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2.
Gac. méd. Méx ; 156(6): 509-518, nov.-dic. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1249960

ABSTRACT

Resumen Introducción: La desnutrición infantil en México alcanza prevalencias de 27.5 % en zonas rurales. Objetivo: Evaluar la efectividad de un suplemento alimenticio listo para consumir (SALC) para corregir desnutrición aguda leve y prevenir desnutrición aguda moderada en preescolares de comunidades rurales. Método: Ensayo clínico aleatorizado por grupos: con y sin SALC (g-SALC y g-S/SALC); se incluyeron niños de dos a cinco años, con puntuaciones-Z de peso para la talla (pZ-P/T) mayor de −2 y menor de −1 y nivel socioeconómico bajo. Todos recibieron educación sobre nutrición, salud e higiene dos veces al mes; los niños del g-SALC debieron consumir diariamente una porción del suplemento. Se evaluó pZ-P/T al inicio y a los cuatro, seis y 12 meses. La comparación entre grupos se realizó con el modelo de riesgos proporcionales de Cox. Resultados: Respecto a la recuperación de desnutrición aguda leve, en g-SALC se observó 68.7 versus 52.1% en el grupo control en el análisis de intención para tratar, con una razón de riesgo (HR) = 1.25; en el análisis por protocolo del primer semestre se observó una HR = 1.48 y en el segundo semestre, HR = 1.56. Un paciente progresó a desnutrición aguda moderada. Conclusiones: El g-SALC mostró resolución significativamente mayor de desnutrición aguda leve.


Abstract Introduction: Child malnutrition in Mexico reaches a prevalence as high as 27.5 % in rural areas. Objective: To assess the effectiveness of a ready-to-use supplementary food (RUSF) to correct mild acute malnutrition and prevent moderate acute malnutrition in preschool children from rural communities. Method: Randomized clinical trial, with assignment to two groups: group with RUSF (RUSF-g) or group without it (non-RUSF-g); children aged from two to five years, with weight-for-height Z-scores (WHZ) between -2 and -1 and low socioeconomic status were included. All received education on nutrition, health and hygiene twice monthly; the RUSF-g children had to consume four biscuits of the supplement every day. WHZ was assessed at baseline and at four, six, and 12 months. The comparison between groups was carried out with Cox proportional hazards model. Results: With regard to mild acute malnutrition correction in the RUSF-g, 68.7 versus 52.1 % in the control group was observed in the intent-to-treat analysis, with a hazard ratio (HR) = 1.25; in the per-protocol analysis of first semester, a HR = 1.48 was observed, and in the second semester, HR = 1.56. One patient progressed to moderate acute malnutrition. Conclusions: The RUSF-g showed a significantly higher resolution of mild acute malnutrition.


Subject(s)
Humans , Male , Female , Child, Preschool , Rural Population/statistics & numerical data , Child Nutrition Disorders/prevention & control , Dietary Supplements , Fast Foods , Social Class , Time Factors , Child Nutrition Disorders/epidemiology , Proportional Hazards Models , Acute Disease , Prevalence , Intention to Treat Analysis , Mexico/epidemiology
5.
Article in Korean | WPRIM | ID: wpr-742135

ABSTRACT

BACKGROUND/AIMS: The Helicobacter pylori (H. pylori) eradication rate of standard triple therapy is unsatisfactory in Korea, and sequential therapy (SQT) has been suggested to be a practical first-line alternative regimen. The aim of this prospective study was to document changes in annual eradication rates of SQT. METHODS: A total of 983 H. pylori-positive subjects were enrolled from 2010 to 2018 and their data were subjected to intention-to-treat (ITT) and per-protocol (PP) analysis. All subjects received 10-day sequential therapy consisting of 40 mg esomeprazole and 1 g amoxicillin b.i.d for 5 days followed by 40 mg esomeprazole b.i.d, 500 mg clarithromycin b.i.d and 500 mg metronidazole t.i.d for 5 days. The 13C-urea breath test, rapid urease test (CLO test®), and histology were used to confirm eradication. Compliance and side effects were also investigated. RESULTS: ITT and PP eradication rates of SQT were 69.9% (687 of 983) and 87.1% (657 of 754), respectively. The annual eradication rate of ITT remained consistent over the 8-year study period (p for trend=0.167), whereas PP analysis showed the eradication rate increased (p for trend=0.042). The overall adverse event rate for SQT was 41.7% (410 subjects). CONCLUSIONS: Despite high antibiotic resistance rates in Korea, the eradication rate of SQT did not decrease over the 8-year study period.


