1.Application of Quality Evaluation of Blind Method in Clinical Trials of Traditional Chinese Medicine
Zeyang SHI ; Yuan SUN ; Wenxin MA ; Yuyi WANG ; Zhijun BU ; Xuehui WANG ; Youyou ZHENG ; Jianping LIU ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(3):75-80
The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years, randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine (TCM), but the quality of the implementation of blind methods is uneven, and the evaluation criteria have not yet been formed. In this paper, the data collection methods, calculation principles, advantages, and disadvantages of two quantitative quality evaluation methods of blind methods, namely James Blinding Index (JBI) and Bang Blinding Index (BBI), were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time, a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally, the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
2.Bionic design,preparation and clinical translation of oral hard tissue restorative materials
Han ZHAO ; Yan WEI ; Xuehui ZHANG ; Xiaoping YANG ; Qing CAI ; Chengyun NING ; Mingming XU ; Wenwen LIU ; Ying HUANG ; Ying HE ; Yaru GUO ; Shengjie JIANG ; Yunyang BAI ; Yujia WU ; Yusi GUO ; Xiaona ZHENG ; Wenjing LI ; Xuliang DENG
Journal of Peking University(Health Sciences) 2024;56(1):4-8
Oral diseases concern almost every individual and are a serious health risk to the popula-tion.The restorative treatment of tooth and jaw defects is an important means to achieve oral function and support the appearance of the contour.Based on the principle of"learning from the nature",Deng Xu-liang's group of Peking University School and Hospital of Stomatology has proposed a new concept of"microstructural biomimetic design and tissue adaptation of tooth/jaw materials"to address the worldwide problems of difficulty in treating dentine hypersensitivity,poor prognosis of restoration of tooth defects,and vertical bone augmentation of alveolar bone after tooth loss.The group has broken through the bottle-neck of multi-stage biomimetic technology from the design of microscopic features to the enhancement of macroscopic effects,and invented key technologies such as crystalline/amorphous multi-level assembly,ion-transportation blocking,and multi-physical properties of the micro-environment reconstruction,etc.The group also pioneered the cationic-hydrogel desensitizer,digital stump and core integrated restora-tions,and developed new crown and bridge restorative materials,gradient functionalisation guided tissue regeneration membrane,and electrically responsive alveolar bone augmentation restorative membranes,etc.These products have established new clinical strategies for tooth/jaw defect repair and achieved inno-vative results.In conclusion,the research results of our group have strongly supported the theoretical im-provement of stomatology,developed the technical system of oral hard tissue restoration,innovated the clinical treatment strategy,and led the progress of the stomatology industry.
3.Efficacy and safety of enhanced external counterpulsation in elderly patients with acute ischemic stroke complicated by coronary heart disease
Lina MA ; Yuqiao ZHENG ; Yulin WANG ; Ning XIANG ; Jingyuan LI ; Xuehui QIN
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(2):175-178
Objective To explore the efficacy and safety of enhanced external counterpulsation(EECP)in elderly patients with acute ischemic stroke(AIS)complicated by coronary heart dis-ease(CHD).Methods A total of 65 AIS patients with CHD admitted in our hospital from Janu-ary to June 2023 were recruited and randomly divided into a control group(drug secondary pre-vention,n=32)and a treatment group(drug combined with EECP therapy,n=33).Their NIHSS score,mRS score and Canadian Cardiovascular Society(CCS)angina grade were evaluated before and after treatment and compared between the two groups.The incidences of recurrent ischemic stroke,new hemorrhagic stroke and major adverse cardiovascular events(MACE)were also recor-ded during treatment.Results The NIHSS score and mRS score were significantly decreased in both groups after treatment(P<0.01).After treatment,the NIHSS score(2.67±1.63 vs 3.56± 1.83),mRS score[1.0(0.0,1.0)vs 2.0(1.0,2.0)]and CCS grade[1.0(1.0,2.0)vs 2.0(1.0,2.0)]were obviously lower in the treatment group than the control group(P<0.05,P<0.01).There were no statistical differences in the incidence rates of recurrent ischemic stroke,new-onset hem-orrhagic stroke,and MACE between the control group and the treatment group(9.4%vs 6.1%,6.3%vs 3.0%,12.5%vs 6.1%,P>0.0 5).Conclusion EECP is a safe and effective treatment option for elderly AIS patients with CHD.
