OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution， providing a basis for optimizing the training system for committee members， improving the quality of ethical review， and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation， a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it， ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system， a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide， comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators （ethics and professional knowledge， ethics review ability， communication and expression ability， moral integrity and work style） and 39 secondary indicators （familiarity with the content of clinical trial-related laws and regulations， ability to complete project ethics review and identify ethical defects in research protocols within a short period of time， ability to judge the scientific value of clinical research， etc.）. The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge， ethical norms， review efficiency， risk judgment， and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training， qualification certification， and standardized management of ethics committees.

Aim To investigate the regulatory effect of morphine postconditioning in the LSG on remodeling after myocardial infarction. Methods SD rats were randomly divided into four groups: sham operation group (Sham), myocardial infarction group (MI), myocardial infarction + saline group (Control) and myocardial infarction + morphine postconditioning group (MI + Morphine) . The rat MI model was constructed by ligating the left anterior descending coronary artery, and then morphine was given to the LSG by percutaneous posterior approach. After four weeks, the changes of cardiac function in rats were detected by ultrasound. Masson staining was used to detect fibrosis changes; the expression of Collagen I and Collagen III protein was detected by Western blot. The mRNA expression of ANP and BNP was detected by RT-qPCR. The expression of JJLOR in LSG was detected by immunofluorescence. The concentration of catecholamine in plasma and myocardial tissue was detected by ELISA. Results Compared with the sham group, the cardiac function of the MI group was significantly impaired, the myocardial tissue showed significant fibrosis changes, and the concentration of catecholamine in plasma and myocardial tissue significantly increased. Compared with the control group, the MI + Morphine group reduced myocardial fibrosis collagen deposition in rats after MI, inhibited the expression of ANP and BNP in myocardial tissue, reduced the concentration of catecholamine, and improved the cardiac function of MI rats. Immunofluorescence results showed that JJLOR was expressed in LSG after MI and increased after morphine postconditioning. Conclusions This study shows that morphine postconditioning in the LSG has a protective effect on myocardial remodeling after myocardial infarction. The mechanism may be related to the activation of JJLOR in the LSG by morphine and the reduction of catecholamine release from sympathetic nerve endings.

Objective To explore the clinical effect of honey in preoperative bowel preparation for colonoscopy in hospitalized patients.Methods 87 patients from April 2022 to July 2022 and underwent preoperative bowel preparation for colonoscopy were selected as the research subjects.Convenience sampling was used to divide them into a control group(n=43)and an observation group(n=44).The control group received a conventional regimen of taking compound polyethylene glycol(PEG)electrolyte powder(Heshuang),while the observation group added 20 mL of honey to the Heshuang solution.Compare the cleanliness of intestine,and palatability of the taste,the incidence of adverse reactions,satisfaction of patients,and the rate of willingness for prepeat bowel preparation between the two groups.Results The intestinal cleanliness of the two groups of patients was equivalent,the difference was not statistically significant(P＞0.05).The incidence and severity of nausea,abdominal bloating,hypoglycemia,and anal irritation in the observation group were lower than those in the control group,the differences were statistically significant(P＜0.05).The observation group had better taste,patients satisfaction,and the willingness for prepeat bowel preparation compared to the control group,the differences were statistically significant(P＜0.05).Conclusion Honey can improve the taste of Heshuang,reduce the severity of oral adverse reactions,increase patient satisfaction,and increase the rate of willingness for prepeat bowel preparation.

Objective:To compare the postoperative effects of double eyelid surgery with different exophthalmos to find its influence on the surgery and necessary changes in preoperative design and during operation.Methods:A total of 50 female patients with single eyelid seeking beauty from June 2021 to March 2022 were selected from the Department of Plastic Surgery, Affiliated Hospital of Qingdao University. The ocular protrusion was measured by HETEL ophthalmostatometer before surgery. Both eyes at 12-15 mm were taken as normal group ( n=26), both eyes at 16-18 mm as mild protrusion group ( n=14) and both eyes at 19-22 mm as severe protrusion group ( n=10). All the patients were treated with double-eyelid surgery by orbital septum and unified postoperative nursing. Results:After six months of follow-up, there was no difference in eyelid width with closed eyes (all P>0.05). The width of double eyelid with open eyes in normal group was smaller than that in mild protrusion group ( F=23.23, all P<0.05), and the width of double eyelid with open eyes in mild protrusion group was smaller than that in severe protrusion group ( F=47.70, all P<0.05). There was no difference in the improvement rate of facial aesthetics among the three groups ( P>0.05). The " feeling of meet" and scar formation in the normal group were less than those in the mild protrusion group ( F=16.92, F=33.45, all P<0.05), and the " feeling of meet" and scar formation in the mild protrusion group were less than those in the severe protrusion group ( F=27.93, F=28.53, all P<0.05). The improvement rate of normal group was higher than that of mild and severe protrusion group (χ 2=7.25, 7.89, all P<0.05). There was no difference in the improvement rate between the mild and severe protrusion groups ( P>0.05). Conclusions:In clinical practice, it is necessary to make corresponding changes in the preoperative design and operation of double eyelid surgery for patients with high eyeball protrusion.

