1.Anticancer Activity of Diosgenin and Its Molecular Mechanism.
Qun-Li REN ; Qian WANG ; Xin-Qun ZHANG ; Miao WANG ; Huan HU ; Jun-Jie TANG ; Xiong-Tong YANG ; Ying-Hui RAN ; Huan-Huan LIU ; Zhi-Xing SONG ; Jian-Guo LIU ; Xiao-Lan LI
Chinese journal of integrative medicine 2023;29(8):738-749
		                        		
		                        			
		                        			Diosgenin, a steroidal sapogenin, obtained from Trigonella foenum-graecum, Dioscorea, and Rhizoma polgonati, has shown high potential and interest in the treatment of various cancers such as oral squamous cell carcinoma, laryngeal cancer, esophageal cancer, liver cancer, gastric cancer, lung cancer, cervical cancer, prostate cancer, glioma, and leukemia. This article aims to provide an overview of the in vivo, in vitro, and clinical studies reporting the diosgenin's anticancer effects. Preclinical studies have shown promising effects of diosgenin on inhibiting tumor cell proliferation and growth, promoting apoptosis, inducing differentiation and autophagy, inhibiting tumor cell metastasis and invasion, blocking cell cycle, regulating immunity and improving gut microbiome. Clinical investigations have revealed clinical dosage and safety property of diosgenin. Furthermore, in order to improve the biological activity and bioavailability of diosgenin, this review focuses on the development of diosgenin nano drug carriers, combined drugs and the diosgenin derivatives. However, further designed trials are needed to unravel the diosgenin's deficiencies in clinical application.
		                        		
		                        		
		                        		
		                        			Male
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Carcinoma, Squamous Cell/drug therapy*
		                        			;
		                        		
		                        			Diosgenin/metabolism*
		                        			;
		                        		
		                        			Mouth Neoplasms/drug therapy*
		                        			;
		                        		
		                        			Apoptosis
		                        			;
		                        		
		                        			Prostatic Neoplasms/drug therapy*
		                        			
		                        		
		                        	
2.Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly (version 2023)
Yan HU ; Dongliang WANG ; Xiao CHEN ; Zhongmin SHI ; Fengjin ZHOU ; Jianzheng ZHANG ; Yanxi CHEN ; Liehu CAO ; Sicheng WANG ; Jianfei WANG ; Hongliang WANG ; Yong FENG ; Zhimin YING ; Chengdong HU ; Qinglin HAN ; Ming LI ; Xiaotao CHEN ; Zhengrong GU ; Biaotong HUANG ; Liming XIONG ; Yunfei ZHANG ; Zhiwei WANG ; Baoqing YU ; Yong WANG ; Lei ZHANG ; Lei YANG ; Peijian TONG ; Ximing LIU ; Qiang ZHOU ; Feng NIU ; Weiguo YANG ; Wencai ZHANG ; Shijie CHEN ; Jinpeng JIA ; Qiang YANG ; Tao SHEN ; Bin YU ; Peng ZHANG ; Yong ZHANG ; Jun MIAO ; Kuo SUN ; Haodong LIN ; Yinxian YU ; Jinwu WANG ; Kun TAO ; Daqian WAN ; Lei WANG ; Xin MA ; Chengqing YI ; Hongjian LIU ; Kun ZHANG ; Guohui LIU ; Dianying ZHANG ; Zhiyong HOU ; Xisheng WENG ; Yingze ZHANG ; Jiacan SU
Chinese Journal of Trauma 2023;39(4):289-298
		                        		
		                        			
		                        			Periarticular fracture of the shoulder is a common type of fractures in the elderly. Postoperative adverse events such as internal fixation failure, humeral head ischemic necrosis and upper limb dysfunction occur frequently, which seriously endangers the exercise and health of the elderly. Compared with the fracture with normal bone mass, the osteoporotic periarticular fracture of the shoulder is complicated with slow healing and poor rehabilitation, so the clinical management becomes more difficult. At present, there is no targeted guideline or consensus for this type of fracture in China. In such context, experts from Youth Osteoporosis Group of Chinese Orthopedic Association, Orthopedic Expert Committee of Geriatrics Branch of Chinese Association of Gerontology and Geriatrics, Osteoporosis Group of Youth Committee of Chinese Association of Orthopedic Surgeons and Osteoporosis Committee of Shanghai Association of Chinese Integrative Medicine developed the Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly ( version 2023). Nine recommendations were put forward from the aspects of diagnosis, treatment strategies and rehabilitation of osteoporotic periarticular fracture of the shoulder, hoping to promote the standardized, systematic and personalized diagnosis and treatment concept and improve functional outcomes and quality of life in elderly patients with osteoporotic periarticular fracture of the shoulder.
		                        		
