HPLC-MS/MS method for determination of betamethasone in human plasma with application to a dichorionic twin pregnancy pharmacokinetic and placental transfers studies

Abstract Betamethasone (BET) is a synthetic glucocorticoid recommended for pregnant women at imminent risk of preterm birth before 34 weeks to reduce neonatal complications. There are different techniques to describe BET plasma quantification. However, none quantified the plasmatic concentration of BET in dichorionic (DC) twin pregnancies using LC-MS. Our objectives were to develop and validate a method for quantifying BET by LC-MS for pharmacokinetic (PK) and placental transfer studies in DC twin pregnancies. Blood samples were collected after intramuscular administration of a single BET dose containing 6 mg disodium phosphate + 6 mg acetate. BET was determined in plasma by liquid-liquid extraction. The method showed linearity in the range of 2-250 ng/mL, as well as precision and accuracy with a coefficient of variation and relative standard errors ≤ 15%. Additionally, the method presented selectivity and did not present matrix or carry-over effect. Stability tests also presented coefficient of variation and relative standard errors ≤ 15%. This is the first study which describe maternal and fetal plasma concentrations of BET in a DC twin pregnancy. The BET PK parameters were AUC0-∞, CL/F, Vd/F, Cmax, Tmax of 292.20 h*ng/mL, 39.08 L/h, 278.72 L, 25.55 ng/mL and 0.58 h, respectively. The placental transfer ratios of umbilical vein/maternal vein and intervillous space/maternal vein were 0.14 and 0.19 and 0.40 and 0.27 for both twins, respectively. However, a clinical study with more subjects is imperative to confirm this higher concentration of BET in the intervillous space

Use of Corticosteroids in Prenatal Treatment of Congenital Pulmonary Adenomatoid Malformation: Integrative Review / Uso de corticosteroides no tratamento pré-natal da malformação adenomatoide pulmonar congênita: Revisão integrativa

Abstract Objective To review data on the use of corticosteroids for the treatment of fetuses with high-risk congenital pulmonary adenomatoid malformation (CPAM). Methods Integrative review based on the literature available onMEDLINE and LILACS, including articles published until November, 2020. Results The initial search resulted in 87 articles, 4 of which were selected for analysis, with all of them being retrospective descriptive observational studies. In the group of fetuses that received only a single corticosteroid cycle, the hydrops resolution rate was 70%, and the survival rate was 83.8%. In fetuses treated with 2 or more cycles of corticosteroids, there was an improvement in the condition of hydrops or edema in a single body compartment in 47%, and survival of 81.8% of the fetuses. Conclusion The use of corticosteroids for the prenatal treatment of high-risk CPAM appears to be associated with an improvement in perinatal outcomes.

Resumo Objetivo Revisar os dados sobre o uso de corticoide no tratamento de fetos com malformação adenomatoide pulmonar congênita (MAPC) de alto risco. Métodos Revisão integrativa com base na literatura disponível no MEDLINE e LILACS, incluindo artigos publicados até novembro de 2020. Resultados A busca inicial resultou em 87 artigos, dos quais 4 foram selecionados para análise, todos tratando-se de estudos observacionais descritivos retrospectivos. No grupo de fetos que recebeu apenas um único ciclo de corticosteroide, a taxa de resolução da hidropsia foi de 70% e a taxa de sobrevida de 83,8%. Emfetos tratados com 2 ou mais ciclos de corticosteroides, houve melhora do quadro de hidropsia ou edema em um único compartimento corporal em 47% dos fetos e taxa de sobrevida de 81,8%. Conclusão O uso de corticosteroides para o tratamento pré-natal da MAPC de alto risco parece estar associado à melhora dos resultados perinatais.

A comparative physicochemical and pharmacological evaluation of dexamethasone sodium phosphate and betamethasone sodium phosphate mucoadhesive gels for the treatment of oral submucous fibrosis in rats

