scholarly journals A PROSPECTIVE SINGLE-BLINDED STUDY ON THE SAFETY AND EFFICACY OF ZINC SUPPLEMENTATION IN PULMONARY TUBERCULOSIS

Author(s):  
Yeswanth Prasanna Kumar B ◽  
Praveen D ◽  
Vijey Aanandhi M

Aim and Objectives: The aim of the study was to study the serum zinc (Zn) levels, safety, and efficacy of Zn supplementation in pulmonary tuberculosis (PTB) patients.Methods: A randomized single-blinded study of two groups: Group A received conventional TB therapy while Group B received conventional TB therapy along with 15 mg of Zn tablet. 40 patients were assigned in each group by randomized permuted blocks.Results: After 8 weeks of treatment in Group A 27 patients and Group B 36 patients were found to be sputum negative with p=0.0421 and 0.0629. After 24 weeks of treatment in Group A 37 patients and Group B 40 patients were found to be sputum negative with p=0.00976 and 0.00971. By this, the given treatment was effective in the patients with PTB.Conclusion: Zn supplementation improves the effect of TB medication treatment and results in earlier sputum smear conversion.

2007 ◽  
Vol 122 (6) ◽  
pp. 603-608 ◽  
Author(s):  
S Elwany ◽  
Y A Nour ◽  
E A Magdy

AbstractIntroduction:Laryngopharyngeal reflux is increasingly being implicated in several otolaryngological disorders.Aims:To study a potential correlation between pre-operative laryngopharyngeal reflux and wound healing and recovery after tonsillectomy, based on subjective and objective findings.Materials and methods:A prospective, blinded study was undertaken, including 60 patients scheduled for tonsillectomy, divided into two equal groups: a study group (group A) with pre-operative laryngopharyngeal reflux documented using ambulatory 24-hour pH monitoring; and a control group (group B) without laryngopharyngeal reflux.Results:Group A had significantly higher pain scores on the seventh and 14th post-operative days (p = 0.022 and p = 0.000, respectively) and took a significantly longer time to return to normal eating (p = 0.013), compared with group B. Group A also showed significantly slower healing on the seventh and 14th post-operative days, as estimated by assessing the grade of post-operative slough formation (p = 0.016 and p = 0.029, respectively). A significant correlation between the number of pharyngeal reflux episodes and the degree of post-operative slough was also found.Conclusions:Laryngopharyngeal reflux can significantly decrease wound healing following tonsillectomy. Therefore, pre-operative recognition and management of this condition is desirable in order to eliminate its negative post-operative effect.


1970 ◽  
Vol 7 (2) ◽  
pp. 84-88
Author(s):  
AR Khagi ◽  
S Singh ◽  
S Subba ◽  
A Bajracharya ◽  
R Tuladhar ◽  
...  

Background: Microbial examination of smear of AFB by Z-N stain is currently the most rapid method for the detection of M. tuberculosis but its sensitivity is low i.e. required at least 10,000 bacterial cells per ml of sputum and also none specific, but auramine staining method has higher sensitivity than that of the Z-N stain but there are chances of false positive. Objective of this study was to find the correlation between chest X-ray, direct sputum smear examination by Ziehl-Neelsen stain, Auramine fluorochrome stain and sputum culture for M. tuberculosis. Methods: During that study period 250 x 3 samples were taken three each from 250 patients and divided into two groups A and B by performing Auramine fluorochrome stain in all samples . In group A, there were 150 fluorochrome stain positive samples. One each from 150 patient for comparative study of direct sputum smear examination by Ziehl-Neelsen stain, , culture on LJ medium and chest X-ray. Similarly in group B, next 100 fluorochrome stain negative specimens one each from 100 patients were taken for the comparative study of direct sputum smear examination by Ziehl-Neelsen stain, culture and chest X-ray. Results: In the study group A (n=150) all the specimens were positive in Auramine fluorochrome stain and all of them show positive in X-ray but only 134 showed positive in Ziehl-Neelsen stain and 136 showed positive in culture. In the study group B (n=100), all the specimens were negative in Auramine fluorochrome stain and all of them show negative in Ziehl-Neelsen stain but 14 of them were positive in culture and 24 were positive in chest X-ray. Conclusions: The diagnosis of PTB could be made by Auramine fluorochrome microscopy and culture. Key words: auramine fluorochrome stain; culture; mycobacterium tuberculosis; x-ray; ziehl-neelsen. DOI: 10.3126/jnhrc.v7i2.3012 Journal of Nepal Health Research Council Vol.7(2) Apr 2009 84-88


1996 ◽  
Vol 24 (6) ◽  
pp. 669-673 ◽  
Author(s):  
B. Anderson ◽  
S. Kanagasundarum ◽  
G. Woollard