Subject(s)
Amoxicillin , Breath Tests , Clarithromycin , Compliance , Drug Resistance, Microbial , Esomeprazole , Helicobacter pylori , Helicobacter , Intention to Treat Analysis , Korea , Metronidazole , Prospective Studies , Urease
8.
Article in English | WPRIM | ID: wpr-691383

ABSTRACT

<p><b>OBJECTIVE</b>To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction (, TSD) in the treatment of early-stage, mild-moderate diffuse cutaneous systemic sclerosis (dcSSc).</p><p><b>METHODS</b>This randomized, placebo-controlled trial enrolled 148 men and women (18-60 years) with dcSSc (disease duration 12 months) and baseline modified Rodnan skin score (MRSS) 10. Patients were randomized into a TSD group (71 cases bathing with TSD plus oral prednisone) or control group (71 cases bathing with placebo plus oral prednisone). Bathing (40 °C, 30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks. The primary outcome measure was MRSS; secondary outcomes were Raynaud's phenomenon (RP) score, quality of life (QOL), physician visual analogue scale (VAS), patient VAS, percent predicted diffusing capacity for carbon monoxide (DLCO), percent predicted forced vital capacity (FVC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level and overall treatment effect.</p><p><b>RESULTS</b>The final analysis included 135 patients (control group, 68 cases; TSD group, 67 cases). Primary and secondary outcome measures after 2 weeks of treatment showed no improvement (versus baseline) in both groups, with no differences between groups. At 12 weeks, QOL, physician VAS, patient VAS, ESR and CRP were improved in both groups, but MRSS and RP score were improved only in the TSD group (all P<0.05). MRSS, RP score, QOL, physician VAS, patient VAS, ESR and CRP differed significantly between groups (all P<0.05). Meanwhile, the overall treatment effect was significantly higher in the TSD group than in the control group (P<0.05). Adverse events in the two groups were similar (P>0.05).</p><p><b>CONCLUSIONS</b>Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcSSc and is not associated with serious adverse events.</p>


Subject(s)
Adult , Drugs, Chinese Herbal , Therapeutic Uses , Female , Humans , Hygiene , Intention to Treat Analysis , Male , Middle Aged , Outcome Assessment, Health Care , Placebos , Scleroderma, Diffuse , Drug Therapy , Treatment Outcome
9.
Ann. hepatol ; 16(3): 402-411, May.-Jun. 2017. tab, graf
Article in English | LILACS | ID: biblio-887252

ABSTRACT

ABSTRACT Introduction and aim. Liver transplantation (LT) provides durable survival for hepatocellular carcinoma (HCC). However, there is continuing debate concerning the impact of wait time and acceptable tumor burden on outcomes after LT. We sought to review outcomes of LT for HCC at a single, large U.S. center, examining the influence of wait time on post-LT outcomes. Material and methods. We reviewed LT for HCC at Mayo Clinic in Florida from 1/1/2003 until 6/30/2014. Follow up was updated through 8/1/ 2015. Results. From 2003-2014,978 patients were referred for management of HCC. 376 patients were transplanted for presumed HCC within Milan criteria, and the results of these 376 cases were analyzed. The median diagnosis to LT time was 183 days (8 - 4,337), and median transplant list wait time was 62 days (0 -1815). There was no statistical difference in recurrence-free or overall survival for those with wait time of less than or greater than 180 days from diagnosis of HCC to LT. The most important predictor of long term survival after LT was HCC recurrence (HR: 18.61, p < 0.001). Recurrences of HCC as well as survival were predicted by factors related to tumor biology, including histopathological grade, vascular invasion, and pre-LT serum alpha-fetoprotein levels. Disease recurrence occurred in 13%. The overall 5-year patient survival was 65.8%, while the probability of 5-year recurrence-free survival was 62.2%. Conclusions. In this large, single-center experience with long-term data, factors of tumor biology, but not a longer wait time, were associated with recurrence-free and overall survival.


