中国医院用药评价与分析
中國醫院用藥評價與分析
중국의원용약평개여분석
EVALUATION AND ANAL YSIS OF DRUG-USE IN HOSPITALS OF CHINA
2015年
4期
472-475
,共4页
李玮%刘洋%郑学海%赵克勤
李瑋%劉洋%鄭學海%趙剋勤
리위%류양%정학해%조극근
普卢利沙星片%盐酸左氧氟沙星片%急性细菌性感染%随机对照试验
普盧利沙星片%鹽痠左氧氟沙星片%急性細菌性感染%隨機對照試驗
보로리사성편%염산좌양불사성편%급성세균성감염%수궤대조시험
Prulifloxacin tablet%Levofloxacin hydrochloride tablet%Acute bacterial infection%Randomized controlled trial
目的：评价普卢利沙星片与盐酸左氧氟沙星片随机对照治疗急性泌尿道及呼吸道感染的安全性和临床疗效。方法：采用随机对照的临床试验设计，急性细菌性感染患者随机分为试验组和对照组，试验组患者给予普卢利沙星片200 mg 口服2／日，疗程7～14 d；对照组患者给予盐酸左氧氟沙星片200 mg 口服2／日，疗程7～14 d。结果：本研究共纳入223例患者，除去脱落和剔除患者，入组共210例，其中试验组104例，对照组106例。治疗结束后，试验组的临床总痊愈率和总有效率分别为70．19％与91．35％，对照组的临床总痊愈率和总有效率分别为71．70％与89．62％；2组细菌清除率分别为86．27％和88．68％，以上结果经统计学检验差异均无统计学意义（ P＞0．05）。2组均有不良反应发生，主要表现为腹泻、皮疹、胃痛等，不良反应发生率分别为4．81％和6．60％，2组不良反应发生率比较差异无统计学意义（ P＞0．05）。结论：普卢利沙星片与盐酸左氧氟沙星片相似，具有较好的抗菌活性，对治疗泌尿道及呼吸道感染临床疗效显著且安全性高，同时治疗急性细菌性感染疾病的经济性较佳。
目的：評價普盧利沙星片與鹽痠左氧氟沙星片隨機對照治療急性泌尿道及呼吸道感染的安全性和臨床療效。方法：採用隨機對照的臨床試驗設計，急性細菌性感染患者隨機分為試驗組和對照組，試驗組患者給予普盧利沙星片200 mg 口服2／日，療程7～14 d；對照組患者給予鹽痠左氧氟沙星片200 mg 口服2／日，療程7～14 d。結果：本研究共納入223例患者，除去脫落和剔除患者，入組共210例，其中試驗組104例，對照組106例。治療結束後，試驗組的臨床總痊愈率和總有效率分彆為70．19％與91．35％，對照組的臨床總痊愈率和總有效率分彆為71．70％與89．62％；2組細菌清除率分彆為86．27％和88．68％，以上結果經統計學檢驗差異均無統計學意義（ P＞0．05）。2組均有不良反應髮生，主要錶現為腹瀉、皮疹、胃痛等，不良反應髮生率分彆為4．81％和6．60％，2組不良反應髮生率比較差異無統計學意義（ P＞0．05）。結論：普盧利沙星片與鹽痠左氧氟沙星片相似，具有較好的抗菌活性，對治療泌尿道及呼吸道感染臨床療效顯著且安全性高，同時治療急性細菌性感染疾病的經濟性較佳。
목적：평개보로리사성편여염산좌양불사성편수궤대조치료급성비뇨도급호흡도감염적안전성화림상료효。방법：채용수궤대조적림상시험설계，급성세균성감염환자수궤분위시험조화대조조，시험조환자급여보로리사성편200 mg 구복2／일，료정7～14 d；대조조환자급여염산좌양불사성편200 mg 구복2／일，료정7～14 d。결과：본연구공납입223례환자，제거탈락화척제환자，입조공210례，기중시험조104례，대조조106례。치료결속후，시험조적림상총전유솔화총유효솔분별위70．19％여91．35％，대조조적림상총전유솔화총유효솔분별위71．70％여89．62％；2조세균청제솔분별위86．27％화88．68％，이상결과경통계학검험차이균무통계학의의（ P＞0．05）。2조균유불량반응발생，주요표현위복사、피진、위통등，불량반응발생솔분별위4．81％화6．60％，2조불량반응발생솔비교차이무통계학의의（ P＞0．05）。결론：보로리사성편여염산좌양불사성편상사，구유교호적항균활성，대치료비뇨도급호흡도감염림상료효현저차안전성고，동시치료급성세균성감염질병적경제성교가。
OBJECTIVE:To evaluate the clinical efficacy and safety of prulifloxacin tablet vs.levofloxacin hydrochloride tablet for acute respiratory tract or urinary tract infection.METHODS: By a randomized controlled clinical trial, the patients with acute bacterial infection were randomly assigned to either trial group administered orally with Prulifloxacin tablets ( at a dosage of 0.2 g twice daily for 7 to 14 days) or control group administered orally with levofloxacin hydrochloride tablet ( at a dosage of 0.2 g twice daily for 7 to 14 days) .RESULTS:A total of 223 patients were enrolled, of whom, 210 patients were assigned to either trial group ( n=104) or control group ( n=106) ( the others were lost follow-up or excluded from our study) .At treatment completion, the cure rate and response rate were 70.19%and 91.35% in trial group, as compared with 71.70% and 89.62% in the control group; the bacterial clearance rates in the trial group and the control group were 86.27%and 88.68%, respectively, with all of the above results showing no statistical differences between the two groups ( P >0.05 ) .Adverse drug reactions including diarrhea, skin rash and stomachache were noted in both groups, which occurred in 4.81% of the trial group vs. 6.60%of the control group, showing statistical difference between the two groups ( P >0.05 ) .CONCLUSION:Prulifloxacin tablet is similar to levofloxacin hydrochloride tablet in that both have remarkable antibacterial activity, and which was safe and effective in the treatment of acute bacterial infection of respiratory or urinary tract, furthermore it is cost-effective in the treatment of acute bacterial infection.
