 8 for dietary knowledge and dietary intentions , but not for social support for physical activity . | Significant differences in favor of the intervention students also persisted at grade 8 for dietary knowledge and dietary intentions, but not for social support for physical activity. |
RESULTS | No impact on smoking behavior or stages of contemplating smoking was detected at grade 8 . | No impact on smoking behavior or stages of contemplating smoking was detected at grade 8. |
RESULTS | No significant differences were noted among physiologic indicators of body mass index , blood pressure , or serum lipid and cholesterol levels . | No significant differences were noted among physiologic indicators of body mass index, blood pressure, or serum lipid and cholesterol levels. |
CONCLUSIONS | The original CATCH results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors . | The original CATCH results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors. |
CONCLUSIONS | This 3-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors . | This 3-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors. |
BACKGROUND | Intralesional vinblastine has been used to treat Kaposi 's sarcoma associated with acquired immunodeficiency syndrome ( AIDS-KS ) . | Intralesional vinblastine has been used to treat Kaposi 's sarcoma associated with acquired immunodeficiency syndrome (AIDS-KS). |
BACKGROUND | Injections are painful and anticipated response rates are not well documented . | Injections are painful and anticipated response rates are not well documented. |
OBJECTIVE | Eleven homosexual men were studied to evaluate the efficacy and pain associated with intralesional vinblastine with or without 1 % bicarbonate buffered lidocaine ( BBL ) . | Eleven homosexual men were studied to evaluate the efficacy and pain associated with intralesional vinblastine with or without 1 % bicarbonate buffered lidocaine (BBL). |
METHODS | Six lesions on each patient were selected and treated with either vinblastine , vinblastine mixed with BBL , or vinblastine 5 minutes after BBL injection . | Six lesions on each patient were selected and treated with either vinblastine, vinblastine mixed with BBL, or vinblastine 5 minutes after BBL injection. |
METHODS | Control lesions received BBL , saline , or no treatment . | Control lesions received BBL, saline, or no treatment. |
METHODS | Patients recorded injection pain on a visual analog scale . | Patients recorded injection pain on a visual analog scale. |
RESULTS | There was a complete or partial clinical response in 88 % of vinblastine-treated lesions . | There was a complete or partial clinical response in 88 % of vinblastine-treated lesions. |
RESULTS | Pain scores for BBL , vinblastine , and the mixture of BBL and vinblastine were not statistically different . | Pain scores for BBL, vinblastine, and the mixture of BBL and vinblastine were not statistically different. |
CONCLUSIONS | Intralesional vinblastine is effective therapy for AIDS-KS . | Intralesional vinblastine is effective therapy for AIDS-KS. |
CONCLUSIONS | Local anesthesia does not reduce efficacy of treatment , or reduce the pain experienced by the patient . | Local anesthesia does not reduce efficacy of treatment, or reduce the pain experienced by the patient. |
BACKGROUND | Although lumbar spinal fusion has been performed for more than 70years , few studies have examined rehabilitation strategies for spinal fusion patients , and there is only sparse information about the patient 's activity level after surgery . | Although lumbar spinal fusion has been performed for more than 70years, few studies have examined rehabilitation strategies for spinal fusion patients, and there is only sparse information about the patient 's activity level after surgery. |
BACKGROUND | The Canadian Occupational Performance Measure ( COPM ) is a standardized semi-structured interview , developed to identify patients ' problems in relation to activities of daily living ( ADL ) . | The Canadian Occupational Performance Measure (COPM) is a standardized semi-structured interview, developed to identify patients'problems in relation to activities of daily living (ADL). |
BACKGROUND | The COPM has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients . | The COPM has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients. |
BACKGROUND | We aimed to examine whether or not the use of the semi-structured interview COPM during in-hospital rehabilitation could : ( 1 ) identify more ADL-related problems of importance to the patients after discharge from the hospital , ( 2 ) enhance the patients ' ADL performance after discharge from hospital | We aimed to examine whether or not the use of the semi-structured interview COPM during in-hospital rehabilitation could : (1) identify more ADL-related problems of importance to the patients after discharge from the hospital, (2) enhance the patients'ADL performance after discharge from hospital |
