Reduction Of Adverse Effects Research Articles

De-Escalation of Anti-Tumor Necrosis Factor Alpha Agents and Reduction in Adverse Effects: A Systematic Review.

Background: The long-term use of anti-TNF-α agents can lead to adverse effects, such as infections and immune-mediated cutaneous reactions. Whether de-escalation by dose reduction or interval lengthening reduces these adverse effects is uncertain. This systematic review aims to compare the incidence of infections and skin manifestations after anti-TNF-α dose de-escalation with standard dosing. Methods: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception to 14 January 2022. Randomized controlled trials (RCTs) and observational studies comparing anti-TNF-α de-escalation strategies with standard dosing among patients with inflammatory conditions, that report on infections, skin manifestations, or both, were included. The risk of bias was assessed with the revised Cochrane risk-of bias tool (RCTs) or the Newcastle–Ottawa scale (non-RCTs). Results: Fourteen RCTs and six observational studies (or 2706 patients) were included. Eight RCTs had low risk of bias or some concerns. Four non-RCTs were of good methodological quality. The studies described patients with axial spondyloarthritis (8 studies, 780 patients), rheumatoid arthritis (7 studies, 1458 patients), psoriasis (3 studies, 332 patients), or inflammatory bowel disease (2 studies, 136 patients). De-escalation strategies included interval lengthening (12 studies, 1317 patients), dose reduction (6 studies, 1130 patients), or both (2 studies, 259 patients). Overall, the occurrence of infections and skin manifestations did not differ between standard treatment and de-escalation. The disappearance of infections or skin manifestations after de-escalation was only reported in two studies. The majority of studies focused on etanercept and adalimumab. Heterogeneity in reporting of infections and skin manifestations precluded meta-analysis. Conclusion: We found that anti-TNF-α de-escalation does not reduce infections or skin reactions. A de-escalation strategy should not be recommended for the sole purpose of reducing drug-related adverse effects. The meticulous documentation of adverse effects is recommended to further address this question. Registration: PROSPERO CRD42021252977.

Salvia miltiorrhiza-Containing Chinese Herbal Medicine Combined With GnRH Agonist for Postoperative Treatment of Endometriosis: A Systematic Review and meta-Analysis.

Background: Endometriosis is an estrogen-dependent gynecological inflammatory condition that may lead to infertility and recurrent pelvic pain. The purpose of this research was to determine the efficacy and safety of Salvia miltiorrhiza-containing Chinese herbal medicine (CHM) combined with gonadotropin-releasing hormone agonist (GnRH-a) for postoperative endometriosis management. Methods:Eight databases were systematically searched before October 2021, including PubMed, Embase, Cochrane Library, Scopus, Web of Sceince, CNKI, VIP, and Wanfang. Finally, all randomized controlled studies comparing Salvia miltiorrhiza-containing CHM paired with GnRH-a to GnRH-a alone for postoperative endometriosis management were included. Results: A total of 10 trials involving 836 patients were reported and analyzed. Compared with the control group, the Salvia miltiorrhiza-containing CHM combined with GnRH-a group showed significant superiority in decreasing endometriosis recurrence (risk ratio [RR] = 0.26; 95% confidence intervals [CI]: 0.16–0.41) and increasing the pregnancy rate ([RR] = 1.96; 95% CI: 1.58–2.44). Similarly, the effect of the Salvia miltiorrhiza-containing CHM combined with GnRH-a on CA-125 serum levels was positive (standardized mean difference [SMD] = -0.79; 95% CI: −1.11 to −0.47). Furthermore, this group showed a significant reduction in adverse effects. Conclusion: The results indicate that Salvia miltiorrhiza-containing CHM may be a viable choice for postoperative endometriosis therapy, with the potential to enhance pregnancy while decreasing recurrence and adverse effects.

Oncolytic Vaccinia Virus in Lung Cancer Vaccines.