The analgesic efficacy of paracetamol was assessed in a prospective, randomized, double-blinded study of 100 children undergoing tonsillectomy with or without adenoidectomy. Fifty children were given paracetamol elixir 40 mg/kg 40 minutes preoperatively (Group A); the remaining 50 children were given an oral placebo 40 minutes pre-operatively and paracetamol suppositories 40 mg/kg after induction of anaesthesia (Group B). Paracetamol was the only analgesic given and was given either orally or rectally in order to produce high variations in plasma paracetamol concentrations postoperatively. At 30 minutes after the end of surgery a pain score (0–10) was obtained and a venous blood sample was taken for serum paracetamol concentration analysis. Children given paracetamol elixir had a higher mean paracetamol concentration (0.15 [SD 0.06] mmol/l vs 0.05 [SD 0.03] mmol/l, P < 0.001) and a lower median pain score (5 vs 7, P < 0.02) than those who were given suppositories. The use of rescue morphine was higher (10 vs 23, P < 0.001) in the latter group. The incidence of nausea and vomiting was the same in both groups (20%) during the 24 hour postoperative period. Plasma paracetamol concentrations of 0.066–0.132 mmol/l are known to reduce temperature; plasma paracetamol concentrations which provide analgesia are unknown. Children with plasma paracetamol concentrations above 0.07 mmol/l had superior analgesia to those with concentrations below this level (P < 0.05).


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6041-6041 ◽  
Author(s):  
B. Krishnamurthyreddy ◽  
M. S. Vidyasagar ◽  
R. Koteshwar ◽  
A. Shenoy ◽  
L. Viswanath ◽  
...  

6041 Background: Patients (pt) with advanced inoperable squamous cell carcinoma of the head and neck (SCCHN) have poor radiotherapy alone (RT) outcome. EGFR is over-expressed in >90% SCCHN. h-R3mAb (BIOMAb/nimotuzumab/TheraCIM) is a humanized monoclonal antibody, a validated oncotherapeutic-targeting EGFR. Objective: To investigate the safety and efficacy of concurrent h-R3mAb in combination with chemoradiotherapy of SCCHN. Methods: September 2004–2005, pt 18–70 yrs, SCCHN stageIII-IVA, 113 screened, 92 enrolled and randomly asssigned to, Group A: radical radiotherapy (pt) and Group B: chemoradiotherapy (pt). Randomization within Group A: [RT]v/s[RT+h-R3mAb] and within Group B: [RT+CT]v/s[RT+CT+ h-R3mAb] (n = 23 in each arm). Protocol: Radiotherapy: TD: 66 Gy,2Gy/Fr,5Fr/w,6.5wks. Radiation sensitizer (chemotherapy): CDDP-50mg/wk x 6wks. Study Drug (h-R3mAb): 200 mg/wk I.V.60min x 6weeks. Results: Evaluable (n = 76) in Group A-36 and Group B-40. F/u Analysis at 30 months after end of RT. Survival rate ITT: Group B: CT+RT+hR3- 69.5% v/s CT+RT-21.7% (p - 0.0011), Group A: RT alone - 21.7% v/s RT+ hR3–39.1% (ns). Progression-free survival: RT alone - 3(13.04 %) v/s RT+hR3mAb-8 (34.78 %), RT+CT-5 (21.74 %) v/s RT+CT+hR3mAb-13 (56.52%). Median overall survival (OS): CT+RT+hR3 - NR* v/s CT+RT- 21.96 months (hazard ratio [HR]-0.337, p - 0.0018) and RT alone - 25.02 v/s RT+hR3 - NR*(HR-0.678, p - 0.39). Disease-free survival: CT+RT+hR3- NR*v/sCT+RT-21.30 mths (HR-0.344, p - 0.0052) and RT alone-25.02 v/s RT+hR3- NA* (HR-0.599, p - 0.32). (NR*- median OS is yet to be reached). Safety: few grade - 1/2AE, no HAMA observed. OS per protocol - adding h-R3mAb to chemoradiation resulted in a reduction in risk of death (rrd) by 85% (HR 0.15, p - 0.0006) and to RT a 36 % rrd (HR0.64, p - 0.33). Conclusions: Concurrent use of h-R3mAb with RT or RT+CT is safe and efficacious. It enhances radiation and chemotherapy responses. Concurrent use of h-R3mAb with chemoradiotherapy enhances long-term loco-regional control and survival. Adding biological agents to physically targeted modality improves long-term therapeutic outcome of SCCHN. No significant financial relationships to disclose.


2013 ◽  
Vol 57 (5) ◽  
pp. 2199-2203 ◽  
Author(s):  
Andreas H. Diacon ◽  
Rodney Dawson ◽  
Florian Von Groote-Bidlingmaier ◽  
Gregory Symons ◽  
Amour Venter ◽  
...  

