中国提供普遍获得痰涂片阳性耐多药结核病护理综合方案的效果：前后对照研究。

Effect of a comprehensive programme to provide universal access to care for sputum-smear-positive multidrug-resistant tuberculosis in China: a before-and-after study.

机构信息

National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.

Center for Health Management and Policy, Shandong University, Jinan, Shandong, China.

出版信息

Lancet Glob Health. 2015 Apr;3(4):e217-28. doi: 10.1016/S2214-109X(15)70021-5.

DOI:10.1016/S2214-109X(15)70021-5

PMID:25794675

Abstract

BACKGROUND

China has a quarter of all patients with multidrug-resistant tuberculosis (MDRTB) worldwide, but less than 5% are in quality treatment programmes. In a before-and-after study we aimed to assess the effect of a comprehensive programme to provide universal access to diagnosis, treatment, and follow-up for MDRTB in four Chinese cities (population 18 million).

METHODS

We designated city-level hospitals in each city to diagnose and treat MDRTB. All patients with smear-positive pulmonary tuberculosis diagnosed in Center for Disease Control (CDC) clinics and hospitals were tested for MDRTB with molecular and conventional drug susceptibility tests. Patients were treated with a 24 month treatment package for MDRTB based on WHO guidelines. Outpatients were referred to the CDC for directly observed therapy. We capped total treatment package cost at US$4644. Insurance reimbursement and project subsidies limited patients' expenses to 10% of charges for services within the package. We compared data from a 12 month programme period (2011) to those from a retrospective survey of all patients with MDRTB diagnosed in the same cities during a baseline period (2006-09).

FINDINGS

243 patients were diagnosed with MDRTB or rifampicin-resistant tuberculosis during the 12 month programme period compared with 92 patients (equivalent to 24 per year) during the baseline period. 172 (71%) of 243 individuals were enrolled in the programme. Time from specimen collection for resistance testing to treatment initiation decreased by 90% (from median 139 days [IQR 69-207] to 14 days [10-21]), the proportion of patients who started on appropriate drug regimen increased 2·7 times (from nine [35%] of 26 patients treated to 166 [97%] of 172), and follow-up by the CDC after initial hospitalisation increased 24 times (from one [4%] of 23 patients to 163 [99%] of 164 patients). 6 months after starting treatment, the proportion of patients remaining on treatment increased ten times (from two [8%] of 26 patients to 137 [80%] of 172), and 116 (67%) of 172 patients in the programme period had negative cultures or clinical-radiographic improvement. Patients' expenses for hospital admission after MDRTB diagnosis decreased by 78% (from $796 to $174), reducing the ratio of patients' expenses to annual household income from 17·6% to 3·5% (p<0·0001 for all comparisons between baseline and programme periods). However, 36 (15%) patients did not start or had to discontinue treatment in the programme period because of financial difficulties.

INTERPRETATION

This comprehensive programme substantially increased access to diagnosis, quality treatment, and affordable treatment for MDRTB. The programme could help China to achieve universal access to MDRTB care but greater financial risk protection for patients is needed.

FUNDING

Bill & Melinda Gates Foundation.

摘要

背景

中国拥有全球四分之一的耐多药结核病（MDRTB）患者，但仅有不到 5%的患者接受了高质量的治疗方案。在一项前后对照研究中，我们旨在评估在中国四个城市（1800 万人口）实施一项综合性方案，为 MDRTB 的诊断、治疗和随访提供普遍可及性的效果。

方法

我们指定每个城市的市级医院来诊断和治疗 MDRTB。在疾病控制中心（CDC）诊所和医院诊断为痰涂片阳性的肺结核患者均接受分子和常规药物敏感性测试，以检测 MDRTB。患者根据世界卫生组织（WHO）指南接受为期 24 个月的 MDRTB 治疗方案。门诊患者被转介到 CDC 接受直接观察治疗。我们将总治疗方案的费用上限设定为 4644 美元。保险报销和项目补贴将患者的费用限制在套餐内服务费用的 10%。我们将 12 个月的项目期间（2011 年）的数据与同一城市基线期间（2006-09 年）所有 MDRTB 患者的回顾性调查数据进行比较。

结果

在 12 个月的项目期间，有 243 名患者被诊断为 MDRTB 或利福平耐药性肺结核，而在基线期间，有 92 名患者（相当于每年 24 名）被诊断为 MDRTB。243 名患者中有 172 名（71%）入组了该方案。从标本采集进行耐药性检测到开始治疗的时间减少了 90%（中位数从 139 天[IQR 69-207]降至 14 天[10-21]），开始使用适当药物治疗方案的患者比例增加了 2.7 倍（从 26 名患者中的 9 名[35%]增至 172 名患者中的 166 名[97%]），CDC 在患者初始住院后的随访增加了 24 倍（从 23 名患者中的 1 名[4%]增至 164 名患者中的 163 名[99%]）。在开始治疗后 6 个月，仍在接受治疗的患者比例增加了 10 倍（从 26 名患者中的 2 名[8%]增至 172 名患者中的 137 名[80%]），172 名患者中有 116 名（67%）的培养物或临床-影像学得到改善。MDRTB 诊断后住院患者的费用减少了 78%（从 796 美元降至 174 美元），患者费用占家庭年收入的比例从基线期的 17.6%降至方案期的 3.5%（所有比较均为 p<0.0001）。然而，在方案期间，有 36 名（15%）患者因经济困难未能开始或不得不中断治疗。