Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

OBJECTIVE: To evaluate the early efficacy of local application of tranexamic acid on the osteotomy surface during hallux valgus surgery in reducing postoperative occult blood loss and thus postoperative swelling. METHODS: The data of 40 cases with hallux valgus osteotomy admitted to the Department of Foot and Ankle Surgery of Jishuitan Hospital from July 11, 2022 to October 8, 2022, including 5 males and 35 females were retrospectively analyzed. According to the inclusion and exclusion criteria, 32 cases were finally divided into 16 cases in the observation group (application of tranexamic acid) and 16 cases in the control group (no application of tranexamic acid). The observation group was paired with the control group one by one in accordance with the operation style, and the change in the anterior and posterior diameter of the first metatarsal head, the change in the circumferential diameter of the foot, the length of the first metatarsal midline and the length of the plumbline of the foot measured by postoperative CT were compared between the two groups before and after surgery, in order to evaluate the degree of swelling around the incision after the surgery. The first metatarsal midline and plumb line were measured by reference to the two auxiliary lines that intersect the soft tissue border in the sesamoid bone position to measure the rotation angle of the first metatarsal. A total of three clinicians completed the measurements of these two line segments and interobserver comparisons were performed. RESULTS: By interobserver comparison, the consistency of the length of the midline of the first metatarsal and the plumbline measured by CT was high and could be considered a reliable measurement. After the paired t-test, there was no statistical difference in the amount of changes in the anteroposterior diameter of the first metatarsal before and after surgery between the observation and control groups (P>0.05), and the amount of changes in the circumferential diameter of the foot before and after surgery was smaller in the observation group than in the control group, which was statistically significant (P < 0.05); the length of the midline of the first metatarsal and the plumbline of the foot measured by CT after surgery was smaller in the observation group than in the control group, which was statistically significant (P < 0.05). CONCLUSION Local application of tranexamic acid on the osteotomy surface during hallux valgus osteotomy can relieve postoperative swelling to some extent, which may be related to the fact that tranexamic acid reduces occult blood loss in the postoperative period.
Humans ; Hallux Valgus/surgery* ; Tranexamic Acid/administration & dosage* ; Female ; Male ; Osteotomy/adverse effects* ; Retrospective Studies ; Edema/etiology* ; Adult ; Middle Aged ; Postoperative Complications/prevention & control* ; Antifibrinolytic Agents/administration & dosage*

This study was aimed at performing epidemiologic investigation of the first psittacosis death case in Hangzhou City,to provide a reference for the investigation and disposal of psittacosis cases,as well as prevention and control.Epidemio-logic data were collected through field epidemiologic investigation,and close contacts and environmental samples were collected for pathogenicity testing.The first symptom in the patient was cough,which did not raise concerns at the time.Several days later,the patient developed abdominal distension and black stools,and visited two medical institutions for treatment and hospi-talization.The patient's sputum and peripheral blood were tested for Chlamydia psittaci infection by metagenomic analysis via next-generation sequencing.Samples collected from the patient's family members,close contacts,and home environment test-ed negative with real-time quantitative polymerase chain reaction.The patient later died of gastrointestinal bleeding.This article is the first report of a case of psittacosis contracted from exposure to a sick parrot in Hangzhou City,in a patient who died be-cause of an underlying disease.Operational training should be provided for medical personnel,and early diagnosis with mNGS and treatment of patients with underlying diseases should be performed as early as possible to avoid fatality.In addition,health education should be carried out to raise public awareness of the disease.

