1.Clinical trial of spironolactone combined with sacubitril/valsartan in the treatment of patients with hypertensive nephropathy
Lin-Lin WANG ; Jia-Li FENG ; Sheng-Jun LIU ; Zhen-Hua QIAO ; Xiu-Ling JIA ; Xiao-Li HAN
The Chinese Journal of Clinical Pharmacology 2024;40(8):1091-1095
Objective To observe the clinical efficacy and safety of spironolactone combined with sacubitril/valsartan in the treatment of patients with hypertensive nephropathy.Methods The patients with hypertensive nephropathy were randomly divided into control group and treatment group.The control group was treated with sacubitril/valsartan(100-200 mg·d-1 in the morning),and treatment group was combined with low-dose spironolactone treatment(20 mg·d-1 in the morning)on the basis of control group.Both groups were treated continuously for 12 weeks.The clinical efficacy was compared;the blood pressure,urinary microalbumin(mAlb),urinary β2 microglobulin(β2-MG)and serum cystatin C(Cys-C),transforming growth factor-β1(TGF-β1),connective tissue growth factor(CTGF)and angiotensin Ⅱ(Ang Ⅱ)and adverse drug reactions were observed before and after treatment.Results There were 87 cases in treatment group and 86 cases in control group were included respectively.After treatment,the total effective rates in treatment group and control group were 95.40%(83 cases/87 cases)and 82.56%(71 cases/86 cases),with significant difference(P<0.05).After treatment,the systolic blood pressure values in treatment group and control group were(124.65±9.65)and(130.27±8.93)mmHg,the diastolic blood pressure values were(75.08±7.14)and(80.45±7.35)mmHg,urinary mAlb levels were(42.58±5.65)and(51.28±6.64)mg·L-1,urinary β2-MG levels were(0.46±0.17)and(0.75±0.25)mg·L-1,24 h urinary protein quantitation levels were(138.49±46.64)and(216.48±65.27)mg,serum Cys-C levels were(0.63±0.26)and(0.85±0.24)mg·L-1,TGF-β1 levels were(98.67±21.43)and(112.46±26.72)pg·mL-1,CTGF levels were(1 206.54±236.56)and(1 340.51±248.25)pg·mL-1,Ang Ⅱ levels were(101.55±17.62)and(115.65±20.08)pg·mL-1,all with significant difference(all P<0.05).The incidence of adverse drug reactions in treatment group and control group were 6.90%(6 cases/87 cases)and 2.33%(2 cases/86 cases),with no significant difference(P>0.05).Conclusion Compared with sacubitril/valsartan alone,spironolactone combined with sacubitril/valsartan can better reduce blood pressure,improve renal function and delay progression of renal fibrosis in the treatment of hypertensive nephropathy,and has definite efficacy,with good safety.
2.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
3.Clinical Significance of Genetic and Molecular Changes in Primary Myeloid Sarcoma
Ya-Jun JIANG ; Chun-Fang ZHANG ; Hong-Xia WANG ; Lan ZHAO ; Fei-Fei ZHANG ; Xiu-Hua HAN
Journal of Experimental Hematology 2024;32(1):27-32
Objective:To investigate the clinical significance of genetic and molecular changes in primary myeloid sarcoma(MS).Methods:Fourteen patients with primary MS were selected in Jiading District Central Hospital Affiliated Shanghai University of Medicine & Health Sciences,The First People's Hospital of Lianyungang from September 2010 to December 2021.AML1-ETO fusion,PML-RARα fusion and CBFβ breakage were detected by fluorescence in situ hybridization(FISH),and the mutations of NPM1,CEBPA,FLT3,RUNX1,ASXL1,KIT and TP53 genes were detected by new generation sequencing(NGS).Results:Among 14 patients,the MS occurred in bone,breast,epididymis,lung,chest wall,cervix,small intestine,ovary,lymph nodes and central nervous system.The tumor cells expressed MPO(13 cases),CD34(7 cases),CD43(8 cases),CD68(7 cases),CD99(8 cases)and CD117(6 cases).Cytogenetic abnormalities were observed in 4 cases,including 3 cases of AML1-ETO fusion and 1 case of CBF β breakage,while no PML-RAR α fusion was detected.There were no significant differences in overall survival(OS)and leukemia-free survival(LFS)between patients with and without AML1-ETO fusion/CBFβ breakage(both P>0.05).Among the 14 patients,the number of NPM1,CEBPA,FLT3-ITD,RUNX1,ASXL1,KIT and TP53 gene mutations was 5,3,5,3,2,2,1.respectively,of which 7 cases had at least one mutation in FLT3-ITD,RUNX1,ASXL1 and TP53 gene.The OS and LFS of patients with FLT3-ITD,RUNX1,ASXL1 or TP53 mutation were shorter than those without mutations(both P<0.01).Conclusion:The genetic and molecular abnormalities of primary MS can be detected by FISH and NGS techniques.FLT3-ITD,RUNX1,ASXL1 or TP53 mutation indicates a worse prognosis,but further clinical studies are needed to confirm it.
