耐多药结核病诊疗管理试点地区耐药基线调查结果分析

摘要/Abstract

摘要： 摘要：目的 根据中国全球基金耐多药结核病（multidrug-resistant tuberculosis, MDR-TB）项目（简称“项目”）试点地区深圳、武汉市耐药基线调查结果，检验深圳、武汉市使用的耐多药结核病标准化治疗方案的合理性。方法对2008年1月1日至12月31日期间，深圳（41株）和武汉市（64株）耐药基线调查分离出的105株耐HR（异烟肼，利福平）菌株进行链霉素（stréptomycin, S）、乙胺丁醇（ethambutol, E）、卡那霉素（kanamycin，Km）和氧氟沙星（ofloxacin, Ofx）4种药物的药敏试验，其中58株来自初治患者，47株来自复治患者。利用获得的耐药谱分析标准化治疗方案制定的合理性。将检测结果录入Epidata数据库，利用SAS软件进行分析。对耐药情况采用率和构成比描述。计数资料的组间比较采用χ²检验、Fisher确切概率法检验。P值＜0.05为差异有统计学意义。结果 105株MDR-TB菌株中，对S、E、Km和Ofx的耐药率分别为74.3%、41.0%、11.4%、22.9%，其中初治组对S、E、Km和Ofx的耐药率分别为75.9%、41.4%、10.3%和19.0%；复治组对S、E、Km和Ofx的耐药率分别为72.3%、40.4%、12.8%和27.7%，比较初、复治MDR-TB患者对S、E、Km和Ofx的耐药率，差异无统计学意义（χ²值分别为0.001、0.013、0.231和1.423，P值均＞0.05）。深圳市初治组对S、E、Km和Ofx的耐药率分别为76.0%、40.0%、16.0%和4.0%；复治组对S、E、Km和Ofx的耐药率分别为68.8%、43.8%、6.3%和18.8%，武汉市初治组对S、E、Km和Ofx的耐药率分别为75.8%、42.4%、6.1%和30.3%；复治组对S、E、Km和Ofx的耐药率分别为74.2%、38.7%、16.1%和32.3%。比较深圳和武汉市MDR-TB患者耐药情况，武汉市初治患者对Ofx的耐药率高于深圳市（χ²=6.4033，P<0.05），其他3种药的耐药率差异无统计学意义；两市复治患者的4种药耐药率差异均无统计学意义（P值均＞0.05）。结论目前采用的标准化治疗方案基本符合深圳市耐药谱，适用于深圳市的初、复治MDR-TB患者治疗；该方案用于武汉市MDR-TB患者治疗时，能否将Ofx作为标准方案的主要药物之一有待进一步研究。

关键词: 结核, 抗多种药物性/药物疗法, 临床方案

Abstract: Abstract：Objective To examine the rationality of MDR-TB standardized treatment regimen according to the MDR-TB baseline survey results in China Global Fund MDR-TB pilot areas-Wuhan and Shenzhen. Methods One hundred and five MDRTB bacterial strains acquired from drug resistant surveillance in Shenzhen and Wuhan during January 1 to December 31 of 2008 were given drug susceptibility test (DST) for stréptomycin(S), ethambutol(E), kanamycin (Km), and ofloxacin(Ofx). Among them, 58 bacterial strains came from new patients and 47 came from retreatment cases. The rationality of treatment regimen was analyzed based on the drug resistant spectrum. Test results were entered into database designed by Epidata and SAS was used for data analysis. Constituent ratios of drug resistance status were described. χ² test and Fisher's exact test were used to examine the difference between groups for enumeration data. P value<0.05 was considered statistically significant. Results Among the 105 MDR-TB strains, 74.3%, 41.0%, 11.4% and 22.9% of strains were resistant to S, E, Km and Ofx respectively. The resistant proportions to these four drugs were 75.9%, 41.4%, 10.3%, 19.0% respectively for new cases and 72.3%, 40.4%, 12.8%, 27.7% for retreatment cases. There has no statistically significant difference between new cases and retreatment cases in terms of the resistance proportion to the four drugs (χ² are 0.001, 0.013, 0.231 and 1.423 respectively, all P＞0.05). In Shenzhen, the resistant proportions to these four drugs were 76.0%, 40.0%, 16.0% and 4.0% for new cases and 68.8%, 43.8%, 6.3% and 18.8% for retreatment cases. In Wuhan, these proportions were 75.8%, 42.4%, 6.1% and 30.3% for new cases, and 74.2%, 38.7%, 16.1% and 32.3% for retreatment cases. Comparison between Shenzhen and Wuhan showed that for new patients, Ofx resistant in Wuhan is significantly higher than that in Shenzhen (χ²=6.4033, P＜0.05). Between the two cities, there has no significant difference in other three drugs for new cases and in all drugs for retreatment cases. Conclusion The current standardized regimen is applicable to new and retreatment MDR-TB cases in Shenzhen, however, whether Ofx could be taken as one of main drugs in Wuhan needs to be further studied.

Key words: Tuberculosis, multidrug-resistant/drug therapy, Clinical protocols

弭凤玲杜建徐彩红姜晓颖马艳高静韬岳淑敏端木宏谨傅瑜王黎霞李亮. 耐多药结核病诊疗管理试点地区耐药基线调查结果分析[J]. 中国防痨杂志, 2011, 33(8): 466-470.

Mi Fengling, Du Jian, Xu Caihong, Jiang Xiaoying, Ma Yan, Gao Jingtao. Baseline survey of multidrugresistant tuberculosis (MDR-TB) in MDR-TB diagnosis and management pilot areas[J]. Chinese Journal of Antituberculosis, 2011, 33(8): 466-470.

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