Therapeutic cancer vaccines represent a promising therapeutic modality via the induction of long-term immune response and reduction in adverse effects by specifically targeting tumor-associated antigens. Oncolytic virus, especially vaccinia virus (VV) is a promising cancer treatment option for effective cancer immunotherapy and thus can also be utilized in cancer vaccines. Non-small cell lung cancer (NSCLC) is likely to respond to immunotherapy, such as immune checkpoint inhibitors or cancer vaccines, since it has a high tumor mutational burden. In this review, we will summarize recent applications of VV in lung cancer treatment and discuss the potential and direction of VV-based therapeutic vaccines.

PRO AND CONTRA ON ADJUVANTS TO NEUROAXIAL ANESTHESIA AND PERIPHERAL NERVE BLOCKS.

Modern approach in surgical treatment and in managing acute and chronic pain is nowadays more and more based on the implementation of all possible techniques of regional anesthesia (RA). Local anesthetics (LA) are needed to achieve standard regional anesthesia. Local anesthetics are primarily characterized by time constraints and duration of action, and depending on the amount applied, adverse effects on the cardiac and central nervous system may occur. Adjuvants are drugs used together with LA due to their synergistic effect, i.e. they improve start latency and duration of sensory and motor blockade and enable reduction of cumulative dose of LA and reduction of adverse effects on cardiac and nervous system. Nowadays, there is a huge variety of drugs that can be administered in combination with LA, and they, in general, can be divided into opioid and non-opioid adjuvants. The administration of opioids in RA over an extended time period was accompanied by some negative characteristics as respiratory depression, nausea, vomiting. So, their usage is still under a special control. Due to the positive effects shown by drugs from non-opioid adjuvants group (e.g. adrenaline, alpha adrenergic agonists, steroids, magnesium, midazolam, ketamine etc.), indications for their administration broadened. However, there are still some restrains in clinical practice based on the fact that neurotoxicity and demonstration of neurological complications in regional anesthesia haven't been properly researched yet.

Metronomic chemotherapy with oral Navelbine produces clinical benefit and low toxicity in metastatic breast cancer in K Hospital

Background: The metronomic concept emerged more than 20 year sago, however, a significant development in various solidtumors was noticed in the past 10 years. There are potentially several mechanisms of action against tumor cells including inhibition of angiogenesis. This study aims to assess the efficacy and the safety of ametronomic schedule of oral Vinorelbine (Navelbine) in treatment of metastatic breast cancer. Methods: For the duration from January 2020 to June 2021 there were 30 metastatic breast cancer patients at the median age of 53 years (range 34 - 72), were treated with a metronomic schedule of oral Vinorelbine (VNR). Oral VNR was administered 40 mg three times weekly, continuously. Patients took oral VNR continuously on days 1, 3 and 5 of the week until the disease progression or unacceptable side effects. The difference between before and after 9 weeks treatment was conducted via the matched t - tests to discern the quality - of - life indicator (p < 0.05 was considered significant). Progression - free survival analysis was performed using Kaplan Maier. Results: All 30 patients received at least 9 weeks of therapy and were evaluated. 7 achieved partial responses (23.3%) and 13 achieved stable disease responses (43.4%). Median progression - free survival entailed 6.9 months. The quality of life was notified significantly. A good result was found in our metastatic breast cancer patients, who were given with a Metronomic Vinorelbine (mVNR) administration. Conclusions: As a result of our latest study indicated that themetronomic vinorelbine might become a potential treatment for metastatic breast cancer patients via the reduction of adverse effects and improvement of life quality and sets the stage for future extensive clinical trials.