		                        		
		                        		
		                        	
3.Effects of caloric restriction and rope-skipping exercise on cardiometabolic risk factors in overweight or obese college students.
Miao WU ; Xiao Tong WANG ; Su Hua XU ; Zhao Xie TANG ; Hai Lin LI ; Jia Jia JING ; Wei Ke TANG ; Xiao Yan CHEN ; Rui Ling LAN ; Yan Na ZHU
Chinese Journal of Preventive Medicine 2022;56(9):1272-1278
		                        		
		                        			
		                        			Objective: To explore the effect of three interventions including caloric restriction, rope-skipping exercise and caloric restriction combined with rope-skipping exercise on cardiometabolic risk factors in overweight or obese college students. Methods: This study was a pilot randomized controlled trial. Overweight or obese students who met the inclusion criteria were recruited at Sun Yat-sen University in September 2019 and were randomly divided into four groups: caloric restriction group (CR), rope-skipping group (RS), combined group (CR-RS) and control group (CT). The intervention in each group lasted 8 weeks, specifically: the daily energy intake of CR was 100% to 110% of the basal metabolic energy; RS was instructed to rope three times a week, and CR-RS combined caloric restriction with rope-skipping. At the baseline and end of 8-week intervention, basic information, anthropometric indicators and fasting vein blood of students were collected. Paired t test and Wilcoxon paired-samples signed rank test were used for comparison before and after intervention, and analysis of covariance was used for comparison between groups after intervention. Results: A total of 29 students completed the trial and were included in the final analysis (7, 9, 7 and 6 students in CR, RS, CR-RS and CT, respectively). The mean age of students were (19.00±1.00) years, including 11 males and 18 females. The baseline characteristics of four groups were comparable. After 8 weeks of intervention, compared with CT, there was an increase in the body fat percentage and fat mass index in CR and CR-RS (P<0.05). Insulin level decreased in CR-RS (P<0.05). Systolic blood pressure in CR and diastolic blood pressure in CR-RS were higher (P<0.05). Compared with baseline, fat mass index decreased in CR (P<0.05), while body weight, BMI, and fat mass index decreased in CR-RS (P<0.05). Conclusion: It is suggested that the caloric restriction alone and calorie restriction combined with rope-skipping exercise can benefit overweight or obese college students with cardiometabolic risk factors.
		                        		
		                        		
		                        		
		                        			Adolescent
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Caloric Restriction
		                        			;
		                        		
		                        			Cardiometabolic Risk Factors
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Insulins
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Obesity
		                        			;
		                        		
		                        			Overweight
		                        			;
		                        		
		                        			Students
		                        			;
		                        		
		                        			Weight Loss/physiology*
		                        			;
		                        		
		                        			Young Adult
		                        			
		                        		
		                        	
4.Evaluation of root resorption after surgical orthodontic treatment of skeletal Class Ⅲ malocclusion by three-dimensional volumetric measurement with cone-beam CT.
Juan GAO ; Hang Miao LV ; Hui Min MA ; Yi Jiao ZHAO ; Xiao Tong LI
Journal of Peking University(Health Sciences) 2022;54(4):719-726
		                        		
		                        			OBJECTIVE:
		                        			To explore the method of measuring root volume with cone-beam computed tomography (CBCT) three-dimensional reconstruction technology, and to study root length and root volume of upper and lower central incisors in patients with skeletal Class Ⅲ malocclusion treated by surgical orthodontic treatment.
		                        		
		                        			METHODS:
		                        			Twenty patients with skeletal Class Ⅲ malocclusion undergoing surgical orthodontic treatment were selected. CBCT data at three time points, before decompensation treatment (T0), after decompensation treatment (before orthognathic surgery, T1), and the end of post-operative orthodontic treatment (T2) were collected. Three-dimensional reconstruction technology was used to measure the root length and root volume of the upper and lower central incisors (including total root volume, cervical root and apical root), calculate the percentage of reduction volume, and measure the distance of tooth movement after orthodontic treatment. Data were statistically analyzed by SPSS 20.0 software. Least significant difference (LSD) method was used for pair comparison between the groups subject to normal distribution, and non-parametric test was used for comparison between the groups not subject to normal distribution. The differences of root length and root volume of upper and lower incisors were compared, and the characteristics of root absorption were analyzed.
		                        		
