Objective To mine the adverse drug event(ADE)signals of galcanezumab based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)to provide reference for clinical drug safety.Methods The data from the FAERS database from the third quarter of 2018 to the fourth quarter of 2023 were extracted.After data cleaning and standardization,the duplicate data was removed using structured query language,ADE reports with galcanezumab as the main suspected drug were screened.ADE reports were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities.The reporting odds ratio(ROR)method and information component(IC)method were applied for signal detection.Results A total of 60 ADE signals were detected after screening,11 system organ classes were involved,mainly general disorders and administration site conditions.The ADE signals that occurred most frequently were a variety of discomfort reactions at the injection site,consistent with the most common ADEs documented in the drug insert.The top 3 new ADE signals in order of occurrence frequency were alopecia,weight increased and constipation,and in order of ROR and IC values were injection site pustule,vertebral artery dissection and Raynaud's phenomenon.Conclusion ADE related to galcanezumab mainly involve systemic diseases and various reactions at the site of administration,among which vertebral artery dissection and Raynaud's phenomenon are stronger signals and newer ADEs.The patient's disease progression should be closely monitored during the treatment period to avoid serious consequences.

Objective:To explore the effects of home hospice care team service model in patients with end-stage malignant tumors and main caregivers, so as to provide intervention programs for improving the quality of life of patients with end-stage malignant tumors.Methods:In the prospective and controlled study, 106 patients with malignant tumors who received end-stage hospice care in Yuebei People′s Hospital and main caregivers from May 2021 to July 2021 were selected by convenience sampling method, and divided into trial group (53 pairs) and control group (53 pairs) according to the random number table method. The control group was treated with routine nursing intervention, and the trial group was given home hospice care team service model intervention based on the control group. The occurrence of falls and negative emotions and quality of life of patients, psychological stress of primary caregivers before and after intervention were observed by using Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Relative Stress Scale (RSS) and European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30).Results:Finally, 103 patients and main caregivers completed the study, with 52 pairs in the control group and 51 pairs in the trial group. In the control group, the patients were 29 males and 23 females, aged (54.33 ± 12.24) years old,and the main caregivers were 22 males and 30 females, aged (41.67 ± 8.14) years old. In the trial group,the patients were 27 males and 24 females,aged (55.17 ± 10.56) years old,and the main caregivers were 24 males and 27 females, aged (43.62 ± 7.39) years old. After intervention, the total incidence of falls and the total incidence of fall complications in the trial group were 7.84% (4/51) and 1.96% (1/51), respectively, which were lower than 25.00% (13/52) and 11.54% (7/52) in the control group, the differences were statistically significant ( χ2=5.50, 4.75, both P<0.05). There was no significant difference in the score of SAS, SDS, RSS, EORTC QLQ-C30 before intervention between the two groups (all P>0.05). After intervention, the scores of SAS and SDS in trial group were (32.66 ± 3.18), (31.19 ± 4.50) points,which lower than those in control group (34.54 ± 3.91), (34.31 ± 4.03) points, the differences were statistically significant ( t=2.67, 2.51, both P<0.05). After intervention, the RSS scores of psychological distress, life disruption, negative emotion and total score of the main caregivers in trial group were (3.52 ± 0.48), (3.66 ±0.56), (3.47 ± 0.82), (10.65 ± 0.67) points, which were lower than those in the control group (4.74 ± 2.75), (4.67 ± 2.64), (4.12 ± 2.13), (13.53 ± 2.26) points, the differences were statistically significant ( t values were 2.04-8.73, all P<0.05). After intervention, the EORTC QLQ-C30 score in the trial group was (74.14 ± 5.64) points, which was lower than that in the control group (70.54 ± 7.07) points, the difference was statistically significant ( t=2.85, P<0.05). Conclusions:The application of home hospice care team service model can effectively reduce the risk of falls in patients with malignant tumor chemotherapy, improve the negative emotions of patients and the psychological stress state of their main caregivers, and improve the quality of life of patients.

Jianwei Xiaoshi tablets， as a common variety of Chinese patent medicine with "one product with many manufacturers"， have many manufacturers and huge market sales. However， the phenomenon about uneven quality and discrepant price is prominent. Based on this， this study was carried out for the quality evaluation of Jianwei Xiaoshi tablets by applying the high-quality evaluation criteria with the quality as core for Chinese patent medicine， which was based on the full production cycle， from the multi-dimension including raw material selection， production process， quality control， post-marketing research and so on. The evaluation results showed that the quality evaluation scores of Jianwei Xiaoshi tablets from different manufacturers varied greatly （ranging from 35 to 66）， indicating that the quality was significantly different. In the actual production， generally inadequate attention was paid to the quality of raw materials， and the quality of raw materials was insufficient with the score ratio of 43%， especially the poor consistency control of them. The role of good manufacturing practice was obvious， and the scores of production process were generally high with the average score ratio of 62%， and the maximum up to 80%. The technological advancement of the manufacturer was outstanding. The score ratio of quality control was only 31% that the internal quality standard of each manufacture almost stayed at the qualified line， which was equal to the national standard， and the consistency of products was insufficient. The post-marketing research was lacking with the score ratio of 37%. Manufacturers with high brand awareness and market share were upper scores， while the others lagged far behind. The results of this evaluation are in line with the overall prediction， which can provide a reference for the high-quality evaluation of Chinese patent medicine， and supply the scientific data for high-quality and high-price application.