4.To compare the efficacy and incidence of severe hematological adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia.
Xiao Shuai ZHANG ; Bing Cheng LIU ; Xin DU ; Yan Li ZHANG ; Na XU ; Xiao Li LIU ; Wei Ming LI ; Hai LIN ; Rong LIANG ; Chun Yan CHEN ; Jian HUANG ; Yun Fan YANG ; Huan Ling ZHU ; Ling PAN ; Xiao Dong WANG ; Gui Hui LI ; Zhuo Gang LIU ; Yan Qing ZHANG ; Zhen Fang LIU ; Jian Da HU ; Chun Shui LIU ; Fei LI ; Wei YANG ; Li MENG ; Yan Qiu HAN ; Li E LIN ; Zhen Yu ZHAO ; Chuan Qing TU ; Cai Feng ZHENG ; Yan Liang BAI ; Ze Ping ZHOU ; Su Ning CHEN ; Hui Ying QIU ; Li Jie YANG ; Xiu Li SUN ; Hui SUN ; Li ZHOU ; Ze Lin LIU ; Dan Yu WANG ; Jian Xin GUO ; Li Ping PANG ; Qing Shu ZENG ; Xiao Hui SUO ; Wei Hua ZHANG ; Yuan Jun ZHENG ; Qian JIANG
Chinese Journal of Hematology 2023;44(9):728-736
Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
Adult
;
Humans
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Adolescent
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Imatinib Mesylate/adverse effects*
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Incidence
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Antineoplastic Agents/adverse effects*
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Retrospective Studies
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Pyrimidines/adverse effects*
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy*
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Treatment Outcome
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Benzamides/adverse effects*
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Leukemia, Myeloid, Chronic-Phase/drug therapy*
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Aminopyridines/therapeutic use*
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Protein Kinase Inhibitors/therapeutic use*
5.Overview of systematic reviews of acupuncture for vascular cognitive impairment.
Fu-Hua HAN ; Lin-Juan SUN ; Yun-Ling ZHANG ; Zi-Xiu ZENG ; Wei SHEN ; Min ZHAN ; Ying WANG ; Jing-Zi SHI ; Xin-Yun ZENG ; Xi-Yue LU ; Xing LIAO
Chinese Acupuncture & Moxibustion 2022;42(1):109-115
OBJECTIVE:
To overview the methodological quality, report quality and evidence quality of the systematic review (SR) of acupuncture for vascular cognitive impairment ( VCI ).
METHODS:
The SRs regarding acupuncture for VCI were searched in PubMed, Cochrane Library, EMbase, CNKI, SinoMed, Wanfang and VIP databases. The retrieval period was from the establishment of the database to September 24, 2020. The report quality, methodological quality and evidence quality of the included SRs were evaluated by PRISMA statement, the AMSTAR 2 tool and the GRADE system.
RESULTS:
A total of 22 SRs were included, including 102 outcome indexes. The methodological quality was generally low, with low scores on items 2, 5, 7, 10, 14, 15 and 16. The report quality was good, with scores ranging from 19 points to 24.5 points. The problems of report quality were mainly reflected in the aspects of structural abstract, program and registration, other analysis and funding sources. The level of outcome indexes of SRs was mostly low or very low, and the main leading factor was limitation, followed by inconsistency and inaccuracy.
CONCLUSION
Acupuncture for VCI is supported by low quality evidence of evidence-based medicine, but the methodological quality and evidence body quality of relevant SRs are poor, and the standardization is needed to be improved.