THE VASCULAR ENDOTHELIUM FUNCTION INDICATORS IN ORAL LIQUID OF IQOS SMOKING ADOLESCENTS

Heated tobacco products (HTP) were introduced to the world market as an alternative to conventional tobacco cigarettes. Active advertising, readily available to purchase and the public's perception that HTP are a safer alternative to conventional tobacco cigarettes lead to increasing their consumption by young age group in Ukraine. Despite the claims by the tobacco corporations about reduction of adverse effects the HTP on the activity of cardiovascular system, the published studies of potential vascular endothelial consequences were not found. Therefore, the aim of our study is to assess the HTP effect on vascular endothelial cells by determination of the nitrate, nitrite, S-nitrosothiols, and endothelin-1 levels in saliva of smoking adolescents. The object and research methods. Thirty adolescents aged 14-17 years old were divided to three groups. Group I was introduced by ten healthy non-smoking adolescents (control group). Group II consists of ten smoking adolescents have smoked the IQOS for two years. Group III is formed by ten smoking adolescents who have smoked the IQOS for three years. The salivary nitrate and nitrite levels were measured using the Griess assay such as an indicator of NO production. The salivary S-nitrosothiols were measured spectrophotometrically. The salivary endothelin-1 level was measured with ELISA kit. Statistical analysis of the data was carried out using the STATISTICA 7.0 program. The data were presented as Median values (Me), lower and upper quartile, i.e. Me [Lq; Uq]. Statistical significance was accepted if p < 0.05. Results. The salivary nitrate concentrations in groups II (Me = 14.11 [13.98; 14.52] μmol/l) and III (Me = 12.06 [11.44; 12.31] μmol/l) were significantly decreased compared to group I (Me = 15.89 [14.98; 16.89] μmol/l, KW test: H = 23.59, p=0.000. The values of nitrite in groups II and III were the following: Me = 2.32 [1.47; 2.48] μmol/l and 1.37 [1.25; 1.44] μmol/l, respectively. The indices were lower in 1.41 and 2.36 times than in group I: Me = 3. 24 [3.05; 3.78] μmol/l, KW test: Н = 22.92, p = 0.000. The levels of salivary S-nitrosothiols in group II are: Me = 1.02 [0.84; 1.27] μmol/l and group III Me = 0.36 [0.25; 0.62] μmol/l were reduced in 1.75 and 4.97 times compared to group I: Me = 1.79 [1.67; 1.97] μmol/l, KW test: Н = 24.46, р = 0.000. We assume that the reduction of salivary nitrate and nitrite concentrations is associated with a low level of S-nitrosothiols which serve as deposited and released nitric oxide (NO). Probably, the decrease of nitrates and nitrites is associated with the inhibition of endothelial NO synthase. The salivary endothelin-1 level was significantly higher in group II: Ме=0.58 [0.53; 0.73] pmol/ml and in group III: Ме = 0.82 [0.79; 0.93] pmol/ml than in group I: Ме = 0.17 [0.14; 0.26] pmol/ml, KW test: Н = 23.94, р = 0.000. It should be noted, the significant differences between data of nitrate, nitrite, S-nitrosothiol and endothelin-1 content in groups II and III were found (Mann-Whitney U test, nitrates - Z = 3.62, p = 0.000; nitrites - Z = 2.91 , p = 0.003; S-nitrosothiols - Z = 3.74, p = 0.00; endothelin-1 - Z = 3.36, p = 0.000). These results showed interrelation between adverse IQOS effect on vascular endothelium of adolescents duration of IQOS smoke. Conclusions. The adverse effect of heated tobacco product (IQOS) on the biochemical indicators of the vascular endothelium function of adolescents was found in our experimental study. The salivary nitrate, nitrite and S-nitrosothiols levels were significantly decreased in IQOS smoking adolescents. The salivary endothelin-1 content was significantly elevated in IQOS smoking adolescents. The revealed changes indicate the endothelial dysfunction in young smokers. The development of pathological processes in the vascular endothelium depends on the smoking duration.

Appraisal of amiodarone-loaded PLGA nanoparticles for prospective safety and toxicity in a rat model