Subject(s)
Humans , Liver Transplantation/adverse effects , Liver Transplantation/mortality , Carcinoma, Hepatocellular/surgery , Carcinoma, Hepatocellular/diagnosis , Carcinoma, Hepatocellular/mortality , Neoplasm Recurrence, Local , Time Factors , Proportional Hazards Models , Risk Factors , Waiting Lists/mortality , Disease-Free Survival , Kaplan-Meier Estimate , Intention to Treat Analysis , Time-to-Treatment , Liver Neoplasms/surgery , Liver Neoplasms/diagnosis , Liver Neoplasms/mortality
12.
Ciênc. saúde coletiva ; 20(4): 1109-1118, 04/2015. graf
Article in English | LILACS | ID: lil-744871

ABSTRACT

The study of HIV transmission and the implementation of AIDS prevention actions recognize the importance of social networks in the transmission of the disease, the adherence to treatment and the quality of life of those infected. For this relevance there was a review of articles on social support networks to people living with HIV /AIDS available in the Virtual Health Library (VHL) were published in Brazil between 2002 and 2012. In this study 31 articles were used from journals covering the following áreas: Nursing (n = 15), Psychology (n = 6) and Science Health / Biomedica (n = 6), were included, which some principal authors were affiliated to higher education public institutions (n = 17). In relation to the methodology used, priority wasgiven to conducting: qualitative research (n = 18), cross-sectional studies (n = 19) and studies that involved talking to people living with HIV/AIDS (n = 13). Particular importance was placed on analytic categories related to: adherence to treatment (n = 6), the family (n = 4), vulnerability (n = 3) and support from social networks (n = 5). Within this paper we argue for more investments into studies that focus on the family, carers and their households, as well as deepening the theoretical study of the themes discussed and the use of developed theories for the analysis of Social Networks.


O estudo da transmissão do HIV e a implementação de ações de prevenção da AIDS reconhece a importância das redes sociais na contaminação, adesão ao tratamento e qualidade de vida das pessoas infectadas. Por tal relevância, realizou-se uma revisão de artigos sobre redes sociais de apoio às pessoas que vivem com HIV/ AIDS, disponíveis na Biblioteca Virtual em Saúde (BVS) e publicados no Brasil no período de 2002 a 2012. Encontraram-se 31 artigos em revistas de Enfermagem (n = 15), Psicologia (n = 6) e Ciências da Saúde/Biomédicas (n = 6), produzidos por primeiros autores associados a Instituições de Ensino Superior públicas (n = 17). Quanto à metodologia, priorizou-se o método qualitativo (n = 18), estudos transversais (n = 19) e a participação exclusiva de pessoas que vivem com HIV/AIDS (n = 13). Houve predomínio de categorias analíticas relacionadas à adesão ao tratamento (n = 6), família (n = 4), vulnerabilidade (n = 3) e apoio/suporte social/ rede de apoio (n = 5). Discute-se a necessidade de investimento em estudos que privilegiem familiares e cuidadores como participantes e seus domicílios como lócus de investigação, bem como maior aprofundamento teórico nos estudos das temáticas abordadas e utilização de teorias desenvolvidas para análise de Redes Sociais.


Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Young Adult , Antibiotic Prophylaxis , Anti-Bacterial Agents/administration & dosage , Mupirocin/administration & dosage , Povidone-Iodine/administration & dosage , Staphylococcal Infections/prevention & control , Staphylococcus aureus/drug effects , Surgical Wound Infection/prevention & control , Administration, Intranasal , Arthroplasty , Intention to Treat Analysis , Mupirocin/pharmacology , Nose/microbiology , Ointments , Povidone-Iodine/pharmacology , Spinal Fusion
13.
Gut and Liver ; : 478-485, 2015.
Article in English | WPRIM | ID: wpr-149102

ABSTRACT

BACKGROUND/AIMS: Bismuth-containing quadruple and moxifloxacin-based triple regimens are recommended as second-line therapy for Helicobacter pylori infection. The aim of this study was to compare the efficacy of each regimen. METHODS: From August 2004 to October 2012, a total of 949 patients (mean age, 54.32+/-12.08 years; male, 49.4%) who failed H. pylori eradication with a standard triple regimen were included. Patients treated with a bismuth-containing quadruple regimen for 7 and 14 days were designated as 7-BMT and 14-BMT, respectively, and those treated with a moxifloxacin-based triple regimen for 7 and 14 days were designated as 7-MA and 14-MA, respectively. H. pylori eradication was confirmed using the 13C-urea breath test, rapid urease test or histology. RESULTS: The eradication rates by 7-BMT, 14-BMT, 7-MA, and 14-MA were 66.4% (290/437), 71.1% (113/159), 53.1% (51/96), and 73.5% (189/257), respectively, by intention-to-treat analysis (ITT) and 76.5% (284/371), 83.8% (109/130), 55.6% (50/90), and 80.6% (187/232), respectively, by per-protocol analysis (PP). The eradication rates were higher in 14-BMT than 7-BMT by the ITT and PP analyses (p=0.277 and p=0.082, respectively). The 14-BMT and 14-MA treatments showed similar efficacies by ITT and PP (p=0.583 and p=0.443, respectively). CONCLUSIONS: The 7-BMT, 14-BMT, and 14-MA treatments showed similar and suboptimal efficacies. In both regimens, extending the duration of treatment may be reasonable considering the high level of antibiotic resistance in Korea.


Subject(s)
Adult , Aged , Amoxicillin/administration & dosage , Antacids/administration & dosage , Anti-Infective Agents/administration & dosage , Bismuth/administration & dosage , Drug Administration Schedule , Drug Therapy, Combination/methods , Female , Fluoroquinolones/administration & dosage , Helicobacter Infections/drug therapy , Helicobacter pylori , Humans , Intention to Treat Analysis , Male , Metronidazole/administration & dosage , Middle Aged , Proton Pump Inhibitors/administration & dosage , Retrospective Studies , Tetracycline/administration & dosage , Treatment Outcome
14.
Gut and Liver ; : 494-501, 2015.
Article in English | WPRIM | ID: wpr-149100

ABSTRACT

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.


Subject(s)
Adult , Aged , Cathartics/administration & dosage , Citrates/administration & dosage , Citric Acid/administration & dosage , Colon/drug effects , Colonoscopy , Drug Combinations , Drug Therapy, Combination/methods , Female , Humans , Intention to Treat Analysis , Laxatives/administration & dosage , Male , Middle Aged , Organometallic Compounds/administration & dosage , Patient Compliance , Patient Satisfaction , Picolines/administration & dosage , Polyethylene Glycols/administration & dosage , Preoperative Care/methods , Single-Blind Method , Young Adult
15.
Gut and Liver ; : 607-614, 2015.
Article in English | WPRIM | ID: wpr-216110

ABSTRACT

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) act by irreversibly binding to the H+-K+-ATPase of the proton pump in parietal cells and may possibly affect the vacuolar H+-ATPase in osteoclasts. METHODS: We investigated the effect of 8 weeks of PPI treatment on the parameters of bone turnover and compared PPI with revaprazan, which acts by reversibly binding to H+-K+-ATPase in proton pumps. This study was a parallel randomized controlled trial. For 8 weeks, either a PPI or revaprazan was randomly assigned to patients with gastric ulcers. The parameters of bone turnover were measured at the beginning of and after the 8-week treatment period. RESULTS: Twenty-six patients (PPI, n=13; revaprazan, n=13) completed the intention-to-treat analysis. After the 8-week treatment period, serum calcium and urine deoxypyridinoline (DPD) were increased in the PPI group (serum calcium, p=0.046; urine DPD, p=0.046) but not in the revaprazan group. According to multivariate linear regression analysis, age > or =60 years was an independent predictor for the changes in serum calcium and urine DPD. CONCLUSIONS: In elderly patients, administering a PPI for 8 weeks altered bone parameters. Our study suggested that PPIs might directly alter bone metabolism via the vacuolar H+-ATPase in osteoclasts.