METHODS | Eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the COPM or to standard treatment . | Eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the COPM or to standard treatment. |
CONCLUSIONS | Use of the COPM during hospitalization helped in identifying more ADL problems encountered by patients during the first 3months post-discharge period as COPM served to identify more treatment goals and plans of action . | Use of the COPM during hospitalization helped in identifying more ADL problems encountered by patients during the first 3months post-discharge period as COPM served to identify more treatment goals and plans of action. |
CONCLUSIONS | Use of the COPM had no impact on the patients ' ADL performance , and the difference is so small that COPM may be of little clinical consequence . | Use of the COPM had no impact on the patients'ADL performance, and the difference is so small that COPM may be of little clinical consequence. |
BACKGROUND | Several occupational exposures adversely affect lung function . | Several occupational exposures adversely affect lung function. |
OBJECTIVE | This study reports the influence of continued occupational dust and fume exposures on the rate of decline of lung function in participants with early chronic obstructive pulmonary disease ( COPD ) studied in a population-based study . | This study reports the influence of continued occupational dust and fume exposures on the rate of decline of lung function in participants with early chronic obstructive pulmonary disease (COPD) studied in a population-based study. |
METHODS | Subjects consisted of 5,724 participants in the Lung Health Study , a multicenter study of smoking cessation and anticholinergic bronchodilator administration in smokers with early COPD ( 3,592 men ; 2,132 women ) . | Subjects consisted of 5, 724 participants in the Lung Health Study, a multicenter study of smoking cessation and anticholinergic bronchodilator administration in smokers with early COPD (3, 592 men ; 2, 132 women). |
METHODS | Average post-bronchodilator FEV1 at entry was 78.4 % predicted for men and 78.2 % predicted for women ; all participants had an FEV1/FVC ratio less than 0.70 . | Average post-bronchodilator FEV1 at entry was 78. 4 % predicted for men and 78. 2 % predicted for women ; all participants had an FEV1/FVC ratio less than 0. 70. |
RESULTS | Participants underwent a baseline evaluation and five annual follow-up assessments , including questionnaires and spirometry . | Participants underwent a baseline evaluation and five annual follow-up assessments, including questionnaires and spirometry. |
RESULTS | The effect of ongoing dust or fume exposure on FEV1 in each follow-up year was statistically evaluated with a mixed-effects regression model , which was adjusted for FEV1 at entry , age , airway responsiveness to methacholine , baseline smoking intensity , and time-varying ( yearly ) smoking status during each follow-up year . | The effect of ongoing dust or fume exposure on FEV1 in each follow-up year was statistically evaluated with a mixed-effects regression model, which was adjusted for FEV1 at entry, age, airway responsiveness to methacholine, baseline smoking intensity, and time-varying (yearly) smoking status during each follow-up year. |
RESULTS | In men with early COPD , each year of continued fume exposure was associated with a 0.25 % predicted reduction in post-bronchodilator FEV1 % predicted . | In men with early COPD, each year of continued fume exposure was associated with a 0. 25 % predicted reduction in post-bronchodilator FEV1 % predicted. |
RESULTS | Continued smoking and airway hyperresponsiveness were also associated with reduction in FEV1 during each year of follow-up in both men and women . | Continued smoking and airway hyperresponsiveness were also associated with reduction in FEV1 during each year of follow-up in both men and women. |
RESULTS | Statistically significant effects of dust exposure on the rate of decline were not found , nor were effects of fume exposure noted in women . | Statistically significant effects of dust exposure on the rate of decline were not found, nor were effects of fume exposure noted in women. |
CONCLUSIONS | These results suggest a need for secondary prevention by controlling occupational fume exposures . | These results suggest a need for secondary prevention by controlling occupational fume exposures. |
OBJECTIVE | To identify differences in lower extremity kinematic movement patterns between genders during walking through the application of an expected perturbation . | To identify differences in lower extremity kinematic movement patterns between genders during walking through the application of an expected perturbation. |
