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Abstract：
BACKGROUND: People with radiographic evidence for pulmonary tuberculosis (TB), but negative sputum cultures, have increased risk of developing culture-positive TB. Recent expansion of X-ray screening is leading to increased identification of this group. We set out to synthesise the evidence for treatment to prevent progression to culture-positive disease.
METHODS: We conducted a systematic review and meta-analysis. We searched for prospective trials evaluating the efficacy of TB regimens against placebo, observation, or alternative regimens, for the treatment of adults and children with radiographic evidence of TB but culture-negative respiratory samples. Databases were searched up to 18 Oct 2022. Study quality was assessed using ROB 2·0 and ROBINS-I. The primary outcome was progression to culture-positive TB. Meta-analysis with a random effects model was conducted to estimate pooled efficacy. This study was registered with PROSPERO (CRD42021248486).
RESULTS: We included 13 trials (32,568 individuals) conducted between 1955 and 2018. Radiographic and bacteriological criteria for inclusion varied. 19·1% to 57·9% of participants with active x-ray changes and no treatment progressed to culture-positive disease. Progression was reduced with any treatment (6 studies, risk ratio [RR] 0·27, 95%CI 0·13-0·56), although multi-drug TB treatment (RR 0·11, 95%CI 0·05-0·23) was significantly more effective than isoniazid treatment (RR 0·63, 95%CI 0·35-1·13) (p = 0·0002).
CONCLUSIONS: Multi-drug regimens were associated with significantly reduced risk of progression to TB disease for individuals with radiographically apparent, but culture-negative TB. However, most studies were old, conducted prior to the HIV epidemic and with outdated regimens. New clinical trials are required to identify the optimal treatment approach.
METHODS: We conducted a systematic review and meta-analysis. We searched for prospective trials evaluating the efficacy of TB regimens against placebo, observation, or alternative regimens, for the treatment of adults and children with radiographic evidence of TB but culture-negative respiratory samples. Databases were searched up to 18 Oct 2022. Study quality was assessed using ROB 2·0 and ROBINS-I. The primary outcome was progression to culture-positive TB. Meta-analysis with a random effects model was conducted to estimate pooled efficacy. This study was registered with PROSPERO (CRD42021248486).
RESULTS: We included 13 trials (32,568 individuals) conducted between 1955 and 2018. Radiographic and bacteriological criteria for inclusion varied. 19·1% to 57·9% of participants with active x-ray changes and no treatment progressed to culture-positive disease. Progression was reduced with any treatment (6 studies, risk ratio [RR] 0·27, 95%CI 0·13-0·56), although multi-drug TB treatment (RR 0·11, 95%CI 0·05-0·23) was significantly more effective than isoniazid treatment (RR 0·63, 95%CI 0·35-1·13) (p = 0·0002).
CONCLUSIONS: Multi-drug regimens were associated with significantly reduced risk of progression to TB disease for individuals with radiographically apparent, but culture-negative TB. However, most studies were old, conducted prior to the HIV epidemic and with outdated regimens. New clinical trials are required to identify the optimal treatment approach.
摘要：
背景：有肺结核（TB）影像学证据的人，但是痰培养阴性,发展为文化阳性结核病的风险增加。X射线筛查的最新扩展导致对该组的识别增加。我们着手综合治疗的证据，以防止发展为文化阳性疾病。
方法：我们进行了系统评价和荟萃分析。我们搜索了评估结核病方案对安慰剂疗效的前瞻性试验，观察,或者替代方案，用于治疗具有结核病影像学证据但培养阴性呼吸道样本的成人和儿童。搜索数据库直至2022年10月18日。使用ROB2·0和ROBINS-I评估研究质量。主要结果是进展为培养阳性TB。使用随机效应模型进行荟萃分析以评估合并疗效。本研究在PROSPERO（CRD42021248486）注册。
结果：我们纳入了1955年至2018年进行的13项试验（32,568例）。纳入的放射学和细菌学标准各不相同。19·1%至57·9%的参与者有活跃的X线变化，没有治疗进展为培养阳性疾病。任何治疗都会降低进展（6项研究，风险比[RR]0·27，95CI0·13-0·56)，尽管多药结核病治疗（RR0·11，95CI0·05-0·23）明显优于异烟肼治疗（RR0·63，95CI0·35-1·13）（p=0·0002）。
结论：对于放射学上明显的结核病患者，多药物治疗方案可显著降低结核病进展风险，而是文化阴性结核病。然而,大多数研究都是古老的，在艾滋病毒流行之前进行，并采用过时的治疗方案。需要新的临床试验来确定最佳的治疗方法。
方法：我们进行了系统评价和荟萃分析。我们搜索了评估结核病方案对安慰剂疗效的前瞻性试验，观察,或者替代方案，用于治疗具有结核病影像学证据但培养阴性呼吸道样本的成人和儿童。搜索数据库直至2022年10月18日。使用ROB2·0和ROBINS-I评估研究质量。主要结果是进展为培养阳性TB。使用随机效应模型进行荟萃分析以评估合并疗效。本研究在PROSPERO（CRD42021248486）注册。
结果：我们纳入了1955年至2018年进行的13项试验（32,568例）。纳入的放射学和细菌学标准各不相同。19·1%至57·9%的参与者有活跃的X线变化，没有治疗进展为培养阳性疾病。任何治疗都会降低进展（6项研究，风险比[RR]0·27，95CI0·13-0·56)，尽管多药结核病治疗（RR0·11，95CI0·05-0·23）明显优于异烟肼治疗（RR0·63，95CI0·35-1·13）（p=0·0002）。
结论：对于放射学上明显的结核病患者，多药物治疗方案可显著降低结核病进展风险，而是文化阴性结核病。然而,大多数研究都是古老的，在艾滋病毒流行之前进行，并采用过时的治疗方案。需要新的临床试验来确定最佳的治疗方法。
