Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Objective To verify the effectiveness of the"10S"management method in improving the efficiency of the traditional Chinese medicine pharmacy.Methods A controlled experiment was conducted to compare the expenditure on daily supplies,the environment of the place,the pharmacists'competence in pharmacy services,the quality and efficiency of the dispensing work,the error rate of dispensing,and the patients'satisfaction to the traditional Chinese medicine pharmacy,using the period before the implementation of the"10S"management(January to July 2022)as the control group and the period after the implementation of the"10S"management(January to July 2023)as the experimental group.Results After the implementation of the"10S"management,the daily expenditure of the Chinese medicine pharmacy was reduced,the place was tidy and orderly,the pharmacists'competence in pharmacy services was significantly improved,the quality and efficiency of the dispensing work were significantly improved,the dispensing error rate was reduced,and the patients'satisfaction was further enhanced.The data showed that the dispensing time of the Chinese medicine pharmacy was reduced from(7.77±0.21)min to(6.64±0.27)min during the busy phase,and the average dispensing time was reduced from(32.44±1.32)min to(17.05±2.23)min during the busy phase.Conclusion The"10S"management method is recommended to be promoted in traditional Chinese medicine pharmacies to improve the efficiency and service quality of Chinese pharmacists.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Since the end of 2019,severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection has swept the world,bringing great harm to human society and significantly increasing the health burden.Due to stron-ger infectivity,faster transmission,and higher reinfection rate of the Omicron variant,it has now replaced the Delta variant as the main epidemic strain for both imported and local outbreaks in China.Chinese Diagnosis and treatment protocol for SARS-CoV-2 infection(10th trial version)emphasizes"strengthening the protection of key popula-tions,"which includes the increasing number of immunocompromised population.These people have a high inci-dence of severe diseases and a high fatality rate after infected with SARS-CoV-2,and belong to the high-risk popula-tions of severe or critical diseases.Moreover,due to underlying diseases,these people take immunosuppressants and other related drugs chronically.The interactions between anti-SARS-CoV-2 infection treatment drugs and origi-nal drugs are complicated,thus bring significant challenges to the treatment after the SARS-CoV-2 infection.Cur-rently,there is a lack of guidelines or consensus on the diagnosis and treatment of SARS-CoV-2 infection among im-munocompromised population.Therefore,the Guangzhou Institute of Respiratory Health and National Center for Respiratory Medicine organized experts from multiple disciplines(respiratory and critical care medicine,organ transplantation,rheumatology and immunology,hematology,infection,critical care medicine,etc.)in China.Af-ter multiple rounds of discussions,13 items of recommendations are made as the reference for peers based on evi-dence-based medical evidence,so as to provide a theoretical and practical reference for the diagnosis and treatment strategies of this population.

Humans ; Hematopoietic Stem Cell Transplantation ; Hemoglobinopathies/therapy* ; Hemoglobins, Abnormal

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
Tibet ; Medicine, Tibetan Traditional ; Quality Control ; Pharmaceutical Research ; Drug Industry

Through consulting the ancient herbs， medical books and modern literature， this paper made textual research on the name， origin， producing area， quality evaluation， collection and processing of medicinal materials of Sang （Mori Folium， Mori Cortex， Mori Ramulus， Mori Fructus） in famous classical formulas， in order to provide a basis for the development of famous classical formulas containing medicinal materials of Sang. According to the research， Mori Folium and Mori Cortex were first used as medicines in Shengnong Bencaojing ， Mori Ramulus was first used as medicine in Jinxiaofang， and Mori Fructus was first used as medicine in Xinxiu Bencao. Before the Tang dynasty， there were Nyusang and Shansang. Since Tang dynasty， there were many sources of medicinal materials of Sang， including Baisang （Morus alba）， Jisang （M. australis）， Shansang （M. mongolica）， etc. According to textual research， the mainstream varieties were M. australis， M. alba and their cultivated varieties. In modern times， according to the relevant information and the Chinese Pharmacopoeia， M. alba is the original base. In ancient times， the origin of mulberry changed with the development of sericulture， mulberry has been widely planted since the Song dynasty. In the Ming and Qing dynasties， mulberry has been planted most in Jiangsu and Zhejiang. In modern times， they are mainly produced in Jiangsu， Zhejiang， Anhui， Hunan and other places. In recent years， due to the related policies and strategies such as "moving silkworms from east to west"， the center of silkworm breeding has gradually transferred to the west. As for the quality evaluation and harvesting and processing of mulberry medicinal materials， Most of the ancient and modern records of Mori Folium are the same. They are harvested after frost， and dried after removing impurities. The quality is better when the leaves are large and thick， yellowish green， holding prickly hands and undergoing frost. The harvesting period of Mori Cortex is slightly different in ancient and modern records. Ancient books record that it can be harvested all the year round， but in modern times， it is mostly harvested from late autumn to the next spring. The processing methods include removing soil and fibrous roots， scraping off yellow-brown rough skin， peeling off white skin and drying in the sun. The quality is better when they are white， thick， flexible， free of rough skin and full of powder. There are few records about the collection， processing and quality evaluation of Mori Ramulus and Mori Fructus in ancient Chinese herbal books. According to modern literature， Mori Ramulus is usually collected in late spring and early summer， with leaves removed， slightly dried， sliced while fresh， and dried in the sun. The best quality of Mori Ramulus is fine and tender with the yellow and white section. Mori Fructus is harvested from April to June when the fruit turns red， and dried in the sun， or slightly steamed and dried in the sun， and it is better to be big， dark purple， oily and thick. There are many processing methods of mulberry medicinal materials. Ancient books record stir frying， baking， burning and steaming of Mori Folium， in modern times， there is honey-roasted method， but most of them are used as raw products. In ancient materia medica， Mori Cortex has firing method， baking method， stir-frying method， honey-fried method， etc. In modern times， there are stir-fried and honey-fried methods， and most of them are used as raw products. Ancient books record that Mori Ramulus has cutting and frying methods， while modern ones have cutting， frying， wine-processed and bran-processed methods. Processing methods of Mori Fructus are consistent in ancient and modern times， and they are mostly dried after being cleaned or steamed. Based on the research results， it is suggested that M. alba should be selected as mulberry medicinal materials in the famous classical formulas， and appropriate medicinal parts and processing methods can be selected according to the indications of the famous classical formulas.

