Reduction Of Adverse Reactions Research Articles

Reduction of adverse reactions and correlation between post-vaccination fever and specific antibody response across successive SARS-CoV-2 mRNA vaccinations

BackgroundSARS-CoV-2 mRNA vaccination, recognized for high immunogenicity, frequently induces adverse reactions, especially fever. We previously reported a correlation between post-vaccination fever and specific antibody responses to the primary series and first booster. We herein report changes in adverse reactions and the correlation between post-vaccination fever and antibody responses across successive vaccinations, from monovalent to bivalent mRNA vaccines. MethodsThis cohort study was conducted at a Japanese hospital to investigate adverse reactions to the monovalent primary, first booster, and BA.4/5 bivalent BNT162b2 vaccinations. Local and systemic reactions were reported through a self-reporting diary after each dose. The spike-specific IgG titers were measured following each vaccination. ResultsAcross 727 vaccinations in the vaccine series, the bivalent booster induced fewer adverse reactions than earlier doses. Fever ≥ 38.0 °C was significantly less frequent in the bivalent booster (12.3 %) compared to the primary series and monovalent booster (22.0 %, 26.2 %, p < 0.001). Reaction severity was also reduced in the bivalent booster. In the analysis of 70 participants with complete data for all doses, post-vaccination fever ≥ 38.0 °C exhibited the highest relative risk (RR) among all solicited reactions throughout the vaccine series (RR: 5.24 [95 % CI: 2.40–11.42] for monovalent and 6.24 [95 % CI: 2.14–18.15] for bivalent). The frequency of fever ≥ 38.0 °C after all doses was 8.6 % (6/70), with no fever ≥ 39.0 °C across all vaccinations. A high-grade post-vaccination fever was correlated with higher IgG titers, with multivariate analyses confirming this correlation as independent for each dose and unaffected by previous post-vaccination fever. ConclusionsThe bivalent mRNA vaccine booster showed fewer and milder adverse reactions than the monovalent doses. Although vaccinees with a history of post-vaccination fever were more likely to experience fever after a subsequent dose, such recurrences were infrequent. A correlation between post-vaccination fever and increased IgG titers was identified for each vaccination, irrespective of post-vaccination fever history.

Evaluation of thermal shock therapy for reducing pain during intense pulsed light therapy: An intrapatient randomized controlled study.

Intense pulsed light (IPL) is used for the treatment and improvement of various skin issues. However, patients often experience local skin burning and pain after IPL treatment. Cooling and analgesic measures are indispensable. To investigate the clinical effect of thermal shock therapy on pain relief and reduction of adverse reactions during IPL therapy. A total of 60 female patients with facial photoaging who received IPL therapy were enrolled in the study. As a comparative split-face study, one side of the face was randomly selected as the control side. The other side was given thermal shock therapy before and after the IPL treatment immediately as analgesic side. The visual analog scale (VAS) was used to evaluate the pain degree of the patients. The telephone follow-ups regarding the occurrence of adverse reactions were conducted respectively on the 2nd day, 7th day, and 1 month after treatment. The VAS score and skin temperature of analgesia side was lower than that of control side at different stages of treatment. In terms of adverse reactions, the incidence of transient facial redness on the analgesic side was lower than that on the control side. Two patients showed slight secondary pigmentation on the control side, and the other patients showed no other adverse reactions on both sides. Thermal shock therapy assisted IPL therapy can reduce skin temperature during treatment, effectively relieve patients' pain, reduce the occurrence of adverse reactions caused by heat injury, and improve patients' comfort level.

Meta-analysis of the efficacy and safety of Xihuang Pills/capsules in adjuvant treatment of uterine cervical neoplasms.

