1.Clinical Observation of Salmeterol Fluticasone Combined with Tiotropium Bromide in the Treatment of COPD via Different Inhalation Devices
Huilan ZHU ; Xiumei XIANG ; Limei ZHOU ; Lu SHI ; Feifei WANG
China Pharmacy 2017;28(8):1084-1087
OBJECTIVE:To observe clinical efficacy and safety of salmeterol fluticasone combined with tiotropium bromide in the treatment of COPD via different inhalation devices.METHODS:Eighty COPD patients were selected from our hospital during Jan.2014 to Jan.2015,and then divided into trial group and control group according to random number table,with 40 cases in each group.Both groups were given Salmeterol fluticasone inhalant 500 μg,bid+Tiotropium bromide inhalant 18 μg,qd.Control group was given medicine via inhalation device coming with medicine,while trial group was given medicine via gas compression type ultrasonic spray inhalator.Both groups were treated for 1 year.Blood concentration of medicine 0.5 h after medication,mMRC score and COPD acsessment test (CAT) score 3,6,9 months after treatment,the times of acute exacerbation during treatment,FEV1% before and af ter treatment were all observed in 2 groups.The occurrence of ADR was recorded.RESULTS:Four cases withdrew from trial group and 1 case from control group.After medication,there was no statistical significance in blood concentration of fluticasone,salmeterol and tiotropium bromide between 2 groups (P>0.05).0.5 h after medication,mMRC score of trial group was slightly lower than that of control group,without statistical significance (P>0.05);CAT score of it was significantly lower than that of control group,with statistical significance (P<0.05).The times of acute exacerbation in trial group during treatment was significantly less than control group,with statistical significance (P<0.05).The decrease of FEV1% in trial group was slightly lower than control group,without statistical significance (P>0.05).The incidence of ADR in trial group was significantly lower than control group,with statistical significance (P<0.05).CONCLUSIONS:For COPD patients,salmeterol fluticasone combined with tiotropium bromide via gas compression type ultrasonic spray inhalator is better than inhalation device coming with medicine in clinical efficacy and safety.
2.Case recruitment in large-scale clinical trials of traditional Chinese medicine
Hongbo CAO ; Hongcai SHANG ; Ming REN ; Junhua ZHANG ; Xin GAO ; Yaozu XIANG ; Guohua DAI ; Yang WANG ; Xiumei GAO ; Boli ZHANG
Journal of Integrative Medicine 2007;5(3):243-6
Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".
3.Discovery of four splicing isoforms of Beagle estrogen receptor β
Qin XU ; Xiang DONG ; Jianying LI ; Yonghua XU ; Xiumei REN ; Yanbin ZHAO ; Jieying BAI ; Zhaozeng SUN ; Lin ZENG ; Zhongming HU
Chinese Journal of Comparative Medicine 2014;(11):33-40
Objective To screen the splicing isoforms of estrogen receptor βin the Beagle hypothalamic -pituitary -gonadal axis.Methods For ERβmRNA CDS sequence of eight exons, primers were designed confined to the CDS sequences of two sequential exons.Beagle hypothalamus, pituitary, ovary and uterus tissue cDNA were used as template, and corresponding sequences were amplified by PCR.PCR products were sequenced and aligned in the NCBI web site.The correct gene was then analyzed with DNAMAN comparative analysis software and handwork checking up, thus got the ERβsplicing isoforms of Beagle. Results Four beagle ER beta splicing isomers were obtained:exon 4 complete skipping ER βisomer (300 bp missing), two kind of Beagle ERβisoforms with partial exon 4 and partial exon 5 complicated missing (isoformⅠ334 bp missing and isoformⅡ265 bp missing), and exon 7 complete missing ERβsplicing isoforms (181 bp missing).Exon 4 complete skipping and exon 7 complete missing isomers had been obtained full length coding sequence, and the other two splicing isomers were partial coding sequence.Conclusion This project gained four ERβsplicing isomers of Beagle, and that will lay an important foundation for further study of their roles in the Beagle reproductive regulation mechanism.
4.Network pharmacology study on major active compounds of Fufang Danshen formula.
Xiang LI ; Leihong WU ; Xiaohui FAN ; Boli ZHANG ; Xiumei GAO ; Yi WANG ; Yiyu CHENG
China Journal of Chinese Materia Medica 2011;36(21):2911-2915
OBJECTIVETo investigate the correlations between multi-compounds of Fufang Danshen formula and their multi targets and multi diseases.
METHODLiterature knowledge of nine major active compounds from Fufang Danshen formula, including tanshinone II(A), salvianolic acid B, protocatechuic aldehyde, danshensu, cryptotanshinone, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1 and borneol were collected from PubMed. Combined with cardiovascular related diseases and genes from OMIM database, the corresponding multi-compound-multi- target-multi-disease network was constructed and visualized by Cytoscape software.