Objective:Surgical site infection (SSI) can markedly prolong postoperative hospital stay, aggravate the burden on patients and society, even endanger the life of patients. This study aims to investigate the national incidence of SSI following abdominal surgery and to analyze the related risk factors in order to provide reference for the control and prevention of SSI following abdominal surgery.Methods:A multicenter cross-sectional study was conducted. Clinical data of all the adult patients undergoing abdominal surgery in 68 hospitals across the country from June 1 to 30, 2020 were collected, including demographic characteristics, clinical parameters during the perioperative period, and the results of microbial culture of infected incisions. The primary outcome was the incidence of SSI within postoperative 30 days, and the secondary outcomes were ICU stay, postoperative hospital stay, cost of hospitalization and the mortality within postoperative 30-day. Multivariable logistic regression was used to analyze risk factors of SSI after abdominal surgery.Results:A total of 5560 patients undergoing abdominal surgery were included, and 163 cases (2.9%) developed SSI after surgery, including 98 cases (60.1%) with organ/space infections, 19 cases (11.7%) with deep incisional infections, and 46 cases (28.2%) with superficial incisional infections. The results from microbial culture showed that Escherichia coli was the main pathogen of SSI. Multivariate analysis revealed hypertension (OR=1.792, 95% CI: 1.194-2.687, P=0.005), small intestine as surgical site (OR=6.911, 95% CI: 1.846-25.878, P=0.004), surgical duration (OR=1.002, 95% CI: 1.001-1.003, P<0.001), and surgical incision grade (contaminated incision: OR=3.212, 95% CI: 1.495-6.903, P=0.003; Infection incision: OR=11.562, 95%CI: 3.777-35.391, P<0.001) were risk factors for SSI, while laparoscopic or robotic surgery (OR=0.564, 95%CI: 0.376-0.846, P=0.006) and increased preoperative albumin level (OR=0.920, 95%CI: 0.888-0.952, P<0.001) were protective factors for SSI. In addition, as compared to non-SSI patients, the SSI patients had significantly higher rate of ICU stay [26.4% (43/163) vs. 9.5% (514/5397), χ 2=54.999, P<0.001] and mortality within postoperative 30-day [1.84% (3/163) vs.0.01% (5/5397), χ 2=33.642, P<0.001], longer ICU stay (median: 0 vs. 0, U=518 414, P<0.001), postoperative hospital stay (median: 17 days vs. 7 days, U=656 386, P<0.001), and total duration of hospitalization (median: 25 days vs. 12 days, U=648 129, P<0.001), and higher hospitalization costs (median: 71 000 yuan vs. 39 000 yuan, U=557 966, P<0.001). Conclusions:The incidence of SSI after abdominal surgery is 2.9%. In order to reduce the incidence of postoperative SSI, hypoproteinemia should be corrected before surgery, laparoscopic or robotic surgery should be selected when feasible, and the operating time should be minimized. More attentions should be paid and nursing should be strengthened for those patients with hypertension, small bowel surgery and seriously contaminated incision during the perioperative period.

