1.Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine(Part 1): Development Status and Characteristics
Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Ziteng HU ; Yaxin CHEN ; Huizhen LI ; Haili ZHANG ; Zhao CHEN ; Yin JIANG ; Bin LIU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):44-49
The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM.
2.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 3): Identification of Clinical Questions
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Zhao CHEN ; Yin JIANG ; Cuicui CHENG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):55-59
The identification of clinical questions for clinical practice guidelines of Chinese patent medicine (CPM) is important for subsequent evidence retrieval, evaluation of evidence quality, formation of recommendations. This paper described a methodological proposal for the identification of clinical questions for CPM guidelines to highlight the characteristics of Chinese patent medicine and reflect its effect in specific stage of the disease. Considering four aspects, namely, the drug of Chinese patent medicine (D), the specific disease stage (S), comparison (C), and specific outcome (O), DSCO framework has been proposed to formulate the clinical questions. Multi-source information through scientific research, policy or standard documents, and clinical data are suggested for collecting clinical questions, and clear selection criteria should be set to finalize the clinical questions to be addressed by the guideline. In addition, the above process needs to be transparently and publicly reported in order to ensure the clarity and completeness of the guidelines.
3.Application effect of a dual release system of androgen and its antagonist in the repair of full-thickness burn wounds in mice
Rizhong HUANG ; Yiwei WANG ; Heyan HUANG ; Ruihan JIANG ; Nannan XUE ; Shaoping YIN ; Hongyu ZHAO
Chinese Journal of Burns 2024;40(2):180-189
Objective:To explore the optimal ratio of dihydrotestosterone and hydroxyflutamide (hereinafter referred to as DH), construct a dual release system of androgen and its antagonist, and analyze the application effect of this system in the repair of full-thickness burn wounds in mice.Methods:This study was an experimental study. The HaCaT cells were divided into blank group (without drug culture), low baseline group, medium baseline group, and high baseline group according to the random number table (the same grouping method below), and the last three groups of cells were cultured by adding three different ratios of DH. Under a medium ratio, the mass of dihydrotestosterone in the three baseline groups from low to high was 1.4, 2.8, and 4.0 μg, respectively, and the mass of hydroxyflutamide was 1.2, 1.6, and 2.0 μg, respectively. On this basis, under a small ratio, the mass of dihydrotestosterone was reduced by half and the mass of hydroxyflutamide was increased by half; under a large ratio, the mass of dihydrotestosterone was increased by half and the mass of hydroxyflutamide was reduced by half. After culture of 2 days, the cell proliferation level was detected by cell counting kit 8 ( n=4). Sixteen 6-8-week-old male BALB/c mice were used to establish a full-thickness burn wound on the back and divided into blank group, small ratio group, medium ratio group, and large ratio group, with 4 mice in each group. On post injury day (PID) 7, normal saline containing different ratios of DH was locally dropped to the wounds of mice in the last three groups of mice (the total mass of DH in the three ratio groups from small to large was 127.5, 165.0, and 202.5 μg, respectively, and the mass ratios of dihydrotestosterone to hydroxyflutamide (hereinafter referred to as drug mass ratio) were 8∶9, 8∶3, and 8∶1, respectively), afterwards, the administration was repeated every 48 hours until PID 27; normal saline was dropped to the wound of mice in blank group at the aforementioned time points. The wound healing status on PID 0 (immediately), 7, 14, 21, and 28 was observed, and the wound healing rates on PID 7, 14, 21, and 28 were calculated ( n=4). On PID 28, the wound tissue was taken, which was stained with hematoxylin and eosin for observing re-epithelialization and with Masson for observing collagen fibers, and the proportion of collagen fibers was analyzed ( n=3). Twenty 6-8-week-old male BALB/c mice were used to establish a full-thickness burn wound on the back and divided into ordinary scaffold group, small proportion scaffold group, medium proportion scaffold group, and large proportion scaffold group (with 5 mice in each group). On PID 7, the wound was continuously dressed with a polycaprolactone scaffold without drug and a polycaprolactone scaffold containing DH with a drug mass ratio of 1∶3, 1∶1, or 3∶1 (i.e. the dual release system of androgen and its antagonist, with total mass of DH being about 1.7 mg) prepared by using electrospinning technology until the end of the experiment. Histopathological analyses of tissue ( n=3) at the same time points as those in the previous animal experiment were performed. On PID 7 and 14, the wound exudates were collected and the relative abundance of bacterial communities was analyzed using 16S ribosomal RNA high-throughput sequencing ( n=3). Results:After culture of 2 days, under a small ratio, the proliferation levels of HaCaT cells in low baseline group and high baseline group were significantly