Objective:To investigate the efficacy of pixel 2 940 nm erbium laser combined with vitamin B12 in the treatment of acne sunken scar.Methods:From July 2017 to June 2019, 96 patients with acne sunken scar were treated in the Department of Burn and Plastic Surgery of the Second People＇s Hospital of Jiaozuo City, Henan Province. They were randomly divided into two groups with 48 cases in each group. The control group was treated with routine therapy and the observation group was treated with pixel 2 940 nm erbium laser combined with vitamin B12. The therapeutic effects, acne scar weight score (ECCA), skin condition and adverse reactions were compared between the two groups.Results:The total effective rate of the control group was 77.08% (37/48), which was lower than that of the observation group 91.67% (44/48) ( P<0.05); The incidence of adverse reactions, pore and amethyst in ECCA score of the control group were (18.14±9.33), 18.75% (9/48), (32.25±8.41) and (18.24±5.12), which were higher than those of the observation group (26.45±12.60), 4.17% (2/48), (28.24±7.52) and (15.63±4.34) ( P<0.05), respectively. Conclusions:Pixel 2 940 nm erbium laser combined with vitamin B12 is effective in the treatment of acne sunken scar, with less adverse reactions and high safety. It is worthy of clinical application.

Objective: To understand indoor air quality in middle and primary schools of Hangzhou in autumn and winter seasons, and to provide references of promoting indoor air quality of schools. Methods: Totally 33 classrooms of 11 schools in urban area were selected into study during Sept.2018 to Jan.2019. Daily measurements of PM2.5 and CO2 were performed in selected classes during school working time by air quality monitors. Totally, monitoring data of 35 964 hours were analyzed using univariate and multiplicity analysis for PM2.5 and CO2 level, variability and possible influence factors. Results: In autumn and winter, hourly average values of classroom PM2.5 and CO2 concentration level in Hangzhou were between 35.30 to 74.65 μg/m3 and between 949.17 to 2 029.98 mg/m3, respectively. The concentration levels of PM2.5 and CO2 were higher with the temperature(F=1 412.84, 775.66, P<0.01). No statistical significance was be found for the difference of PM2.5 concentration among monitoring times. Wave changes in CO2 were observed with time variation PM2.5 and CO2 concentration level of 68.42% monitoring times was complied with standards. School type and temperature correlated with PM2.5 concentration level. The PM2.5 concentration level in senior high school was higher than that in junior high school, while the value in primary school was the minimum(β=0.44, P<0.01). And the PM2.5 concentration increased with the temperature decreased(β=8.31, P<0.01). School type, temperature and monitoring time correlated with CO2 concentration level. CO2 concentration increased with the increase of grade, decrease in temperature and later time during the day(β=213.64, 162.38, P<0.01). The CO2 concentration level in later monitoring time was lower than that in earlier monitoring time(β=-16.28, P<0.01). Conclusion Classroom CO2 concentration level in Hangzhou was closed to that in European schools, while PM2.5 concentration level was much higher. Comparing with other cities in China, classroom PM2.5 and CO2 concentration level in Hangzhou is better. The results highlighted that school location, design and routine management should be advanced consideration for good air quality in classroom.

Objective    To summarize the clinical experience in the treatment of high-risk patients with severe aortic valve disease by transcatheter aortic valve implantation (TAVI) via heart apex approach and to evaluate the early efficacy. Method    Five patients who underwent TAVI via heart apex approach from September 2017 to February 2019 in Henan Thoracic Hospital were retrospectively analyzed, including 3 males and 2 females, aged 65-84 (74.6±4.5) years. Result    All operations were performed through a small left incision into the thoracic cavity (3-5 cm), and then through the J-Valve transport system, the aortic valve was successfully released via heart apex after precise positioning under digital subtraction angiography. One patient developed ventricular fibrillation during the operation, and the operation was completed with the assistance of emergency femoral arteriovenous catheterization cardiopulmonary bypass; one patient underwent percutaneous coronary intervention first because of severe coronary stenosis; one patient had paroxysmal atrial fibrillation during the perioperative period, and had hepatorenal insufficiency and thrombocytopenia after the operation, and was improved after medical treatment; one patient had perivalvular leak during the operation, and was improved after re-implantation of the valve; one patient was in stable condition during operation and recovered smoothly after operation. Surgery was successful in all 5 patients. The follow-up time was 2-19 months, and the early clinical effect was good. Conclusion    The short-term clinical efficacy of TAVI via heart apex approach in the treatment of high-risk severe aortic valve disease is definite and safe, but the long-term and medium-term effects need to be further evaluated.