AimsAmiodarone (AM) is a highly efficient drug for arrhythmias treatment, but its extra-cardiac adverse effects offset its therapeutic efficacy. Nanoparticles (NPs)-based delivery system could provide a strategy to allow sustained delivery of AM to the myocardium and reduction of adverse effects. The primary purpose was to develop AM-loaded NPs and explore their ameliorative effects versus off-target toxicities. Materials and methodsPolymeric NPs were prepared using poly lactic-co-glycolic acid and their physicochemical properties were characterized. Animal studies were conducted using a rat model to compare exposure to AM versus that of the AM-loaded NPs. Biochemical evaluation of liver enzymes, lipid profile, and thyroid hormones was achieved. Besides, histopathological changes in liver and lung were studied. Key findingsUnder optimal experimental conditions, the AM-loaded NPs had a size of 186.90 nm and a negative zeta potential (−14.67 mV). Biochemical evaluation of AM-treated animal group showed a significant increase in cholesterol, TG, LDL, T4, and TSH levels (ρ < 0.05). Remarkably, the AM-treated group exhibited a significant increase of liver enzymes (ρ < 0.05) coupled with an obvious change in liver architecture. The AM-loaded NPs displayed a reduction of liver damage and enzyme levels. Lung sections of the AM-treated group demonstrated thickening of interalveolar septa, mononuclear cellular infiltration with congested blood vessels, and heavy collagenous fibers deposition. Conversely, less cellular infiltration and septal thickening were observed in the animal lungs treated with the AM-loaded NPs-treated. SignificanceOur findings demonstrate the competence of the AM-loaded NPs to open several exciting avenues for evading the AM-induced off-target toxicities.

Improvement of Indoor Residual Spraying and Long\u2010Lasting Insecticidal Net services through structured monitoring and supervision as part of the Malaria Elimination Demonstration Project in Mandla, Madhya Pradesh

BackgroundThe Government of Madhya Pradesh employed Indoor Residual Spraying (IRS) with alpha-cypermethrin synthetic pyrethroids in sub-centres with Annual Parasite Incidence (API) from 2 to 4.99. In sub-centres with API more than 5, Long-Lasting Insecticidal Nets (LLINs) were distributed. At the request of the State Government, the Malaria Elimination Demonstration Project (MEDP) staff observed and provided support to both IRS and LLINs campaigns. In the year 2017, the study team monitored only the IRS campaigns, however, in the year 2018, the supportive supervision was provided to the IRS campaign teams along with post-distribution monitoring of the LLINs.MethodsThe study was carried out during IRS spraying using a pre-tested, closed-ended monitoring checklist which consisted of two parts- observations of spraying team and observation of sprayed houses. For LLINs, a sample of the households that received the bed nets was taken for the study. For IRS, the spraying teams were monitored for quality and technique for a total of 159 times in 2017 and 183 times in the year 2018, respectively. For post spraying observations, a total of 1261 and 1791 households were observed in the years 2017 and 2018, respectively. The use of LLINs was observed in 5 % of the households in 2018 and 2020, which is about 2,000 houses in each survey where each house received about 2.5 LLINs per household. The results of surveys were compared to assess impact of supportive supervision and monitoring.ResultsSignificant improvement was noted after supportive supervision in year 2018 in various aspects of spraying. Preparedness of spraying, such as advance information to villagers, presence of equipment and records improved by up to 70 %. The methodology of spraying preparation improved from 50 to 90 %, spraying technique improved from 54 to 80 %, and proper use equipment during spraying improved from 51 to 92 %. After eight months post distribution of the LLINs in 2019, improvement was seen in regular usage of LLINs by 28 %. It was found that on-spot demonstrations during distribution and carrying of LLINs when sleeping outside homes increased by 56 %. Results of IEC campaigns revealed the reduction in adverse effects by 64 % and increase in awareness by 97 %.ConclusionsEffective supervision improved the quality of IRS and usage of LLINs in the study area. Based on these results, continued training and monitoring of staff that is deployed to spraying houses and distribute bed nets was suggested. The study also revealed that proper IEC/BCC drives help increase community acceptance of vector control measures and their rational usage.

CONSIDERACIONES SOBRE LA INNOVACIÓN INCREMENTAL EN MEDICAMENTOS

The concept of incremental innovation encompasses adaptations resulting from the analysis of the use of existing medicinal products, in order to incorporate a modification or propose a new use designed to benefit patients. It can be classified into 6 different categories, depending on the nature or objective of the innovation carried out. Incremental innovation can be very interesting for health professionals because these variations provide improvements in treatment, in the continuation of treatments, in the reduction of adverse effects or in adherence. Incremental innovation is also very well received from the patient’s perspective, since it facilitates treatment and in many cases opens up a therapeutic expectation for certain subgroups that did not exist before the medicinal product was marketed. It is also interesting for the National Health System, since certain patients treated with incremental innovations obtain better health results and require less frequent use of other health services. From an economic perspective, many pharmaceutical companies established in our country and relevant from a strategic point of view, could also improve the therapeutic arsenal with this type of innovations by providing products of therapeutic interest that, unfortunately, do not currently have the ideal conditions for viability. For all these reasons, the promulgation of a Spanish regulation that protects and provides legal certainty to the marketing authorization holders of this type of innovations seems necessary. This future regulation should include a procedure to qualify incremental innovations of interest to the National Health System and have economic effects to guarantee their effective commercialization.

