Objective: In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826. Methods: Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator’s discretion. PFS and OS were dual primary endpoints. Results: Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23−0.77); median OS was not reached and 20.4 months, respectively (HR=0.53;95% CI=0.28−0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19−0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22−0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%). Conclusion These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.

Background: The U.S. Food and Drug Administration has prohibited epidural steroid injection (ESI) with particulate steroids. Thus, this study aimed to compare the efficacy and safety of ESI with two nonparticulate steroids, dexamethasone and betamethasone. Methods: The eligible patients (n = 600) who received ESI (0 week) with dexamethasone (ESI-dexa) or betamethasone (ESI-beta) had follow-up visits at 2, 4, and 8 weeks with a phone interview at 12 weeks. The primary endpoint was the proportion of effective responders without pain or who were much improved at 2 weeks. The secondary endpoints were the proportion of crossover injections at 2 weeks; changes in the visual analog scale (VAS) and disability index scores at 2, 4, and 8 weeks; the number of additional ESIs in 12 weeks; the number of participants having spinal surgery, as well as the incidence of adverse events over the 12 weeks. Results: The proportion of effective responders at 2 weeks was not different between ESI-beta (72/216, 33.3%) and ESI-dexa (63/200, 31.5%; P = 0.670). Adverse events were more common with ESI-dexa (40/200, 20.0%) than with ESI-beta (24/216, 11.1%; P = 0.012). VAS scores decreased more with ESI-beta than with ESI-dexa at 2 weeks (difference, 0.35; P = 0.023) and 4 weeks (difference, 0.42; P = 0.011). The disability score improved significantly more with ESI-beta compared with ESI-dexa at 2 weeks (difference, 3.37; P = 0.009), 4 weeks (difference, 4.01; P = 0.002), and 8 weeks (difference, 3.54; P = 0.007). Conclusions Betamethasone would be more appropriate for ESI.

Objective: To assess the incremental prognostic value of coronary computed tomography angiography (CCTA) in comparison toa clinical risk model (Framingham risk score, FRS) and coronary artery calcium score (CACS) for future cardiac events in ischemicstroke patients without chest pain. Materials and Methods: This retrospective study included 1418 patients with acute stroke who had no previous cardiac diseaseand underwent CCTA, including CACS. Stenosis degree and plaque types (high-risk, non-calcified, mixed, or calcified plaques) wereassessed as CCTA variables. High-risk plaque was defined when at least two of the following characteristics were observed:low-density plaque, positive remodeling, spotty calcification, or napkin-ring sign. We compared the incremental prognosticvalue of CCTA for major adverse cardiovascular events (MACE) over CACS and FRS. Results: The prevalence of any plaque and obstructive coronary artery disease (CAD) (stenosis ≥ 50%) were 70.7% and 30.2%,respectively. During the median follow-up period of 48 months, 108 patients (7.6%) experienced MACE. Increasing FRS, CACS,and stenosis degree were positively associated with MACE (all p< 0.05). Patients with high-risk plaque type showed the highestincidence of MACE, followed by non-calcified, mixed, and calcified plaque, respectively (log-rank p< 0.001). Among theprediction models for MACE, adding stenosis degree to FRS showed better discrimination and risk reclassification compared toFRS or the FRS + CACS model (all p< 0.05). Furthermore, incorporating plaque type in the prediction model significantly improvedreclassification (integrated discrimination improvement, 0.08; p= 0.023) and showed the highest discrimination index(C-statistics, 0.85). However, the addition of CACS on CCTA with FRS did not add to the prediction ability for MACE (p> 0.05). Conclusion Assessment of stenosis degree and plaque type using CCTA provided additional prognostic value over CACS andFRS to risk stratify stroke patients without prior history of CAD better.

OBJECTIVE: To evaluate the incidence, types and association of systemic reactions after an epidural steroid injection (ESI) with patient demographics, ESI factors and repeated occurrence of an ESI. MATERIALS AND METHODS: This prospective observational study was approved by the Institutional Review Board of our hospital, and written informed consent was obtained from all the participants. From October to December 2011, systemic reactions at 2 weeks after 960 ESIs among 885 patients were measured. Patients were evaluated by phone interviews to obtain the patients' demographics, history of previous ESI, ESI factors, and ESI reoccurrence. Statistical analyses were performed using the chi-square tests, Fisher's exact tests and a binary logistic regression analysis. RESULTS: Overall, 557 types of systemic reactions occurred after 292 injections (30.4%) of a total of 960 ESIs in which facial flushing was most common (131/557, 23.5%) and 144 ESIs were followed by a mixed form of systemic reactions (49.3%). Age of 62 years or younger (odds ratio [OR], 2.361), female sex (OR, 1.674), and history of diabetes mellitus (OR, 1.681) were significant risk factors in the occurrence of systemic reactions after an ESI. In 73 patients with repeated ESI, 14 patients re-experienced systemic reactions (19.2%), of which twelve re-experienced the same systemic reaction as the previous one. CONCLUSION: Systemic reactions followed about 30% of ESIs, and more commonly occurred in patients 62 years of age or younger, women, and diabetic patients. Half of the patients experienced a mixed form of systemic reactions. Patients with recurring systemic reactions tend to re-experience the same systemic reaction as the prior one after an ESI.
Chronic Pain ; Demography ; Diabetes Mellitus ; Ethics Committees, Research ; Female ; Flushing ; Humans ; Incidence* ; Informed Consent ; Logistic Models ; Observational Study* ; Prospective Studies* ; Risk Factors ; Spine