Acupuncture Therapy
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Cognitive Dysfunction/therapy*
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Databases, Factual
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Humans
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Research Report
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Systematic Reviews as Topic
6.Outcomes in randomized controlled trials of acupuncture for vascular cognitive impairment during recent five years.
Xin-Yun ZENG ; Xing LIAO ; Yun-Ling ZHANG ; Zi-Xiu ZENG ; Wei SHEN ; Min ZHAN ; Ying WANG ; Fu-Hua HAN ; Jing-Zi SHI ; Xi-Yue LU
Chinese Acupuncture & Moxibustion 2022;42(5):590-594
The existing problems in the outcomes of randomized controlled trials (RCTs) of acupuncture for vascular cognitive impairment (VCI) during recent five years are analyzed and suggestions are proposed. The RCTs of acupuncture for VCI were selected in PubMed, EMbase, Cochrane Library, Clinical Trials, CNKI database, Wanfang database, VIP database, SinoMed database and Chinese Clinical Trial Registry (ChiCTR) from January 1, 2015 to September 14, 2020. The outcomes were extracted and analyzed. As a result, 21 RCTs were included and the outcomes used were divided into 9 categories: clinical symptom/sign indexes, quality of life indexes, neuroimaging indexes, neuroelectrophysiology indexes, blood biochemical indexes, hemorheology indexes, TCM syndrome score indexes, clinical efficacy indexes, and safety indexes. Among them, the top three of the most used outcomes were clinical symptoms/signs indexes (21, 100.0%), clinical efficacy indexes (14, 66.7%) and quality of life indexes (12, 57.1%). In the RCTs of acupuncture for VCI, attention should be paid to distinguish the primary outcomes and secondary outcomes, adopt objective and standardized efficacy evaluation, and give consideration to report the outcomes of safety, health economic and TCM characteristic indexes.
Acupuncture Therapy
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Cognitive Dysfunction/therapy*
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Humans
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Randomized Controlled Trials as Topic
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Treatment Outcome
7.Application effects of feedforward control theory in the rollover bed treatment of mass patients with burn-explosion combined injury.
Hua Qing CHEN ; Xiu Qin FENG ; Cai Juan XU ; Yu Ping ZHANG ; Fei ZENG ; Zu Ai ZHONG ; Yi Lan XIA ; Chun Mao HAN
Chinese Journal of Burns 2022;38(4):373-377
Objective: To explore the application effects of feedforward control theory in the rollover bed treatment of mass patients with burn-explosion combined injury. Methods: A retrospective observational research was conducted. From June 13 to 14, 2020, 15 patients with severe burn-explosion combined injury caused by liquefied natural gas tank car explosion and conforming to the inclusion criteria were admitted to the Second Affiliated Hospital of Zhejiang University School of Medicine. There were 13 males and 2 females, aged 33-92 (66±17) years. All the patients were treated with rollover bed from 48 h post admission, and the feedforward control theory was introduced, including establishing a special feedforward control management team for rollover bed, clarifying the duties of the medical staff in the rollover bed treatment of patients, implementing the cooperation strategy of multidisciplinary physician, training and examining for 80 nurses in the temporarily organized nurse team in the form of "rollover bed workshop", and formulating the checklist and valuation list of rollover bed treatment for continuous quality control. The frequency and the total number of turning over, and successful rate of one-time posture change with the rollover bed of patients within 30 days of admission were recorded, the occurrences of adverse events caused by improper operation for the rollover bed during the treatment were observed, including respiratory and cardiac arrests, treatment interruption, unplanned extubation, bed falling, and skin graft displacement. The lowest levels of arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2), the number of patients with oxygenation index>300 mmHg (1 mmHg=0.133 kPa), and the occurrence of acute respiratory distress syndrome (ARDS) of patients within 2 days of admission and on the 30th day of admission were recorded. Results: Within 30 days of admission, the patients were turned over with the rollover bed for 2 to 6 times each day, with a total of 1 320 turning over operations, the successful rate of one-time posture change reached 99.9% (1 319/1 320), and no adverse event occurred. Within 2 days of admission, the lowest levels of PaO2 and PaCO2 of the patients were (100±19) and (42±4) mmHg, respectively, and the number of patients with mild, moderate, and severe ARDS were 10, 2, and 3, respectively, and none of the patients had oxygenation index>300 mmHg. On the 30th day of admission, the lowest levels of PaO2 and PaCO2 of the patients were (135±28) and (37±8) mmHg, respectively, 3 patients developed moderate ARDS, 1 patient developed severe ARDS, and 11 patients had oxygenation index>300 mmHg. Conclusions: The introduction of feedforward control theory in the treatment of rollover bed of mass patients with burn-explosion combined injury can ensure safe and successful completion of turning over with the rollover bed, promote the repair of burn wound, and improve respiratory function, and therefore improve the treatment quality of patients.