METHODS | Randomized limb kinematics were compared between healthy active males and females . | Randomized limb kinematics were compared between healthy active males and females. |
BACKGROUND | Lower extremity kinematics during jump landing and cutting have been implicated as a potential source of the discrepancy in anterior cruciate ligament injury rates between genders . | Lower extremity kinematics during jump landing and cutting have been implicated as a potential source of the discrepancy in anterior cruciate ligament injury rates between genders. |
BACKGROUND | Kinematic differences between genders have been identified during tasks that are not provocative of anterior cruciate ligament injury but do result in increased ligament strain . | Kinematic differences between genders have been identified during tasks that are not provocative of anterior cruciate ligament injury but do result in increased ligament strain. |
BACKGROUND | Repetition of movement patterns that increase anterior cruciate ligament strain may increase the likelihood they will be reproduced during athletic tasks that produce force loads that exceed anterior cruciate ligament tensile strength . | Repetition of movement patterns that increase anterior cruciate ligament strain may increase the likelihood they will be reproduced during athletic tasks that produce force loads that exceed anterior cruciate ligament tensile strength. |
METHODS | Twenty subjects ( 10 women , 10 men ) classified as a level I or II athlete underwent motion analyses while performing self-paced walking trials . | Twenty subjects (10 women, 10 men) classified as a level I or II athlete underwent motion analyses while performing self-paced walking trials. |
METHODS | Five trials were undisturbed , and five each with a platform translating either laterally or anteriorly at heel contact . | Five trials were undisturbed, and five each with a platform translating either laterally or anteriorly at heel contact. |
METHODS | Sagittal , frontal , and transverse hip angles as well as sagittal and frontal knee angles were collected during stance . | Sagittal, frontal, and transverse hip angles as well as sagittal and frontal knee angles were collected during stance. |
RESULTS | Excursions in the frontal and transverse planes were greater at the hip and knee for females compared to males in each walking condition . | Excursions in the frontal and transverse planes were greater at the hip and knee for females compared to males in each walking condition. |
RESULTS | The rate of these excursions also occurred more rapidly for females than males . | The rate of these excursions also occurred more rapidly for females than males. |
RESULTS | There was no difference for joint angles at initial contact between genders , and there was no difference in the amount of sagittal plane excursion for the hip and knee when comparing genders . | There was no difference for joint angles at initial contact between genders, and there was no difference in the amount of sagittal plane excursion for the hip and knee when comparing genders. |
CONCLUSIONS | Females demonstrate characteristics during both normal and perturbed gait that may potentially contribute to increased anterior cruciate ligament strain . | Females demonstrate characteristics during both normal and perturbed gait that may potentially contribute to increased anterior cruciate ligament strain. |
CONCLUSIONS | Repetition of these potentially harmful movement patterns during provocative athletic maneuvers may lead to anterior cruciate ligament injury . | Repetition of these potentially harmful movement patterns during provocative athletic maneuvers may lead to anterior cruciate ligament injury. |
CONCLUSIONS | Females exhibit lower extremity kinematic patterns that differ from males . | Females exhibit lower extremity kinematic patterns that differ from males. |
CONCLUSIONS | Female kinematic patterns may contribute to an increased risk for anterior cruciate ligament injury . | Female kinematic patterns may contribute to an increased risk for anterior cruciate ligament injury. |
BACKGROUND | Oxycodone is metabolized in the liver by means of O-demethylation to form oxymorphone in a reaction catalyzed by the enzyme cytochrome P450 2D6 ( CYP2D6 ) . | Oxycodone is metabolized in the liver by means of O-demethylation to form oxymorphone in a reaction catalyzed by the enzyme cytochrome P450 2D6 (CYP2D6). |
BACKGROUND | This enzyme is expressed as 2 phenotypes ( extensive and poor metabolizers ) . | This enzyme is expressed as 2 phenotypes (extensive and poor metabolizers). |
BACKGROUND | Several drugs are metabolized by CYP2D6 , and clinically relevant drug interactions may occur . | Several drugs are metabolized by CYP2D6, and clinically relevant drug interactions may occur. |