Subject(s)
Aged , Amino Acids/drug effects , Bone Remodeling/drug effects , Bone and Bones/metabolism , Calcium/blood , Female , Humans , Intention to Treat Analysis , Linear Models , Male , Middle Aged , Multivariate Analysis , Osteoclasts/metabolism , Prospective Studies , Proton Pump Inhibitors/pharmacology , Pyrimidinones/pharmacology , Tetrahydroisoquinolines/pharmacology
16.
Article in English | WPRIM | ID: wpr-106130

ABSTRACT

BACKGROUND/AIMS: Little is known about the efficacy of low-dose transdermal fentanyl (TDF) patches in opioid-naive patients with moderate-to-severe cancer pain. METHODS: This study had an open-label, prospective design, and was conducted between April 2007 and February 2009 in seven tertiary cancer hospitals; 98 patients were enrolled. TDF was started using a low-dose formulation (12.5 microg/hr), and the dose was adjusted according to the clinical situation of individual patients. Pain intensity, the TDF doses used, and adverse events (AEs) were monitored over 4 weeks. Data were analyzed using the intent-to-treat and per-protocol principles. RESULTS: Of the 98 patients enrolled, 64 (65%) completed the study. The median pain intensity decreased from 6.0 to 3.0 (p < 0.001) at the follow-up visit. The efficacy of low-dose TDF on pain relief was consistent across groups separated according to gender (p < 0.001), age (p < 0.001), metastasis (p < 0.001), previous treatment (p < 0.001), and baseline pain intensity (p < 0.001). The decrease in pain intensity was significantly greater in the severe group compared with the moderate group (mean +/- SD, 5.10 +/- 2.48 vs. 2.48 +/- 1.56; p < 0.001). TDF dose (27.8 microg/hr vs. 24.8 microg/hr, p = 0.423) and the mean treatment time (7.5 days vs. 7.9 days, p = 0.740) required for pain control were not different between the two pain-intensity groups. Patients had AEs of only mild or moderate intensity; among these, nausea (38%) was the most common, followed by vomiting (22%) and somnolence (22%). CONCLUSIONS: Low-dose TDF was an effective treatment for patients with cancer pain of moderate-to-severe intensity. Further randomized trials assessing the efficacy of TDF for severe pain and/or optimal starting doses are warranted.


Subject(s)
Administration, Cutaneous , Adult , Aged , Aged, 80 and over , Analgesics, Opioid/administration & dosage , Female , Fentanyl/administration & dosage , Humans , Intention to Treat Analysis , Male , Middle Aged , Neoplasms/complications , Pain/diagnosis , Pain Measurement , Prospective Studies , Republic of Korea , Severity of Illness Index , Tertiary Care Centers , Time Factors , Transdermal Patch , Treatment Outcome
17.
Article in English | WPRIM | ID: wpr-105991