4.Treatment progress of cirrhotic portal hypertension
Guoshun ZHANG ; Chao LIU ; Suying WANG ; Meiyu JIANG ; Dongxue MEI ; Xuehui YANG ; Yingying XIN ; Zheng SHI
Clinical Medicine of China 2024;40(3):223-227
Cirrhotic portal hypertension (CPH) is a manifestation of decompensated liver cirrhosis, with ascites, portal collateral circulation formation, hypersplenism and splenomegaly as the typical clinical symptoms. In recent years, the incidence of CPH has been increasing year by year, and the treatment of CPH has gradually become a hot issue in medical research. In order to further explore the diagnosis and treatment scheme of CPH. We briefly describe the pathophysiological mechanism and diagnosis of CPH, and the current situation of CPH treatment and the new progress of internal and external treatment were reviewed.
5.Carbazole and tetrahydro-carboline derivatives as dopamine D3 receptor antagonists with the multiple antipsychotic-like properties.
Zhongtang LI ; Fan FANG ; Yiyan LI ; Xuehui LV ; Ruqiu ZHENG ; Peili JIAO ; Yuxi WANG ; Guiwang ZHU ; Zefang JIN ; Xiangqing XU ; Yinli QIU ; Guisen ZHANG ; Zhongjun LI ; Zhenming LIU ; Liangren ZHANG
Acta Pharmaceutica Sinica B 2023;13(11):4553-4577
Dopamine D3 receptor (D3R) is implicated in multiple psychotic symptoms. Increasing the D3R selectivity over dopamine D2 receptor (D2R) would facilitate the antipsychotic treatments. Herein, novel carbazole and tetrahydro-carboline derivatives were reported as D3R selective ligands. Through a structure-based virtual screen, ZLG-25 (D3R Ki = 685 nmol/L; D2R Ki > 10,000 nmol/L) was identified as a novel D3R selective bitopic ligand with a carbazole scaffold. Scaffolds hopping led to the discovery of novel D3R-selective analogs with tetrahydro-β-carboline or tetrahydro-γ-carboline core. Further functional studies showed that most derivatives acted as hD3R-selective antagonists. Several lead compounds could dose-dependently inhibit the MK-801-induced hyperactivity. Additional investigation revealed that 23j and 36b could decrease the apomorphine-induced climbing without cataleptic reaction. Furthermore, 36b demonstrated unusual antidepressant-like activity in the forced swimming tests and the tail suspension tests, and alleviated the MK-801-induced disruption of novel object recognition in mice. Additionally, preliminary studies confirmed the favorable PK/PD profiles, no weight gain and limited serum prolactin levels in mice. These results revealed that 36b provided potential opportunities to new antipsychotic drugs with the multiple antipsychotic-like properties.