Abstract The present study is aimed to formulate steroidal oral mucoadhesive gels of dexamethasone sodium phosphate and betamethasone sodium phosphate. Six gel formulations each of dexamethasone sodium phosphate and betamethasone sodium phosphate prepared using two different polymers carboxymethyl cellulose sodium and hydroxypropyl methylcellulose, in variable proportions. All the formulations subjected for assessment of various physicochemical parameters and mechanical properties. The formulations BSP5 and DSP5, both containing 1.25 % carboxymethyl cellulose sodium, 1.25 % hydroxypropyl methylcellulose, exhibiting mucoadhesive strength of 12.300 ± 0.004 and 12.600 ± 0.01, adhesiveness of 28.04 ± 00 and 30.02 ± 00, cohesiveness of 28.04 ± 00 and 30.02 ± 00, drug release of 86.869 ± 0.380 % and 88.473 ± 0.457 % respectively were considered as promising ones and were further subjected for stability studies and in vivo study in male albino rats. Formulation DSP5 upon oral application for 4 months in arecoline induced oral submucous fibrosis rats, showed more than 80 % reduction in fibrosis as compared with BSP5 which showed nearly 50 % reduction. These results were concluded on the basis of histopathological profile and weight gain among the experimental animals during in vivo study. Hence, DSP5 by minimizing the painful injuries and morbidities justifies being suitable noninvasive model for OSMF treatment.

Clinical effects of nanoneedle injection of compound betamethasone combined with 308 nm excimer laser on patients with stable vitiligo / 中华医学美学美容杂志

Objective:To evaluate the efficacy for nanoscale microneedle injection of compound betamethasone combined with 308 nm excimer laser in the treatment of stable vitiligo patients.Methods:A total of 80 patients with stable vitiligo were enrolled in Guangzhou Dermatology Hospital from May 2018 to May 2020. There were 40 patients (21 males and 19 females) in control group, aged 17-65 (32.4±1.7) years, and 40 patients (20 males and 20 females) in observation group, aged 18-67 (28.7±1.8) years. The control group was treated with compound betamethasone injection packet combined with 308 nm excimer laser. The observation group was treated with nanoneedle injection of compound betamethasone combined with 308 nm excimer laser. We compared the clinical efficacy and incidence of adverse reactions between the two groups.Results:Comparison of clinical efficacy showed that after 3 months of treatment, the total effective rates of the observation group and the control group were 80.00% and 67.50%, respectively, with significant difference (χ 2=4.560, P<0.05). After 3 months of treatment, the white spot area of the control group was (9.89±1.65) cm 2, which was significantly higher than that of the observation group (7.83±1.78) cm 2 ( t=5.370, P<0.05). Conclusions:The nanoneedle injection of compound betamethasone combined with 308 nm excimer laser in the treatment of stable vitiligo is effective and safe.

Efficacy and safety of two prolonged therapeutic regimens in patients with plaque psoriasis after treatment with tazarotene/betamethasone dipropionate cream: a multicenter clinical observation / 中华皮肤科杂志

Objective:To explore the prolonged therapeutic regimen for patients with plaque psoriasis, who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream, but were not completely cured.Methods:A multicenter, randomized, open-labelled, parallel-controlled clinical study was conducted. A total of 232 patients with plaque psoriasis were collected, who showed a positive response to previous 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured with the psoriasis area and severity index[PASI] improvement rate being 50%-90%. At week 5, they were randomly and equally divided into 2 groups: test group receiving treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream once a day, and control group receiving a sequential regimen of 0.05% tazarotene gel on weekdays once a day followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream on weekends once a day. After 2-and 4-week prolonged treatment, the efficacy and safety of the 2 therapeutic regimens were evaluated and compared. Measurement data were compared between 2 groups by using covariance analysis or t test, and enumeration data were compared by using chi-square test. Results:From the 5th to the 8th week, 200 out of the 232 patients completed the treatment. Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set, and those from both 113 patients in the test group and control group were enrolled into safety analysis set. After consecutive 6-and 8-week treatment, the decline rates of the PASI score were 73.05% ± 16.69% and 78.46% ± 15.40% respectively in the test group, which were significantly higher than those in the control group (66.73% ± 21.77%, 67.02% ± 34.19%, respectively, both P < 0.05) . After 6-week treatment, the proportion of subjects who achieved PASI90 was significantly higher in the test group (14 cases, 12.7%) than in the control group (5 cases, 4.5%, χ2=4.842, P=0.028) ; After 8-week treatment, the proportions of subjects who achieved PASI75 and PASI90 (61.8%, 23.6%, respectively) were significantly higher in the test group than in the control group (48.2%, 12.5%, respectively, both P < 0.05) . During the consecutive 8-week treatment, there was no significant difference in the incidence rate of adverse reactions between the test group (15.0%) and control group (23.9%, χ2=2.822, P=0.093) . Conclusion:For patients who showed a positive response to 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured, the continuous use of 0.05%/0.05% tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05% tazarotene gel followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream.