		                        			RESULTS:
		                        			Root length and root volume of the upper and lower central incisors were reduced during the surgical orthodontic treatment (P < 0.05) in cases. Both the root volume of cervical root and apical root were significantly reduced (P < 0.05), the reduction of apical root was more significant. The percentage of root volume reduction of the upper central incisor was (30.51±23.23)%, and lower central incisor (23.24±11.96)%. Compared with the upper central incisor, the root volume reduction amount and percentage of the lower central incisor were smaller, and apical root volume reduction of the upper central incisor was greater than that of the lower central incisor, which was statistically significant (P < 0.05). During pre-surgical orthodontic treatment, maxillary central incisor palatal moving was in a controlled tipping manner, and the mandibular central incisor tipped labially.
		                        		
		                        			CONCLUSION
		                        			In patients with skeletal Class Ⅲ malocclusion, root length and total root volume of upper and lower central incisors decreased during surgical orthodontic treatment. Root volume measurement indicated that the cervical root also had root resorption. The difference in root resorption of the upper and lower central incisors might be related to the distance and direction of teeth movement. CBCT three-dimensional reconstruction will compensate for the limitation of root length measurement in evaluating root resorption.
		                        		
		                        		
		                        		
		                        			Cone-Beam Computed Tomography/methods*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Incisor/diagnostic imaging*
		                        			;
		                        		
		                        			Malocclusion, Angle Class III/surgery*
		                        			;
		                        		
		                        			Maxilla/surgery*
		                        			;
		                        		
		                        			Root Resorption/etiology*
		                        			
		                        		
		                        	
5.Clinical research progress and implications of therapeutic vaccines for cervical cancer and precancerous lesions: a qualitative systematic review.
Shan CAI ; Ke MIAO ; Xiao Yu TAN ; Si CHENG ; Dan Tong LI ; Xue Yang ZENG ; Yu YANG ; Ruo Gu MENG ; Zhi Ke LIU ; Yan LI ; Ke Li LI ; Feng SUN ; Si Yan ZHAN
Chinese Journal of Oncology 2022;44(7):743-760
		                        		
		                        			
		                        			Objective: To systematically summarize and analyze the clinical research progress of therapeutic vaccines for cervical cancer or precancerous lesions. Methods: English databases (PubMed, Embase, Web of Science, Cochrane library, Proquest, and ClinicalTrails.gov) and Chinese databases (SinoMed, CNKI, WanFang, and VIP Database) were systematically searched to collect literature on therapeutic vaccines for cervical cancer or precancerous lesions from inception to February 18, 2021. After screening, we evaluated the risk of bias of included studies, and combed the basic information of the literature, research designs, information of vaccines, study patients, outcome indicators and so on, qualitatively summarized the clinical research progress. Results: A total of 71 studies were included in this systematic review, including 14 random controlled trials, 15 quasi-random controlled trials, 4 cohort studies, 1 case-control study, 34 case series studies and 3 case reports. The study patients included women aged 15~79 with cervical cancer or precancerous lesions in 18 countries from 1989 to 2021. On the one hand, there were 40 studies on therapeutic vaccines for cervical precancerous lesions (22 867 participants), involving 21 kinds of vaccines in 6 categories. Results showed 3 marketed vaccines (Cervarix, Gardasil, Gardasil 9) as adjuvant immunotherapies were significant effective in preventing the recurrence of precancerous lesions compared with the conization only. In addition, MVA E2 vaccine had been in phase Ⅲ clinical trials as a specific therapeutic vaccine, with relative literature showing it could eliminate most high-grade precancerous lesions. Therapeutic vaccines for precancerous lesions all showed good safety. On the other hand, there were 31 studies on therapeutic vaccines for cervical cancer (781 participants), involving 19 kinds of vaccines in 7categories, with none had been marketed. 25 studies were with no control group, showing the vaccines could effectively eliminate solid tumors, prevent recurrence, and prolong the median survival time. However, the vaccines effectiveness couldn't be statistically calculated due to the lack of a control group. As for the safety of therapeutic vaccines for cervical cancer, 9 studies showed that patients experienced serious adverse events after treatments, where 7 studies reported that serious adverse events occurred in patients couldn't be ruled out as the results of therapeutic vaccines. Conclusions: The literature review shows that the literature evidence for the therapeutic vaccines for cervical precancerous lesions is relatively mature compared with the therapeutic vaccines for cervical cancer. The four kinds of vaccines on the market are all therapeutic vaccines for precancerous lesions, but they are generally used as vaginal infection treatments or adjuvant immunotherapies for cervical precancerous lesions, not used for the specific treatments of cervical precancerous lesions. Other specific therapeutic vaccines are in the early stage of clinical trials, mainly phase Ⅰ/Ⅱ clinical trials with small sample size. The effectiveness and safety data are limited, and further research is still needed.
		                        		