Abstract PO-063: A systematic review of tandem cognitive behavioral therapy and healthy lifestyle interventions on health-related outcomes

Abstract Background Early screening and innovative treatments has elongated the lives of cancer survivors, bringing more focus on minimizing the adverse effects of cancer and its treatment. Healthy lifestyle (HL) behaviors reduce the risk of cancer recurrence and intensity of cancer-related adverse effects such as fatigue and cognitive dysfunction. However, maintaining a HL may be difficult for many. Cognitive behavioral therapy (CBT) has been used to help change behavior. Studies with patients engaged in healthy lifestyle behaviors alone and CBT alone have improved adverse effects. Yet, little is known about how such programs in tandem affect health-related outcomes. Here, we evaluate extant literature on tandem interventions with CBT and HL on health-related outcomes in cancer survivors. Methods We conducted a systematic review of randomized controlled studies examining CBT plus healthy lifestyle against a control condition in PubMed, Embase, and CINAHL databases published between 1990-2019. The search yielded 1494 studies which were evaluated by two reviewers based on pre-determined inclusion and exclusion criteria. Thirty-nine articles met inclusion criteria and were critically appraised for bias. Findings The 39 articles included a total of 5239 participants, primarily breast cancer and prostate cancer survivors. Most (27 of 39) articles omitted racial demographic data or noted that the participants were majority White. Only four articles recorded over 10% of blacks. Intervention conditions ranged from CBT with smoking cessation to CBT with physical activity. These conditions were which were compared against no intervention, usual care, and/or CBT alone or HL alone. Interventions were delivered by a variety of trained interventionists and over different durations. The most common HL targets were stress, insomnia, and quality of life. Nearly all articles (36 of 39) reported a clinically significant reduction in adverse effects. Of note, 2 studies compared CBT/HL vs HL vs usual care finding that physical activity alone was no different than CBT/HL. Moreover, only 24 articles addressed long term (&amp;gt;2 months) outcomes. Of those, positive effects ranged from being sustained (21 articles), attenuating over time (1 article), and disappearing (2 articles). Articles were appraised as poor to good quality. Conclusion This review showed that tandem interventions with CBT and healthy lifestyle components can improve health-related outcomes for cancer survivors as compared to usual care, but there is a paucity of knowledge to suggest differential outcomes in tandem interventions as compared to CBT alone or HL alone. Findings were biased with the overrepresentation of breast and prostate cancer survivors, and underrepresentation of minority groups. Thus, this review highlights the need for further research to test tandem interventions against CBT alone and HL alone, toward identifying the most efficacious interventions for dissemination and implementation across diverse groups of cancer survivors. Citation Format: Sarah Addison, Damalie Shirima, Shanon Dunovan, Maryam Lustberg, Elizabeth K. Arthur, Timiya S. Nolan. A systematic review of tandem cognitive behavioral therapy and healthy lifestyle interventions on health-related outcomes [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-063.

Determinants of the Adoption of Climate-Smart Agricultural Practices in Siyadebrina Wayu District, North Shewa, Ethiopia