Objective: To analyze the difference of application methods and effects of local flap in small and medium-sized defects of different aesthetic subunits of nose, in order to provide reference for clinical work. Methods: A retrospective analysis was made on 59 patients with external nasal masses and scars who underwent surgical treatment in the Department of Aesthetic Plastic Surgery of the Affiliated Hospital of Qingdao University from July 1, 2021 to January 30, 2022, including 27 females and 32 males, aged 15 to 69 years. Using Likert scale, the repair methods and effects of local flap for nasal soft tissue defects were evaluated and summarized from three aspects of texture, flatness and scar concealment. GraphPad Prism 5.0 software was used for data statistics and analysis. Results: The use of skin flaps to repair small and medium-sized areas of the nose could achieve satisfactory results. For patients with different subunits, in terms of skin flatness and scar concealment degree in the operation area, patients' satisfaction with the dorsal and lateral nasal areas was higher than that of the alar and tip areas, respectively (F=6.40, P=0.001; F=10.57, P<0.001). For patients with different skin flap repair methods, the satisfaction of patients with Z-plasty and Dufourmentel skin flap was higher than that of other skin flap repair methods (F=4.38, P=0.002), and the satisfaction of patients with Dufourmentel skin flap was the highest in the degree of scar concealment (F=2.57, P=0.038). Conclusions: In the small and medium-sized defects of the nose, the use of multiple local flaps can achieve good cosmetic effects and functional recovery. The operator should select the appropriate flap repair method according to the characteristics of different aesthetic subunits of the nose.

Objective:To analyze the acupoint selection law of acupuncture for autism spectrum disorder (ASD) using data mining techniques.Methods:Literature related to acupuncture for ASD was retrieved from the CNKI, SinoMed, VIP, Wanfang, and PubMed databases from the establishment of the databases to April 1, 2022, and then a database of acupuncture prescriptions was established. The frequency analysis of acupoint use was performed using Microsoft Excel 2019; the Apriori algorithm was used to analyze the association law of acupoints/acupoint areas; SPSS 26.0 was used to perform intergroup cluster analysis.Results:A total of 97 relevant articles with 97 acupuncture prescriptions and 98 acupoints/acupoint areas were included. The most frequently used acupoint was Shenmen (HT 7). The acupoint area of Jin's three-needle therapy and the Governor Vessel acupoints are commonly used. The most frequently occurring part of the acupoint/acupoint area was the head, and the most commonly used specific acupoint was the rendezvous acupoint. Association rule analysis yielded 40 groups of acupoints/acupoint areas, and the most commonly used combination was Laogong (PC 8) and Shenmen (HT 7). Four categories were extracted among high-frequency acupoints/acupoint areas by cluster analysis.Conclusion:Acupuncture treatment for ASD mainly selects the head acupoints, mainly selecting the acupoint area of Jin's three-needle therapy and the Governor Vessel acupoints, and paying attention to the use of specific acupoints.

Applying Chinese medicine (CM) is an important strategy for malignant tumor treatment in China. One of the significant characteristics of CM is to treat diseases based on syndrome differentiation. For Western medicine, it is of important clinical significance to formulate guidelines for the diagnosis and treatment of cancer patients based on the characteristics of disease differentiation. In Chinese clinical practice, the combination of disease differentiation and syndrome differentiation is an important feature for cancer treatment in the past. Currently, molecular profiling and genomic analysis-based precision medicine optimizes the anticancer drug design and holds the greatest success in treating cancer patients. Therefore, we want to know which populations of cancer patients can benefit more from CM treatment if the theory of precision medicine is applied to CM clinical practice. So, we developed a novel diagnostic and therapeutic strategy "disease-syndrome differentiation-genomic profiling-prescriptions" for cancer patients by CM syndrome differentiation and precision medicine. As a result, this strategy has greatly enhanced the anti-tumor efficacy of CM and improved clinical outcomes for cancer patients with some gene mutations. Our idea will hopefully establish a novel approach for the inheritance and innovation of CM.
Antineoplastic Agents ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Neoplasms/therapy* ; Precision Medicine ; Syndrome