Although both medical and surgical approaches have been investigated, recurrent symblepharon due to chronic ocular surface inflammation is a difficult disease to manage.This condition can also result in many complications such as cosmetic and visual deteriorations.In this condition, we can use the amniotic membrane transplantation that has a biological contact inhibition effect for the prevention of recurrent symblepharon. We treated successfully a case of a progressive symblepharon involving central cornea from 2-year old. The 14 year-old male patient had suffered from serious cosmetic problem and undergone multiple dissection, argon laser photocoagulation, using cyclosporin eyedrops. He was treated using allograft amniotic membrane, autograft limbal-conjunctiva, and buccal mucosa transplantation. we think that amniotic membrane transplantation was very effective method for the prevention of recurrent symblepharon.
Adolescent ; Allografts ; Amnion* ; Argon ; Autografts* ; Child, Preschool ; Contact Inhibition ; Cornea ; Cyclosporine ; Humans ; Inflammation ; Light Coagulation ; Male ; Mouth Mucosa ; Ophthalmic Solutions

BACKGROUND AND OBJECTIVES: Snoring generated at the level of the velopharynx is usually treated with laser-assisted uvulopalatoplasty (LAUP), which is mostly performed under local anesthesia and on an out-patient basis. However, if adequate sedation is not achieved during this procedure, patients may suffer from anxiety, disgusting smell of tissue vaporization, and doctors may even be disturbed by the patients gagging or repetitive swallowing. A relatively new sedative drug, midazolam, is known for its improved safety, effectiveness, more rapid onset of action and shorter life in comparison to the classical sedative agent, diazepam. The authors tried to evaluate the efficacy and safety of intravenous midazolam as a sedative premedication for LAUP surgery. MATERIALS AND METHODS: Thirty-two patients designated for LAUP were divided into three groups by random double-blinded sampling. Each group received an intravenous injection of midazolam (0.05 mg/kg), diazepam (0.1 mg/kg), and normal saline (0.01 ml/kg) 5 minutes before the laser procedure. Vital signs were monitored before, during and after the procedure. Questionnaires about the effectiveness were given to the operator and the patients, and the scores of the three groups were compared statistically. RESULTS: Vital signs were stable in all three groups throughout the entire procedure. Midazolam showed better sedative effect than placebo and diazepam. It also showed stronger analgesic and anti-anxiety, and more potent antegrade amnesic effects than placebo. CONCLUSION: Intravenous injection of midazolam is one of the effective and safe ways of premedication for patients receiving LAUP.
Anesthesia, Local ; Anxiety ; Deglutition ; Diazepam ; Gagging ; Humans ; Hypnotics and Sedatives ; Injections, Intravenous ; Midazolam* ; Outpatients ; Premedication* ; Surveys and Questionnaires ; Smell ; Snoring ; Vital Signs ; Volatilization

We examined two different corneal preservatives, Optisol and Likorol which contain different concentrations of chondroitin sulfate and evaluated their ability to maintain cellular viability and corneal deturgescence. The corneal thickness(12 days storage, at 4degrees C) and endothelial cell cytotoxicity(24, 48, 72, and 120 hours incubation at 35.5degrees C) were measured in 8 paired human corneas. Corneas stored in Optisol were thinner than Likorol-stored corneas throughout the examination period. Alkaline Phosphatase activity and [3H]-Thymidine incorporation showed increased mitotic activity in endothelial cells cultured in Optisol when compared with Likorol-cultured cells. These results suggest that Optisol provides better maintenance of corneal deturgescence and increased corneal endothelial viability with prolonged storage time.
Alkaline Phosphatase ; Chondroitin Sulfates ; Cornea ; Endothelial Cells ; Humans

The diagnostic value of the DNA polymerase chain reaction for the detection of M. tuberculosis in tuberculous meningitis uas established by using cerebrospinal fluids obtained from 7 bacteriologically confirmed patients (Group IA), 17 clinically diagnosed patients (Group IB), 21 patients with other bacterial or viral meningitis (Group IIA) and two norrnal persons (Group IIB) The PCR was perforrned with P1 and P2 primer set which directed against the 123bp segment of IS5110. A repetitive sequence of M. tuberculosis chromosome. The sensitivity and specificity of the PCR for the detection of M. tuberculosis was evaluated by using DNAs purified from cultured M tuberculosis and M intracellulare . The detection limit by the PCR amplication with Pl and P2 primer was lfg of DNA for M. tuberculosis and lpg for M. intracellulare indicating that the PCR was very sensitive for M. tubererculosis DNA detection; although weakly cross-reactive with DNA of M. tuberculosis. Of the 7 cerebrospinnal fluids from bacterologically proven tuberculous meningitis patients (Group IA), 7 samples were all positive by PCR (10Q%). 15 sarnples of 17 the AFB smear-negative and culture-negative samples from tuberculous meningitis patients (Group IB) were positive by PCR (88.2%) and 2 of 2l sanples from other meningitis patients (Group IIA) showed positive reaction (9.5%). There were no sarnples whick showed positive reaction by PCR among 2 sarnples from normal persons (Group IIB). This results indicated that the PCR using P1 and P2 primer set was useful for the early diagosis of tuberculous meningitis.
Cerebrospinal Fluid ; DNA ; Humans ; Limit of Detection ; Meningitis ; Meningitis, Viral ; Penicillin G Benzathine ; Polymerase Chain Reaction* ; Repetitive Sequences, Nucleic Acid ; Sensitivity and Specificity* ; Tuberculosis ; Tuberculosis, Meningeal*