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女性急性膀胱炎三日抗菌治疗方案的随机对照试验及成本分析

Randomized comparative trial and cost analysis of 3-day antimicrobial regimens for treatment of acute cystitis in women.

作者信息

Hooton T M, Winter C, Tiu F, Stamm W E

机构信息

Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, Seattle.

出版信息

JAMA. 1995 Jan 4;273(1):41-5.

PMID:7654268
Abstract

OBJECTIVE

To determine the efficacy, safety, and costs associated with four different 3-day regimens for the treatment of acute uncomplicated cystitis in women.

DESIGN

A prospective randomized trial with a cost analysis.

STUDY POPULATION

Women with acute cystitis attending a student health center.

INTERVENTIONS

Treatment with 3-day oral regimens of trimethoprim-sulfamethoxazole, 160 mg/800 mg twice daily, macrocrystalline nitrofurantoin, 100 mg four times daily, cefadroxil, 500 mg twice daily, or amoxicillin, 500 mg three times daily.

RESULTS

Six weeks after treatment, 32 (82%) of 39 women treated with trimethoprim-sulfamethoxazole were cured compared with 22 (61%) of 36 treated with nitrofurantoin (P = .04 vs trimethoprim-sulfamethoxazole), 21 (66%) of 32 treated with cefadroxil (P = .11 vs trimethoprim-sulfamethoxazole), and 28 (67%) of 42 treated with amoxicillin (P = .11 vs trimethoprim-sulfamethoxazole). Persistence of significant bacteriuria was less common with trimethoprim-sulfamethoxazole (3%) and cefadroxil (0%) compared with nitrofurantoin (16%; P = .05 vs trimethoprim-sulfamethoxazole) and amoxicillin (14%; P = .11 vs trimethoprim-sulfamethoxazole). Persistence of bacteriuria was associated with amoxicillin-resistant strains in the amoxicillin group but nitrofurantoin-susceptible strains in the nitrofurantoin group. Trimethoprim-sulfamethoxazole was more successful in eradicating Escherichia coli from rectal cultures soon after therapy and from urethral and vaginal cultures at all follow-up visits compared with the other treatment regimens. Adverse effects were reported by 16 (35%) of 46 patients receiving trimethoprim-sulfamethoxazole, 18 (43%) of 42 receiving nitrofurantoin, 12 (30%) of 40 receiving cefadroxil, and 13 (25%) of 52 receiving amoxicillin. The mean costs per patient were less with trimethoprim-sulfamethoxazole ($114) and amoxicillin ($131) compared with nitrofurantoin ($155) and cefadroxil ($155).

CONCLUSIONS

A 3-day regimen of trimethoprim-sulfamethoxazole is more effective and less expensive than 3-day regimens of nitrofurantoin, cefadroxil, or amoxicillin for treatment of uncomplicated cystitis in women. The increased efficacy of trimethoprim-sulfamethoxazole is likely related to its antimicrobial effects against E coli in the rectum, urethra, and vagina.

摘要

目的

确定四种不同的三日疗法治疗女性急性单纯性膀胱炎的疗效、安全性及成本。

设计

一项带有成本分析的前瞻性随机试验。

研究人群

就诊于学生健康中心的急性膀胱炎女性患者。

干预措施

采用三日口服疗法,分别为:甲氧苄啶 - 磺胺甲恶唑,每日两次,每次160毫克/800毫克;大结晶型呋喃妥因,每日四次,每次100毫克;头孢羟氨苄,每日两次,每次500毫克;阿莫西林,每日三次,每次500毫克。

结果

治疗六周后,39例接受甲氧苄啶 - 磺胺甲恶唑治疗的女性中有32例(82%)治愈,而接受呋喃妥因治疗的36例中有22例(61%)治愈(与甲氧苄啶 - 磺胺甲恶唑相比,P = 0.04);接受头孢羟氨苄治疗的32例中有21例(66%)治愈(与甲氧苄啶 - 磺胺甲恶唑相比,P = 0.11);接受阿莫西林治疗的42例中有28例(67%)治愈(与甲氧苄啶 - 磺胺甲恶唑相比,P = 0.1)。与呋喃妥因(16%;与甲氧苄啶 - 磺胺甲恶唑相比,P = 0.05)和阿莫西林(14%;与甲氧苄啶 - 磺胺甲恶唑相比,P = 0.11)相比,甲氧苄啶 - 磺胺甲恶唑(3%)和头孢羟氨苄(0%)持续存在显著菌尿的情况较少见。阿莫西林组中菌尿持续存在与阿莫西林耐药菌株有关,而呋喃妥因组中与呋喃妥因敏感菌株有关。与其他治疗方案相比,甲氧苄啶 - 磺胺甲恶唑在治疗后不久从直肠培养物中以及在所有随访中从尿道和阴道培养物中根除大肠杆菌方面更成功。接受甲氧苄啶 - 磺胺甲恶唑治疗的46例患者中有16例(35%)报告有不良反应,接受呋喃妥因治疗的42例中有18例(43%),接受头孢羟氨苄治疗的40例中有12例(30%),接受阿莫西林治疗的52例中有13例(25%)。与呋喃妥因(155美元)和头孢羟氨苄(155美元)相比,甲氧苄啶 - 磺胺甲恶唑(114美元)和阿莫西林(131美元)的人均成本较低。

结论

对于治疗女性单纯性膀胱炎,三日疗程的甲氧苄啶 - 磺胺甲恶唑比三日疗程的呋喃妥因、头孢羟氨苄或阿莫西林更有效且成本更低。甲氧苄啶 - 磺胺甲恶唑疗效增加可能与其对直肠、尿道和阴道中的大肠杆菌的抗菌作用有关。

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