ABSTRACT

BACKGROUND/AIMS: Combination single-pill therapy can improve cost-effectiveness in a typical medical therapy. However, there is a little evidence about the efficacy and tolerability of combination single-pill antiplatelet therapy after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: From June to November 2012, in total, 142 patients who met the following criteria were enrolled: at least 18 years old; successful PCI with DES at least 3 months earlier; and regular medication of aspirin and clopidogrel with no side effects. After VerifyNow P2Y12 and aspirin assays, the combination single pill of aspirin and clopidogrel was given and laboratory tests were repeated 6 weeks later. RESULTS: At baseline, the incidence of aspirin resistance, defined as aspirin reaction unit (ARU) > or = 550, was 9.2%, that of clopidogrel resistance, defined as P2Y12 reaction unit (PRU) > or = 230, was 46.5%, and that of percent inhibition of PRU < 20% was 32.4%. At follow-up, the incidence of resistance by ARU value was 7.0%, 50.0% by PRU value, and 35.9% by percentage inhibition of PRU, respectively. The mean values of ARU (431.5 +/- 63.6 vs. 439.8 +/- 55.2; p = 0.216) and PRU (227.5 +/- 71.4 vs. 223.3 +/- 76.0; p = 0.350) were not significantly different before versus after antiplatelet-combination single-pill therapy. Five adverse events (3.5%) were observed during the study period. CONCLUSIONS: Combination single-pill antiplatelet therapy, which may reduce daily pill burden for patients after PCI with DES, demonstrated similar efficacy to separate dual-pill antiplatelet therapy.


Subject(s)
Aged , Antiplatyhelmintic Agents/administration & dosage , Aspirin/administration & dosage , Drug Combinations , Drug Resistance , Drug-Eluting Stents , Female , Humans , Intention to Treat Analysis , Male , Middle Aged , Myocardial Ischemia/blood , Percutaneous Coronary Intervention/adverse effects , Platelet Function Tests , Prospective Studies , Tablets , Ticlopidine/administration & dosage , Time Factors , Treatment Outcome
18.
Article in English | WPRIM | ID: wpr-633431

ABSTRACT

INTRODUCTION:Radioactive iodine(I131) therapy is an established definitive treatment for Graves' hyperthyroidism.However,the optimal method of determining the radioiodine treatment dose remains controversial.OBJECTIVE: To compare the efficacy of fixed dose versus  calculated  dose  regimen  in  the  treatment  of  Graves'  hyperthyroidism  among  Filipinos  METHODOLOGY: Diagnosed   Graves'   disease   patients underwent  thyroid  ultrasound  to  estimate  thyroid  size. Patients  were  randomized  to  either  fixed  or  calculated dose  of  radioiodine  treatment.  For  fixed  dose  group,the  WHO  goiter  grading  was  utilized:  Grade   0   (5mCi),  Grade   1  (7mCi),  Grade2  (10mCi),  Grade  3  (15mCi).  For calculated  dose  group  the  following  formula  was  used:                    Dose(mCi)= 160uCi/g thyroid x thyroid gland weight in grams x 100  /  24-hour RAIU(%)Thyroid function test (TSH,FT4)  was monitored every  three  months  for  one  year.  RESULTS: Of  the  60  patients  enrolled,  45  (fixed  dose;  n= 27,  calculated  dose;  n=  18)  completed  the  six  months follow-up  study.  Analysis  was  done  by  application  of  the  intention-to-treat  principle.  The  percentage  failure  rate  at  third  month  in  the  fixed  vs.  calculated  dose  group  was:  26  v.  28%  with  a  relative  risk  (RR)  value  of  0.93.  At  six  months  post-therapy,  there  was  a  noted  reduction  in  the  failure  rates  for  both  study  groups  (11  vs.  22%,  respectively),  with   a   further   reduction   in   the   relative   risk   value (0.67),  favoring  the  fixed  dose  group.CONCLUSION: Fixed   dose   radioiodine   therapy   for Graves'   disease   is   observed   to   have   a   lower   risk   of   treatment   failure   (persistent   hyperthyroidism)   at   three  and  six  months  post-therapy  compared  to  the calculated  dose.