6.Significance of HRMRI in subtyping NCAIS in the elderly
Lina MA ; Yuqiao ZHENG ; Xuemei YIN ; Yulin WANG ; Jun ZHANG ; Ning XIANG ; Jingyuan LI ; Xuehui QIN
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2023;25(12):1260-1263
Objective To investigate the diagnostic value of high-resolution magnetic resonance im-aging(HRMRI)in elderly patients with non-cardioembolic acute ischemic stroke(NCAIS).Meth-ods A retrospective analysis was conducted on 101 elderly NCAIS patients having HRMRI in our hospital from July 2022 to July 2023.Stroke subtypes were classified according to the Trial of Org 10172 in Acute Stroke Treatment(TOAST)system and the Chinese Ischemic Stroke Sub-classification(CISS)system.The constituent ratio distribution of each subtype classification was compared before and after HRMRI in both classification systems.Results TOAST system identi-fied 8 cases of small-artery occlusion(SAO),1 case of other determined etiology(SOE),5 cases of undetermined etiology(SUE)and then reclassified as large artery atherosclerosis(LAA),1 case of SUE which was reclassified as SAO,and 7 cases of LAA and 4 cases of SUE being reclas-sified as SOE after HRMRI.In total,the diagnosis of 26 cases(25.74%)was modified.In the CISS system,10 cases of penetrating artery disease(PAD),1 case of other etiologies(OE),and 4 cases of undetermined etiology(UE)were reclassified as LAA.Furthermore,9 cases of LAA and 3 cases of UE were reclassified as OE after HRMRI.In total,the diagnosis of 27 cases(26.73%)was modified.There were statistical differences in the constituent ratio before and after HRMRI in both TOAST(x2=15.425,P<0.01)and CISS(x2=17.300,P<0.01)systems.Conclusion HRMRI is of diagnostic value and significance in accurately diagnosing the etiology of AIS in eld-erly patients without cardioembolic causes.
7.Attention Situation of Chinese Patent Medicine for Constipation in Traditional Chinese Medicine Diagnosis and Treatment Guidelines/Consensus and National Reimbursement Drug List
Youyou ZHENG ; Xuehui WANG ; Yunru CHEN ; Mei HAN ; Hongguo RONG ; Jianping LIU ; Xing LIAO ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):135-143
ObjectiveTo evaluate the methodological quality of traditional Chinese medicine (TCM) diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ)tool, and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI,VIP,Wanfang Data,SinoMed,PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then,the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare (RIGHT) Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included,involving 794 experts. The scores of AGREE II were clarity of presentation(59.0%),scope and purpose(44.0%),stakeholder involvement(23.1%),rigor of development (12.1%),applicability (11.1%),and editorial independence (8.3%) from high to low. Five articles were recommended at B level(recommended after revision) and 8 articles were at C level (not recommended). The average scores of RIGHT Statement were as follows:basic information (93.59%),background (57.69%),evidence (18.46%),recommendations (20.88%),review and quality assurance (19.23%),funding,declaration and management of interests (0.00%), and other information (0.00%). The included guidelines/consensus recommended a total of 27 Chinese patent medicines,among which 20 were included in the National Reimbursement Drug List,with 4 species of Class A and 16 species of Class B, accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus,accounting for 50% of all purgative drugs, and 8 were not recommended. There were prescriptions for purgation, for promoting digestion and removing food stagnation, for clearing heat and purging fire,and for warming the middle and dissipating cold,Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment,the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover,the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However, the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
8.Early lung-protective ventilation techniques for preventing bronchopulmonary dysplasia in premature infants
Xuehui ZHENG ; Chuanzhong YANG
Chinese Pediatric Emergency Medicine 2022;29(6):401-406
Bronchopulmonary dysplasia is a common respiratory complication in premature infants.With the improvement of neonatal treatment, premature infants are surviving more than ever.However, the incidence of bronchopulmonary dysplasia remains high, which seriously affects the outcomes of premature infants.The immature lung of preterm infants are susceptible to damage from a variety of factors, which are modifiable by the early use of lung-protective strategies of respiratory support.This review focused on summarizing the research progress of early lung-protective ventilation techniques for preventing bronchopulmonary dysplasia in premature infants.