Feasibility study on local infiltration anesthesia for postoperative analgesia in patients with hallux valgus / 中国骨伤

OBJECTIVE@#To evaluate the clinical efficacy of local infiltration anesthesia of ropivacaine combined with compound betamethasone for postoperative analgesia in patients with hallux valgus.@*METHODS@#From September 2019 to December 2020, 48 patients with hallux valgus were treated surgically. According to different postoperative analgesia methods, the patients were divided into combined local infiltration group and intravenous analgesia pump group. There were 24 cases, in the combined local infiltration group including 2 males and 22 females;the age ranged from 21 to 78 years old, with an average of (58.3±7.7) years old;soft tissue release and chevron osteotomy were performed in 15 cases and metatarsophalangeal joint fusion in 9 cases;immediately after operation, 20 ml of ropivacaine combined with compound betamethasone mixed diluent was used for local infiltration anesthesia once. There were 24 patients in intravenous analgesia pump group, including 3 males and 21 females;the age ranged from 23 to 81 years old, with an average of(56.8±8.3) years old;soft tissue release and Chevron osteotomy were performed in 17 cases and metatarsophalangeal joint fusion in 7 cases;immediately after operation, intravenous analgesia pump was used for analgesia. The basic flow was 2 ml / h;the self control dose was 0.5 ml;and the locking time was 15 min. Visual analogue scale (VAS) was recorded at 12, 24, 48 and 72 hours after operation;and the VAS was recorded at 24 hours after operation. The occurrence of adverse drug reactions at 0 to 12 hours, 12 to 24 hours and 24 to 48 hours after operation were recorded;and the healing of incision was recorded.@*RESULTS@#All patients were followed up, and the duration ranged from 14 to 17 days, with a mean of (14.60±0.92) days. There was significantdifference in VAS at 12, 24 and 48 hours between the combined local infiltration group and the intravenous analgesia pump group(@*CONCLUSION@#Compared with intravenous analgesia pump group, ropivacaine combined with compound betamethasone can significantly reduce postoperative wound pain without increasing adverse drug reactions, and does not increase wound infection.

Intra-articular injection of compound betamethasone and hyaluronic acid for the treatment of moderate-severe knee osteoarthritis:a randomized controlled trial / 中国骨伤

OBJECTIVE@#To compare clinical effects of compound betamethasone and compound betamethasone with hyaluronic acid in treating moderate-severe knee osteoarthritis (KOA).@*METHODS@#A prospective randomized controlled study was conducted in 116 patients with unilateral moderate-severe KOA patients from February 2017 to November 2017 and divided into observation group and control group, 58 patients in each group. In observation group, there were 15 males and 43 females aged from 45 to 80 years old with an average of (66.45±6.31) years old;according to Kellgren-Lawrence(K-L) classification, 42 patients were type Ⅲ and 16 patients were type Ⅳ;the courses of disease ranged from 4 to 8 years with an average of (5.25±2.21) years;the patients were treated by injecting 1 ml compound betamethasone into knee joint. In control group, there were 13 males and 45 females aged from 45 to 80 years old with an average of (64.89±6.41) years old;according to K-L classification, 43 patients were type Ⅲ and 15 patients were type Ⅳ;the courses of disease ranged from 4 to 10 years with an average of (5.41±2.35) years;the patients were treated by knee joint injection of 4 ml hyaluronic acid and 1 ml compound betamethasone. Visual analog scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC) were used to evaluate clinical effects before treatment and 1 week, 1, month, 3 and 6 months after treatment.@*RESULTS@#Totally 55 patients in observation group were followed up for 6 months, and 3 patients were quit at 3 months after treatment for poor efficacy. Totally 56 patients in control group were followed up for 6 months, and 2 patients were withdrew from the follow-up on the first and third month respectively for poor efficacy. There were no statistical difference in VAS and WOMAC between two groups before treatment and different time points after treatment (@*CONCLUSION@#For patients with moderate-severe KOA, there is no significant difference in therapeutic effect between compound betamethasone injection and compound betamethasone combined with hyaluronic acid injection, and long-term effect of two methods is not good.