Climate-Smart Agriculture (CSA) is one of the solutions that simultaneously address the issues of food security, climate change and agricultural productivity. Climate-smart agricultural (CSA) practices have the potential of its triple potential benefits of improved productivity and high income, reduction or removal of greenhouse gases and improved household food security. The objective of this study was to examine the determinants of adoption of climate smart agricultural practices. The methodology of the study was conducted using mixed methods approaches, in which 368 randomly selected households were surveyed, 10 key informants were interviewed, and 6 focus group discussions participants were held. The analysis was based on survey data and a binary logistic regression model was used. Findings revealed that highly adopted CSA practices in the study area were integrated soil fertility management, conservation agriculture, small scale irrigation, and improved livestock feed. Factors influencing adoption of CSA practices were also explored such as household size, farming system, off-farm income, access to irrigated farm, distance to market, farm size, and access to agricultural credit. The study concludes that a large proportion of respondents were aware of most of the practices, but adoption of CSA practices examined was very low. Therefore, as a recommendation sensitization of farmers on reality of climate change and the need to adopt CSA practices towards reduction of adverse effect of climate change should continue. Policy and support program should focus on dissemination of CSA practices to a larger proportion of smallholder farmers. Keywords: Climate Smart Agriculture, Adoption, Determinants, Food security, Ethiopia DOI: 10.7176/JAAS/68-08 Publication date: September 30 th 2020

Opioid-induced constipation in palliative care: state of the art

OBJECTIVE: The study’s purpose has been to address the state of the art in investigations such as clinical trials, systematic reviews with meta-analysis and case studies, which report how to minimize opioid-induced constipation in patients undergoing palliative care. METHODS: This is an exploratory study through an integrative review of four databases addressing published articles from 2013 to 2017. RESULTS: A total of 117 publications were presented, which 17 presented the inclusion criteria. The studies describe the prevalence of constipation rates induced by the use of opioids. CONCLUSION: Although these drugs alleviate pain, the adverse reactions may generate discomfort and loss of the patient’s life quality. There are limited data on the treatment of constipation. It was observed that few authors mentioned diet as a helper on this situation, emphasizing the use of medications. Further studies should be encouraged aiming to find the balance between analgesia and reduction of adverse effects.

Crop insurance and pesticide use in European agriculture

The provision of better risk management tools for farmers and the reduction of adverse effects from pesticide use are both important goals of agricultural policy – but are potentially interrelated and might contradict each other. In this article, we analyze the relation of crop insurance and pesticide use in European agriculture using the examples of France and Switzerland. In our conceptual and empirical framework, we account for the complex structure of insurance uptake, land use and pesticide use decisions of farmers, potentially leading to insurance - pesticide use interactions both at the intensive and extensive margin. Our empirical results indicate a positive and economically significant relation between crop insurance and pesticide use in European agriculture. The findings suggest that without crop insurance, pesticide expenditures would be 6 to 11% lower. However, the importance of extensive and intensive margin relations differs between France and Switzerland and is related to country specific characteristics. We conclude that new risk management instruments should account for potential effects on input use.

Kanglaite injection plus fluorouracil-based chemotherapy on the reduction of adverse effects and improvement of clinical effectiveness in patients with advanced malignant tumors of the digestive tract: A meta-analysis of 20 RCTs following the PRISMA guidelines.

Background:The digestive tract malignancies are a series of malignant tumor with high morbidity and mortality. Traditional Chinese medicine (TCM) combined with chemotherapy drugs interventions have been applied for the treatment of malignant tumors in Asian countries for dacades. This study aimed to assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for treating digestive tract malignancies.Purpose:To assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for digestive tract malignancies.Methods:The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed when conducting the meta-analysis. Randomized controlled trials (RCTs) of Kanglaite injection combined with fluorouracil-based chemotherapy in the treatment of digestive tract malignant tumors were selected and assessed for inclusion. RevMan 5.3 software (Cochrane Collaboration, Oxford, UK) was used for meta-analysis. The objective response rate (ORR) was defined as the primary endpoint, and the disease control rate (DCR), quality of life (QoL), and toxicities were the secondary outcomes.Results:20 RCTs enrolling 1339 patients with advanced digestive tract malignancies were included. The methodological quality of most included trials was low to moderate. Compared with fluorouracil-based chemotherapy alone, Kanglaite injection plus fluorouracil-based chemotherapy can improve DCR (risk ratio (RR) = 1.18, 95% confidence interval (CI) 1.11–1.25, P < .00001), ORR (RR = 1.35, 95% CI 1.18–1.54, P < .00001), QoL (RR = 1.58, 95% CI 1.35–1.85, P < .00001), and can reduce adverse drug reactions (ADRs) such as myelosuppression (RR = 0.33, 95% CI 0.25–0.43, P < .00001), leukopenia (RR = 0.31, 95% CI 0.22–0.43, P < .00001), thrombocytopenia (RR = 0.6, 95% CI 0.38–0.49, P = .03), neutropenia (RR = 0.26, 95% CI 0.12–0.55, P = .0005), anemia (RR = 0.41, 95% CI 0.23–0.75, P = .004), gastrointestinal reaction (RR = 0.35, 95% CI 0.27–0.46, P < .00001), nausea/vomiting (RR = 0.41, 95% CI 0.28–0.61, P < .00001), diarrhea (RR = 0.34, 95% CI 0.18–0.62, P = .0004), hepatotoxicity (RR = 0.28, 95% CI 0.17–0.47, P < .00001), neurotoxicity (RR = 0.58, 95% CI 0.41–0.82, P = .002), mucositis (RR = 0.59, 95% CI 0.29–1.21, P = .15).Conclusion:Kanglaite injection combined with fluorouracil-based chemotherapy could remarkably improve the clinical effectiveness and reduce the adverse effects in patients with advanced malignant tumors of the digestive tract which may provide evidence to judge whether TCM is an effective and safe intervention for the digestive tract malignancies.

