OBJECTIVE: The aim of this study was to assess the effectiveness and tolerability of scalp cooling among breast cancer patients in our study population.
METHODS: Consecutive breast cancer patients receiving FE75C, FE100C, FE100C-D, docetaxel75 or docetaxel, and cyclophosphamide (TC) at our treatment center were recruited and allocated to the treatment (scalp cooling, DigniCapTM system) or control group in this prospective nonrandomized controlled study. The assessment of alopecia was carried out using the World Health Organization grading system and clinical photographs.
RESULTS: Seventy patients were recruited, but only 25 completed the study and were evaluable for analysis. Five of 12 patients (42%) in the scalp cooling group managed to preserve hair. Two of three patients who received FE75C and TC regimens had minimal hair loss. All patients treated with FE100C had severe hair loss. Half of all patients who received scalp cooling throughout chemotherapy rated the treatment as reasonably well tolerated. The most common reason for discontinuing scalp cooling was intolerance to its side effects.
CONCLUSION: Scalp cooling is potentially effective in reducing CIA caused by docetaxel, TC, and FE75C chemotherapy regimen. However, it was not well tolerated by our study population. The dropout rate was high, and this needs to be taken into consideration when pursuing further trials in a similar setting.
CLINICAL CASE: A 56-year-old Chinese woman, an active smoker, presented with a hearing deficit, persistent tinnitus and nasal congestion. Examination and investigations revealed the presence of a mass in the nasopharynx. Tissue biopsy revealed nasopharyngeal carcinoma. However, the Epstein-Barr virus was not tested. She was counseled for chemotherapy, but refused and was subsequently lost to follow up. She presented one year later with right eye ptosis associated with progressive worsening of diplopia and blurring of vision. Examination revealed multiple (second, third, fourth and sixth) cranial nerve involvement. Systemic examination and investigations revealed cervical lymphadenopathy and liver metastasis. Repeated imaging showed that the mass had invaded the base of the skull, cavernous sinus and orbital apices. Pulse dosing of corticosteroid therapy was commenced, resulting in dramatic improvement of vision.
CONCLUSION: Optic neuropathy may be the presenting sign of NPC. Corticosteroid therapy can offer immediate visual improvement.
METHODS: Surgical samples from seven patients with a total of 17 sequential biopsies were retrieved for the study of p53 gene expression using immunohistochemical stain, and gene status by PCR-SSCP for exons 5-8. The tumours were graded according to the WHO classification criteria. P53 was distinctly over-expressed in five transformed higher grade biopsies, and all except one showed electrophoretic mobility shift in PCR-SSCP analysis. Sequencing analysis revealed single nucleotide substitutions in three of four of these high-grade transformed cases with band shift (75%), whereas some other studies reported a lower frequency of 25-30%, and mobility shift result was found to correlate with P53 expression. Lower grade tumours without P53 over-expression did not demonstrate band shift, and sequencing analysis did not reveal mutations.
CONCLUSIONS: We demonstrated the feasibility of adopting PCR-SSCP for screening of p53 mutations in archival tissue samples in this study, and there is a strong correlation of p53 gene over-expression and mutation events in high-grade transformed tumours.
Patients and methods: This was a prospective study conducted in Hospital Pulau Pinang, Malaysia, between March 2015 and June 2015. Educational intervention was provided to 96 patients (11 males, 85 females; mean age 52.4±12.9 years; range, 20 to 83 years) who fulfilled the inclusion/exclusion criteria. Questionnaires to assess knowledge of CVD risk were given to patients to be answered before reading the informative leaflet, after one hour of intervention, and during their next follow-up three months from the intervention. Both the informative leaflet and questionnaires were prepared in English and then translated into Malay and Chinese languages to suit the need of local patients.
Results: Our results showed that RA patients had good knowledge at baseline regarding risk of smoking, hypertension, and hyperlipidemia on increasing CVD risk and that exercise would not damage their joints. However, they had low knowledge at baseline regarding the amount of exercise needed for lower CVD risks and risk of CVD with use of anti-inflammatory drugs in RA. Total knowledge score increased significantly from baseline immediately after educational intervention. However, total knowledge score decreased after three months compared to immediate post- intervention phase while it was still significantly higher compared to baseline. The improvement was most obvious for knowledge regarding anti- inflammatory drugs and CVD risk and knowledge regarding the number of flares and CVD risk. Our study did not find any significant association between demographic characteristics and traditional cardiovascular risk factors with knowledge of CVD risk.
Conclusion: Rheumatoid arthritis patients have low knowledge regarding their CVD risk related to their disease. The intervention of providing an informative leaflet effectively improved the knowledge of this group of patients on CVD risk particularly in the field related to RA-specific risk.
MATERIALS AND METHODS: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient's condition by patient and physician) over a period of 24 weeks.
RESULTS: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study.
DISCUSSION: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.
OBJECTIVE: We aimed to compare the efficacy and safety of 1.8% SPHNSI and 0.9% commercial isotonic nasal saline irrigation (0.9% CINSI) in patients with AR.
METHODS: A randomised, single-blinded, placebo-controlled trial was performed as a pilot study. Seventy-eight patients with AR were included. Each patient was randomised to nasal irrigation with 80 mL of either 1.8% SPHNSI or 0.9% CINSI twice-daily for 4 weeks. Randomised codes were generated using a computer and a block of 4 procedure. The primary outcome was improvement of quality of life scores in Thai patients with allergic rhinoconjunctivitis (Rcq-36). Secondary outcomes were clinical symptoms using total nasal symptom scores (TNSS) and adverse events. All outcomes were assessed by blinded assessors at baseline, week 2, and week 4.
RESULTS: At week 4, nasal irrigation with 1.8% SPHNSI had significantly improved the Rcq-36 score (54% versus 50%; p < 0.032) and congestion symptom score (96% versus 84%; p < 0.018) compared to nasal irrigation with 0.9% CINSI. Adverse events were comparable for both groups at week 4.
CONCLUSIONS: This pilot study indicates that regular use of 1.8% SPHNSI in AR patients for 4 weeks is safe and has superior efficacy to 0.9% CINSI for alleviating congestion and improving quality of life scores.