Utilidad de la betametasona en la prevención del dolor postoperatorio en cirugía de hernia discal lumbar / Usefulness of betamethasone in the prevention of postoperative pain in lumbar disc herniation

RESUMEN Introducción: el empleo de corticoesteroides es una estrategia eficaz para reducir el dolor postoperatorio. Objetivo: determinar la utilidad de la betametasona en la prevención del dolor postoperatorio en pacientes intervenidos por hernia discal lumbar. Métodos: se realizó un estudio cuasi-experimental en 100 pacientes intervenidos por hernia discal lumbar en el Hospital Universitario Clínico-Quirúrgico «Arnaldo Milián Castro¼, de la provincia de Villa Clara, durante el período de abril de 2013 a diciembre de 2015. Se dividieron en un grupo control y en un grupo estudio; previo a la incisión quirúrgica, se les administró diclofenaco 75 mg endovenoso y 8 mg de betametasona (solo en el grupo estudio). Resultados: el 70 % de los pacientes eran masculinos, y la edad media fue 45,99 años. En el grupo estudio el tiempo de aparición del dolor () y su intensidad, a las 4, 8 y 24 horas, fue significativamente menor que en el grupo control (pα< 0,010, pα< 0,001 y <0,001); el 48 % de los pacientes pudieron levantarse sin dolor, 32 % menos requirieron analgesia de rescate, y el grado de satisfacción fue significativamente mejor. Conclusiones: la administración de betametasona antes de la incisión quirúrgica resultó muy útil en la prevención del dolor postoperatorio en los pacientes intervenidos de hernia discal lumbar.

ABSTRACT Introduction: use of corticosteroids is an effective strategy to reduce postoperative pain. Objective: to determine usefulness of betamethasone in the prevention of postoperative pain in patients operated for lumbar disc herniation. Methods: a quasi-experimental study was carried out in 100 patients operated for lumbar disc herniation at "Arnaldo Milián Castro" Clinico-Surgical University Hospital, in Villa Clara province from April 2013 to December 2015. They were divided into a control group and a study one; prior to surgical incision, intravenous diclofenac 75mg and betamethasone 8mg were administered (only in the study group). Results: 70% of the patients were male, and the mean age was 45.99 years. In the study group, the time of onset of pain () and its intensity, at 4, 8 and 24 hours, was significantly lower than in the control group (pα <0.010, pα <0.001 and <0.001); 48% of the patients were able to get up without pain, 32 % less required rescue analgesia, and the degree of satisfaction was significantly better. Conclusions: administration of betamethasone before surgical incision was very useful in the prevention of postoperative pain in patients operated for lumbar disc herniation.

Effects of antenatal corticosteroids administration on fetoplacental circulation in preterm pregnancies with intrauterine growth restriction and its correlation with perinatal outcome

Background: Antenatal corticosteroid administration in preterm pregnancies is recommended to promote fetal lung maturation. Studies have reported temporary reduction in fetal heart rate, breathing and movements following maternal corticosteroid administration. Authors studied effect of maternal corticosteroid administration on fetoplacental circulation in preterm pregnancies with IUGR and its correlation with perinatal outcome.Methods: Observational study included 77 preterm singleton pregnant women with IUGR. Color doppler day 0 (before betamethasone) of umbilical artery of 77 cases done. All received two doses of 12 mg of betamethasone intramuscularly 24 hours apart. Umbilical artery doppler on day 2 (24 to 48 hours of 1st dose of betamethasone) and day 4 (72 to 96 hours of 1st dose of betamethasone) done. Pulsatility index (PI) of umbilical artery on doppler and Neonatal details of all women noted.Results: On day 2 doppler, 56 (73%) women (Group A) showed decrease in umbilical artery PI while 21 (27%) women (Group B) did not show decrease in umbilical artery PI. Mean umbilical artery PI of 77 cases on day 0 and day 2 were 1.73±0.73 and 1.54±0.76 respectively (p<0.001). Mean Umbilical artery PI values of undelivered 60 cases on day 0, day 2 and day 4 were 1.55±0.61, 1.33±0.55 and 1.47±0.63 respectively (p<0.001). Group B neonates had poorer Apgar scores, higher neonatal complication, longer hospital stay, lesser umbilical pH at birth and higher perinatal mortality rate than Group A neonates.Conclusions: Significant reduction in mean umbilical artery PI observed on day 2 following betamethasone administration (p<0.001), which was maintained till 4th day after 1st dose of betamethasone (p<0.05). Women who showed improvement in umbilical artery pulsatility index following betamethasone administration had a better perinatal outcome as compared to women who did not.

