摘要
目的回顾性分析以左氧氟沙星（Lfx）或莫西沙星（Mfx）作为核心药物的化疗方案治疗耐多药结核病（MDR-TB）患者的疗效、转归及其相关因素，为氟喹诺酮类药物在MDRTB治疗中的合理选择提供依据。方法选取2009年7月至2010年7月我国10家结核病诊疗机构确诊为MDR-TB的患者共232例。其中，应用含Mfx（含Mfx组）化疗方案的患者124例，含Lfx（含Lfx组）化疗方案的患者108例。收集治疗前、中、末的细菌学、影像学等资料，疗程末评估疗效和治疗转归。采用SPSS17．0软件进行数据分析。计量资料呈正态分布时采用t检验、非正态分布时采用秩和检验。计数资料采用x2检验，当理论频数〈1时，采用Fisher确切概率法检验。采用logistic回归对与治疗转归相关的因素进行分析，以P〈0．05为差异有统计学意义。结果（1）治疗6个月末，含Lfx组患者和含Mfx组患者的痰涂片阴转率[S8．4％（61／69）、79．0％（79／100）]和痰培养阴转率[81．5％（53／65）、（73．6％（67／91）]相接近（x2值分别为2．541、2．404，P值均〉0．05）。治疗24个月末，含Lfx组患者的痰培养阴转率（92．2％，47／51）高于含Mfx组（76．9％，50／65）（x2=3．794，P〈0．05）。（2）治疗24个月末，含I。fx组的空洞闭合率（48．8％，20／41）高于含Mfx组（23．2％，13／56）（x2=5．801，P〈0．05），而病变吸收好转率在两组间[81.0％（64／79）、76．2％（64／84）]差异无统计学意义（x2=0．561，P〉0．05）。（3）含I．fX组与含Mfx组总不良反应发生率[（25．0％（27／108）、26．6％（33／124）]相接近（x2=0．012，P〉0．05）。其中，两组药物性肝损伤的发生率最高，分别达16．7％o（18／108）和10．5％（13／124）。（4）含Iffx组与含Mfx组治疗成功率相接近，分别达61．1％（66／108）和59．70（74／124）（x2=0．050，P〉0．05）。含Mfx组的死亡率（6．5％，8／124）高于含Lfx组（0．9％，1／los）（Fisher确切概率法，P〈0．05），丢失率（14．5％，18／124）低于含Lfx组（24．1％，26／108）（x2=3．341，P〈0．05）。（5）logistic回归分析显示仅症状体征评分≤6分和既往未应用阿米卡星（Am）是影响治疗成功的独立因素（β=-0．670、-0．679；Wald x2=4．696、3．866；OR=0．512、0．507；95％CJ=0．279～0．938、0．258～0．998；P值均〈0．05）。结论含Lfx与含Mfx的化疗方案的疗效与治疗成功率接近，患者临床状况和既往相关核心药物使用情况与治疗成功有关。
Objective To analyze efficacy, prognosis and its related factors of patients with multidrug-resistant pulmonary tuberculosis （MDR-TB） treated with levofloxacin （Lfx） or moxifloxacin （Mfx） as core drug, and to provide the basis for the rational choice of fluoroquinolones in the treatment of MDR-TB. Methods We analyze retrospectively 232 patients confirmed with MDR-TB from 10 special hospitals of tuberculosis in China during July 2009 to July 2010. One hundred and twenty-four eases were treated with regimen containing Mfx （Mfx group） and 108 cases were treated with regimen containing Lfx （Lfx group）. The data of bacteriology and radiology were collected before treatment, medium-term treatment and at the end of treatment. The efficacy and prognosis were assessed at the end of treatment. Data were analyzed using SPSS 17.0 software. Measurement data showed a normal distribution or non normal distribution were used by t test or rank sum test, respectively. Enumeration data were used by Chi-square test and Fisher exact probability test was used when the frequency theory was less than 1. The efficacy and the related factors of prognosis were tested using logistic regression. P〈0.05 was considered sig- nificant difference statistically. Results （1） The rates of sputum smear and culture negative conversion were 79.0% （79/100） and 73.6% （67/91） in the Mfx group, and 88.4% （61/69） and 81.5% （53/65） in the Lfx group at the end of sixth month, respectively （X2 =2. 541,2. 404,P〉0.05）. However, the rates of sputum culture nega- tive conversion （92.2%, 47/51） in the Lfx group was higher than that （76.9 %, 50/65） in the Mfx group （Z2 = 3. 794,P〈0. 05） at the end of 24th month. （2） The rate of cavity closure （48.8%,20/41） in the Lfx group was higher than that （23.2%, 13/56） in the Mfx group at the end of 24th month （x2 =5. 801,P〈0.05）. But the rates of focus absorption improvement were not different between groups （X2 = 0. 561, P：〉 0.05）. （3） Incidence of ad- verse reactions were similar in two groups （Lfx group： 25.0% （27/108）; Mfx group： 26.6% （33/124）; x2 = 0. 012,P〉0.05）. The incidence of drug-induced liver injury in the two groups was the highest, reaching 16.7% （18/108） and 10.5% （13/124）, respectively. （4） The rate of treatment success was also similar in two groups with 59.7% （74/124） and 61. 1% （66/108）, respectively （X2 =0. 050,P〈0.05）. The mortality in Mfx group （6.5%, 8/124） was higher than that （0.9%, 1/108） in Lfx group （Fisher exact test,P〈0. 05）, but the default in the Mfx group （14. 5%,18/124） was less than that （24.1%,26/108） in the Lfx group （x2=3. 341, P%0. 05）. （5） Analy- sis using logistic regression showed that symptom and sign score less than 6 in patients and no use with amikacin in the past were the independent factors （β=-0. 670,-0. 679;Wald x2=4. 696,3. 866;OR=0. 512,0. 507;95% CI= 0. 279-0. 938,0. 258-0. 998;all P values were less than 0.05）. Conclusion The efficacy and the rate of treat- ment success are similar in two groups. The treatment success is associated with symptom and core drug used or not in MDR-TB patients.
出处
《中国防痨杂志》
CAS
2016年第6期436-442,共7页
Chinese Journal of Antituberculosis
关键词
结核/治疗
抗结核药
药物疗法
Tuberculosis/treatment
Antitubercular agents
Drug therapy