Xihuang Pills/Capsules have a longstanding history of utilization in traditional Chinese medicine (TCM) for treating cancer. Nevertheless, a comprehensive investigation is required regarding the specific impacts and safety of Xihuang Pills/Capsules in individuals with uterine cervical neoplasms. Thus, conducting a meta-analysis is essential to evaluate the clinical effectiveness of combining Xihuang Pills/Capsules with Western medicine in patients with cervical neoplasms. The research involved searching 5 English and 4 Chinese databases for randomized controlled trials (RCTs) investigating the use of Xihuang Pills/Capsules in conjunction with Western medicine for treating uterine cervical neoplasms. Subsequently, statistical analysis was carried out using Review Manager software (version 5.3). This research encompassed 10 RCTs involving 937 patients. The findings revealed that the combination of Xihuang Pills/Capsules with Western medicine treatment led to improvements in various aspects of the patients' condition. Specifically, there was an enhancement in the short-term efficacy rate (risk ratio [RR] = 1.14, 95% confidence interval [CI]: 1.06-1.22, P = .0003), Karnofsky performance score (KPS) (mean difference [MD] = 5.90, 95% CI: 0.54-11.26, P = .03), survival rates, CD3+, CD3 + CD4+, CD3 + CD8+, CD3-CD56 + cells, and immunoglobulin M in patients with uterine cervical neoplasms. Moreover, the combination treatment resulted in a reduction of adverse reactions, including gastrointestinal reactions (RR = 0.52, 95% CI: 0.42-0.64, P < .00001), radiation proctitis (RR = 0.47, 95% CI: 0.33-0.68, P < .0001), myelosuppression (RR = 0.41, 95% CI: 0.26-0.64, P < .0001), as well as carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCC-Ag) levels. Additionally, the treatment exhibited an inhibitory effect on white blood cells (WBCs) and platelets (PLTs). The amalgamation of Xihuang Pills/Capsules with conventional anti-tumor therapy proves to be both effective and safe in the treatment of cervical neoplasms. However, further validation through high-quality RCTs is necessary to substantiate these findings.

Patient Preferences for Rescue Medications in the Treatment of Breakthrough Cancer Pain.

The discrete choice experiment (DCE) is conducted in this study to discuss Chinese cancer patients' risk-benefit preferences for rescue medications (RD) and their willingness to pay (WTP) in the treatment of breakthrough cancer pain (BTcP). Through literature reviews, specialist consultation, and patient surveys, this work finally included five attributes in the DCE questionnaire, i.e., the remission time of breakthrough pain, adverse reactions of the digestive system, adverse reactions of the neuropsychiatric system, administration routes, and drug costs (estimating patients' WTP). The alternative-specific conditional logit model is used to analyze patients' preferences and WTP for each attribute and its level and to assess the sociodemographic impact and clinical characteristics. A total of 134 effective questionnaires were collected from January, 1 to April, 5 in 2022. Results show that the five attributes all have a significant impact on cancer patients' choice of "rescue medications" (P<0.05). Among these attributes, the remission time after drug administration (10.0; 95%CI 8.5-11.5) is the most important concern for patients, followed by adverse reactions of the digestive system (8.5; 95%CI 7.0-10.0), adverse reactions of the neuropsychiatric system (2.9; 95%CI 1.4-4.3), and administration routes (0.9; 95%CI 0-1.8). The respondents are willing to spend 1182 yuan (95%CI 605-1720 yuan) per month for "rescue medications" to take effect within 15 minutes and spend 1002 yuan (95%CI 605-1760 yuan) per month on reducing the incidence of drug-induced adverse reactions in the digestive system to 5%. For Chinese cancer patients, especially those with moderate/severe cancer pain, the priority is to relieve the BTcP more rapidly and reduce adverse drug reactions more effectively. This study indicates these patients' expectations for the quick control of breakthrough pain and their emphasis on the reduction of adverse reactions. These findings are useful for doctors, who are encouraged to communicate with cancer patients about how to better alleviate the BTcP.

Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021

Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.

Study on the Effect and Mechanism of Paclitaxel-Succini Acid Drug-Loaded Nanofibers in Treating Lung Cancer.

In recent years, nanotechnology has made great progress in the development and application of tumor detection, diagnosis, and treatment, and eventually formed a "tumor nanomedicine." The emerging field of "materials." Nanoparticles have attracted much attention because they can overcome physiological barriers, effectively deliver hydrophobic drugs, and specifically target tumor tissues. At present, nanomedicines mainly include lipid nanoparticles, polymer nanoparticles granules, gold nanoparticles, magnetic nanoparticles, mesoporous silica, and other dosage forms. The use of nanomaterials as carriers in the treatment of lung cancer has unique advantages in achieving targeted drug delivery, slow-release drugs, and improvement of poorly soluble drugs and peptide drugs show obvious advantages in terms of bioavailability and reduction of adverse reactions, and have broad research and development prospects. This paper reports a new type of self-assembled Ptx-SA drug-loaded nanometers based on the carrier-free concept fiber, and it was found that the drug-loaded fiber has better cellophilicity, anti-tumor effect in vitro and in vivo than naked drug, and may be mediated by regulating the expression of related proteins. Therefore, the paclitaxel-loaded nano drug delivery system serves as a new type of nano preparation for treating lung cancer is worth further research.