higher than the level in blank group ( P<0.05). As the time after injury prolonged, the wounds of all four groups of mice continued to shrink. On PID 14, the wound healing rate of mice in large ratio group was 72.5% (61.7%, 75.1%), which was close to 53.3% (49.5%, 64.4%) in blank group ( P>0.05); the wound healing rates of mice in small and medium ratio groups were 74.2% (71.0%, 84.2%) and 70.4% (65.1%, 74.4%), respectively, which were significantly higher than the rate in blank group (with both Z values being -2.31, P<0.05). On PID 21, the wound healing rate of mice in small ratio group was significantly higher than that in blank group ( Z=-2.31, P<0.05). On PID 28, the wounds of mice in the three ratio groups were completely re-epithelialized and the epidermis was thicker than that in blank group; compared with that in blank group, the collagen fiber content in the wound tissue of mice in the three ratio groups was higher and arranged more orderly, and the proportions of collagen fibers in the wound tissue of mice in small and large ratio groups were significantly increased ( P<0.05). On PID 28, the wounds of mice in ordinary scaffold group were partially epithelialized, while the wounds of mice in the three proportion scaffold groups were almost completely epithelialized. Among them, the wounds of mice in small proportion scaffold group had the thickest epidermis. The proportion of collagen fibers in the wound tissue of mice in small proportion scaffold group was significantly increased compared with that in ordinary scaffold group ( P<0.05). On PID 7, the bacterial communities with high relative abundance in the wound exudation of mice in the four groups included bacteria of Corynebacterium, Staphylococcus, and Rhodococcus. On PID 14, the bacterial communities with high relative abundance in the wound exudation of mice in the four groups included bacteria of Stenotrophomonas, Rhodococcus, and Staphylococcus, and the number of bacterial species in the wound exudation of mice in the three proportion scaffold groups was more than that in ordinary scaffold group. Conclusions:When the drug mass ratio is relatively small, DH has the effect of promoting the proliferation of HaCaT cells. The ratio of 8∶9 is the optimal mass ratio of dihydrotestosterone to hydroxyflutamide, and DH with this mass ratio can promote re-epithelialization and collagen deposition of full-thickness burn wounds in mice, and promote wound healing. The constructed dual release system of androgen and its antagonist with DH in a 1∶3 drug mass ratio contributes to the re-epithelialization and collagen deposition of the full-thickness burn wounds in mice, and can improve the diversity of wound microbiota.
4.The value of adenosine loading 99Tc m-MIBI SPECT in evaluating the therapeutic effect of nicorandil on coronary microvascular angina pectoris
Nan TANG ; Bo YU ; Dan WANG ; Xiaodan FAN ; Nannan YIN ; Chunmei QI
Journal of Chinese Physician 2024;26(7):1035-1041
Objective:To explore the value of adenosine loaded 99Tc m-MIBI single photon emission computed tomography (SPECT) in evaluating the therapeutic effect of nicorandil on coronary microvascular angina (CMVA). Methods:Sixty eight patients diagnosed with CMVA in the Second Affiliated Hospital of Xuzhou Medical University from January 2021 to March 2022 were selected and randomly divided into a control group and a nicorandil group, with 34 patients in each group, using a random number table method. The control group received isosorbide mononitrate in addition to conventional treatment, while the nicorandil group received nicorandil in addition to conventional treatment. Both groups were treated continuously for 3 months. All patients underwent adenosine loading 99Tc m-MIBI SPECT before and after treatment to measure the degree of myocardial perfusion defect (SDS), myocardial perfusion defect area (SRS), and degree of improvement of myocardial perfusion defect (SIS). Clinical symptoms, electrocardiogram changes, myocardial enzyme indicators [cardiac troponin I (cTnI), creatine kinase-MB (CK-MB), lactate dehydrogenase (LDH)], hemodynamic parameters [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), stroke volume (SV), cardiac output (CO), peripheral resistance (TPR), left ventricular work index (LVWI), and myocardial oxygen consumption (MVO 2)] were evaluated. Results:After treatment, the SDS and SRS of the nicorandil group were significantly lower than those of the control group ( P<0.01), and the SIS was significantly higher than that of the control group (all P<0.01); The improvement of abnormal myocardial perfusion imaging was significantly better than that of the control group (χ 2=4.976, P<0.05); the frequency, duration, and severity of angina attacks, Canadian Heart Association (CCS) grading, and incidence of ischemic changes on electrocardiogram were all lower than those of the control group ( P<0.01); The levels of serum cTnI, CK-MB, and LDH were significantly lower than those in the control group (all P<0.01); SBP, DBP, HR, LVWI, and MVO 2 were significantly lower than those in the control group (all P<0.01), while SV and CO were significantly higher than those in the control group (all P<0.01). Conclusions:Adenosine loaded 99Tc m-MIBI SPECT can effectively evaluate the therapeutic effect of nicorandil on CMVA, and nicorandil can improve myocardial perfusion defects and clinical manifestations in CMVA patients.