BACKGROUND | The aim of this study was to evaluate the role of oxymorphone in mediating the opioid effects of oxycodone by means of blocking CYP2D6 with quinidine . | The aim of this study was to evaluate the role of oxymorphone in mediating the opioid effects of oxycodone by means of blocking CYP2D6 with quinidine. |
METHODS | Ten healthy extensive metabolizers were administered 20 mg controlled-release oxycodone after premedication with placebo or 200 mg quinidine in this randomized , double-blind crossover study . | Ten healthy extensive metabolizers were administered 20 mg controlled-release oxycodone after premedication with placebo or 200 mg quinidine in this randomized, double-blind crossover study. |
METHODS | A dose of 100 mg quinidine was administered 6 hours later . | A dose of 100 mg quinidine was administered 6 hours later. |
METHODS | Plasma opioid concentrations , subjective pharmacodynamic ratings , and psychomotor function were assessed for 24 hours after drug administration . | Plasma opioid concentrations, subjective pharmacodynamic ratings, and psychomotor function were assessed for 24 hours after drug administration. |
RESULTS | No oxymorphone was detected at any time after quinidine premedication in 8 of 10 subjects . | No oxymorphone was detected at any time after quinidine premedication in 8 of 10 subjects. |
RESULTS | Plasma oxycodone ( difference not significant ) and noroxycodone ( P < .01 ) concentrations were greater after quinidine pretreatment . | Plasma oxycodone (difference not significant) and noroxycodone (P <. 01) concentrations were greater after quinidine pretreatment. |
RESULTS | Prevention of the production of oxymorphone by quinidine did not affect the psychomotor or subjective drug effects of oxycodone . | Prevention of the production of oxymorphone by quinidine did not affect the psychomotor or subjective drug effects of oxycodone. |
RESULTS | No difference in number of adverse effects was observed after the 2 pretreatments . | No difference in number of adverse effects was observed after the 2 pretreatments. |
CONCLUSIONS | A significant reduction in plasma oxymorphone levels did not substantially alter the pharmacodynamic effects of oxycodone . | A significant reduction in plasma oxymorphone levels did not substantially alter the pharmacodynamic effects of oxycodone. |
CONCLUSIONS | Analgesia was not evaluated because pain was not present . | Analgesia was not evaluated because pain was not present. |
OBJECTIVE | Safety and reactogenicity of a new heptavalent DTPw-HBV/Hib-MenAC ( diphtheria , tetanus , whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C ) vaccine was compared with a widely used pentavalent DTPw-HBV/Hib vaccine . | Safety and reactogenicity of a new heptavalent DTPw-HBV/Hib-MenAC (diphtheria, tetanus, whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C) vaccine was compared with a widely used pentavalent DTPw-HBV/Hib vaccine. |
METHODS | Three phase III randomized studies comparable in design and methodology , in which healthy infants received DTPw-HBV/Hib-MenAC ( N = 1334 ) or DTPw-HBV/Hib ( N = 446 ) at 2 , 4 , and 6 months , were pooled for analysis . | Three phase III randomized studies comparable in design and methodology, in which healthy infants received DTPw-HBV/Hib-MenAC (N = 1334) or DTPw-HBV/Hib (N = 446) at 2, 4, and 6 months, were pooled for analysis. |
METHODS | Solicited symptoms were recorded for 4 days , and unsolicited adverse events for 31 days after each dose . | Solicited symptoms were recorded for 4 days, and unsolicited adverse events for 31 days after each dose. |
METHODS | Serious adverse events ( SAEs ) were recorded throughout the studies . | Serious adverse events (SAEs) were recorded throughout the studies. |
RESULTS | There were no significant differences between the two groups in the proportion of subjects with fever > 39.5 degrees C or > 40.0 degrees C ( p < 0.005 ) . | There were no significant differences between the two groups in the proportion of subjects with fever > 39. 5 degrees C or > 40. 0 degrees C (p < 0. 005). |
RESULTS | Compared to group DTPw-HBV/Hib , a significantly higher percentage of subjects in group DTPw-HBV/Hib-MenAC reported fever > 39 degrees C ( 21.2 % vs. 14.8 % , p = 0.004 ) . | Compared to group DTPw-HBV/Hib, a significantly higher percentage of subjects in group DTPw-HBV/Hib-MenAC reported fever > 39 degrees C (21. 2 % vs. 14. 8 %, p = 0. 004). |
RESULTS | Fever subsided quickly , did not lead to differences in attendance to medical services and did not increase from dose to dose . | Fever subsided quickly, did not lead to differences in attendance to medical services and did not increase from dose to dose. |
RESULTS | Sixty-seven SAEs were reported , 56/1334 ( 4.2 % ) in group DTPw-HBV/Hib-MenAC and 11/446 ( 2.5 % ) in the DTPw-HBV/Hib group . | Sixty-seven SAEs were reported, 56/1334 (4. 2 %) in group DTPw-HBV/Hib-MenAC and 11/446 (2. 5 %) in the DTPw-HBV/Hib group. |