Effects of preoperative doses of betamethasone acetate 0.1% on dry eye control after cataract surgery

Purpose: The aim of the present study was to compare the effects of the preoperative doses of betamethasone acetate 0.1% and placebo on controlling dry eye after cataract surgery. Methods: This randomized triple-blind clinical trial was conducted on 62 patients. For the purpose of the study, the participants were assigned into two groups of betamethasone (n = 28) and placebo (n = 34). The groups were administered with drops A or B three days before the operation, four times a day. These drops contained either betamethasone 0.1% or normal saline (placebo). Postoperative follow-up was performed 1, 7, and 30 days after the surgery. Dry eye symptoms were evaluated by means of the ocular surface disease index (OSDI) using the meniscometry test. Repeated measures analysis was also used to study the effect of the interaction between betamethasone and time on meniscometry and OSDI variables. Results: A total of 62 patients, including 51.6% female and 48.4% male, were investigated in this study with a mean age o 69.19 ± 12.80 years. The results of the analysis of variance of the repeated measures plot indicated that the OSDI and meniscometry dry eye variables were not affected by the interaction between time and betamethasone (P = 0.192 and P = 0.578, respectively). Conclusion: As the findings indicated, the use of betamethasone acetate 0.1% prior to cataract surgery had no significant effect on postoperative dry eye indices.

Intralesional corticosteroid injection as an effective treatment method for oral lesions: a meta-analysis

Intralesional corticosteroid injection (ICSI) is known as one of the main methods used for treating a wide range of lesions. It also results in a high concentration of drugs at lesion sites, with minimal systemic absorption. Thus, this study aimed to provide a review of the intralesional corticosteroid injection (ICSI) indications in the treatment of oral lesions. To this end; relevant key words were searched in the databases of PubMed, Google Scholar, Scopus, ScienceDirect, and UpToDate in the present study. Accordingly, the results of a total number of 62 case reports or case series articles were used in this study and the positive therapeutic effects of intralesional corticosteroid injection (ICSI) in 23 common oral lesions were reported. The most common type of intralesional steroid in the treatment of oral lesions was triamcinolone. No significant difference was also observed in terms of pain in patients following the use of steroid alone or in combination with anesthetic agents; moreover, the reported side effects of this method were exceptionally rare and transient. It was concluded that the intralesional corticosteroid injection (ICSI) could be one of the effective therapeutic methods with no significant problems in many oral lesions such as inflammatory, immunologic, and vascular ones due to its higher therapeutic effects than other topical forms of steroids and fewer side effects than systemic corticosteroid.

The effect of antenatal corticosteroids on maternal glycemic control, in a tertiary care centre in North Kerala - India

Background: Antenatal glucocorticoid therapy (ACT) can be life-saving in preterm babies and risk of PTL is increasing in. The prevalence of GDM also increasing. Virtually, all women will experience deterioration in their glycaemic control following ACT. The NICE guideline recommends additional insulin and the national Indian guidelines recommend a 20% increase. Objective of this study was to evaluate the changes in maternal serum glucose following corticosteroids in antenatal women.Methods: Prospective controlled trial of 206 patients, divided into 2 groups. Group 1:105 patients with no GDM and Group 2: 101 patients with GDM. Ethical committee approved. FBS and PPBS measured for following 5 days of D1. BMI and starting dose of insulin and dose of insulin hike were recorded. FBS >90 mg/dL and PPBS >120 mg/dL were taken as abnormal. Data were analyzed using SPSSV22.Results: There were a total of 206 of which 105 were in group 1(51%) and 101(49%) were in Group 2. FBS >90 mg/dL in over 65% of all women on D2 10 new cases on D3 and PPBS >120 mg/dL in over 66% of all women on D2 and 13 new cases on D3. Insulin was started in a total of 66 patients of 105 (62.9%) in Group 1 and 33 out of 40 (82.5%) in GDM on MNT. Of the 66 patients who started on insulin in Group 1, 17 (16.2%) patients had to continue insulin and out of 33. In MNT subgroup 10 (25%) had to continue. BMI was high in the patients, who was given and continued insulin.Conclusions: The findings support the concept of increasing the dose of insulin even before the hyperglycemia documented. In the Group 1 66 of 105 patients were started on insulin due to hyperglycemia and 17 had to continue insulin 25.7%), and 33 of 40 patients in GDM on MNT were started on insulin and 10 (30.33%) had to continue. We suggest testing all patients for hyperglycemia and to start  insulin especially in the those with high BMI (>25 as per the Asian Indian).