		                        		
		                        		
		                        			Cancer Vaccines/therapeutic use*
		                        			;
		                        		
		                        			Cervical Intraepithelial Neoplasia/prevention & control*
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Papillomavirus Infections/prevention & control*
		                        			;
		                        		
		                        			Papillomavirus Vaccines/therapeutic use*
		                        			;
		                        		
		                        			Precancerous Conditions/therapy*
		                        			;
		                        		
		                        			Uterine Cervical Neoplasms/prevention & control*
		                        			
		                        		
		                        	
6.Incidence and risk factors of anastomotic leak after transanal total mesorectal excision in China: a retrospective analysis based on national database.
Lei GU ; Yong Bo AN ; Ming Yang REN ; Quan WANG ; Hong Yu ZHANG ; Gang YU ; Jian Zhi CHEN ; Miao WU ; Yi XIAO ; Zhi Cong FU ; Hong ZHANG ; Wei Dong TONG ; Dan MA ; Qing XU ; Hong Wei YAO ; Zhong Tao ZHANG
Chinese Journal of Gastrointestinal Surgery 2021;24(6):505-512
		                        		
		                        			
		                        			Objective: Transanal total mesorectal excision (taTME) was a very hot topic in the first few years since its appearance, but now more introspections and controversies on this procedure have emerged. One of the reasons why the Norwegian Ministry of Health stopped taTME was the high incidence of postoperative anastomotic leak. In current study, the incidence and risk factors of anastomotic leak after taTME were analyzed based on the data registered in the Chinese taTME Registry Collaborative (CTRC). Methods: A case-control study was carried out. Between November 15, 2017 and December 31, 2020, clinical data of 1668 patients undergoing taTME procedure registered in the CTRC database from 43 domestic centers were collected retrospectively. After excluding 98 cases without anastomosis and 109 cases without complete postoperative complication data, 1461 patients were finally enrolled for analysis. There were 1036 males (70.9%) and 425 females (29.1%) with mean age of (58.2±15.6) years and mean body mass index of (23.6±3.8) kg/m(2). Anastomotic leak was diagnosed and classified according to the International Study Group of Rectal Cancer (ISREC) criteria. The risk factors associated with postoperative anastomotic leak cases were analyzed. The impact of the cumulative number of taTME surgeries in a single center on the incidence of anastomotic leak was evaluated. As for those centers with the number of taTME surgery ≥ 40 cases, incidence of anastomic leak between 20 cases of taTME surgery in the early and later phases was compared. Results: Of 1461 patients undergoing taTME, 103(7.0%) developed anastomotic leak, including 71 (68.9%) males and 32 (31.1%) females with mean age of (59.0±13.9) years and mean body mass index of (24.5±5.7) kg/m(2). The mean distance between anastomosis site and anal verge was (2.6±1.4) cm. Thirty-nine cases (37.9%) were classified as ISREC grade A, 30 cases (29.1%) as grade B and 34 cases (33.0%) as grade C. Anastomotic leak occurred in 89 cases (7.0%,89/1263) in the laparoscopic taTME group and 14 cases (7.1%, 14/198) in the pure taTME group. Multivariate analysis showed that hand-sewn anastomosis (P=0.004) and the absence of defunctioning stoma (P=0.013) were independently associated with anastomotic leak after taTME. In the 16 centers (37.2%) which performed ≥ 30 taTME surgeries with cumulative number of 1317 taTME surgeries, 86 cases developed anastomotic leak (6.5%, 86/1317). And in the 27 centers which performed less than 30 taTME surgeries with cumulative number of 144 taTME surgeries, 17 cases developed anastomotic leak (11.8%, 17/144). There was significant difference between two kinds of center (χ(2)=5.513, P=0.019). Thirteen centers performed ≥ 40 taTME surgeries. In the early phase (the first 20 cases in each center), 29 cases (11.2%, 29/260) developed anastomotic leak, and in the later phase, 12 cases (4.6%, 12/260) developed anastomotic leak. The difference between the early phase and the later phase was statistically significant (χ(2)=7.652, P=0.006). Conclusion: The incidence of anastomotic leak after taTME may be reduced by using stapler and defunctioning stoma, or by accumulating experience.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Anastomotic Leak/etiology*
		                        			;
		                        		