RESULTAND CONCLUSION: Network analysis showed that the 9 compounds could modulate 42 cardiovascular associated genes (e. g. PPARG, ACE, KCNJ11, KCNQ1, ABCC8, et al), which related to 30 cardiovascular associated diseases including non-insulin-dependent diabetes mellitus, hyperinsulinemic hypoglycemia, hypertension, and coronary heart disease. These results suggested new potential indications of Fufang Danshen formula.
Animals ; Disease ; genetics ; Drug Therapy ; Drugs, Chinese Herbal ; analysis ; pharmacology ; Gene Regulatory Networks ; Humans ; Salvia miltiorrhiza ; chemistry
5.Qualitative research on the construction of pneumoconiosis rehabilitation station in Beijing from the perspective of ecosystem theory
Li GUAN ; Xiang AO ; Xiumei ZHANG ; Guotai SHI ; Yanlin ZHANG ; Shuqiang LI
China Occupational Medicine 2023;50(2):200-204
6.Clinical effect of re-hepatic resection versus radiofrequency ablation in treatment of recurrent hepatocellular carcinoma in Asia: A Meta-analysis
Minjun LI ; Zhujian DENG ; Haotian LIU ; Yuxian TENG ; Rongrui HUO ; Xiumei LIANG ; Bangde XIANG ; Lequn LI ; Jianhong ZHONG
Journal of Clinical Hepatology 2021;37(5):1103-1109.
ObjectiveTo investigate the safety and efficacy of re-hepatic resection (rHR) versus radiofrequency ablation (RFA) in the treatment of recurrent hepatocellular carcinoma (RHCC) in Asia through a meta-analysis. MethodsPubMed, CNKI, and Wanfang Data were searched for related studies published up to June 15, 2020. Two reviewers independently searched for the articles and extracted related data, and RevMan 5.4.1 was used to perform the meta-analysis. ResultsA total of 2 randomized controlled trials and 18 retrospective cohort studies met the inclusion criteria and involved 2903 patients with RHCC from Asian countries. The mortality rate in the perioperative period was 2% in the rHR group and 0 in the RFA group, and the incidence rate of perioperative complications was 22.4% in the rHR group and 3.3% in the RFA group. The 1-, 3-, and 5-year overall survival rates were 92.3%, 66.3%, and 51.1%, respectively, in the rHR group and 91.4%, 69.2%, and 39.9%, respectively, in the RFA group. The 1-, 3-, and 5-year disease-free survival rates were 67.9%, 48.3%, and 34.4%, respectively, in the rHR group and 57.5%, 27.9%, and 14.0%, respectively, in the RFA group. The Meta-analysis showed that there was no significant difference in overall survival rate between the two groups (hazard ratio [HR]=089, 95% confidence interval [CI]: 0.77-1.02, P=0.10), while the rHR group had a significantly higher disease-free survival rate than the RFA group (HR=0.79, 95% CI: 0.72-0.87, P<0.001). ConclusionCurrent evidence shows that rHR may help to achieve a higher disease-free survival rate than RFA in the treatment of RHCC, while rHR and RFA have a similar overall survival rate.
7.Animal Model of Cold Congeal and Blood Stasis Syndrome: A Review
Xiaodan SONG ; Xiumei CHENG ; Xiang ZHOU ; Sufen BAI ; Xinhua LI
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(15):267-274
The cold congeal and blood stasis syndrome is a common clinical traditional Chinese medicine(TCM) syndrome. The animal model of cold ongeal and blood stasis syndrome is the basis for exploring the essence of TCM cold congeal and blood stasis syndrome,and the premise of follow-up TCM clinical research.This paper summarized the preparation method, theoretical support,and evaluation method of animal models of cold congeal and blood stasis syndrome in recent years and analysed the strengthens and weaknesses of different models. At present,the common animal models of cold congeal and blood stasis syndrome mainly include etiological model,etiological and pathological composite model and disease-syndrome combination model. The etiological model was mainly prepared by cold exposure,which could be divided into whole-body freezing, ice bath and local frostbite. The etiological and pathological composite model was mainly prepared by cold stimulation combined with epinephrine injection. The common disease-syndrome combination models included the coronary heart disease model of cold congeal and blood stasis syndrome,primary dysmenorrhea model of cold congeal and blood stasis syndrome,endometriosis model of cold congeal and blood stasis syndrome, and arteriosclerosis obliterans model of cold congeal and blood stasis syndrome. The three models have both advantages and disadvantages. Specifically, the disease-syndrome combination model had the highest consistency with clinical practice and was more reliable and practical. However, the disease types of this model were specific,and the combination method of disease and syndrome was controversial. The evaluation indicators of the animal models of cold congeal and blood stasis syndrome focused on the characterization of the syndrome and the physico-chemical indicators related to blood flow,such as blood rheology,coagulation function and microcirculation. In addition, some scholars explored the evaluation indicators from the aspects of vasomotor function,endocrine and energy metabolism. The objectivity and specificity of the current model evaluation methods needed to be further improved. The research of animal model of cold congeal and blood stasis syndrome should be based on clinical practice and oriented by clinical demand. Only by establishing animal models that are highly consistent with the characteristics of clinical disease and syndrome can we better reveal the essence of cold congeal and blood stasis syndrome and promote the modernization of TCM.
