1.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
2.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Perimenopausal Syndrome
Shiwan HU ; Haiyan LIANG ; Kun MA ; Xiaona MA ; Zihan FANG ; Wenpei BAI ; Xinmin LIU ; Hongtian LI ; Fengmei LIAN ; Wei ZHANG ; Lihua QIN ; Min SHANG ; Ailuan LAI ; Xiuxiang TENG ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):234-242
Perimenopausal syndrome (MPS), a common endocrine system disease, is one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in endocrinology, gynecology, and interdisciplinary fields of both Western and Chinese medicine to discuss the advantages and challenges of diagnosing and treating MPS with Western medicine, TCM, and integrative medicine. Experts at the conference believe that MPS is initiated by estrogen decline and rooted in deficiency, with the pathogenesis being imbalance between Yin and Yang in the kidney. The hormone replacement therapy in Western medicine for menopause can rapidly alleviate related symptoms by quickly restoring the estrogen level and timely detect and delay complications of menopause, whereas such a therapy has certain risks, necessitating close monitoring of adverse reactions. Moreover, the various contraindications and precautions limit the clinical application of the hormone replacement therapy. TCM has advantages in synergistically alleviating symptoms such as hot flashes, sweating, sleep disorders, and emotional abnormalities of MPS without causing obvious adverse reactions. However, its efficacy is slower than the hormone replacement therapy, and the TCM evidence for preventing and treating complications of menopause remains unclear. Three suggestions were proposed for the future development of both Western and TCM for ameliorating MPS. First, an integrated diagnosis and treatment system for MPS with both Western and Chinese medicine should be established. Second, high-quality evidence-based interventions for MPS should be developed with TCM alone or in combination with Western medicine. Third, efforts should be made to promote the new TCM drug development and the interdisciplinary cooperation for treating MPS.
3.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
4.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
5.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.
6.Serum metabolomics of small cell lung cancer patients based on UPLC-TOF/MS
Jiawen ZHANG ; Yan YU ; Wei ZHANG ; Jingyan CAO ; Wen LUO ; Lihua SHANG
Practical Oncology Journal 2019;33(3):200-205
Objective The objective of this study was to explore the differences of serum metabolomics between small cell lung cancer(SCLC)patients and healthy volunteers,and to discover serum potential biomarkers for identification and small cell lung cancer staging. Methods Ultra-performance liquid chromatography time of flight mass spectrometry(UPLS-TOF/MS)was used to establish the serum metabolic profile of SCLC. Principal Component Analysis(PCA)and orthogonal hidden variables were analyzed by the EZinfo2. 0 software. Orthogonal Partial Least Squares Discriminant Analysis(OPLS-DA)was used to analyze the metabolic differ-ences between the case and normal control groups. Through cluster analysis using HMDB and METLIN database to search for the exact mass-to-charge ratio of the difference,preliminary identification of some substances with significant differences was carried out. Results Ten differential metabolites such as lysophosphatidylcholine between patients and control groups were screened and identi-fied by mass spectrometry and database search. There were 10 different metabolites such as glycocholic acid in the contour analysis of SCLC patients with different stages. Conclusion There is a significant difference in serum metabolism between SCLC patients and healthy controls. The discovery of differential metabolites provides experimental evidence for the identification of small cell lung cancer and potential markers of staging.
7. Combined anluohuaxianwan and entecavir treatment significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection
Liang MIAO ; Wanna YANG ; Xiaoqin DONG ; Zhanqing ZHANG ; Shibin XIE ; Dazhi ZHANG ; Xuqing ZHANG ; Jun CHENG ; Guo ZHANG ; Weifeng ZHAO ; Qing XIE ; Yingxia LIU ; Anlin MA ; Jun LI ; Jia SHANG ; Lang BAI ; Lihua CAO ; Zhiqiang ZOU ; Jiabin LI ; Fudong LYU ; Hui LIU ; Zhijin WANG ; Mingxiang ZHANG ; Liming CHEN ; Weifeng LIANG ; Hui GAO ; Hui ZHUANG ; Hong ZHAO ; Guiqiang WANG
Chinese Journal of Hepatology 2019;27(7):521-526
Objective:
To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks.
Methods:
Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman’s rank correlation coefficient was used to test bivariate associations.