		                        			Case-Control Studies
		                        			;
		                        		
		                        			China/epidemiology*
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Laparoscopy
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Postoperative Complications/epidemiology*
		                        			;
		                        		
		                        			Rectal Neoplasms/surgery*
		                        			;
		                        		
		                        			Rectum/surgery*
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Risk Factors
		                        			
		                        		
		                        	
7.Schroth exercises improve health-related quality of life and radiographic parameters in adolescent idiopathic scoliosis patients.
Ang GAO ; Jun-Yu LI ; Rui SHAO ; Tong-Xuan WU ; Yong-Qiang WANG ; Xiao-Guang LIU ; Miao YU
Chinese Medical Journal 2021;134(21):2589-2596
		                        		
		                        			BACKGROUND:
		                        			Finding an optimal treatment strategy for adolescent idiopathic scoliosis (AIS) patients remains challenging because of its intrinsic complexity. For mild to moderate scoliosis patients with lower skeletal growth potential (Risser 3-5), most clinicians agree with observation treatment; however, the curve progression that occurs during puberty, the adolescent period, and even in adulthood, remains a challenging issue for clinicians. The aim of the study is to investigate the efficacy of Schroth exercise in AIS patients with lower skeletal growth potential (Risser 3-5) and moderate scoliosis (Cobb angle 20°-40°).
		                        		
		                        			METHODS:
		                        			From 2015 to 2017, data of 64 patients diagnosed with AIS in Peking University Third Hospital were reviewed. Forty-three patients underwent Schroth exercise were classified as Schroth group, and 21 patients underwent observation were classified as observation group. Outcomes were measured by health-related quality of life (HRQOL) and radiographic parameters. HRQOL was assessed using the visual analog scale (VAS) scores for back, Scoliosis Research Society-22 (SRS-22) patient questionnaire. Radiographic spinopelvic parameters were obtained from anteroposterior and lateral X-rays. The pre-treatment and post-treatment HRQOL and radiographic parameters were tested to validate Schroth exercise efficacy. The inter-rater reliability of the radiographic parameters was tested using the interclass correlation coefficient (ICC). The paired t test was used to examine HRQOL and radiographic parameters. Clinical relevance between C2-C7 sagittal vertical axis (SVA) and thoracic kyphosis was analyzed using Spearman correlation.
		                        		
		                        			RESULTS:
		                        			In Schroth group, VAS back score, SRS-22 pain, and SRS-22 self-image domain were significantly improved from pre-treatment 3.0 ± 0.8, 3.6 ± 0.5, and 3.5 ± 0.7 to post-treatment 1.6 ± 0.6 (t = 5.578, P = 0.013), 4.0 ± 0.3 (t = -3.918, P = 0.001), and 3.7 ± 0.4 (t = -6.468, P < 0.001), respectively. No significant improvements of SRS-22 function domain (t = -2.825, P = 0.088) and mental health domain (t = -3.174, P = 0.061) were observed. The mean Cobb angle decreased from 28.9 ± 5.5° to 26.3 ± 5.2° at the final follow-up, despite no statistical significance was observed (t = 1.853, P = 0.102). The mean C2-C7 SVA value decreased from 21.7 ± 8.4 mm to 17.0 ± 8.0 mm (t = -1.224 P = 0.049) and mean T1 tilt decreased from 4.9 ± 4.2 ° to 3.5 ± 3.1° (t = 2.913, P = 0.011). No significant improvement of radiographic parameters and HRQOL were observed in observation group.
		                        		
		                        			CONCLUSIONS
		                        			For AIS patients with a Risser 3-5 and a Cobb angle 20°-40°, Schroth exercises improved HRQOL and halted curve progression during the follow-up period. Both cervical spine alignment and shoulder balance were also significantly improved after Schroth exercises. We recommend Schroth exercises for patients with AIS.
		                        		
