Incidence Of Drug-related Adverse Effects Research Articles

Conscious sedation anesthesia using different doses of remifentanil combined with dexmedetomidine for peritoneal dialysis catheter implantation

Background Conscious sedation anesthesia (CSA) is an anesthetic method during peritoneal dialysis catheter implantation. However, lack of optimal CSA strategies for patients with end-stage renal disease (ESRD). This study aimed to evaluate the analgesic effects and safety of CSA using different doses of remifentanil combined with dexmedetomidine during peritoneal dialysis catheter insertion. Methods Patients who underwent peritoneal dialysis (PD) catheter placement via open surgical incision were retrospectively analyzed and divided into three groups based on the tertile dose of remifentanil. The bispectral index (BIS) was used to monitor the depth of anesthesia. Data regarding clinical findings, the effects of anesthesia, and the incidence of drug-related adverse effects were collected. Results In total, 102 patients completed the surgery successfully and safely. The dose of remifentanil was 0.02–0.07 μg/kg/min, 0.08–0.13 μg/kg/min, and 0.14–0.20 μg/kg/min in Groups A, B, and C, respectively. Only seven patients reported mild pain during the surgery. No significant differences were observed among the numeric rating scale scores of the three groups (p > 0.05). Intraoperative hemodynamics were stable. The incidence of respiratory depression was 8.3%, 20.0%, and 41.9% in Groups A, B, and C, respectively (p < 0.01). The incidence of gastrointestinal symptoms in Group C (51.6%) was higher than that in Groups A and B (p < 0.05). Conclusion Low-dose remifentanil (0.02–0.07 μg/kg/min) combined with dexmedetomidine achieved satisfactory anesthetic effects with fewer adverse drug reactions during PD catheter implantation, indicating its potential for use in patients undergoing PD catheter placement.

Comparative evaluation of the analgesic efficacy of ultrasound-guided erector spinae plane block versus intrathecal morphine in patients undergoing percutaneous nephrolithotomy surgery: A prospective randomized pilot study.

Existing research on erector spinae plane block and intrathecal morphine in patients undergoing percutaneous nephrolithotomy surgery is limited. In this prospective, randomized study, 60 patients aged between 18 and 60 years were randomized into two groups (erector spinae plane block and intrathecal morphine). In the erector spinae plane block group, ultrasound-guided erector spinae plane block was performed, following which a mixture of 20 mL of 0.375% ropivacaine and 0.5 mcg/kg of clonidine was injected. In the intrathecal morphine group, 150 mcg preservative-free morphine with 2 mL of normal saline was administered intrathecally. The primary outcome was to evaluate the perioperative opioid consumption in the first 24 h. The secondary outcomes were to evaluate hemodynamic response to surgical stimulus, visual analogue scale score, time to first analgesic requirement, postoperative nausea and vomiting, postoperative opioid consumption, urethral irritation, and incidence of drug-related adverse effects. Total perioperative opioid consumption in the erector spinae plane block group was 355.0 (265.0, 485.0) μg and 240.0 (145.0, 370.0) μg in the intrathecal morphine group (P = 0.09). However, the patients in the erector spinae plane block group had significantly greater postoperative fentanyl consumption (235.0 [120.0, 345.0] μg) compared with those in the intrathecal morphine group (105.0 [30.0, 225.0] μg). There were no statistically significant differences noted for intraoperative opioid consumption, postoperative visual analogue scale score, time to first analgesic request, postoperative nausea and vomiting, and catheter irritation between the two groups. Although no statistically significant difference in intraoperative opioid consumption was seen between the erector spinae plane block and intrathecal morphine groups, postoperative opioid consumption was significantly higher in the erector spinae plane block group than in the intrathecal morphine group in patients undergoing percutaneous nephrolithotomy surgery.

A prospective comparative study of two regimens of diphenylcyclopropenone (DPCP) in the treatment of alopecia areata

BackgroundAlopecia areata (AA) is a chronic disorder and the best treatment regimen for it is unknown. Currently, one of the best documented treatment modalities for AA is topical immunotherapy. AimTo evaluate the safety and efficacy of a novel method (multi-concentration patch test) versus standard protocol for topical immunotherapy. MethodsA prospective randomized clinical trial was conducted on 30 patients with Alopecia areata, half of them received DPCP with a novel method using multi-concentration patch test to determine the optimal initiating concentration of DPCP (case group) and the other half experienced immunotherapy according to the standard protocol (control group). Percentage of hair regrowth after 6 months of treatment and the incidence of drug-related adverse effects were evaluated and compared between the two groups. (IRCT registration code: IRCT20141209020250N5). ResultsAbsolute and relative hair regrowth percentages were reported 25% and 41.49% in case group and 8.2% and 14.21% in control group respectively. Considerable response (more than 75% hair regrowth) was observed in 4 (26.6%) patients in case and 1 (6.6%) patient in control group. The clinical response was initiated about 7 weeks sooner in case compared to the control group (14 versus 7.38 weeks, P: 0.001). Overall, clinical response was higher in patients received new protocol, compared to control group. Moreover, patients who experienced new protocol had a higher level of treatment satisfaction in comparison with patients having standard protocol (P: 0.012). ConclusionThis study revealed the effectiveness and safety of the novel multi-concentration patch test DPCP therapy for AA and its priority to conventional method, at least in terms of shortened duration of DPCP immunotherapy.