5.Quality Evaluation of the Randomized Controlled Trials of Chinese Medicine Injection for Acute Cerebral Infarction in Last Five Years Based on ROB and CONSORT-CHM Formulas 2017
Ziteng HU ; Qianzi CHE ; Ning LIANG ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Weili WANG ; Haili ZHANG ; Wenjie CAO ; Yijiu YANG ; Tian SONG ; Dingyi WANG ; Xingyu ZONG ; Cuicui CHENG ; Yin JIANG ; Yanping WANG ; Nannan SHI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(7):32-37
Objective To evaluate the risk of bias and reporting quality in randomized controlled trials(RCTs)of the Chinese medicine injection for acute cerebral infarction in the last five years.Methods RCTs literature on Chinese medicine injection in the treatment of acute cerebral infarction was systematically searched in CNKI,Wanfang Data,VIP,China Biology Medicine Database(CBM),PubMed,Embase and Cochrane Library from April 20,2018 to April 20,2023.The risk of bias and reporting quality of included RCTs were evaluated using the Cochrane Risk of Bias Tool(ROB 1.0)and CONSORT-CHM Formulas 2017,respectively.Results A total of 4 301 articles were retrieved,and 408 RCTs were included according to inclusion and exclusion criteria.The ROB evaluation results showed that the the majority of studies were rated as having an unclear risk of bias due to the lack of reporting on allocation concealment,blind method,trial registration information,and funding sources.The evaluation results of CONSORT-CHM Formulas 2017 showed that the number of reported papers of 17 items was greater than or equal to 50%,and the number of reported papers of 25 items was less than 10%,and most of the RCTs did not show the characteristics of TCM syndrome differentiation and treatment.Conclusion The quality of Chinese medicine injection in the treatment of acute cerebral infarction RCTs is generally low.It is recommended that researchers refer to the methodology design of RCTs and international reporting standards,improve the trial design,standardize the trial report,and highlight the characteristics of TCM syndrome differentiation and treatment.
6.Consensus on prescription review of commonly used H 1-antihistamines in pediatrics
Lihua HU ; Lu LIU ; Huiying CHEN ; Heping CAI ; Wentong GE ; Zhiying HAN ; Huijie HUANG ; Xing JI ; Yuntao JIA ; Lingyan JIAN ; Nannan JIANG ; Zhong LI ; Li LI ; Hua LIANG ; Chuanhe LIU ; Qinghong LU ; Xu LU ; Jun′e MA ; Jing MIAO ; Yanli REN ; Yunxiao SHANG ; Kunling SHEN ; Huajun SUN ; Jinqiao SUN ; Yanyan SUN ; Jianping TANG ; Hong WANG ; Lianglu WANG ; Xiaochuan WANG ; Lei XI ; Hua XU ; Zigang XU ; Meixing YAN ; Yong YIN ; Shengnan ZHANG ; Zhongping ZHANG ; Xin ZHAO ; Deyu ZHAO ; Wei ZHOU ; Li XIANG ; Xiaoling WANG
Chinese Journal of Applied Clinical Pediatrics 2023;38(10):733-739
H 1-antihistamines are widely used in the treatment of various allergic diseases, but there are still many challenges in the safe and rational use of H 1-antihistamines in pediatrics, and there is a lack of guidance on the prescription review of H 1-antihistamines for children.In this paper, suggestions are put forward from the indications, dosage, route of administration, pathophysiological characteristics of children with individual difference and drug interactions, so as to provide reference for clinicians and pharmacists.
7.Recommedations for the diagnosis and treatment of anaphylaxis in Chinese children
Li XIANG ; Weilin WAN ; Zhenghai QU ; Jing ZHAO ; Wei ZHOU ; Baoping XU ; Liping WEN ; Lisha LI ; Ju YIN ; Nannan JIANG ; Meiying QUAN ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2021;36(6):410-416
Anaphylaxis is increasingly in children, which is currently undernotified, underdiagnosed, and undertreated in China.In order to further improved the understanding and management of anaphylaxis, this issue reviews the pathogenesis, triggers and risk factors, clinical diagnosis and management of anaphylaxis, thus offers the recommedations of anaphylaxis in Chinese children based on previous published evidence-based guidelines and practice parameters.Recommendation aims to develop guiding principles for the diagnosis and management of anaphylaxis in children, and provide a framework for the development of new guidelines.