Objective:Surgical site infection (SSI) can markedly prolong postoperative hospital stay, aggravate the burden on patients and society, even endanger the life of patients. This study aims to investigate the national incidence of SSI following abdominal surgery and to analyze the related risk factors in order to provide reference for the control and prevention of SSI following abdominal surgery.Methods:A multicenter cross-sectional study was conducted. Clinical data of all the adult patients undergoing abdominal surgery in 68 hospitals across the country from June 1 to 30, 2020 were collected, including demographic characteristics, clinical parameters during the perioperative period, and the results of microbial culture of infected incisions. The primary outcome was the incidence of SSI within postoperative 30 days, and the secondary outcomes were ICU stay, postoperative hospital stay, cost of hospitalization and the mortality within postoperative 30-day. Multivariable logistic regression was used to analyze risk factors of SSI after abdominal surgery.Results:A total of 5560 patients undergoing abdominal surgery were included, and 163 cases (2.9%) developed SSI after surgery, including 98 cases (60.1%) with organ/space infections, 19 cases (11.7%) with deep incisional infections, and 46 cases (28.2%) with superficial incisional infections. The results from microbial culture showed that Escherichia coli was the main pathogen of SSI. Multivariate analysis revealed hypertension (OR=1.792, 95% CI: 1.194-2.687, P=0.005), small intestine as surgical site (OR=6.911, 95% CI: 1.846-25.878, P=0.004), surgical duration (OR=1.002, 95% CI: 1.001-1.003, P<0.001), and surgical incision grade (contaminated incision: OR=3.212, 95% CI: 1.495-6.903, P=0.003; Infection incision: OR=11.562, 95%CI: 3.777-35.391, P<0.001) were risk factors for SSI, while laparoscopic or robotic surgery (OR=0.564, 95%CI: 0.376-0.846, P=0.006) and increased preoperative albumin level (OR=0.920, 95%CI: 0.888-0.952, P<0.001) were protective factors for SSI. In addition, as compared to non-SSI patients, the SSI patients had significantly higher rate of ICU stay [26.4% (43/163) vs. 9.5% (514/5397), χ 2=54.999, P<0.001] and mortality within postoperative 30-day [1.84% (3/163) vs.0.01% (5/5397), χ 2=33.642, P<0.001], longer ICU stay (median: 0 vs. 0, U=518 414, P<0.001), postoperative hospital stay (median: 17 days vs. 7 days, U=656 386, P<0.001), and total duration of hospitalization (median: 25 days vs. 12 days, U=648 129, P<0.001), and higher hospitalization costs (median: 71 000 yuan vs. 39 000 yuan, U=557 966, P<0.001). Conclusions:The incidence of SSI after abdominal surgery is 2.9%. In order to reduce the incidence of postoperative SSI, hypoproteinemia should be corrected before surgery, laparoscopic or robotic surgery should be selected when feasible, and the operating time should be minimized. More attentions should be paid and nursing should be strengthened for those patients with hypertension, small bowel surgery and seriously contaminated incision during the perioperative period.

BackgroundPercutaneous transluminal septal myocardial ablation (PTSMA) and modified Morrow septal myectomy (MMSM) are two invasive strategies used to relieve obstruction in patients with hypertrophic cardiomyopathy (HCM). This study aimed to determine the clinical outcome of these two strategies.

MethodsFrom January 2011 to January 2015, 226 patients with HCM were treated, 68 by PTSMA and 158 by MMSM. Both ultrasonic cardiograms and heart functional class were recorded before, after operations and in the follow-up. Categorical variables were compared using Chi-square or Fisher's exact tests. Quantitative variables were compared using the paired samples t-test.

ResultsInterventricular septal thickness was significantly reduced in both groups (21.27 ± 4.43 mm vs. 18.72 ± 4.13 mm for PTSMA, t = 3.469, P < 0.001, and 21.83 ± 5.03 mm vs. 16.57 ± 3.95 mm for MMSM, t = 10.349, P < 0.001, respectively). The left ventricular outflow tract (LVOT) pressure gradient (PG) significantly decreased after the operations in two groups (70.30 ± 44.79 mmHg vs. 39.78 ± 22.07 mmHg for PTSMA, t = 5.041, P < 0.001, and 74.58 ± 45.52 mmHg vs. 13.95 ± 9.94 mmHg for MMSM, t = 16.357, P < 0.001, respectively). Seven patients (10.29%) in the PTSMA group required a repeat operation in the follow-up. Eight (11.76%) patients were evaluated for New York Heart Association (NYHA) III/IV in the PTSMA group, which was significantly more than the five (3.16%) in the same NYHA classes for the MMSM group at follow-up. Less than 15% of patients in the PTSMA group and none of the patients in the MMSM group complained of chest pain during follow-up.

ConclusionsBoth strategies can not only relieve LVOT PG but also improve heart function in patients with HCM. However, MMSM might provide a more reliable reduction in gradients compared to PTSMA.