Reduction of Adverse Effects from Jayeumganghwa-tang for Pegylated Liposomal Doxorubicin and Carboplatin in Recurrent Ovarian Cancer

Reduction of Adverse Effects from Jayeumganghwa-tang for Pegylated Liposomal Doxorubicin and Carboplatin in Recurrent Ovarian Cancer

448P - Incidence and severity of chemotherapy induced peripheral neuropathy in geriatric population who are receiving chemotherapy

BackgroundUse of chemotherapeutic drugs in advanced age geriatric cancer patients is associated with increased treatment related morbidity, one major neurological complication being peripheral neuropathy is one of major disabling morbidity expected in geriatric population due to poor nutrition status and significant co-morbidities. Our study aims to assess the incidence and severity of chemotherapy induced peripheral neuropathy in geriatric patients with help of CIPN tools when compared to younger patients on chemotherapy. MethodsA prospective observational study was conducted in medical oncology wards of tertiary care hospital, Bangalore. Subjects with histological confirmed malignancies who had received planned chemotherapy were recruited in this study. All patients underwent a detailed clinical evaluation for screening CIPN at 3rd cycle of chemotherapy, 6th cycle, follow up to 3 months after cessation by using activity daily living screening tool (eviQ tool), to assess the incidence and severity of symptoms of peripheral neuropathy with objective gradation according to CTCAE V 4.3. Subjects in the study were divided into two groups to those younger than 60 years (group I, n = 63) and those elder or equal to 60 years (group II, n = 32). The incidence and severity of chemotherapy induced peripheral neuropathy in two groups were assessed by screening tools and clinical evaluation. ResultsThe incidence of CIPN was more in group II (16/32,IR=50%), (p = 0.282) than group 1 (26/63,IR=44.4%), (p= -0.053). Similarly, according to the CTCAE V4.3 grading, the severity of CIPN was more in group II (p = 0.400) than group I (p = -0.145). The between age groups comparison revealed that there is significant association between increased incidence and severity of CIPN in geriatric patients. ConclusionsGeriatric patients have greater risk for developing chemotherapy induced peripheral neuropathy (CIPN) when compared to younger use. Adequate use of supportive care would make the reduction in adverse effects, reduce treatment failures, thus allows adequate dosing of drugs and will improve quality of life. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