Efficacy of Oncoxin-Viusid on the Reduction of Adverse Reactions to Chemotherapy and Radiotherapy in Patients Diagnosed with Cervical Cancer and Endometrial Adenocarcinoma

Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (CT) in patients with cervical cancer and endometrial adenocarcinoma impact quality of life and, therefore, outcomes of these therapies. Objective: To identify Oncoxin-Viusid’s efficacy in reducing acute toxicity produced by onco-specific treatments in patients with cervical cancer and endometrial adenocarcinoma. Materials and Methods: A controlled, randomised double-blind phase II clinical trial was performed with a sample size of 63 patients distributed into 2 groups: one receiving the standard treatment plus the Oncoxin-Viusid nutritional supplement (OV group) and another receiving the standard treatment and placebo (P group). The primary efficacy variable is the proportion of secondary disruptions to acute adverse reactions produced by RT and CT. Results: The number of patients suffering adverse events from chemotherapy was 20.6% less in the OV group (70.0%) than in the placebo group (90.6%) (p = 0.04). We recorded consistently normal values of haemoglobin (-6.2 OV group vs -8.3 P group, p = 0.009), platelet count (-17.4 OV group vs -27.6 P group, p = 0.009) and leukocytes (-31.8 OV group vs -41.4 P group, p = 0.025) in the OV group, tolerating 4 more cytostatic doses on average than the placebo group. Significant increase in quality of life (QLQ-30) was registered in the OV group with a large effect size on such issues as emotional and social function (Cohen’s d = 0.9), as well as in the reduction of symptoms like dyspnea 60%, insomnia 15% and anorexia 30% (item CX-2), (Cohen’s d = 0.98), which were higher than the placebo group. Conclusions: OV administration reduces onco-specific adverse events and improves quality of life in patients diagnosed with cervical cancer and endometrial adenocarcinoma undergoing radiation therapy and chemotherapy.

Systematic review and Meta-analysis of efficacy and safety of Huachansu in treating cancer-related pain

To evaluate the effectiveness and safety of Huachansu in the treatment of cancer-related pain,four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,PubMed) were systematically and comprehensively retrieved since the establishment of each database to October 2018. Randomized controlled trials( RCTs) for the treatment of cancer-related pain with Huachansu were screened out according to pre-established inclusion criteria and exclusion criteria. Rev Man5. 3 software was used for Meta-analysis. A total of 241 articles were retrieved,and finally 10 studies were included. The total sample size was 1 293,including 648 in the experimental group and 645 in the control group. The overall quality of the included studies was generally low. The results of Meta-analysis showed that Huachansu combined with Western medicine acesodynes was superior to the single use of Western medicine acesodynes in the treatment of short-term pain relief,improvement of quality of life and reduction of constipation,nausea and vomiting,dizziness,drowsiness,anorexia and other adverse reactions. And it also has the advantage of a shorter onset time and longer duration time of analgesia,but cannot reduce the incidence of dysuria. Based on the findings,Huachansu had a certain effect in the treatment of cancer-related pain,and a significant positive effect on the improvement of quality of life and the reduction of adverse reactions. No serious adverse reactions occurred. However,due to the small number of studies included,the low quality of the included studies,published biases and other restrictions,the evidence in this study has a low quality,and the conclusion shall be adopted with caution. The effectiveness and safety of Huachansu in the treatment of cancer-related pain remained to be further confirmed in the future with a well-designed,rigorous,and standardized report,with a large sample size,multiple centers,and sufficient follow-up time for randomized controlled trials.

Advantages and perspectives of using medicines in the form of auto injectors and prefilled syringes