8.Prognostic value of arterial lactate combined with central venous-to-arterial carbon dioxide difference to arterial-to-central venous oxygen content difference ratio in septic shock patients
Xueting WANG ; Xuehua GAO ; Wen CAO ; Yin GUAN ; Yannian LUO ; Foyan LIAN ; Nannan HE ; Peijie LI
Chinese Critical Care Medicine 2020;32(1):39-43
Objective:To evaluate the prognostic value of arterial lactate (Lac) combined with central venous-to-arterial carbon dioxide difference to arterial-to-central venous oxygen content difference ratio (Pcv-aCO 2/Ca-cvO 2) in patients with septic shock following early fluid resuscitation. Methods:A total of 97 patients with septic shock admitted to intensive care unit (ICU) of Lanzhou University Second Hospital from January 2017 to December 2019 were enrolled. The Pcv-aCO 2/Ca-cvO 2 ratio was calculated from blood gas analysis of radial artery and superior vena cava which was performed before resuscitation and at 6 hours of resuscitation at the same time. The patients were divided into death group and survival group according to the 28-day prognosis. The baseline data, acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) score, sequential organ failure score (SOFA), clinical therapy, lactate clearance rate (LCR) at 6 hours, the length of ICU stay, hemodynamics and oxygen metabolism parameters before and after resuscitation were compared between the two groups. Risk factors were analyzed by multivariate Cox regression for 28-day mortality of patients with septic shock. The receiver operating characteristic (ROC) curve was plotted to assess the prognostic values of these factors for 28-day mortality. Results:① Compared with the survival group, the patients in the death group showed significantly higher levels of APACHEⅡ score (23.96±4.31 vs. 17.70±3.92) and SOFA score (12.74±2.80 vs. 9.23±2.43, both P < 0.01), significantly higher proportions of mechanical ventilation [85.2% (23/27) vs. 50.0% (35/70)] and continuous renal replacement therapy [CRRT; 51.9% (14/27) vs. 25.7% (18/70), both P < 0.05], a significantly more fluid replacement at 6 hours (L: 2.92±0.24 vs. 2.63±0.25, P < 0.01), a significantly lower level of LCR at 6 hours [(11.61±7.76)% vs. (27.67±13.71)%, P < 0.01], and a shorter length of ICU stay (days: 6.37±2.70 vs. 7.67±2.31, P < 0.05). ② Compared with the survival group, the patients before resuscitation in the death group showed a significantly lower level of mean arterial pressure [MAP (mmHg, 1 mmHg = 0.133 kPa): 52.63±4.35 vs. 55.74±3.01, P < 0.01], significantly higher levels of Lac and Pcv-aCO 2/Ca-cvO 2 ratio [Lac (mmol/L): 7.13±1.75 vs. 5.22±1.36, Pcv-aCO 2/Ca-cvO 2 ratio: 1.67±0.29 vs. 1.48±0.22, both P < 0.01]; and the patients at 6 hours of resuscitation in the death group showed a significantly lower level of MAP (mmHg: 62.59±4.80 vs. 66.71±3.91, P < 0.01), significantly higher levels of central venous pressure (CVP), Lac, Pcv-aCO 2 and Pcv-aCO 2/Ca-cvO 2 ratio [CVP (mmHg): 10.74±1.40 vs. 8.80±0.75, Lac (mmol/L): 6.36±1.86 vs. 3.90±1.95, Pcv-aCO 2 (mmHg): 7.59±2.02 vs. 4.34±1.37, Pcv-aCO 2/Ca-cvO 2 ratio: 1.87±0.51 vs. 1.03±0.27, all P < 0.01]. ③ Multivariate Cox regression analysis showed that the independent risk factors for 28-day mortality in patients with septic shock were Lac and Pcv-aCO 2/Ca-cvO 2 ratio whether before or at 6 hours of resuscitation [Lac before resuscitation: relative risk ( RR) = 1.434, 95% confidence interval (95% CI) was 1.070-1.922, P = 0.016; Lac at 6 hours of resuscitation: RR = 1.564, 95% CI was 1.202-2.035, P = 0.001; Pcv-aCO 2/Ca-cvO 2 ratio before resuscitation: RR = 2.828, 95% CI was 1.108-4.207, P = 0.038; Pcv-aCO 2/Ca-cvO 2 ratio at 6 hours of resuscitation: RR = 4.386, 95% CI was 2.842-5.730, P = 0.000]. ④ ROC curve analysis showed that Lac and Pcv-aCO 2/Ca-cvO 2 ratio at 6 hours of resuscitation had predictive value for the prognosis of patients with septic shock, the area under ROC curve (AUC) was 0.849 (95% CI was 0.762-0.914) and 0.905 (95% CI was 0.828-0.955), respectively. However, the predictive value of Lac combined with Pcv-aCO 2/Ca-cvO 2 ratio in patients with septic shock was significantly higher than Lac [AUC (95% CI): 0.976 (0.923-0.996) vs. 0.849 (0.762-0.914), Z = 3.354, P = 0.001], the sensitivity was 97.14%, and the specificity was 88.89%. Conclusions:Lac and Pcv-aCO 2/Ca-cvO 2 ratio are independent risk factors for predicting 28-day mortality in patients with septic shock. Lac combined with Pcv-aCO 2/Ca-cvO 2 ratio can assess the prognosis of patients with septic shock more accurately.