ABSTRACTBedaquiline is a new antituberculosis agent targeting ATP synthase. This randomized, double-blinded study enrolling 68 sputum smear-positive pulmonary tuberculosis patients evaluated the 14-day early bactericidal activity of daily doses of 100 mg, 200 mg, 300 mg, and 400 mg bedaquiline, preceded by loading doses of 200 mg, 400 mg, 500 mg, and 700 mg, respectively, on the first treatment day and 100 mg, 300 mg, 400 mg, and 500 mg on the second treatment day. All groups showed activity with a mean (standard deviation) daily fall in log10CFU over 14 days of 0.040 (0.068), 0.056 (0.051), 0.077 (0.064), and 0.104 (0.077) in the 100-mg, 200-mg, 300-mg, and 400-mg groups, respectively. The linear trend for dose was significant (P= 0.001), and activity in the 400-mg dose group was greater than that in the 100-mg group (P= 0.014). All of the bedaquiline groups showed significant bactericidal activity that was continued to the end of the 14-day evaluation period. The finding of a linear trend for dose suggests that the highest dose compatible with safety considerations should be taken forward to longer-term clinical studies.


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Tânia Mara Pinto Dabés Guimarães ◽  
Vicente de Paulo Coelho Peixoto de Toledo ◽  
Mery Natali Abreu ◽  
Nayanne Gama Teixeira Dantas ◽  
Silvana Spíndola de Miranda

This study reports the association between Mycobacterium tuberculosis and the immune response to pulmonary tuberculosis (TB). Three groups were analyzed: (a) symptomatic patients with pulmonary tuberculosis (PTB), HIV-negative; (b) healthy individuals, tuberculin skin test reactive (TST+); (c) asymptomatic individuals, TST nonreactive (TST−). Groups B and C presented a negative bacilloscopic smear, normal chest radiographs, and negative HIV. The ELISA was used for IFN-γ, IL-10, TNF-α, and IgG quantification and lymph proliferative assay (LPA) to evaluate the cellular immune response. IgG and LPA increased in all study groups as well as IFN-γ and TNF-α, but IL-10 remained low in all study groups. There was an association between LPA and IFN-γ in group B. It was demonstrated an association between IgG and IL-10 and between IFN-γ and IL-10 in group A. There were direct and significant correlations between LPA and IgG, TNF-α and IFN-γ, IL-10 and IgG, and between IL-10 and IFN-γ, but an inverse relationship was observed between IFN-γ and LPA.


Author(s):  
Xin-Yu Li ◽  
Cong-Hui Li ◽  
Ji-Wei Wang ◽  
Jian-Feng Liu ◽  
Hui Li ◽  
...  

Abstract Purpose The purpose of the study was to investigate the safety and efficacy of endovascular embolization of ruptured intracranial aneurysms within 72 hours of subarachnoid hemorrhage (SAH). Materials and methods Patients with intracranial aneurysms treated with embolization were divided into group A (n = 277), patients with ruptured aneurysms treated within 72 hours of SAH; group B (n = 138), patients with ruptured aneurysms treated beyond 72 hours; and group C (n = 93), patients with unruptured aneurysms. Results Embolization was successful in all but four patients (99.2%). The periprocedural complication rate was 36.2% in group B, significantly (p < 0.05) greater than that in group A (24.5%) or group C (11.8%). The rebleeding rate was 9.7% (6/62 patients) in groups A and B after embolization and only 0.3% (1/346 patients) in aneurysms with total or subtotal occlusion. Of these three groups of patients, 69.7% in group A, 58.7% in group B, and 76.3% in group C achieved Glasgow Outcome Scale (GOS) score of 5 or modified Rankin Scale (mRS) score of 0– to 1 at discharge. A significant difference (p < 0.05) existed in the clinical outcome between the three groups. The percentages of patients without deficits (GOS 5 or mRS 0–1) and slight disability (mRS 2) were 80.2% in group A, 81.2% in group B, and 96.7% in group C. The mortality rate was 4.3% (12/277 patients) in group A and 7.2% (10/138 patients) in group B with no significant (p = 0.21) difference. Follow-up was performed at 3 to 54 months (mean 23.2), and the recanalization rate was 28.6% (32/112 patients) in group A, 22.4% (11/49 patients) in group B, and 28.6% (16/56 patients) in group C, with no significant differences (p = 0.15). Hydrocephalus occurred in 30.5% (39/128 patients) in group B, which was significantly (p < 0.01) greater than that in group A (9.4%) or group C (2.2%). Conclusion Early embolization of ruptured cerebral aneurysms within 72 hours of rupture is safe and effective and can significantly decrease periprocedural complications compared with management beyond 72 hours. Timely management of cisternal and ventricular blood can reduce hydrocephalus incidence and improve prognosis.