OBJECTIVE: To summarize and compare the clinical baseline characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS), primary light chain amyloidosis (pAL), multiple myeloma (MM), or MM with concurrent amyloidosis, especially the differences in cytogenetic abnormalities. METHODS: The clinical data of 15 cases of MGUS, 34 cases of pAL, 842 cases of MM and 23 cases of MM with concurrent amyloidosis were analyzed and compared retrospectively. RESULTS: Cytogenetic statistics showed that the incidence of t (11; 14) in the four groups (MGUS vs pAL vs MM vs MM with concurrent amyloidosis) was 0%, 33.3%, 16.4%, and 15.8%, respectively (P=0.037); that of 13q deletion was 20.0%, 14.7%, 45.8% and 56.5%, respectively (P<0.001); gain of 1q21 was 50.0%, 12.5%, 47.4% and 40.9%, respectively (P=0.001). Proportion of pAL patients with 0, 1 and≥2 cytogenetic abnormalities (including 13q deletion, 17p deletion, 1q21 amplification and IgH translocation) accounted for 41.9%, 41.9% and 16.1%, respectively; while the proportion of the same category in MM was 17.6%, 27.3%, and 55.2% respectively; this ratio of MM with concurrent amyloidosis was more similar to MM. Subgroup analysis showed that genetic abnormalities (including 13q deletion, 17p deletion and 1q21 amplification) were comparable within t (11; 14) negative and positive groups. Compared with positive cases, t(11; 14) negative patients with MM or MGUS were more likely to have 13q deletions and multiple genetic abnormalities. CONCLUSION Clinical characteristics of pAL, especially cytogenetic abnormalities, are significantly different from MM with concurrent amyloidosis. It suggests that although the onset characteristics are similar, actually the two diseases belong to different disease subtypes which should be carefully predicted and identified.
Amyloidosis ; Humans ; In Situ Hybridization, Fluorescence ; Monoclonal Gammopathy of Undetermined Significance/complications* ; Multiple Myeloma ; Retrospective Studies

Processing of Chinese medicinals with vinegar is one of the characteristic processing techniques. Vinegar is vital for the quality of vinegar-processed decoction pieces. However, there have been no specified standards for adjuvants. Through consulting relevant literature and monographs, we comprehensively reviewed the historical evolution of processing with vinegar in records, selection and application of vinegar, and summarized the relevant standards and current status of vinegar as an adjuvant in China. According to the records in literature, vinegar is effective in activating blood, moving qi, dispersing blood stasis, removing toxin, promoting appetite, and nourishing the liver. Traditionally, rice vinegar is chosen in processing. Nowadays, the vinegar made from rice under solid-state fermentation should be chosen. At present, only food standards can be taken for reference for vinegar in the processing. Integrative and specific inspection indicators are lacking, so the standards for adjuvants need to be improved urgently. In addition, the inadequacy in quality control and management is also a major problem to be solved. Through literature research, we reviewed the historical evolution and research advance in vinegar to provide a reference for the standardization and further research of vinegar used in the Chinese medicinal processing.
Acetic Acid ; Adjuvants, Pharmaceutic ; Drugs, Chinese Herbal ; Oryza ; Quality Control

Objective:To analyze and compare the differences between the epidemiological data and clinical indicators of confirmed and suspected undiagnosed cases of COVID-19 in Changning District， Shanghai. Methods:A retrospective comparative study was conducted. We included 20 confirmed and 34 suspected but undiagnosed COVID-19 cases from January 20 to February 29， 2020. We analyzed the differences in epidemiological history， early clinical symptoms， blood routine indicators， and clinical imaging characteristics between the two groups. Results:The epidemic status of COVID-19 in Changning District of Shanghai was mainly imported， and most cases were promptly confirmed. Early clinical symptoms of confirmed and suspected undiagnosed cases often manifested as respiratory symptoms such as fever and dry cough. Compared with the confirmed cases， the cell counts of leukocytes， eosinophils， and neutrophils in suspected undiagnosed cases were significantly higher. Also， the concentration of serum C-reactive protein in suspected cases was higher than that in confirmed cases （P=0.230）. The clinical imaging manifestations of confirmed cases were mainly ground glass opacity （GGO） scattered in both lung leaves， while the suspected undiagnosed cases mainly manifested as plain patch opacity， and the distribution of GGO was more irregular. Conclusion:There exists significant difference in blood routine indicators and clinical imaging features between confirmed and suspected cases of COVID-19.