9.Simpson-Golabi-Behmel syndrome type Ⅰ in neonates caused by GPC3 gene mutation: a case report and literature review
Xuehui ZHENG ; Sufen YE ; Yong YANG ; Chuanzhong YANG ; Jiaping MEI
Chinese Journal of Perinatal Medicine 2021;24(11):840-846
Objective:To investigate the clinical and genetic characteristics of Simpson-Golabi-Behmel syndrome (SGBS) type Ⅰ caused by glypican-3 ( GPC3) gene mutations. Methods:Data of one neonate with SGBS type Ⅰ from Shenzhen Maternity and Child Healthcare Hospital Affiliated to Southern Medical University was reviewed retrospectively. Literature was retrieved to summarize the clinical and genetic characteristics of SGBS type Ⅰ caused by GPC3 mutations, using terms of "Simpson-Golabi-Behmel type Ⅰ", "GPC3" and "glypican-3" from China National Knowledge Infrastructure, VIP database, Wanfang database, and PubMed from January 2010 till April 2021. Results:The male infant was admitted to the hospital at 4 h after birth due to "abdominal distension for 1 h", presenting with dysmorphic facial features, including macrocephaly, coarse face, broad nasal bridge, macrostomia, tongue with a groove in the middle, as well as macrosomatia, supernumerary nipples, and hypospadias. Whole exome sequencing revealed a novel frameshift mutation (c.720delC) in GPC3 gene of the patient and his mother for hemizygous and heterozygous variation, respectively, based on which SGBS type Ⅰwas confirmed. During the follow-up, overgrowth, neuroblastoma, and motor development retardation were found in the boy. In addition to the index patient, 92 cases of SGBS type Ⅰ reported in 31 articles were analyzed, including 89(95.7%) males and 4(4.3%) females. The main clinical features were craniofacial dysmorphism, pre/postnatal overgrowth with multiple congenital anomalies. Most patients were combined with language disorders, motor retardation, and various degrees of dysnoesia, and were more likely to develop embryonic tumors. Among the 93 cases, 11(11.8%) suffered from tumors. Apart from 21 cases of termination, 63 cases were born alive and nine cases died after birth. Pathogenic variants in GPC3 gene were reported in 80 cases, which were nonsense mutation in 25 cases (31.2%), DNA fragment deletion in 21 cases (26.2%), frameshift mutation in 16 cases (20.0%), large duplications in eight cases (10.0%), missense mutation in five cases(6.2%), and splice site mutation in five cases(6.2%). Conclusions:SGBS type Ⅰ is an X-linked recessive genetic disease with various phenotypes. Patients with postnatal craniofacial dysmorphism, overgrowth, and multiple congenital anomalies should be highly suspected of SGBS type Ⅰ. Genetic testing is conducive to its early diagnosis. Treatment requires multidisciplinary cooperation and long-term follow-up, especially for those with tumors.
10.Risk factors of hypotension after ligation of patent ductus arteriosus in very/extremely low birth weight infants
Xuehui ZHENG ; Fang YAO ; Chun CHEN ; Yanliang YU ; Bingchun LIN ; Jie ZHAO ; Zhifeng HUANG ; Chuanzhong YANG
Chinese Journal of Neonatology 2021;36(6):23-27
Objective:To study the risk factors of hypotension after ligation of patent ductus arteriosus (PDA) in very/extremely low birth weight infants (VLBWI/ELBWI).Method:From March 2016 to January 2021, preterm infants with birth weight <1 500 g receiving bedside PDA ligation in the neonatal intensive care unit (NICU) of our hospital were enrolled in the study. According to the occurrence of hypotension within 72 hours after ligation, the infants were assigned into non-hypotension group and hypotension group. The general status and perioperative conditions of the two groups were analyzed. Multivariate Logistic regression was used to analyze the risk factors of hypotension.Result:A total of 44 cases were enrolled, including 33 in non-hypotension group and 11 in hypotension group. Univariate analysis showed that hypotension group had significantly more cases with body weight <1 100 g during surgery and receiving preoperative high frequency oscillatory ventilation (HFOV) than non-hypotension group ( P<0.05). Multivariate Logistic regression analysis showed that weight <1 100 g during surgery ( OR=12.045, 95% CI 1.351~107.394, P=0.026) and receiving preoperative HFOV ( OR=27.832, 95% CI 1.363~568.292, P=0.031)were independent risk factors of hypotension. Conclusion:Hypotension is one of the common complications of PDA ligation in VLBWI/ELBWI. The infant's body weight during ligation and receiving preoperative HFOV are independent risk factors of hypotension.

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