目的 探討芪貝膠囊聯(lián)合2HRZE/4HR方案治療肺結(jié)核(氣陰兩虛型)的臨床療效。方法 納入2020年1月-2020年9月就診于新鄉(xiāng)醫(yī)學(xué)院第一附屬醫(yī)院的160例肺結(jié)核(氣陰兩虛型)患者,隨機(jī)分為對照組和治療組,每組各80例。對照組給予2HRZE/4HR治療方案,口服異煙肼片, 1次/d, 0.3 g/次;利福平膠囊1次/d, 0.45 g/次;鹽酸乙胺丁醇片3次/d,0.5 g/次;吡嗪酰胺片1次/d, 0.75 g/次,治療2個(gè)月, 2個(gè)月后患者停用鹽酸乙胺丁醇片和吡嗪酰胺片,繼續(xù)按照上述劑量口服異煙肼片和利福平膠囊4個(gè)月。治療組在對照組的基礎(chǔ)上口服芪貝膠囊, 3次/d, 10粒/次。兩組治療6個(gè)月。觀察兩組患者臨床療效,比較治療前后兩組患者痰菌轉(zhuǎn)陰率和肺部病灶吸收情況,肺功能和炎癥因子水平。結(jié)果 治療后,對照組和治療組總有效率分別為82.50%、93.75%,兩組比較差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。治療后,對照組痰菌轉(zhuǎn)陰率和肺部病灶吸收率分別為83.75%、85.37%,治療組痰菌轉(zhuǎn)陰率和肺部病灶吸收率分別為95.00%、96.25%,兩組比較差異具有統(tǒng)計(jì)學(xué)意義(P<0.05)。治療后,兩組患者第一秒用力呼氣容積(FEV1)、用力肺活量(FVC)和γ干擾素(IFN-γ)顯著升高,而白細(xì)胞介素-4(IL-4)和IL-10顯著降低(P<0.05),且治療組這些指標(biāo)顯著好于對照組(P<0.05)。結(jié)論 芪貝膠囊聯(lián)合2HRZE/4HR方案治療肺結(jié)核(氣陰兩虛型)的臨床療效顯著且安全性較高,能促進(jìn)病灶吸收和痰菌轉(zhuǎn)陰,且顯著改善患者的肺功能。

Objective To explore the clinical efficacy of Qibei Capsules combined with 2HRZE/4HR regimen in treatment of pulmonary tuberculosis (qi-yin deficiency type).Methods Patients (160 cases) with pulmonary tuberculosis (qi-yin deficiency type) in the First Affiliated Hospital of Xinxiang Medical University from January 2020 to September 2020 were randomly divided into control and treatment group, and each group had 80 cases. Patients in the control group were administered with 2HRZE/4HR regimen. They were po administered with Isoniazid Tablets, 0.3g/time, once daily, with Rifampicin Capsules 0.45g/time, once daily, Ethambutol Hydrochloride Tablets, 0.5g/time, three times daily, Pyrazinamide Tablets, 0.75g/time, once daily. After 2 months of treatment, patient stopped taking Ethambutol Hydrochloride Tablets and Pyrazinamide Tablets, and continued taking Isoniazid Tablets and Rifampicin Capsules at the above doses for 4 months. Patients in the treatment group were po administered with Qibei Capsules on the basis of the control group, 10 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical evaluation was evaluated, the rate of sputum smear negative and lung focus absorption, the lung function, the levels of serum inflammation factors in two groups before and after treatment were compared.Results After treatment, the clinical effective rates of the control group and treatment group were 82.50%, and 93.75% respectively (P < 0.05). After treatment, the sputum negative conversion rate and lung focus absorption rate in the control group were 83.75% and 85.37%, which were significantly lower than 95.00% and 96.25% in the treatment group, respectively, and there were differences between two groups (P < 0.05). After treatment, FEV₁, FVC and IFN-γ were significantly increased, while IL-4 and IL-10 were significantly decreased in two groups (P < 0.05), and these indexes in the treatment group were significantly better than those in the control group (P < 0.05).Conclusion Qibei Capsules combined with 2HRZE/4HR regimen in treatment of pulmonary tuberculosis (qi-yin deficiency type) has significant clinical efficacy and high safety, can promote focus absorption and sputum negative conversion, and significantly improve the lung function of patients.

R974

河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃聯(lián)合共建項(xiàng)目(2018020344)