Authors defined the concept of drug packaging wastes,and analyzed the current administration of such waste recycling in China.With reference to experiences of other countries and Taiwan,the paper proposed to refine the legal framework for recycling drug packaging waste in China,by categorizing to set up the categorized recycling mechanism,and by refining the process to build the reverse logistics recycling system.

Objective To investigate the effects of berberine on tumor-associated macrophages (TAM)and the expression of cyclooxygenase-2 (COX-2)of intestinal polyps in Apc(Min/+) mice.Methods A total of 20 Apc(Min/+) mice,four weeks old,were equally divided into the control group and the berberine group,10 in each group.The mice of the control group drank plain water,while the mice of berberine group drank water with 0.1 % berberine.After 12 weeks,all the mice were sacrificed.The intestine and colon were isolated,and the numbers of polyps were counted.The expression of F4/80,inducible nitric oxide synthase-2 (iNOS),macrophage mannose receptor (MR)and COX-2 was detected by immunohisto-chemistry method.The relative expression of COX-2 at protein level was measured by Western blotting. The t test was performed for comparison between two independent groups.Results The total number of intestinal polyps,the number of small intestinal polyps and the number of colon polyps of the berberine group (11 .50±2.05 ,10.50±1 .77 and 1 .00±0.46,respectively)were all less than those of the control group (30.63±1 .69,28.00±2.00 and 2.63±0.74,respectively),and the differences were statistically significant (t=16.727,16.952 and 3.162,P =0.001 ,0.001 and 0.010,respectively).The percentage of F4/80 positive cells in the stroma of polyps of the berberine group ((17.40 ±4.23 )%)was less than that of the control group ((31 .24±6.34)%),and the difference was statistically significant (t =5 .327, P =0.043).The percentage of iNOS positive cells in the stroma of polyps of the berberine group ((7.43± 1 .78 )%) was higher than that of the control group ((2.72±0.68)%), and the difference was statistically significant (t=7.335 ,P =0.004).The percentage of MR positive cells in stroma of polyps of the berberine group ((19.52±1 .54)%)was less than that of the control group ((12.63±0.68)%),and the difference was statistically significant (t=5 .634,P =0.016).The percentage of COX-2 positive cells in stroma of polyps of berberine group ((3.38 ± 0.51 )%)was less than that of the control group ((7.60±0.57 )%),and the difference was statistically significant (t = 7.234,P = 0.001 ).The relative expression of COX-2 at protein level of polyps of the berberine group was lower than that of the control group. Conclusion Berberine may take the role in inhibiting the growth of intestinal polyps in Apc(Min/+) mice through interfering the differentiation of TAM in polyps and suppression the expression of COX-2.

Objective&Methods The mutagenicity of natural Borneol and synthetic Borneol was studied by using Ames test.Results Natural Borneol and Synthetic Borneol in the dose range of 0.4～250.0 ?g/plate had no effect in reducing the reversion frequencies of Salmonella Typhimurium histidine auxotrophic mutant(TA97,TA98,TA100,TA102)whether if metabolic activation system(S9mix)existed or not.Moreover,the backward mutant colony had normal background.Conclusion Natural Borneol and Synthetic Borneol do not possess evident mutagenicity under experimental condition.

Abstract: Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.

Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".

Traditional Chinese medicine (TCM) has a long history in treating infectious diseases, and the form of intervention varies with different medical conditions and disease types. "The battle field of Chinese doctor for anti-epidemic" was formed in fighting against severe acute respiratory syndrome (SARS) epidemics in China, and from the battle, valuable experiences of using TCM for prevention and treatment had been obtained. During responding to coronavirus disease 2019 (COVID-19) epidemics, we followed the principle of keeping summary and perfection while treament. And a whole process of TCM pattern or a model was organized, including early prevention in communities, cluster intervention in isolated places, comprehensive intervention in mobile cabin hospitals, centralized treatment in designated hospitals and rehabilitation support in rehabilitation posts. Thus, the innovation of whole process of TCM intervention was involved in the "trench warfare" strategy and platform system for prevention and treatment of new infectious COVID-19 epidemics. At different stages or conditions, different TCMs were used to play advantageous roles to solve various problems and elevate the effects of prevention and treatment of the disease. The construction of TCM mobile cabin hospitals was an innovation of organization form that might offset the constraints in technology and scale of simple community isolation or simple hospital treatment, exploring a new way for TCM to cope with public health emergencies.

Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.

Objective To investigate the morphological factors related to the rupture of very small (≤3mm) anterior communicating artery (AComA) aneurysms, which provides basis for decision-making of whether or not taking intervention in very small un-ruptured AComA aneurysms. Methods (1) One hundred patients with primary AComA aneurysms, admitted to our hospital from January 2008 to June 2013, were enrolled; 84 AComA aneurysms were ruptured while 16 were un-ruptured; the morphological parameters of aneurysms were obtained by three-dimensional reconstruction with CT angiography (CTA) of the patients, and the clinical data and aneurysm morphological parameters were compared between the ruptured aneurysm group and the un-ruptured aneurysm group; multivariate Logistic regression was used to analyze the risk factors of small aneurysm rupture in the AComA, and receiver operating characteristic (ROC) curve was used to analyze the predictive efficacy of size ratio (SR) of maximum tumor depth to proximal carrier artery diameter in rupture of small aneurysms in the AComA. (2) Ninety-nine patients with primary AComA aneurysms, admitted to our hospital from June 2013 to January 2016, were enrolled; the parameters from the above analyses were applied to these patients to verify their predictive effectiveness. Results (1) Perpendicular height, AR value (Height/Neck), SR value and vessel angle were significantly different between ruptured aneurysm group and un-ruptured aneurysm group (P<0.05); multivariate Logistic analysis indicated that SR value was the independent risk factor of rupture of very small AComA aneurysms (OR=4.201, 95％CI: 1.175-15.019, P=0.012), and the lager the SR value, the higher the risk of rupture; ROC curve analysis revealed that the area under the curve was 0.699 with the optimal cut-off value being 0.9, and its diagnostic sensitivity, specificity and accuracy was 0.786, 0.625 and 0.760, respectively. (2) The SR value was then applied to the 99 patients, showing a stable predictive potential with sensitivity, specificity and accuracy of 0.676, 0.714 and 0.687, respectively. Conclusion SR value (≥0.9) is identified as independent morphological risk factor for rupture of very small AComA aneurysms; SR value is closely related to the state of aneurysms, which help make a better individualized and effective decision on the treatment of very small AComA aneurysms in clinic.

Objective To investigate the application value of metronidazole combined with cefuroxime sodium in the laparoscopic treatment of patients with acute non-simple appendicitis.Methods The subjects were 80 patients with acute non-simple appendicitis who underwent laparoscopic appendectomy from July 2020 to June 2023.Among them,41 patients with acute non-simple appendicitis who were treated with metronidazole combined with cefuroxime sodium for laparoscopic surgery were used as the observation group,and 39 patients with acute non-simple appendicitis who were treated with metronidazole combined with ceftriaxone sodium for laparoscopic surgery were used as the control group.The intraoperative situation,inflammation control before and after surgery,postoperative recovery status,and adverse reactions after medication were compared between the two groups.Results There were no statistically significant difference between the two groups in terms of periappendiceal abscess/peritonitis,surgical time,and intraoperative bleeding,the differences were not statistically significant(P>0.05);The inflammatory indexes of acute non-simple appendicitis in both groups gradually returned to normal after surgery,and the white blood cell count,procalcitonin(PCT)and C-reaction protein(CRP)levels in the observation group showed greater decrease than those in the control group,the differences were statistically significant(P<0.05)on the first day and the third day after surgery.The duration of analgesics use and hospital stay in the observation group were(1.8±1.2)and(3.5±0.7)d,respectively,which were significantly shorter than those of(2.7±1.4)and(4.6±0.4)d,the differences were statistically significant(P<0.05).The incidence of intra-abdominal infection in the observation group was 7.7%,which was significantly lower than that of 24.4%in the control group,the difference was statistically significant(P<0.05).The adverse reactions in the two groups were 4.9%and 7.7%,respectively,and the difference was not significant(P>0.05).Conclusion Metronidazole combined with cefuroxime sodium combined with laparoscopic appendectomy can significantly reduce the incidence of abdominal infection in patients with acute non-simple appendicitis,it has high safety.

Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods: RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. Results: A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized. Conclusion Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.