Objective:To evaluate the clinical efficacy of pushing reduction with our self-designed spinal fracture reduction device in the treatment of A3N0/1 thoracolumbar fractures.Methods:A retrospective study was conducted to analyze the medical records of 53 patients who had undergone surgery for thoracolumbar vertebrae fracture at Department of Minimally Invasive Spine Surgery, Zhengzhou Orthopedic Hospital from January 2019 to January 2022. All patients were treated by internal fixation via the Wiltse approach and bone grafting through the pedicle of the injured vertebrae. Clinical data: 35 males and 18 females; age: (37.8±10.2) years; injured segments: 23 cases at the thoracic spine and 30 cases at the lumbar spine; time from injury to surgery: (3.3±1.5) days. According to whether our self-designed spinal fracture reduction device was used or not, the patients were assigned into group A (23 cases) in which the injured vertebrae were pushed and reduced using our novel spinal fracture reduction device after vertebral distraction reduction by the pedicle screw and group B (30 cases) in which the injured vertebrae were distracted and reduced using the pedicle screw alone. The operation time, intraoperative blood loss and complications were compared between the 2 groups. The anterior vertebral body height ratio (AVBHr), middle vertebral body height ratio (MVBHr), posterior vertebral body height ratio (PVBHr), Cobb angle of the injured vertebra, visual analogue scale (VAS) and Oswestry disability index (ODI) at preoperation, postoperative 3 and 6 months, and the last follow-up were compared between the 2 groups.Results:There was no statistically significant difference in the preoperative general data between the 2 groups, indicating comparability ( P>0.05). All patients were followed up for (16.3±5.9) months. All incisions healed at one stage postoperatively without any related complications. The operation time in group A was significantly longer than that in group B [(115.1±16.6) min. versus (101.0±11.5) min.], the intraoperative blood loss in group A was significantly greater than that in group B [(136.5±17.0) mL versus (121.6±19.8) mL], the MVBHr at postoperative 3 months in group A (93.9%±4.0%) was significantly better than that in group B (83.3%±7.6%), and the MVBHr, AVBHr, Cobb angle, VAS, and ODI at the last follow-up in group A [86.6%±5.5%, 89.8%±4.1%, 4°(4°, 6°), 1 (0, 1) point, and 4.7%±2.0%] were significantly better than those in group B [78.0% (74.0%, 79.0%), 84.5%±4.9%, 12.2°±3.3°, 2 (1, 3) points, and 7.3%±2.7%] (all P<0.05). However, there was no statistically significant difference in PVBHr between the 2 groups at postoperative 3 months or at the last follow-up ( P>0.05). Conclusion:In the treatment of A3N0/1 thoracolumbar fractures, pushing reduction with our self-designed spinal fracture reduction device can directly and effectively reduce the fracture zone of the injured vertebra, which is conducive to maintaining postoperative vertebral reduction, reducing vertebral height loss and kyphotic deformity at a later stage, relieving lumbar pain and improving lumbar spine function.

COVID-19 has been prevalent for three years. The virulence of SARS-CoV-2 is weaken as it mutates continuously. However, elderly patients, especially those with underlying diseases, are still at high risk of developing severe infections. With the continuous study of the molecular structure and pathogenic mechanism of SARS-CoV-2, antiviral drugs for COVID-19 have been successively marketed, and these anti-SARS-CoV-2 drugs can effectively reduce the severe rate and mortality of elderly patients. This article reviews the mechanism, clinical medication regimens, drug interactions and adverse reactions of five small molecule antiviral drugs currently approved for marketing in China, so as to provide advice for the clinical rational use of anti-SARS-CoV-2 in the elderly.

Objective : To analyze the epidemiological characteristics and pathogen spectrum of hand，foot mouth disease (HFMD) in Anhui province from 2015 to 2022，and to provide scientific evidence for prevention and control measures of HFMD． Methods : The surveillance data of hand，foot and mouth disease in Anhui province from 2015 to 2022 were analyzed by descriptive epidemiology. Real-time PCR was used to detect and classify HFMD samples. Results : A total of 650 590 HFMD cases were reported in Anhui province from 2015 to 2022，including 1 406 se- vere cases and 17 deaths．The annual reported incidence was 131. 45 /100 000．The epidemic features of“low incidence in odd years and high incidence in even years”were presented from 2015 to 2019．The incidence showed a continuous decline from 2020 to 2022．The monthly distribution showed the characteristics of bimodal epidemic，and the main peak was not obvious in 2020．Hefei，Fuyang，Bozhou，Chuzhou and Suzhou ranked the top five cities in terms of cumulative incidence．The age of onset was mainly distributed in children aged 5 years and below，accounting for 89. 26% of the total cases．The male to female ratio was 1. 48 ∶ 1．A total of 28 657 laboratory-confirmed cases had been reported from 2015 to 2022．EV71 cases accounted for 10. 57% ，Cox A16 cases accounted for 24. 90% ，and other enterovirus cases accounted for 64. 53%．The dominant pathogens showed dynamic changes in different years．Since 2018，the proportion of EV71 decreased significantly，and the proportion of other enteroviruses gradually increased to become the dominant pathogens．Among other enteroviruses，Cox A6 strain was dominant (80. 48% ) ． Conclusion This study suggests that the prevention and control of HFMD in Anhui province should be paid more attention from April to July and from October to December．The focus areas are the cities in northern Anhui and Hefei where the floating population is large．The focus of prevention and control is on children aged 5 years and below．Other enteroviruses have become the dominant pathogens of hand-foot-mouth disease in Anhui province，Cox A6 strain is dominant.