Subject(s)
Humans , Male , Female , Middle Aged , Adult , Iodine Radioisotopes , Iodine , Intention to Treat Analysis , Graves Disease , Hyperthyroidism , Goiter , Thyroid Function Tests , Treatment Failure
19.
Article in English | IMSEAR | ID: sea-156273

ABSTRACT

Background. Under the Revised National Tuberculosis Control Programme of India, patients with new smear-positive pulmonary tuberculosis are treated with a thrice-weekly regimen of antitubercular drugs (2H3R3Z3E3/4H3R3 [H isoniazid, R rifampicin, Z pyrazinamide and E ethambutol]) for 6 months. We conducted a retrospective analysis of the efficacy and tolerability of this regimen under clinical trial conditions in HIV-negative patients with newly diagnosed smear-positive pulmonary tuberculosis. Methods. We retrospectively analysed the data on patients assigned to the control regimen (2H3R3Z3E3/4H3R3) in two clinical trials during 2001–06 at the National Institute for Research in Tuberculosis, Chennai, India. Results. Of the 268 patients treated with this regimen, data for efficacy analysis were available for 249. At the end of treatment, of 249 patients, 238 (96%) had a favourable status. Treatment failure occurred in the remaining 11: 7 in whom the organisms were initially drug-susceptible and 4 with initial drug resistance. Of the 238 patients who had a favourable status at the end of treatment, 14 (6%) had recurrence of tuberculosis during the following 24 months. In the intention-to-treat analysis, 245 (94%) of 262 patients had a favourable status at the end of treatment. Of the 28 patients with initial drug resistance, 24 (86%) had a favourable outcome. Only 4 of these 24 patients were found to have recurrence of tuberculosis in 2 years of follow-up. Among the 221 patients initially infected with drug-susceptible organisms, drug resistance did not develop in any of the 7 patients in whom the treatment failed or the 10 who had recurrence of tuberculosis. Further, 5 of the 7 patients in whom the treatment failed continued to excrete drug-susceptible bacilli at 6 months. Adverse drug reactions were observed in 38 (14%) of the 262 patients. Only 3 (1.1%) needed a modification in the treatment. Conclusion. This thrice-weekly 6-month regimen of antitubercular drugs, when administered under full supervision, is associated with a high rate of favourable treatment outcomes in HIV-negative patients with newly diagnosed sputum smearpositive pulmonary tuberculosis. There are few adverse drug reactions in these patients.


Subject(s)
Adult , Antitubercular Agents/administration & dosage , Antitubercular Agents/adverse effects , Antitubercular Agents/therapeutic use , Drug Resistance, Bacterial , Drug Therapy, Combination , Ethambutol/therapeutic use , Female , Humans , Intention to Treat Analysis , Isoniazid/therapeutic use , Male , Pyrazinamide/therapeutic use , Recurrence , Rifampin/therapeutic use , Sputum/microbiology , Treatment Outcome , Tuberculosis/drug therapy
20.
Article in English | WPRIM | ID: wpr-328441

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the effects of Qingre Huoxue Decoction , clearing heat and promoting blood flow; QRHXD), on the radiographic progression in patients with rheumatoid arthritis (RA) by X-ray imaging.</p><p><b>METHODS</b>Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate (MTX) group, with 43 cases in each group. After one-year of treatment, 21 cases in each group (42 in total) were evaluated. Radiographs of hands were obtained at the baseline and after 12 months of treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to the Sharp/Van der Heijde methods.</p><p><b>RESULTS</b>High intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months in either group; and the differences between the two groups were not significant (P>0.05). The mean of the changing score in the QRHXD group was 3.5 ± 4.1, and 2.4 ± 3.5 in the QRHXD+MTX group, while the baseline radiographic score of patients in the QRHXD group was relatively higher (18.9 ± 19.1 vs. 14.0 ± 14.0). The mean rates of the changing scores of the two groups were similar (0.24 ± 0.28 vs. 0.25 ± 0.44, P=0.40). The severity of progression in the two groups was also similar (P=0.46), 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group, 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group.</p><p><b>CONCLUSION</b>Radiographic progression of RA patients in both groups is similar, indicating that the QRHXD Decoction has a potential role in preventing bone destruction.</p>


Subject(s)
Adult , Arthritis, Rheumatoid , Diagnostic Imaging , Drug Therapy , Disease Progression , Drugs, Chinese Herbal , Therapeutic Uses , Female , Humans , Intention to Treat Analysis , Male , Methotrexate , Therapeutic Uses , Middle Aged , Radiography
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