Study of changes in non-stress test following antenatal corticosteroid therapy in preterm pregnancy

Background: Preterm birth is the largest unsolved problem in obstetrics and the single most significant cause of neonatal morbidity and mortality. Preterm labour constitutes 5-10% of pregnancies and is the leading cause of neonatal morbidity and mortality worldwide. It is a major public health problem in terms of loss of life, long term disability (cerebral palsy, blindness, deafness, chronic lung disease). The objectives of this study were to determine whether antenatal corticosteroid administration affects the non-stress test. To evaluate the effect of antenatal steroid on foetal movements. To assess the incidence of respiratory distress syndrome and neonatal mortality after antenatal corticosteroid administration.Methods: All antenatal cases between 28-32 weeks of gestation judged to be at risk for preterm delivery attending the outpatient department or admitted in a tertiary care hospital, Tamil Nadu during the study period of 3 years.Results: The present study was undertaken to evaluate the NST for a period of 3 days following antenatal corticosteroid administration and to study the immediate changes in the mother and the foetus. We found out that there was a statistically significant change (p <0.01) in non-stress test when compared with the pre-betamethasone assay.Conclusions: Corticosteroids can cause metabolic alterations in mother, short- and long-term effect in the foetus.

A Comparative Study of Laryngeal Mask Airway Lubrication with Lignocaine 2% V/S Beclamethasone 005% Cream

Postoperative sore throat (POST) is a minor complication after general anaesthesia. Many agents have been used as lubricant to reduce the incidence of POST with variable efficacy. Methods: We conducted a study to compare the incidence of POST with 0.05% betamethasone gel and 2% lignocaine jelly as a lubricant for LMA insertion in patients undergoing general anaesthesia. Sixty subjects were divided randomly into two groups. Patients in Group B (n = 30) had 2.5 ml of 0.05% of betamethasone gel while the Group L had 2.5 ml of 2% lignocaine jelly applied on the cuff of LMA. After standard induction and insertion of LMA cuff inflated to 60 cm of H2O and was maintained at the same throughout the surgery. Results: In PACU, patients were inquired about sore throat at immediate and 24 h post operative period. POST was not observed in any of the patients of Group B. In group L 13% of the patients had 1st degree and 3% had 2nd degree of sore-throat in immediate post-operative period. After 24 h 3%patients had 1st degree sore-throat and 1% patients had 2nd degree of sore-throat in Group L patients. Conclusion: We conclude that lubricating cuff of LMA with 0.05% of betamethasone gel is effective in reducing the incidence of POST.

Evaluation of corticosteroid use in outpatient department of dermatology of a tertiary care teaching hospital: a prospective observational study

Background: Corticosteroids are widely prescribed drugs in dermatology. Rational prescribing of steroids is important for best therapeutic outcome at lowest possible dose. A study was carried out at a tertiary care teaching hospital in order to evaluate the use of corticosteroids which provided a picture of trends in the usage of corticosteroids in dermatology at that set-up. Materials and Methods: This prospective, observational study was carried out in department of dermatology for 1 year after ethical approval. Data was analysed for parameters related to corticosteroids, their potency, WHO drug prescribing indicators, effectiveness as well as effects of corticosteroids on quality of life of patients. Statistical analysis was done using Microsoft Excel Office 365. Results: In the 223 patients, 44.84% patients belonged to 21-40 years age group. Mostcommon indication was eczema in 29.15% cases. Topical betamethasone (25.11%) and oral prednisolone (20.17%) were most frequently prescribed. 95/140 topical steroids prescribed were super highly potent. Among concomitant drugs, a majority of 38% were antihistaminics. Degree of polypharmacy showed 04 drugs in a majority (43.15%) of prescriptions. Only 6.27% drugs were prescribed by generic name. Conclusion: Corticosteroids were beneficial to a large no. of patients. Initial usage of low potency steroids topically wherever possible can be emphasized. WHO drug prescribing indicators analysis indicated the need to adhere to WHO guidelines as well as prescribing drugs by generic name. To maintain a balance between judicious use and frequent abuse with corticosteroid is important along with physician’s vigilance and patient education.