In this study, we explored the rationality of processing methods and mechanism of Aconiti Lateralis Radix (Fuzi) through comparing the chemical contents of diester alkaloids (DAs) and monoester alkaloids (MAs) in the raw material of Fuzi and its processed products. The results showed that the toxicity potency of MAs is at least lower than 1/64 to 1/180 of the toxicity potency of DAs. The contents of DAs in processed Fuzi decreased to 1/76.5 to 1/38.3 of the value of raw Fuzi. The contents of MAs in processed Fuzi significantly increased by 4.6 to 5.2 fold or basically the same as that of the raw Fuzi. The values of MAs/DAs of processed Fuzi were enhanced by 30 to 390 fold of the raw Fuzi. It was found that the contents of DAs were insignificantly different between "Wu dan fu pian" (steaming or stir-frying without Danba) and "Dan fu pian" (steaming or stir-frying with Danba). The result suggested that the abilities of "eliminating toxicity" of different processing methods were equivalent at all. In contrast, the contents of MAs contained in "Wu dan fu pian" were of 5.3 to 8.7 fold higher than the values in "Dan fu pian". This result suggested the processing method by steaming or stir-frying without Danba might have better effect for "conserving property" than the method processed with Danba stipulated by China Pharmacopoeia. We believe that the new processing method without Danba can be recommended in further application due to it offers a simple procedure and it will not introduce inorganic impurities in the products.

The prepared slices of Chinese crude drugs are growing important in recent years, and faced with new developments and opportunities. The author analyzed the importance of formulate national processing procedures of prepared slices of Chinese crude drugs combined actual work, proposed the overall objectives and tasks for the formulation, and emphasized to need to correctly deal with several important factors during the process of formulate "National processing procedures of prepared slices of Chinese crude drugs", unified the national standards of prepared slices, solved the real problems that the prepared slices of Chinese crude drugs industry faced.
Chemistry, Pharmaceutical ; methods ; standards ; China ; Drugs, Chinese Herbal ; chemistry ; Humans ; Medicine, Chinese Traditional ; methods ; standards

White spot syndrome virus (WSSV) is one of the most important pathogens in shrimp farm throughout the world. Many researches on WSSV have been done, but no efficient approach has been gained to protect and cure the disease. In this study, we constructed a single-chain fragment variable (scFv) antibody library displayed on phage using spleen cells from mice immunized with denatured WSSV. After several rounds of panning respectively against purified intact WSSV virions and purified VP28 expressed in Escherichia coli, five novel scFv antibodies specifically against WSSV were selected, one of which, clone P75E8, recognized a linear epitope. The location in virions of the epitopes recognized by the five scFv clones was determined by immunoelectron microscopy. This study provides a new way to obtain more different antibodies specifically binding to WSSV, and especially provides a new strategy to obtain scFvs against linear epitopes.
Amino Acid Sequence ; Animals ; Antibodies, Viral ; immunology ; Antibody Specificity ; immunology ; Antigens, Viral ; immunology ; Epitopes ; immunology ; Immunoglobulin Fragments ; genetics ; immunology ; Immunoglobulin Variable Region ; genetics ; immunology ; Mice ; Molecular Sequence Data ; Penaeidae ; virology ; Peptide Library ; White spot syndrome virus 1 ; immunology

OBJECTIVE: To study the expression of Eotaxin and Eotaxin-2 in nasal polyposis and nasal polyp and explore the different mechanism between polyposis and polyp. METHOD: Fifteen cases of nasal polyposis, thirteen cases of polyp and eight cases of normal middle turbinate were studied with immunohistochemical SP method to detect the expression of Eotaxin and Eotaxin-2. RESULT: There were significant differences between either two groups about the expression of Eotaxin-2 (P < 0.05). The expression of Eotaxin in nasal polyposis and polyp were dramatically higher than in controls (P < 0.05), the expression of Eotaxin between nasal polyposis and polyp was no remarkable difference (P > 0.05). CONCLUSION Both of Eotaxin and Eotaxin-2 likely play key roles in the inflammatory reaction process of nasal polyposis and polyp. The different expression of Eotaxin-2 between nasal polyposis and polyp demonstrates it may be one of the main causes in the different mechanism of the two diseases.
Adolescent ; Adult ; Chemokine CCL11 ; metabolism ; Chemokine CCL24 ; metabolism ; Child ; Female ; Humans ; Male ; Middle Aged ; Nasal Polyps ; metabolism ; pathology ; Young Adult