Results:
Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (
8.Advance in the ultrasound-guided serratus anterior plane block
Lihua SHANG ; Xiangyu WANG ; Zhennan XIAO ; Bo LONG
Chinese Journal of Postgraduates of Medicine 2018;41(3):277-279
Ultrasound-guided serratus anterior plane block is one of the ways to provide analgesia to post thoractomy.It appears to be more easily performed compared with other techniques and is applied to be a postoperative analgesia for chest surgery such as breast cancer,ribs fracture and lung cancer.The review studies the using of serratus anterior plane block in clinical pain management.
9.Effect of ultrasound-guided serratus plane block on efficacy of postoperative analgesia in patients undergoing video-assisted thoracoscopic surgery
Lihua SHANG ; Zhennan XIAO ; Bo LONG
Chinese Journal of Postgraduates of Medicine 2018;41(9):819-822
Objective To investigate the effect of ultrasound-guided serratus plane block (SAPB) on efficacy of postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery. Methods Sixty patients scheduled for video- assisted thoracoscopic radical resection of lung cancer under general anesthesia from October 2017 to April 2018 were divided into 2 groups by random digits table method with 30 cases each: SAPB group and control group. After induction of anesthesia, ultrasound-guided homolateral SAPB was performed, and 0.5% ropivacaine 20 ml was injected in SAPB group, while the equal volume of normal saline was used instead in control group. The patients received intravenous analgesia after operation in 2 groups. The scores of visual analogue score (VAS) and Bruggrmann comfort score (BCS) were evaluated at 1, 2, 4, 6, 12, 24 and 48 h after operation. The consumption of additional pain medication within 48 h after operation and remifentanil during operation were recorded. The adverse effects were also recorded. Results The VAS scores at postoperative 1, 2, 4, 8 and 12 h in SAPB group were significantly lower than those in control group: (2.70 ± 0.92) scores vs. (5.10 ± 2.04) scores, (2.80 ± 1.00) scores vs. (5.13 ± 1.78) scores, (3.07 ± 1.17) scores vs. (4.93 ± 1.53) scores, (3.13 ± 1.07) scores vs. (4.63 ± 1.47) scores and (2.87 ± 0.73) scores vs. (3.83 ± 1.29) scores, P <0.05; the BCS scores at postoperative 1, 2, 4, 8 and 12 h in SAPB group were significantly better than those in control group: (1.90 ± 0.66) scores vs. (0.93 ± 0.91) scores, (2.03 ± 0.41) scores vs. (0.90 ± 0.80) scores, (1.90 ± 0.40) scores vs. (1.07 ± 0.69) scores, (1.97 ± 0.32) vs. (1.20 ± 0.66) scores and (2.03 ± 0.18) scores vs. (1.73 ± 0.45) scores, and there were statistical differences (P<0.05). The dose of remifentanil consumption of additional pain medication within 48 h in SAPB group were significantly lower than those in control group: (0.23 ± 0.03) mg vs. (0.34 ± 0.03) mg and (26.67 ± 25.37) mg vs. (40.00 ± 24.21) mg, and there were statistical differences (P<0.05). There was no significant difference in the incidence of adverse reactions between 2 groups (P > 0.05). Conclusions The SAPB can reduce the early pain after video-assisted thoracoscopic radical resection of lung cancer, improve the comfort of patients, enhance the effect of postoperative analgesia and reduce the use of postoperative analgesic drugs.
10.Nursing care of patients with malignant tumor treated by 3D printing individualized template and 125I seed implantation
Ruicai XU ; Yakun LIU ; Qiongqiong SHANG ; Lihua ZHAO ; Ying ZHANG ; Yanjie WANG ; Qi YANG ; Mingyong HAN
Chinese Journal of Nursing 2017;52(3):293-296
This paper summarized nursing experience of 23 patients with malignant tumor treated by 3D printing individualized template and 125I seed implantation.Nursing points included:preoperative assessment and preparation,reviewing the process of template conduction,assisting the physician to simulate the position of patients,making treatment plans,preparing templates before operation;resetting and maintaining position of patients,performing template alignment,seed implantation,monitoring vital signs and complications during operation;observation of complications,providing radiation protection and discharge guidance after operation.All 23 patients completed 125I seed implantation and no serious complication was observed.All patients recovered well and were discharged after treatment.

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