A Relative Study on Laryngeal Mask Airway Lubrication with 0.005% Beclomethasone Cream v/a 2% Lidocaine

Background: Postoperative sore throat (POST) is a slightcomplication after general anaesthesia. Numerous agents havebeen used as lubricant to lessen the incidence of POST withvariable efficacy.Methods: We compare the incidence of POST with 0.05%betamethasone gel and 2% lignocaine jelly as a lubricant forLMA insertion in patients undergoing general anaesthesia.Sixty subjects were separated randomly into two groups.Patients in Group B (n = 30) had 2.5 ml of 0.05% ofbetamethasone gel while the Group L had 2.5 ml of 2%lignocaine jelly applied on the cuff of LMA. After criterioninduction and insertion of LMA cuff inflated to 60 cm of H2Oand was maintained at the same throughout the surgery.Results: In PACU, patients evaluated about sore throat atimmediate and 24 h post-operative period. POST was not seenin any of the patients of Group B. In group L 13% of thepatients had 1st degree and 3% had 2nd degree of sore-throatin immediate post-operative period. After 24 h 3%patients had1st degree sore-throat and 1% patients had 2nd degree ofsore-throat in Group L patients.Conclusion: We conclude that lubricating cuff of LMA with0.05% of betamethasone gel is efficient in reducing theincidence of POST.

A Comparative Study Of Efficacy Of Topical Difluprednate Ophthalmic Emulsion 0.05% Eyedrops With Betamethasone Suspension 0.1% In Postoperative Small Incision Cataract Surgery

Postoperative operative inflammation following cataract surgery is common occurrence may be due to severalsurgery-dependent factors such as surgical trauma, intraocular lens type, and due to various physical, chemicaland biological agents introduced during surgery and also on patient-dependent factors such as history ofinflammatory disease and degree of iris pigmentation. Anti-inflammatory agents are routinely prescribedfollowing cataract extraction surgery to resolve signs and symptoms of inflammation more rapidly and toimprove patient comfort. For the treatment of postoperative ocular inflammation and pain the most widelyprescribed topical corticosteroid is betamethasone 0.1%, and Difluprednate ophthalmic emulsion 0.05% astrong topical steroid. Hence, this study was to compare the efficacy and safety of topical corticosteroidsDifluprednate 0.05% and betamethasone 0.1%, in managing inflammation and pain following post cataractextraction surgery. In a total 100 patients were randomized into two groups Group –A (50 patients) prescribingtopical Difluprednate emulsion 0.05% and Group-B (50 patients) prescribing betamethasone phosphate 0.1%.in our observation after 15 days no pain in group-A, after 30 days no one are having corneal oedema in groupA. Difluprednate emulsion 0.05% drug was efficient in the reduction of anterior chamber cells and flare withbetamethasone phosphate 0.1% being more rapid. Based on our findings and previous study results,Difluprednate emulsion 0.05% can be used in post-operative management post cataract surgery, however,further clinical trials with long follow- up periods are required.

Betametasona fosfato para la prevención de Síndrome de Dificultad Respiratoria (SDR) del recién nacido de pretérmino / Betamethasone phosphate for the prevention of Respiratory Distress Syndrome (RDS) in the preterm newborn

RESUMEN Introducción: El estándar para inducción de madurez pulmonar en fetos con riesgo de nacer prematuramente es la administración de 12 mg de betametasona acetato/fosfato por dos veces espaciada cada 24 horas. El uso establecido en algunos hospitales públicos en Chile es con dos dosis de 12 mg betametasona fosfato aunque no existen estudios publicados sólo con betametasona fosfato sobre la incidencia de Síndrome de Distress Respiratorio (SDR). Objetivo: Evaluar efecto de betametasona en su forma fosfato como tratamiento antenatal para inducción de madurez fetal pulmonar en la incidencia SDR debido a membrana hialina en prematuros menores de 34 semanas de edad gestacional. Comparar el efecto de betametasona fosfato con el efecto publicado de betametasona acetato/fosfato. Material y método: Análisis de incidencia de SDR en prematuros nacidos en Hospital Padre Hurtado entre 24+0 y 34+0 semanas que recibieron betametasona fosfato para madurez pulmonar y aquellos que no la recibieron. Resultados: De 1.265 neonatos estudiados, 722 completaron dos dosis (57,5%); 436 sólo una dosis (34,5%) y 107 (8,5%) no recibieron corticoides antenatales. La incidencia de SDR debido a membrana hialina en el grupo con dos dosis fue 8,7%, una dosis 25,3% y 32,7% en los no tratados (p<0,001). Para SDR severo las incidencias fueron 6,7%, 12,6% y 16,8% respectivamente (p<0,001). Conclusiones: Inducción de madurez fetal pulmonar con betametasona fosfato en dos dosis de 12 mg IM separadas por 24 horas otorga una reducción significativa de incidencia de SDR semejante a la publicada con betametasona acetato/fosfato en iguales dosis.