2021 ◽  
Vol 8 (4) ◽  
pp. 541-547
Author(s):  
Shilpa Chaudhari ◽  
Aparajita Mishra ◽  
Kishor Hol ◽  
Shraddha Shastri

Currently preterm labour is one of the most challenging problem faced by both obstetricians and perinatologists, this episode in the course of woman’s pregnancy takes a heavy tool for perinatal mortality which accounts for approximately 50-75%. The incidence of preterm labour is estimated to be 5-10% of all pregnancies. It was a prospective randomize control study. All the cases with inclusion and exclusion criteria were selected during the study period. The subjects were randomized into two groups with group A received vaginal micronized progesteron and group B intramuscular 17a hydroxyprogesteron caproate. Total of 100 cases were included in this study. All preterm pregnancy of more than 20 weeks were considered in this study. Initial nefidipine 10 mg, 4 tablets 15 min apart was given for tocolytic activity for 48 hours. Injection bethamethasone 12 mg I.M 2 doses in a duration of 24 hours apart is given for fetal lung maturity. One group will receive weekly intramuscular 17a hydroxyprogesteron (250 mg) injection while other group will receive daily micronized vaginal progesteron suppository (200mg). Subsequently compare the safety and efficacy of intramuscular progesterone versus micronized progesterone as a maintenance therapy in preventing preterm labour and analyse maternal and fetal factors.Subsequently compared the safety and efficacy of intramuscular progesterone versus micronized progesterone as a maintenance therapy in preventing preterm labour.This analysis showed that women who randomized to progesterone prophylaxis had a significantly increase in duration of pregnancy. The mean ± SD of birthweight in Group A and Group B was 2784.2 ± 490.7 gm and 2813.9 ± 363.3 gm respectively which confirmed the positive effects of progesterone on increasing infants’ weights at birth. Authors concluded that progesterone therapy had acceptable efficacy in the prevention of preterm labor in terms of prolongation of delivery and by increasing gestational age at delivery.


2016 ◽  
Vol 8 (1) ◽  
pp. 9
Author(s):  
Parveen Fatima ◽  
Nurjahan Begum ◽  
Shakeela Lshrat ◽  
Jesmin Banu ◽  
Shaheen Ara Anwary ◽  
...  

<p><strong>Background:</strong> Inferile males have been shown to have lower levels of seminal plasma zinc which have been associated with reduced levels of zinc in their blood. Supplementation improve semen parameters by improving zinc level in blood. </p><p><strong>Objective:</strong> To fnd out whether zinc supplementation is effective in improving semen parameters in oligo­asthenozoospermic patients.</p><p><strong>Method:</strong> The study was carried out in the Infertility unit of the Dept of Obs &amp; Gynae, BSMMU during the period of March 2011 to February 2012. Seventy five oligo-asthenozoospermic patients having no history of medical treatment were recruited for the study. The patients were divided into two groups by odd and even numbers. Odd numbers received tablet zinc 20 mg twice daily (Group A) and even numbers received placebo (Group B).Serum zinc level and seminal zinc level estimation were done by Graphite Furnace Atomic Absorption Spectropho­tometry and semen analysis was done according to WHO guidelines (1999). Data analysis was done using software SPSS (version 16) by applying ANOVA (PostHock) and Paired Student's 't' test.</p><p><strong>Results:</strong> Serum zinc level was low in oligo­zoospermic patients which showed significant improvement with zinc supplementation (A+ 197.83 mmol/1, P&lt;0.01). Mean (±SD) seminal plasma zinc level showed significant improvement in group A following zinc supplementation (+942.39 mmol/L, P&lt;0.001). The mean increase in sperm count, sperm motility, sperm rapid linear motility, sperm morphology in group A following zinc supplementation for 12 weeks was 14.83 million/ml (P&lt;0.01), 16.30% (P&lt;0.01), 11.96% (P&lt;0.01), 4.26% (P&lt;0.001) respectively, which was statistically significant.</p><p><strong>Conclusion:</strong> The study shows zinc deficiency affects sperm count, sperm motility, rapid linear motility and sperm morphology and with zinc supplementa­tion there can be significant improvement in semen parameters.</p>


2021 ◽  
Vol 9 (1) ◽  
pp. e001787
Author(s):  
Kohjiro Ueki ◽  
Yukio Tanizawa ◽  
Jiro Nakamura ◽  
Yuichiro Yamada ◽  
Nobuya Inagaki ◽  
...  

IntroductionGiven an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin.Research design and methodsWe registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin.ResultsOf the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups.ConclusionsAlogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting.


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