8.Impact of preoperative hepatitis B virus DNA load on prognosis of hepatocellular carcinoma patients undergoing hepatectomy
Haotian LIU ; Kang CHEN ; Zhujian DENG ; Minjun LI ; Xiumei LIANG ; Liang MA ; Bangde XIANG ; Jianhong ZHONG ; Lequn LI
Chinese Journal of Hepatobiliary Surgery 2021;27(6):429-433
Objective:To study the impact of preoperative serum HBV DNA levels on prognosis of hepatocellular carcinoma (HCC) patients undergoing hepatectomy with curative intent.Methods:The clinical data of patients with HCC treated by hepatectomy with curative intent at the Guangxi Medical University Cancer Hospital from January 2010 to December 2016 were retrospectively analyzed. According to the preoperative serum HBV DNA levels, patients were divided into three groups: the control group (HBV DNA negative), the low load group (<10 4 copy/ml) and the high load group (≥10 4 copy/ml). The clinical data of these patients were collected and long-term survival outcomes of these patients were followed-up. The Kaplan-Meier method was used to compare the overall survival (OS) and recurrence-free survival (RFS) rates among the three groups. Using the Barcelona clinic liver cancer classification (BCLC), patients with different serum HBV DNA levels were further divided into three subgroups: stage 0/A, stage B and stage C. The OS and RFS rates of patients in each of these subgroups were compared. Results:Of 1 180 patients who were enrolled in the study, there were 1 024 males and 156 females, aged (48.6±10.8) years. The 1-, 3- and 5-year OS rates for patients in the control group ( n=258) were 91.5%, 79.3% and 74.9%, respectively; while those in the low load group ( n=289) were 87.2%, 68.6% and 61.6%, respectively; and those in the high load group ( n=633) were 85.4%, 68.9% and 60.7%, respectively. The 1-, 3- and 5-year OS rates in the control group were significantly better than those in the low load group and the high load group ( P<0.05). The 1-, 2- and 3-year RFS rates in the control group were significantly higher than those in the high load group ( P<0.05). Subgroup analysis showed that in the BCLC 0/A subgroup ( n=786) the 1-, 3- and 5-year OS rates in the control group were significantly better than those in the high load group ( P<0.05). In the BCLC B subgroup ( n=181), the 1-, 2- and 3-year RFS rates in the control group were significantly higher than those in the high load group ( P<0.05). In the BCLC C subgroup ( n=214), there were no significant differences in the 1-, 3- and 5-year OS and 1-, 2- and 3-year RFS rates among the three groups ( P>0.05). Conclusion:For HCC patients undergoing hepatectomy with curative intent, the higher the preoperative serum HBV-DNA level, the worse the long-term survival outcomes.
9.The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F.Michae MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Chien Wen HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin?xiang?zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective To verify the safety and efficacy of IONTRIS particle therapy system ( IONTRIS) in clinical implementation. Methods Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial:31 males and 4 females with a median age of 69 yrs ( range 39?80) . Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non?metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation. Results Twenty?two patients received carbon ion and 13 had proton irradiation. With a median follow?up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression?free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological?recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty?five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow?up. Six ( 17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed. Conclusions IONTRIS is safe and effective for clinical use. However, long term follow?up is needed to observe the late toxicity and long term result.
10.The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F.Michae MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Chien Wen HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin?xiang?zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective To verify the safety and efficacy of IONTRIS particle therapy system ( IONTRIS) in clinical implementation. Methods Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial:31 males and 4 females with a median age of 69 yrs ( range 39?80) . Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non?metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation. Results Twenty?two patients received carbon ion and 13 had proton irradiation. With a median follow?up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression?free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological?recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty?five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow?up. Six ( 17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed. Conclusions IONTRIS is safe and effective for clinical use. However, long term follow?up is needed to observe the late toxicity and long term result.