		                        		
		                        		
		                        			Adolescent
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Cervical Vertebrae
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Kyphosis
		                        			;
		                        		
		                        			Lordosis
		                        			;
		                        		
		                        			Quality of Life
		                        			;
		                        		
		                        			Reproducibility of Results
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Scoliosis/therapy*
		                        			;
		                        		
		                        			Treatment Outcome
		                        			
		                        		
		                        	
8.Cortical 5-hydroxytryptamine receptor 3A (Htr3a) positive inhibitory neurons: diversity in type and function.
Jin-Yun WU ; Hong-Zhi LIU ; Yan-Qing QI ; Xiao-Yang WU ; Yang CHEN ; Jiang-Teng LYU ; Ling GONG ; Miao HE
Acta Physiologica Sinica 2021;73(2):295-305
		                        		
		                        			
		                        			Cortical GABAergic inhibitory neurons are composed of three major classes, each expressing parvalbumin (PV), somatostatin (SOM) and 5-hydroxytryptamine receptor 3A (Htr3a), respectively. Htr3a
		                        		
		                        		
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Interneurons/metabolism*
		                        			;
		                        		
		                        			Mice
		                        			;
		                        		
		                        			Neurons/metabolism*
		                        			;
		                        		
		                        			Parvalbumins/metabolism*
		                        			;
		                        		
		                        			Receptors, Serotonin, 5-HT3/genetics*
		                        			;
		                        		
		                        			Serotonin
		                        			;
		                        		
		                        			Somatostatin/metabolism*
		                        			
		                        		
		                        	
9.Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0).
Chong ZOU ; Hong DING ; Rui GAO ; Si-Yuan HU ; Jian-Zhong LIU ; Bo LI ; Xiao-Hui LI ; Ding-Ju PAN ; Jian-Yuan TANG ; Xiao-Yun TONG ; Ju-Yong WANG ; Wei-An YUAN ; Xun ZHANG ; Miao ZHANG ; Yan-Ling ZHAO ; Zhong-Qi YANG
China Journal of Chinese Materia Medica 2021;46(7):1696-1700
		                        		
		                        			
		                        			At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
		                        		
		                        		
		                        		
		                        			Biomedical Research
		                        			;
		                        		
		                        			Clinical Trials as Topic
		                        			;
		                        		
		                        			Consensus
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			Ethical Review
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Medicine, Chinese Traditional
		                        			;
		                        		
		                        			Multicenter Studies as Topic
		                        			;
		                        		
		                        			Pharmaceutical Preparations
		                        			
		                        		
		                        	
10. Effect of Traditional Chinese Medicine and Western Medicine Therapy on Gestational Diabetes Mellitus
Li-qiang WANG ; Jing-xin ZHOU ; Gui-zhen MIAO ; Li-li WU ; Xiao-nan WANG ; Qiao-qiao LIU ; Can CAO ; Zhao-li CUI ; Qi-ming DU ; Tong JIN ; Shan LU
Chinese Journal of Experimental Traditional Medical Formulae 2019;25(23):229-234
		                        		
		                        			
		                        			 In recent years, as the level of economic life has improved, the incidence of gestational diabetes mellitus has increased year by year. Gestational diabetes mellitus (GDM) has been a serious threat to maternal and newborn health. The pathogenesis of gestational diabetes is not very clear, and may be closely associated with insulin resistance, genetic susceptibility, inflammatory response, metabolic disorders. According to the gestational diabetes diagnostic standard,24-28 weeks pregnant women keep an empty stomach over 8 h, taken 75 g oral glucose directly, and then receive the oral glucose tolerance test. GDM is diagnosed as fasting blood-glucose> 5.1 mmol · L-1,1-hour postprandial blood glucose>10.0 mmol · L-1,and 2-hour postprandial blood glucose>8.5 mmol · L-1. Western medicine treatment is mainly based on diet, exercise, drugs, education, monitoring and insulin therapy according to blood glucose. Meanwhile, GDM is a type of diabetes in traditional Chinese medicine. GDM is prevented and treated with diets and traditional method sports and Chinese herbs. Therefore, integrated Chinese and western medicine therapy can maximize the curative effect, reduce the incidence of gestational diabetes mellitus, and effectively improve the adverse outcome and prognosis of patients with gestational diabetes mellitus from mother to child. 
		                        		
		                        		
		                        		
		                        	
            
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