Today, there is a need to introduce medical devices into everyday medical practice with the goal to self-administer injectional drugs. The speed and safety of auto-injectors / pre-filled syringe pens use (AI/PFS) is the introduction of an injectional form drug in a special medical device, which allows patients to enter a pre-designated therapeutic dose due to the characteristics of the structure of the product, automatic dosing, data of the interactive display on some devices, comfortable design, etc. Considering that AI/PFS were developed to improve the quality of life of patients with various pathological conditions, therefore the creation of affordable medical devices for low-income groups of the population is relevant today. Also an actual issue is the provision of high-quality first-aid kits for soldiers, which is a vital component for medical care in the context of active combat conditions and the lack of the required number of field hospitals.The speed of administration, the onset of effect and ease of use provides significant advantages for AI / PFS. Therefore, the issue of affordability for the low-income groups of the population and the army with the necessary drugs should be sufficiently supported by state regulation.Purpose of study – study of the international experience in the implementation and use of drugs (drugs) in the form of affordable, safe and effective modern dosage forms in the form of autoinjectors.Materials and methods – foreign and domestic literature on the use of AI/PFS in complex and monotherapy treatment of various diseases. State registries of medicines of Ukraine, the USA and some EU countries. The study used systematic, statistical and comparative analyzes, as well as the generalization of information. The data used is freely available among various medical scientific and metric bases, the Internet and international scientific conferences.The analysis of the use of AI/PFS indicates that today the world market of medicines and medical devices contains a large number of drugs under different trade names. However, many patients in the world refrain from using these dosage forms due to the significant cost of medical devices, which makes impossible the required regular use of such drugs for the low-income population groups. This is a significant disadvantage, since AI / PFS is implemented to correct not only chronic diseases such as rheumatoid arthritis, multiple sclerosis, but also to provide emergency careinurgent conditions (anaphylactic reactions, intense pain, etc.).In the global market for drugs and medical devices, injectable medicines in the form of AI/PFS are widely represented. The effectiveness of the use of such devices indicates the advantages and prospects for the use of existing AI/PFS on the global market for patients and medical personnel. Today, the most commonly used drugs in AI/PFSare for the treatment of diabetes, emergency conditions in civil and military medicine, chronic diseases of various etiologies, pediatric practice. The use of AI /PFS significantly improves patient compliance for the treatment of chronic diseases due to ease of use and reduction of adverse reactions at the site of administration. Most of the analyzed sources indicate a low level of economic affordability of drugs in the form of AI/PFS for the population and the government sector of drug supply due to the high cost of the medical devices, compared to traditional syringes. But the results of the study indicate a high level of advantages and prospects in the use of drugs in AI/PFS in medical practice for both medical personnel and patients.

The use of omalizumab in allergen immunotherapy.

Although omalizumab (anti-IgE) is currently only approved for the treatment of asthma and chronic idiopathic urticaria, it has also been studied as an off-label treatment for numerous allergic conditions, including use as an adjunct to allergen immunotherapy in the treatment of allergic rhinitis, asthma, venom hypersensitivity and food allergy. We conducted a review of publications involving the use of omalizumab with allergen immunotherapy, by searching PubMed with key search terms of "omalizumab" and "immunotherapy." Omalizumab has been used in combination with inhalant allergen immunotherapy for the treatment of seasonal allergic rhinitis and comorbid asthma. While there have been no randomized controlled trials evaluating the addition of omalizumab to venom IT, several case reports and small patient series have been published on the use of omalizumab with venom IT. Omalizumab has been used in conjunction with oral immunotherapy for the treatment of milk, peanut and egg, as well as other foods in multi-allergen protocols. In conclusion, omalizumab used in conjunction with immunotherapy has shown promising results, especially in the reduction of adverse reactions. At this stage, larger, randomized, placebo-controlled trials are needed to better identify those patients who would benefit the most from the addition of omalizumab to immunotherapy, as well as optimal dosing strategies and duration of treatment.

Niosomes: A Strategy toward Prevention of Clinically Significant Drug Incompatibilities

Drug incompatibilities are considered as one of the most critical problems in intensive care units. In the current study, the ability of nanomaterials to prevent drug incompatibilities in clinical settings has been investigated. As a proof-of-concept, the ability of niosomes to prevent physical and chemical incompatibilities that occur upon mixing acyclovir and vancomycin during management of acute meningitis has been explored. Nanosized spherical particles loaded separately with either vancomycin or acyclovir, with high entrapment efficiency (ca. 46–56%), could be prepared, and sustained release of their entrapped cargoes have been demonstrated over time. We have shown that precipitation, degradation and loss of biological activity of drugs occurred upon mixing solutions of the free drugs. On the contrary, drugs loaded separately inside niosomal structures exhibited high stability, exceptional physical and chemical compatibilities for up to 48 h with complete preservation of the antimicrobial activity of vancomycin. This study opens a venue for a new spectrum of applications of nanomaterials in preventing clinically significant drug incompatibilities, aiming at the reduction of adverse reactions, cost and hospitalization period, and improvement of patient compliance and therapeutic outcomes.

Photodynamic therapy: increasing acceptance through reduction of adverse reactions.

Photodynamic therapy: increasing acceptance through reduction of adverse reactions.