A randomized trial of diphenylcyclopropenone (DPCP) combined with anthralin versus DPCP alone for treating moderate to severe alopecia areata

BackgroundAlopecia areata (AA) is a chronic autoimmune disorder. Finding the best treatment regimen for it remains a challenge. Currently, one of the best documented treatment modalities for AA is topical immunotherapy. AimTo evaluate the safety and efficacy of combined DPCP and anthralin versus standard protocol (DPCP alone). MethodsA prospective randomized clinical trial was conducted on 50 patients with Alopecia areata who received DPCP alone (group D) or in combination with anthralin (group D/A). Percentage of hair regrowth after 6 months of treatment and the incidence of drug-related adverse effects were evaluated and compared between the two groups. ResultsComplete hair regrowth was observed among three patients in each group (18.75% in Group D and 15.79% in Group D/A) after 6 months. Moreover, 25% and 31% of patients in group D and 21% and 47% of patients in group D/A had > 75% and > 50% hair regrowth respectively at the end of the study (P-value: 0.696). In addition, earlier age of onset, chronicity of lesions, nail involvement, facial hair loss and extensive lesions at baseline were associated with poor clinical outcome. ConclusionDPCP and anthralin was as effective as DPCP alone and anthralin did not add to the effect of DPCP in treating AA.

Rituximab exhibits a better safety profile when used as a first line of treatment for pemphigus vulgaris: A retrospective study

BackgroundPemphigus is an autoimmune disease that is challenging to treat and has few available therapeutic options. Recently, several studies have demonstrated that rituximab may be an efficacious first-line treatment in newest guidelines. AimTo compare the side effect profiles of rituximab administered after a course of immunosuppressant agents versus as a first-line therapy and evaluate the impact of patient characteristics and disease severity indices on occurrence of adverse effects. MethodsA retrospective cross-sectional study was conducted on 999 patients with pemphigus vulgaris who received rituximab either as a first-line treatment or after conventional adjuvant therapies. The occurrence of partial or complete remission as well as the incidence of drug-related adverse effects were evaluated and compared between the two groups. ResultsSmoking, pulmonary comorbidity, and mucocutaneous phenotype were associated with an increased risk of developing infectious complications by 12.49, 5.79, and 2.37 fold, respectively. These associations were more prominent among those who received rituximab after immunosuppressant agents. ConclusionsEarly use of rituximab benefits pemphigus patients, especially those with a mucocutaneous phenotype, pulmonary comorbidity, or history of smoking, and reduces their risk of infectious adverse events.

Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy.

This study aimed to evaluate the efficacy and safety of olmesartan medoxomil (OM)/amlodipine (AML) 20/5 mg fixed-dose combination tablet in Chinese mild to moderately hypertensive patients with inadequate blood pressure (BP) control on monotherapy. Two multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group clinical trials were conducted. After screening and a 2-week placebo run-in period, patients with 95 mmHg ≤ seated diastolic blood pressure (SeDBP) < 110 mmHg received monotherapy with OM 20 mg (in Study 1) or AML 5 mg (in Study 2), once daily for 4 weeks. Patients with 90 mmHg ≤ mean SeDBP < 110 mmHg at the end of the monotherapy period were randomized to receive OM/AML 20/5 mg treatment or continue with the monotherapy, once daily for 8 weeks. OM/AML (20/5 mg) treatment significantly lowered both systolic and diastolic BP at 4 and 8 weeks compared to 40 mg olmesartan or 5 mg AML. The incidence of drug-related adverse effects did not differ significantly between the groups. OM/AML 20/5 mg was superior to OM 40 mg or AML 5 mg monotherapy in lowering BP in Chinese mild to moderately hypertensive patients with inadequate BP control on monotherapy. No new or unexpected safety issues were identified with OM/AML combination therapy compared to monotherapy.