ABSTRACT The standard for induction of lung maturity in fetuses at risk of being born prematurely is the administration of 12 mg of betamethasone acetate/phosphate two doses separated by 24 hours. The established use in some public hospitals in Chile is with two doses of 12 mg betamethasone phosphate although there are no studies published with betamethasone phosphate alone on the incidence of respiratory distress syndrome (RDS). Objective: To evaluate the effect of betamethasone in its phosphate form as antenatal treatment for the induction of fetal lung maturity in the incidence of RDS due to hyaline membrane in preterm infants less than 34 weeks of gestational age. To compare the effect of betamethasone phosphate with the published effect of betamethasone acetate/phosphate. Material and method: Analysis of the incidence of RDS in preterm infants born at Hospital Padre Hurtado between 24 + 0 and 34 + 0 weeks who received betamethasone phosphate for lung maturity and those who did not receive it. Results: Of 1,265 infants studied, 722 completed two doses (57.5%); 436 only one dose (34.5%) and 107 (8.5%) did not receive antenatal corticosteroids. The incidence of RDS due to hyaline membrane in the group with two doses was 8.7%, one dose 25.3% and 32.7% in the untreated ones (p <0.001). For severe RDS, incidences were 6.7%, 12.6% and 16.8% respectively (p <0.001). Conclusions: Induction of fetal lung maturity with betamethasone phosphate in two doses of 12 mg IM separated by 24 hours gives a significant reduction in the incidence of RDS similar to that published with betamethasone acetate/phosphate in equal doses.

Meta-analysis of the Therapeutic Efficacy of Sodium Hyaluronate Combined with Compound Betamethasone versus Sodium Hyaluronate in the Treatment of Knee Osteoarthritis / 中国药房

OBJECTIVE： To systematically evaluate therapeutic efficacy of sodium hyaluronate combined with Compound betamethasone versus sodium hyaluronate in the treatment of knee osteoarthritis （KOA）， and to provide evidence-based reference for clinical drug use. METHODS： Randomized controlled clinical trials （RCTs） about sodium hyaluronate combined with Compound betamethasone （observation group） versus sodium hyaluronate （control group） in the treatment of KOA were collected from Cochrane Library， PubMed， Embase， Web of Science， CNKI， Wanfang database and Baidu academics database， etc. By literature screening， data extraction and quality evaluation of included literatures with Jadad scale， Meta-analysis was carried out by using Rev Man 5.3 software. RESULTS： Totally 24 RCTs were included， involving 2 929 patients. Meta-analysis showed that total response rate [OR＝5.33， 95％CI（3.85， 7.38）， P＜0.000 01]， knee joint score of American Special Surgical Hospital [SMD＝1.63， 95％CI（1.32， 1.93）， P＜0.000 01]， knee function score [SMD＝1.22， 95％CI（0.84， 1.59）， P＜0.000 01] of the observation group were significantly higher than those of the control group； visual analogue score was significantly lower than that of control group [SMD＝－1.44， 95％CI（－1.76，－1.11）， P＜0.000 01].  CONCLUSIONS： In the treatment of KOA， therapeutic efficacy of sodium hyaluronate combined with Compound betamethasone is significantly better than sodium hyaluronate， and it can significantly improve knee function.

Comparative Evaluation of the Pharmaceutical Properties of Original and Generic Betamethasone Ophthalmic Solution / 医薬品情報学

Objective: In this study, pharmaceutical properties were compared between the original and generic ophthalmic solutions containing betamethasone.Methods: The squeeze force, drop weight, surface tension, pH, kinematic viscosity, and total number of drops were measured. The drop volume was calculated from the drop weight and specific gravity. Information on preservatives contained in each product was collected from package inserts.Results: There was a significant difference in the squeeze force between the original and generic drugs. The pH and kinematic viscosity did not differ between the drugs. The drop volume was in the range of 30.3 to 47.2 μL, and the surface tension ranged between 33.7 and 65.2 mN/N. The total number of drops was approximately 100 in the original drug, being the lowest.Conclusion: The results of this study showed that the squeeze forces of all generic products but RINBETA PF, which was contained in a specific container, were smaller than that of the original product. The drop volumes of 2 generic products were ≥ 15-μL smaller than that of the original product, but they were within the permissible range. The maximum difference in the surface tension was approximately 33 mN/N, suggesting that drug solution relatively frequently overflows from the eyes. The total number of drops for all generic products was greater than that for the original product, suggesting that the former can be used at a higher frequency. Based on these results, pharmacists must select products in accordance with individual patients.