Role of clinical pharmacy in reduction of adverse reactions induced by traditional Chinese medicine

Objective To explore the role of clinical pharmacy in the reduction of adverse reactions induced by traditional Chinese medicine.Methods The incidence of adverse reactions induced by traditional Chinese medicine before application of clinical pharmacological intervention was compared with that after the application in October 2009.The traditional Chinese medicine formulations easier to cause adverse reactions,the manifestation of adverse reactions,the rate of adverse reactions by different routes of administration,and the risk factors were analyzed.Results 632 kinds of traditional Chinese medicine caused adverse reactions,which was consisted of 13 formulations.Injections had the highest rate of adverse reactions,accounting for 54.32％.The route of administration easiest to cause adverse reactions was intravenous drip.The main adverse reaction was skin and accessory damage,accounting for 43.51％.After clinical pharmacy intervention,the rate of adverse reactions induced by traditional Chinese medicine decreased obviously in our hospital,indicating clinical pharmacy played an important role.Conclusions Comprehensive pharmacological interventions has very important significance in the reduction of adverse reactions induced by traditional Chinese medicine. Key words: Clinical pharmacy; Adverse reactions induced by traditional Chinese medicine; Pharmacists; Effect; Rational medication uses

Enhancement of doxorubicin-induced antitumor activity and reduction of adverse reactions by cucurbitacin I

Using the concept of biochemical modulation, we have previously shown that cucurbitacin E enhances doxorubicin (DOX)-induced antitumor activity. Unlike cucurbitacin E, another derivative called cucurbitacin I has antioxidative ability. However, it is feared that the antioxidative ability of cucurbitacin I will improve DOX-induced adverse reactions whereas reduce its antitumor activity by cucurbitacin I induced suppression on DOX generated reactive oxygen species. In the present study, compared to DOX treatment alone, a combination of cucurbitacin I and DOX produced a significant increase in cytotoxicity (M5076 ovarian sarcoma cell) in vitro and decreased tumor size and weight with a significant increase in DOX concentration in the tumor, using M5076 ovarian sarcoma bearing mice in vivo. Furthermore, the combination significantly suppressed the DOX-induced increase in lipid peroxide (LPO) level in the heart, which is considered to be an index of DOX-induced cardiotoxicity. Thus, it was surmised that cucurbitacin I was responsible for reducing heart damage. It was speculated that the radical trapping effect of cucurbitacin I on free radical lipids directly suppressed the increase in LPO level and DOX-induced cardiotoxicity. Although cucurbitacin I did not have a significant effect on the DOX influx system, it suppressed DOX efflux and increased DOX concentration in tumor cells. In M5076 ovarian sarcoma cells, multidrug resistance-associated protein inhibitors significantly inhibited DOX efflux, similar to cucurbitacin I. Furthermore, cucurbitacin I significantly decreased glutathione (GSH) levels in tumors, similar to DL-buthionine sufoximine (an inhibitor of GSH synthesis). Thus, it is speculated that cucurbitacin I acted via both routes.Based on these results, we conclude that cucurbitacin I increases DOX-induced antitumor activity with enhanced cytotoxicity and elevates DOX levels, thereby inhibiting DOX efflux from tumor cells.

Agreement between medical record documentation and patient-reported use of nonsteroidal antiinflammatory drugs

Nonsteroidal antiinflammatory drugs (NSAIDs), one of the most frequently prescribed medication classes in adult outpatient medicine,1 have the potential to cause substantial toxicity.2 The gastrointestinal,3,–5 cardiovascular,6,–8 and renal9,–12 complications associated with NSAID use have received considerable attention. It has been estimated that NSAID-induced gastrointestinal complications result in the death of over 16,000 patients each year.3 Patients frequently fail to report concomitant use of nonprescription and prescription NSAIDs to their physicians. Serious adverse reactions may occur when nonprescription NSAIDs are used alone or in combination with other medications.3,–13 Two national surveys found that 38% of respondents took prescription and nonprescription NSAIDs.13 Of those respondents, 60% of those taking nonprescription NSAIDs were unaware of the drugs’ risks and 30% believed that there was less risk associated with taking nonprescription NSAIDs. Methods to better ascertain patient nonprescription and prescription NSAID use may assist in the development of educational interventions and reduction of adverse reactions.13

Issues Related to the Decennial Tetanus-Diphtheria Toxoid Booster Recommendations in Adults

In terms of disease prevention, reduction of adverse reactions, and cost benefit studies, a strong case can be made for a policy that focuses on assuring high levels of primary immunization with tetanus and diphtheria (Td) toxoids and abandons the decennial Td booster in favor of a single midlife booster at age 50-65 years. The addition of acellular pertussis antigens to Td for routine use in adults has potential problems in terms of schedule, cost, and possible adverse reactions. Careful risk/benefit studies are necessary to evaluate its effectiveness and priority.