1.A multi-center clinical trial of levofloxacin 750 mg intravenous infusion for 5 days short-course treatment of community-acquired pneumonia
Jufang WU ; Qingyu XIU ; Chen WANG ; Deping ZHANG ; Jianan HUANG ; Canmao XIE ; Shenghua SUN ; Xiaoju Lü ; Bin SI ; Zuke XIAO ; Yingyuan ZHANG
Chinese Journal of Infection and Chemotherapy 2014;(6):493-502
Objective To compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7‐14 days intravenous (IV ) infusion in the treatment of community‐acquired pneumonia (CAP ) . Methods This study was a multi‐center , randomized , open‐label , non‐inferiority , controlled clinical trial .The CAP patients were randomized to receive levofloxacin 750 mg IV daily for 5 days or levofloxacin 500 mg IV daily for 7‐14 days .The clinical symptoms , laboratory tests , imaging results and microbiology data were collected and compared between the two treatment groups in terms of efficacy and safety .Results A total of 241 patients were enrolled in this clinical trial from 10 study centers .Among these patients ,223 were eligible for full analysis set (FAS) analysis ,including 111 in 750 mg group and 112 in 500 mg group .Of the 223 patients in FAS ,211 were eligible for per‐protocol set (PPS) analysis ,including 107 in 750 mg group and 104 in 500 mg group .Two hundred and forty‐one patients were included in safety set (SS) ,including 121 patients in 750 mg group and 120 in 500 mg group .The median treatment duration was 5 .0 days in 750 mg and 9 .0 days in 500 mg group .The median total dose was 3 750 mg in 750 mg group and 4 500 mg in 500 mg group .The overall efficacy rate was 86 .2% in 750 mg group and 84 .7% in 500 mg group in terms of FAS at visit 4 ,which suggested that the efficacy of 750 mg group was non‐inferior to 500 mg group .Of the 111 FAS patients in 750 mg group ,40 were bacteriological evaluable ,and 41 strains of pathogens were isolated .Forty‐nine of the 112 FAS patients in 500 mg group were bacteriological evaluable ,and 51 bacterial strains were obtained .The bacterial eradication rate was 100% in both groups .The clinical treatment efficacy rate for atypical pathogens was 100% in both groups .In 750 mg group ,the most common clinical adverse drug reactions (ADRs) were injection site adverse reactions including injection site pruritus ,pain and hyperemia .The other common ADRs were insomnia ,nausea ,skin rash .The most common drug‐related laboratory abnormalities were neutrophil percentage decreased , decreased white blood cell (WBC ) count , alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation .Most of the ADRs were mild in severity and well‐tolerated .The safety profile of the two treatments was comparable in terms of the drug‐related treatment discontinuation and the incidence of ADRs .Conclusions The short‐course regimen of levofloxacin 750 mg IV for 5 days is at least as effective and well tolerated as the long‐course regimen of 500 mg IV for 7‐14 days in treatment of CAP .
2.A clinical study on the treatment of refractory tennis elbow with arc-edge needle therapy based on zaodian theory
Xuejian MA ; Dongzhe ZHANG ; Chaoyang NIU ; Shuaigang DU ; Wuyang WANG ; Shilong CHENG ; Yingyuan XIAO ; Xuechang WANG
The Journal of Practical Medicine 2024;40(15):2161-2165
Objective To explore the clinical efficacy of arc-edge needle therapy based on Zaodian theory in the treatment of refractory tennis elbow.Methods 64 patients with refractory tennis elbow were collected and randomly divided into a control group and an observation group using a random number table method.Among them,32 cases in the control group were treated with local pain point injection.32 patients in the observation group were treated with arc-edge needle therapy once a week,with two treatments per group.The Number rating scale(NRS)Mayo,elbow joint performance score(MEPS)and Disabilities of the arm,shoulder and hand(DASH)score were recorded and compared between the two groups before treatment and at 1,2,4 and 24 weeks of follow-up after treatment,disease efficacy score(WDES)at 24 weeks of follow-up.Results During the treat-ment process,neither group of patients experienced serious adverse reactions.At each stage after treatment,two groups of NRS MEPS,DASH,and WDES at 24 weeks of follow-up all improved compared to before treatment.After one week of treatment,there was no statistically significant difference in NRS scores between the two groups(P>0.05).At follow-up visits at weeks 2,4,and 24,the NRS scores in the observation group were lower than those in the control group.After 1,2,4,and 24 weeks of follow-up after treatment,the DASH score was lower in the observation group than in the control group,and the MEPS score was higher in the observation group than in the control group,with statistically significant differences(P<0.05).After 24 weeks of treatment,the WDES of the observation group was better than that of the control group,and the difference was statistically significant(P<0.05).Conclusion Local pain point injection and arc-edge Zaodian release can alleviate pain and improve elbow joint function in the early stage of refractory tennis elbow.However,the long-term effect of local pain point injection treatment is not good,and the treatment effect of the observation group gradually improves.
3.Expert consensus onmaintenance treatment formetastatic colorectal cancer in China
Rui-HuaXu ; LinShen ; JinLi ; Jian-MingXu ; FengBi ; YiBa ; LiBai ; Yong-QianShu ; Tian-ShuLiu ; Yu-HongLi ; Chun-MeiBai ; Xiang-LinYuan ; JunZhang ; GongChen ; Ai-PingZhou ; YingYuan ; Xi-JingWang ; Xiao-PingQian ; Yan-HongDeng
Chinese Journal of Cancer 2016;(1):49-54
The impact of maintenance therapy on progression?free survival and overall survival as well as quality of life of Chi?nese patients with metastatic colorectal cancer has long been under discussion. Recently, some phase III clinical trials have revealed that maintenance therapy can signiifcantly prolong the progression?free survival while maintain an acceptable safety proifle. Based on this evidence and common treatment practice in China, we now generated one Expert Consensus on Maintenance Treatment for Metastatic Colorectal Cancer in China to further specify the neces?sity of maintenance therapy, suitable candidates for such treatment, and appropriate regimens.