陸善詞 黃貞 張綺麗 馮健華 郭煒
【摘要】 目的:探討利福平耐藥實時熒光定量核酸擴增技術(shù)(Xpert MTB/RIF)在利福平耐藥可靠性及時效評估方面的應(yīng)用價值。方法:選取2017年8月-2018年9月筆者所在醫(yī)院肺科門診接診的300例初診肺結(jié)核可疑患者,分別實施Xpert MTB/RIF及常規(guī)固體培養(yǎng)檢測,比較兩種方法對患者的診斷結(jié)果。以臨床綜合診斷為金標(biāo)準(zhǔn),對肺結(jié)核患者使用利福平治療,比較傳統(tǒng)藥敏試驗及Xpert Mtb/RIF對耐藥性的檢測結(jié)果。同時,比較常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗、Xpert Mtb/RIF的診斷時效,包括肺結(jié)核診斷用時、耐藥性診斷用時、肺結(jié)核診斷成本、耐藥性診斷成本。結(jié)果:Xpert Mtb/RIF的肺結(jié)核陽性檢出率及陽性符合率均高于常規(guī)固體培養(yǎng)(P<0.05);Xpert Mtb/RIF的耐藥陽性符合率高于傳統(tǒng)藥敏試驗(P<0.05);Xpert Mtb/RIF對肺結(jié)核診斷用時、耐藥性診斷用時均短于常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗,肺結(jié)核診斷成本、耐藥性診斷成本均少于常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗,差異均有統(tǒng)計學(xué)意義(P<0.05)。結(jié)論:Xpert MTB/RIF可提高肺結(jié)核早期檢出率,保證利福平耐藥檢出可靠性,且診斷用時更少,成本更低,具有較高的診斷時效,值得推廣和應(yīng)用。
【關(guān)鍵詞】 Xpert MTB/RIF 利福平 耐藥可靠性 診斷時效
doi:10.14033/j.cnki.cfmr.2020.08.022??文獻標(biāo)識碼 B??文章編號 1674-6805(2020)08-00-03
Evaluation of Xpert MTB/RIF in the Reliability and Aging of Rifampicin Resistance/LU Shanci, HUANG Zhen, ZHANG Qili, FENG Jianhua, GUO Wei. //Chinese and Foreign Medical Research, 2020, 18(8): -55
[Abstract] Objective: To explore the application value of Rifampicin resistance real-time fluorescent quantitative nucleic acid amplification technology (Xpert MTB/RIF) in the reliability and aging evaluation of Rifampicin resistance. Method: A total of 300 suspected patients with newly diagnosed pulmonary tuberculosis were enrolled in the pulmonary outpatient department of our hospital from August 2017 to September 2018, and Xpert MTB/RIF and conventional solid culture were performed respectively, and the diagnostic results of the two methods were compared. The clinical comprehensive diagnosis was used as the gold standard, and patients with pulmonary tuberculosis were treated with Rifampicin, and the detection results of traditional drug sensitive test and Xpert Mtb/RIF for drug resistance were compared. Meanwhile, the diagnostic aging of conventional solid culture and traditional drug sensitive test, Xpert Mtb/RIF were compared, including diagnostic time of pulmonary tuberculosis, diagnostic time of drug resistance, diagnostic cost of pulmonary tuberculosis and diagnostic cost of drug resistance. Result: The positive detection rate and positive coincidence rate of tuberculosis of Xpert Mtb/RIF were higher than those of conventional solid culture (P<0.05). The positive coincidence rate of drug resistance of Xpert Mtb/RIF was higher than that of conventional solid culture (P<0.05). The diagnostic time of pulmonary tuberculosis and drug resistance of Xpert Mtb/RIF were shorter than those of conventional solid culture and traditional drug sensitive test, and diagnostic cost of pulmonary tuberculosis and drug resistance were less than those of conventional solid culture and traditional drug sensitive test, and the differences were statistically significant (P<0.05). Conclusion: Xpert MTB/RIF can improve the early detection rate of tuberculosis, ensure the reliability of Rifampicin resistance detection, and it takes less time to diagnose, costs less, and has higher diagnostic aging, which is worthy of promotion and application.