What is New in New Generation Calcium Channel Blocker

Hypertension is a multifactorial and multisystem disease in which elevated blood pressure is only one sign of multiple underlying physiological abnormalities. It affects approximately 26% of the population worldwide. Hypertension is one of the leading cause of death as a "silent killer". Several classes of antihypertensive agents have been in clinical use, but CCBs exert most potent antihypertensive action and are widely used as a first line antihypertensive drug in elderly with very few contraindication.Four generations of dihydropyridines CCBs are now available.The fourth-generation highly lipophilic dihydropyridines, lercanidipine, cilnidipine and lacidipine are now available which provide a real degree of therapeutic comfort in terms of stable activity, a reduction in adverse effects and a broad therapeutic spectrum. Cilnidipine is a recently developed CCB, and possesses both L- and N-type calcium channel blocking activity.Cilnidipine causing less reflex tachycardia, less pedal edema, better control of proteinuria, suppressing podocyte damage, increasing insulin sensitivity.This article reviews the current understanding of the pharmacological profile and clinical utility of cilnidipine as a unique antihypertensive drug.&#x0D; Anwer Khan Modern Medical College Journal Vol. 10, No. 1: Jan 2019, P 77-83

Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study.

As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited. The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated. In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery-Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36). Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively (p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively (p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants (p = 0.019), although this was non-significant after covarying for baseline values (p = 0.449). Quality of life improved in both groups with no significant between-group differences (p = 0.638). Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.

Is there really a benefit of using minimized cardiopulmonary bypass in CABG? A retrospective propensity score-matched study with 5000 cases.

The concept of minimized cardiopulmonary bypass targets at reduction of adverse effects triggered by extracorporeal circulation. In this study, benefits of minimized bypass in CABG were evaluated under particular consideration of patient body mass index and surgeon impact. From 2004 to 2014, 5164 patients underwent coronary bypass surgery (CABG). Conventional cardiopulmonary bypass (CCPB) was used in 2376 patients, minimized cardiopulmonary bypass (MCPB) in 2788 cases. Multivariate regression models were used in the entire cohort and in a propensity score-matched subgroup after expert CABG to figure out clinical differences such as mortality, postoperative renal function, and thromboembolic events. Overall mortality was 1.5% (n = 41) in the MCPB group and 3.5% (n = 82) in CCPB patients (p < 0.001). Postoperative renal failure and hemodialysis occurred in 2.6% (n = 72/MCPB) vs. 5.3% (n = 122/CCPB (p < 0.001). Multivariable regression revealed use of CCPB as risk factor for increased mortality (OR 2.01, p = 0.001), renal failure (OR 1.79, p < 0.001), and myocardial infarction (OR 1.98, p < 0.001) comparable to risk factors such as preoperative ventilation (OR 2.26, p = 0.048), diabetes mellitus (OR 1.68, p = 0.001), and cardiogenic shock (OR 3.81, p = 0.002). Body mass index had no effect on the analyzed outcome parameters (OR 0.92, p = 0.002). Propensity score-matching analysis of an expert CABG subgroup revealed CCPB as risk factor for mortality (OR 2.26, p = 0.004) and postoperative hemodialysis (OR 1.74, p = 0.017). Compared to conventional circuits, minimized bypass use in CABG is associated with lower mortality and less postoperative renal failure. A high body mass index is feasible and not a risk factor for MCPB surgery.

Assessment of the administration of maropitant and loperamide to dogs with cancer for the prevention and reduction of adverse effects associated with the administration of paclitaxel

To evaluate the efficacy of maropitant and loperamide for the prevention and reduction of adverse gastrointestinal effects associated with administration of paclitaxel to dogs with cancer. 168 dogs with cancer. The study comprised 2 phases. For phase 1, dogs in the intervention group were administered maropitant and loperamide followed by paclitaxel. Outcomes were compared with those for a control group that received only maropitant and paclitaxel. For phase 2, all dogs of phase 1 that did not receive maropitant and loperamide and that had adverse gastrointestinal effects were enrolled; they received maropitant and loperamide and another dose of paclitaxel. In phase 1, significantly fewer dogs in the intervention group had adverse effects. For dogs that had adverse effects, the intervention group had a lower severity of lack of appetite and lethargy. Also, adverse effects for dogs in the intervention group were of significantly shorter duration than for the control group. In phase 2, significant reductions in adverse effects were observed after administration of maropitant and loperamide. In those dogs that still had adverse effects after administration of maropitant and loperamide, there was a significant reduction in severity of signs of nausea and lethargy. A combination of maropitant and loperamide was found to be safe for use and effective for reducing or preventing signs of paclitaxel-induced gastrointestinal effects in dogs.