Fourteen compounds were isolated from the n-butanol fraction of the 95% aqueous ethanol extract of the stems and twigs of Strychnos cathayensis by D101 macroporous resin, silica gel, ODS, Sephadex LH-20 column chromatography, and semipreparative RP-HPLC. Their structures were elucidated as ethyl 4-O-β-D-allopyranosyl-vanillate (1), n-butyl 4-O-β-D-allopyranosyl-vanillate (2), n-butyl 4-O-(6′-O-syringoyl)-β-D-allopyranosyl-vanillate (3), n-butyl 4-O-(6′-O-vanilloyl)-β-D-allopyranosyl-vanillate (4), n-butyl 4-O-(6′-O-syringoyl)-β-D-glucopyranosyl-vanillate (5), n-butyl 4-O-α-L-rhamnopyranosyl-syringate (6), methyl 3-methoxy-4-(β-D-allopyranosyloxy) benzoate (7), pseudolaroside B (8), butyl syringate (9), glucosyringic acid (10), methyl syringate (11), methyl 4-hydroxy-3-methoxybenzoate (12), clemochinenoside C (13), and clemoarmanoside A (14), respectively, on the basis of spectroscopic data interpretation and by comparison with literature information. Compounds 1-6 are artificial products of phenolic acid esterified by ethanol or n-butanol. It is noted that the precursors (4-O-(6′-O-syringoyl)-β-D-allopyranosyl-vanillic acid and 4-O-(6′-O-vanilloyl)-β-D-allopyranosyl-vanillic acid) of compounds 3 and 4 are new compounds. The hepatoprotective, anti-inflammatory, antioxidant and cytotoxic activities of compounds 1-13 were evaluated in vitro at a concentration of 10 μmol·L^-1. Compounds 1, 2 and 6-10 exhibited potential hepatic protection effects with cell survival rates ranging from 53.6% to 55.5% (acetaminophen, 45.4% at 8 mmol·L^-1). Compound 4 demonstrated anti-inflammatory activity with nitric oxide inhibitory rate of 74.6%. Compounds 3 and 5 showed potential antioxidant activities with malondialdehyde inhibitory rates of 53.2% and 56.1%, respectively.

AIM: To investigate the efficacy of micropulse laser combined with intravitreal injection of ranibizumab in the treatment of macular edema(ME)secondary to non-ischemic branch retinal vein occlusion(BRVO).METHODS: A total of 200 cases(200 eyes)of non-ischemic BRVO secondary to ME who were treated in our hospital from January 2020 to March 2022 were selected and divided into the control group(100 cases, 100 eyes)and the observation group(100 cases, 100 eyes)by random number table. The control group was given intravitreal injection of ranibizumab, and the observation group was given micropulse laser combined with intravitreal injection of ranibizumab. The best corrected visual acuity(BCVA), central macular thickness(CMT), subfoveal choroidal thickness(SFCT), total number of injections, macular leakage and complications were compared between two groups.RESULTS: After treatment, the BCVA of the two groups were improved, and the BCVA of the observation group was better than those in the control group at 1, 3, 6 and 12mo after treatment(all P<0.05). After treatment, the CMT and SFCT of the two groups decreased, and the CMT and SFCT of the observation group was lower than those in the control group at 1, 3, 6 and 12mo after treatment(all P<0.05). The total number of injections in the observation group during the treatment period was less than that in the control group [(4.06±1.12)times vs.(5.32±1.15)times](t=5.852, P<0.001). The leakage rates of the control group and the observation group after 12mo of treatment were 69.0% and 27.0% respectively, with statistical significance between the two groups(χ2=35.337, P<0.001). The incidence of complications in the control group and observation group were 11.0% and 5.0% respectively, with no statistical significance between the two groups(χ2=2.446, P=0.118).CONCLUSION: Micropulse laser combined with intravitreal injection of ranibizumab has a significant clinical efficacy in the treatment of ME secondary to non-ischemic BRVO, which is safe and can improve patients' vision and ME, reduce the total doses of ranibizumab without increasing the incidence of complications.

Objective: To investigate the infection sources and the transmission chains of three outbreaks caused by 2019-nCoV Omicron variant possibly spread through cross-border logistics in Beijing. Methods: Epidemiological investigation and big data were used to identify the exposure points of the cases. Close contacts were traced from the exposure points, and the cases' and environmental samples were collected for nucleic acid tests. Positive samples were analyzed by gene sequencing. Results: The Omicron variant causing 3 outbreaks in Beijing from January to April, 2022 belonged to BA.1, BA.1.1 and BA.2. The outbreaks lasted for 8, 12 and 8 days respectively, and 6, 42 and 32 cases infected with 2019-nCoV were reported respectively. International mail might be the infection source for 1 outbreak, and imported clothes might be the infection sources for another 2 outbreaks. The interval between the shipment start time of the imported goods and the infection time of the index case was 3-4 days. The mean incubation period (Q₁, Q₃) was 3 (2,4) days and the mean serial interval (Q₁, Q₃) was 3 (2,4)days. Conclusions: The 3 outbreaks highlighted the risk of infection by Omicron variant from international logistics-related imported goods at normal temperature. Omicron variant has stronger transmissibility, indicating that rapid epidemiological investigation and strict management are needed.
Humans ; Beijing ; SARS-CoV-2 ; COVID-19 ; Disease Outbreaks ; China/epidemiology*