9.Transition and evolution of HIV-1 subtype among HIV-1 infections in Wuxi city, 2013-2016
Yueqi YIN ; Jianshuang CHEN ; Hao CHENG ; Xuan ZHANG ; Nannan WU ; Lusi CHEN ; Bei WANG
Chinese Journal of Epidemiology 2020;41(2):244-248
Objective To understand the distribution of HIV-1 subtype in Wuxi city,to predict the local HIV-1 epidemics.Methods Samples were collected from the'CD4+T lymphocyte monitoring cohort study'in Wuxi from April 2013 to July 2016.HIV-1 gene was amplified,sequenced and with HIV-1 sequence database constructed,using both the ChromasPro 1.6 and MEGA 7.0 softwares.Bayesian phylogenetic inference was used to rebuild the history of HIV-1 transmission,while BEAST 1.7.2 and FastTree 2.1.10 software were used for data analysis.Statistical analysis using SPSS 22.0 software.Results Among the 205 subjects of HIV-1 infection,32.68%(67/205) of them were over 50 years old.Seven subtypes (including CRF01_AE,CRF07_BC,CRF67_01B,B,CRF08_BC,CRF68_0B,CRF78_cpx) and one of the unique recombinant forms (URFs) were detected.The main subtypes were CRF01_ AE (51.67%,93/180) and CRF07_BC (17.22%,31/180).Differences between subtypes and ways of transmission were statistically significant (x2=16.99,P≤0.05).The proportion of CRF67_01B (12.78%,23/180) was higher than before.Results from Bayesian phylogenetic inference analysis showed that the evolution rate was 2.29 × 10-3 and Time to the Most Recent Common Ancestor (tMRCA) was 2 003.10.CRF67_01B was probably related to the reference strains from Jiangsu and Anhui provinces,and had been spreading in Wuxi since 2003.Conclusions HIV-1 subtypes seemed complex and diverse in Wuxi city in 2013-2016,with CRF67_01B being pervasive.Continuous molecular monitor program was still needed to provide reference for the prediction of epidemics,from the molecular perspective.
10.Relationship between PDE4C gene methylation in peripheral blood leukocytes, interaction of environmental factors and pathogenesis of breast cancer
Shuo LI ; Nannan ZHANG ; Liangliang LI ; Zhiping LONG ; Huihui YIN ; Yashuang ZHAO ; Fan WANG
Practical Oncology Journal 2019;33(3):233-238
Objective The objective of this study was to investigate the relationship between the methylation of phosphodies-terase 4C(PDE4C)gene in peripheral blood leukocytes,and its interaction with environmental factors and the pathogenesis of breast cancer. Methods A case-control study was conducted to select 402 cases of breast cancer and 470 cancer-free controls from Octo-ber 2010 to December 2014. The specific DNA methylation-modified quantitative PCR method was used to detect the methylation of PDE4C gene. The use of crossover analysis and multivariate logistic regression was used to analyze the relationship between the level of gene methylation and its interaction with environmental factors and the pathogenesis of breast cancer. Results PDE4C methylation was not found to be significantly associated with the onset of breast cancer. High-frequency/high-intake of whole grains,vegetables, onion-based plants,poultry,milk,and regular exercise could reduce the risk of breast cancer;high-frequency/high-intake of pork, irregular menstrual cycle,and a high psychological stress index could increase the risk of breast cancer. PDE4C hypermethylation had a significant combining effect with edible onion-producing plants greater than 3 times/week,with an OR of 0. 373(95% CI:0. 208~0. 668,P=0. 001). Conclusion Hypermethylation of PDE4C is not an independent risk factor for breast cancer,and its combination with environmental factors affects the risk of breast cancer.

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