Blood Gas Analysis
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Burns/therapy*
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Explosions
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Female
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Humans
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Male
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Respiratory Distress Syndrome
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Retrospective Studies
8.Textual Research on Perillae in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui -hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):55-67
Based on the ancient literature of all dynasties, this article makes a systematic textual research on the name, origin, producing area, quality, harvesting and processing of Zisu (Perillae) in the famous classical formulas, so as to clarify the information of the drug in different historical periods and provide a reference for the development and utilization of the related formulas. The main origin of Perillae in the ancient literature was Perilla frutescens var. frutescens (purple leaf type), followed by P. frutescens var. acuta (purple leaf type), but not Baisu. Modern chemical composition studies also show that there are obvious differences between Perillae and Baisu, which provides a scientific basis for distinguishing them. Although they are often treated as a species in plant classification, P. frutescens var. frutescens (purple leaf type) is recommended in the development of famous classical formulas, and Baisu should be avoided. Perillae is widely distributed, but its producing area did not record in most of the literature in the past dynasties, or the producing area is described as everywhere today. In the period of the Southern and Northern dynasties, the medicinal parts of Perillae included stems, leaves and seeds, and doctors in the Ming dynasty began to pay attention to the differentiation of different medicinal parts. The harvesting and processing methods of Perillae in the past dynasties are close to that of today. Perillae Fructus is mostly stir-fried and ground into medicine, Perillae Folium and Perillae Caulis are mainly simple cleansing. In production, we can refer to the 2020 edition of Chinese Pharmacopoeia.
9.Herbal Textual Research on Jujubae Fructus in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):296-305
This paper made a systematic textual research on the historical evolution and changes of the name, origin, producing area, harvesting and processing methods of Jujubae Fructus used in famous classical formulas by referring to the ancient literature, so as to provide a basis for the sampling and research of the formulas containing the medicinal materials. According to textual research, there are many names of Jujubae Fructus, most of which are named by characters or producing areas, which are called Dazao. Ziziphus jujuba has always been the mainstream variety in all dynasties, and Z. jujuba var. inemmis has also been used. Considering that the differences between the two are not obvious, we can use Z. jujuba and Z. jujuba var. inemmis as the origins of Dazao. The germplasm resources of Jujubae Fructus are rich, which are distributed all over the country. Qingzhou (now Shandong), Jinzhou (now Shanxi) Jiangzhou (now Shanxi), Puzhou (now Shanxi) have been recorded as authentic producing areas of Jujubae Fructus in the past dynasties, especially in Shandong. At the beginning of the 21st century, the planting of Jujubae Fructus in Xinjiang gradually developed, and now has a high market recognition, becoming an emerging production area of high-quality samples. Harvest period of Jujubae Fructus is mostly August in the past dynasties, and this is basically the same as today. The main processing method is simple cleansing and drying. Through textual research, it is suggested that Jujubae Fructus in famous classical formulas should be mainly from Shandong, Shanxi and other traditional high-quality producing areas, the processing method should follow the 2020 edition of Chinese Pharmacopoeia for simple cleansing and drying.
10.Herbal Textual Research on Magnoliae Officinalis Cortex in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):306-317
Based on the ancient literature of all dynasties, this article makes a systematic textual research on the name, origin, producing area, quality, harvesting and processing of Magnoliae Officinalis Cortex used in the famous classical formulas, and clarifies its information of each link in different historical periods, so as to provide a reference and basis for the development and utilization of the related formulas. The results showed that the main varieties of Magnoliae Officinalis Cortex were Magnolia officinalis or M. officinalis var. biloba. The main production areas are Hubei, Sichuan, Chongqing and other places, forming the famous authentic medicine. The processing methods of the past dynasties are mainly cleansing and processing with ginger. In the formulas clearly marked with ginger processing, ginger-processed products is suggested to choose. If not clearly marked, raw or ginger-processed products can be used as needed.

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