Use of Reduced-Dose Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty

We investigated the safety and efficacy of the bilateral periarticular multimodal drug injection (PMDI) at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty (SBTKA). In total, 45 patients undergoing SBTKA received 65 mL PMDI in each knee (reduced-dose group). The incidence of drug-related adverse effects and wound complications were evaluated. Pain levels during the night of the operation and postoperative day 1 and opioid consumption during the first 24 hours after surgery were compared with the regular-dose group of 55 patients undergoing SBTKA who received 100 mL of PMDI in 1 knee. No patient experienced a serious drug-related adverse effect or wound complication. Blood levels of ropivacaine were observed to be lower than a toxic level throughout the monitored period in all patients examined. Patients in the reduced-dose group experienced less pain during the night of operation, but a similar pain level at postoperative day 1.

Increased prevalence of primary drug‐resistant pulmonary tuberculosis in immunocompromised patients

Drug-resistant tuberculosis (DR-TB) is difficult and expensive to treat, and is associated with a higher rate of mortality. We conducted a long-term survey to compare the prevalence of primary drug-resistance, adverse effects of drugs and duration of treatment in immunocompetent and immunocompromised patients. Factors associated with primary drug resistance were also investigated. The patients studied had culture-confirmed pulmonary TB but had not previously received anti-TB treatment. These patients were divided into immunocompetent (IMCPe) and immunocompromised (IMCPr) groups. Baseline data, the prevalence of DR-TB, duration of treatment and adverse effects of drugs were analysed. The rates of resistance to individual first-line anti-TB drugs in the two groups and in subgroups of the IMCPr group were calculated. Multinomial regression analysis was performed to investigate the risk factors associated with primary DR-TB. Among the 394 patients, 159 (40.4%) were in the IMCPr group. The baseline data for the two groups were similar, except that the IMCPr group was slightly older. The prevalence of drug-resistance was higher in the IMCPr group (25.8% vs 17.0%, OR 1.69, 95% CI: 1.04-2.77), especially for isoniazid, rifampicin and streptomycin, and patients with liver cirrhosis, malignancies and those receiving immunosuppressants. The incidence of adverse drug effects was similar in the IMCPr and IMCPe groups. Multinomial regression analysis showed that being in the IMCPr group, and especially treatment with immunosuppressants, were independent risk factors for DR-TB. Immunocompromised patients with underlying diseases had an increased prevalence of primary pulmonary DR-TB but a similar incidence of drug-related adverse effects. Diagnosis and investigation of drug-resistance is important before initiating anti-TB treatment in this group of patients.

Procalcitonin Algorithm Reduces Antibiotic Use for Lower Respiratory Tract Infections

Inappropriate antibiotic prescribing for lower respiratory tract infection (LRTI) is widespread and promotes bacterial resistance while increasing costs and incidence of drug-related adverse effects. Researchers evaluated whether use of a serum procalcitonin (PCT)-based algorithm could safely reduce antibiotic administration for LRTI (defined as community-acquired pneumonia, exacerbation of chronic obstructive pulmonary disease, or acute bronchitis). The algorithm …

Review of select transplant subpopulations at high risk of failure from standard immunosuppressive therapy.

Despite improvements in short-term graft and patient survival rates for solid organ transplants, certain subgroups of transplant recipients experience poorer clinical outcome compared to the general population. Groups including pediatrics, African-Americans, diabetics, cystic fibrosis patients, and pregnant women require special considerations when designing immunosuppressive regimens that optimize transplant outcomes. Problems specific to pediatric transplant recipients include altered pharmacokinetics of immunosuppressive drugs, such as cyclosporine (CsA) and tacrolimus (poor absorption, increased metabolism, rapid clearance), the need to restore growth post-transplantation, and a high incidence of drug-related adverse effects. African-Americans have decreased drug absorption and bioavailability, high immunologic responsiveness, and a high incidence of post-transplant diabetes mellitus. Diabetics and cystic fibrosis patients exhibit poor absorption of immunosuppressive agents, which may lead to underimmunosuppression and subsequent graft rejection. Pregnant women undergo physiologic changes that can alter the pharmacokinetics of immunosuppressives, thus requiring careful clinical management to minimize the risks of either under- or overimmunosuppression to mother and child. To achieve an optimal post-transplant outcome in these high-risk patients, the problems specific to each group must be addressed, and immunosuppressive therapy individualized accordingly. Drug formulation greatly impacts upon pharmacokinetics and the resultant level of immunosuppression. Thus, a formulation with improved absorption (e.g., CsA for microemulsion), higher bioavailability, and less pharmacokinetic variability may facilitate patient management and lead to more favorable outcomes, especially in groups demonstrating low and variable bioavailability. Other strategies aimed at improving transplant outcome include the use of higher immunosuppressive doses, different combinations of immunosuppressive agents, more frequent monitoring, and management of concurrent disease states.