2.4 常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗、Xpert Mtb/RIF對肺結(jié)核及耐藥性診斷時效比較
Xpert Mtb/RIF對肺結(jié)核診斷用時、耐藥性診斷用時均短于常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗,肺結(jié)核診斷成本、耐藥性診斷成本均少于常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗,差異均有統(tǒng)計學(xué)意義(P<0.05),見表3、表4。
3 討論
結(jié)核病已成為嚴(yán)重的社會公共衛(wèi)生問題,其中以肺結(jié)核最為常見[4]。肺結(jié)核可導(dǎo)致肺部發(fā)生嚴(yán)重病變,且活動期肺結(jié)核患者有較高的傳染性,易使密切接觸者被感染[5]。早期對肺結(jié)核進行診斷及治療,有利于降低治療難度,且預(yù)后較好[6]。基于此,注重肺結(jié)核的早期診斷對結(jié)核病防治具有重要意義。
痰涂片查結(jié)核桿菌是診斷肺結(jié)核的重要方法,應(yīng)用較廣。雖然痰涂片檢查方法操作簡單,但其陽性檢出率較低,且對于結(jié)核桿菌的生存狀態(tài)無法做出判斷,易造成實際診斷結(jié)果出現(xiàn)偏差[7]。固體培養(yǎng)基方法是通過對結(jié)核桿菌進行培養(yǎng)以用于診斷肺結(jié)核,但是培養(yǎng)耗時較長,通常需要8周,在此期間可能造成病情延誤。因而,臨床在診斷肺結(jié)核時,不僅需要提高陽性檢出率,還需要提高診斷時效,縮短獲取結(jié)果時間,便于為患者盡早實施治療[8]。
Xpert MTB/RIF是一種新型與快速的診斷方法,應(yīng)用基礎(chǔ)為半巢式實時定量PCR技術(shù),能夠同時對結(jié)核桿菌、利福平耐藥性做出檢測,在保證診斷準(zhǔn)確率的同時可縮短等待結(jié)果時間,有利于對患者進行早期治療與調(diào)整治療方案[9]。
根據(jù)本文研究方法,通過將常規(guī)固體培養(yǎng)及傳統(tǒng)藥敏試驗與Xpert MTB/RIF進行比較,結(jié)果顯示,Xpert MTB/RIF的肺結(jié)核陽性符合率達到98.33%,高于常規(guī)固體培養(yǎng)的89.16%,證實Xpert MTB/RIF對肺結(jié)核診斷準(zhǔn)確率更高。在利福平耐藥性檢測方面,Xpert MTB/RIF的陽性符合率為93.75%,高于傳統(tǒng)藥敏試驗的62.50%,證實Xpert MTB/RIF對利福平耐藥性檢出率更高。在診斷時效方面,Xpert MTB/RIF對肺結(jié)核及利福平耐藥性診斷用時及相應(yīng)成本更少,表明Xpert MTB/RIF可兼顧診斷的時效性與經(jīng)濟性。綜合上述研究結(jié)果,Xpert MTB/RIF在肺結(jié)核診斷、利福平耐藥性早期檢出方面更具有優(yōu)勢。
劉榮梅等[10]指出,通過將實時熒光定量核酸擴增檢測技術(shù)與γ-干擾素釋放試驗有效結(jié)合,能夠提高關(guān)節(jié)結(jié)核疾病的診斷準(zhǔn)確度。此外,文獻[11-12]也分析了耐利福平結(jié)核病中耐多藥結(jié)核病分布特點及Xpert MTB/RIF檢測對其耐藥性的診斷價值。但本研究均以肺結(jié)核患者為研究對象,后續(xù)還應(yīng)重視其他結(jié)核病患者的資料進行研究與分析,以更好地為Xpert MTB/RIF應(yīng)用及推廣奠定基礎(chǔ)。
綜上所述,Xpert MTB/RIF可提高肺結(jié)核早期檢出率,保證利福平耐藥檢出可靠性,且診斷用時更少,成本更低,具有較高的診斷時效,值得推廣和應(yīng)用。
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(收稿日期:2019-11-07) (本文編輯:李盈)
基金項目:廣東省中山市科技計劃基金項目(項目編號:2017B1040)
①中山市第二人民醫(yī)院 廣東 中山 528447