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中国防痨杂志 ›› 2020, Vol. 42 ›› Issue (10): 1092-1099.doi: 10.3969/j.issn.1000-6621.2020.10.015

• 论著 • 上一篇    下一篇


刘二勇, 周林, 薛晓, 刘春法, 白丽琼, 陆伟, 张天华, 成诗明()   

  1. 102206 北京,中国疾病预防控制中心结核病预防控制中心患者关怀部(刘二勇、周林、薛晓),国家结核病参比实验室(刘春法);湖南省结核病防治所 湖南省胸科医院(白丽琼);江苏省疾病预防控制中心(陆伟);陕西省结核病防治所(张天华);中国防痨协会(成诗明)
  • 收稿日期:2020-06-24 出版日期:2020-10-10 发布日期:2020-10-15
  • 通信作者: 成诗明
  • 基金资助:

Evaluation of treatment effect and safety of rifampicin capsule (Ⅱ) on pulmonary tuberculosis

LIU Er-yong, ZHOU Lin, XUE Xiao, LIU Chun-fa, BAI Li-qiong, LU Wei, ZHANG Tian-hua, CHENG Shi-ming()   

  1. Patient’s Care Department, National Center for TB Control and Prevention, Chinese Centre for Disease Control and Prevention,Beijing 102206,China
  • Received:2020-06-24 Online:2020-10-10 Published:2020-10-15
  • Contact: CHENG Shi-ming


目的 评价利福平胶囊(Ⅱ)(利福平脂肪性基质制剂)治疗肺结核的临床疗效和安全性。方法 2017年3月,中国防痨协会按照数字表法随机在全国范围内从东、中、西部地区抽取自愿参加现场研究的江苏、山东、辽宁、湖南、河北、陕西6个省8家结核病定点医院作为实施单位。2017年6—12月,各实施单位按照入组标准,将连续纳入的患者按照课题组制定的随机数字表法进行分组,排除数据无效患者后,最终纳入644例患者,其中观察组330例,对照组314例,两组患者均采用2H-R-Z-E/4H-R标准化疗方案治疗,除观察组采用利福平胶囊(Ⅱ)(0.45g/d)、对照组采用利福平胶囊(0.6g/d)治疗外,其他药物种类、剂量、用法均相同。在项目实施过程中,当患者出现利福平耐药或耐多药或诊断变更等其他原因未能完成治疗时,计为退组。观察两组患者抗结核治疗转归、肺结核相关症状改善、肺部病灶影像学改变、痰涂片变化情况,以及肝肾功能损伤、血细胞减少和总不良反应的发生情况。采用SPSS 19.0软件进行数据的统计学分析,计数资料采用卡方检验或Fisher确切概率法,以P<0.05为差异有统计学意义。结果 观察组患者治疗成功[77.6%(256/330)]、失败[0.6%(2/330)]、丢失或死亡[10.3%(34/330)]、退组[11.5%(38/330)]的转归情况与对照组[分别为77.1%(242/314)、0.6%(2/314)、8.9%(28/314)、13.4%(42/314)]差异无统计学意义(Fisher精确概率法,P=0.874)。完成疗程时,观察组和对照组在咳嗽[91.4%(267/292)和88.2%(240/272)]、乏力[99.3%(290/292)和98.2%(267/272)]、体质量减轻[100.0%(292/292)和99.3%(270/272)]、发热[100.0%(293/293)和99.6%(277/278)]、结核病灶吸收有效率[87.6% (212/242)和84.1% (196/233)]、空洞改善有效率[57.0%(138/242)和49.4%(115/233)]、痰涂片阳性率[0.5%(1/210)和1.0%(2/192)]等方面差异均无统计学意义(χ2=1.590,P=0.207;χ2=0.732,P=0.392;Fisher精确概率法,P=0.234;Fisher精确概率法,P=0.487;χ2=1.189,P=0.276;χ2=2.804,P=0.094;χ2=0.006,P=0.938)。观察组和对照组总不良反应、肝功能损伤、肾功能损伤的发生率[分别为43.3%(143/330)和44.9%(141/314)、16.7%(55/330)和18.5%(58/314)、23.6%(78/330)和24.8%(78/314)]差异均无统计学意义(χ2=0.161、0.362、0.127,P=0.688、0.547、0.721),但对照组血常规指标减少/降低的发生率[26.4%(83/314)]高于观察组[17.9%(59/330)](χ2=6.850,P=0.009)。结论 利福平胶囊(Ⅱ)剂量低,其抗结核疗效和安全性不低于利福平胶囊,为我国抗结核药品的选择提供了新方向。

关键词: 结核, 肺, 利福平胶囊(Ⅱ), 药物评价, 多种药物疗法, 疗效比较研究, 数据说明, 统计


Objective Our aim was to evaluate the clinical efficacy and safety of rifampicin capsule (Ⅱ) (rifampicin capsules embedded by fatty acid matrix) in treatment of pulmonary tuberculosis. Methods In March 2017, Chinese Anti-tuberculosis Association selected 8 designated TB hospitals in 6 provinces from Jiangsu, Shandong, Liaoning, Hunan, Hebei and Shaanxi as the field study implementation units through the method of random number table according to the regions from east, middle or west. From June to December in 2017, each implementing unit enrolled 644 patients in accordance with the inclusion criteria and adopted the continuous inclusion method. Ultimately newly discovered TB patients were assigned into two groups after eliminated invalid data: observated group 330 cases (the rifampicin capsules (Ⅱ) (0.45 g/d, empty stomach, one suit))and the control group 314 cases(the rifampicin capsules (0.6 g/d, empty stomach, one suit)) according to the method of random number table. The two groups all were treated with 2H-R-Z-E/4H-R chemotherapy regimens, all other drugs were the same except rifampicin. During the implementation of the project, if patients fail to complete treatment due to rifampicin resistance or multi-drug resistance or other reasons such as diagnostic changes, they will be included in the withdrawal group. The outcomes of anti-tuberculosis treatment, improvements of tuberculosis-related symptoms, imaging changes of pulmonary lesions, changes of sputum smear, liver and kidney function injury, hemocytopenia and total adverse events in the two groups were observed. SPSS 19.0 software was used for statistical analysis of the data. Chi-square test, Fisher exact probability method or rank sum test were used for enumeration data, and P<0.05 was considered as statistically significant. Results No statistically significant differences between observed group in the outcomes of treatment success (77.6% (256/330)), failure (0.6% (2/330)), loss or death (10.3% (34/330)), withdrawal (11.5% (38/330)) and control group (77.1% (242/314), 0.6% (2/314), 8.9% (28/314), 13.4% (42/314), respectively)(Fisher’s exact probability method, P=0.874). After finishing treatment, in the observed group and the control group, there were no statistically significant differences in cough (91.4%(267/292)and 88.2%(240/272)), fatigue (99.3% (290/292) and 98.2% (267/272)), body mass reduction (100.0% (292/292) and 99.3% (270/272)), fever (100.0% (293/293) and 99.6% (277/278)), the absorption efficiency of TB foci (87.6% (212/242) and 84.1% (196/233)), the cavity improvement rate (57.0% (138/242) and 49.4% (115/233)), and sputum smear positive rate (0.5%(1/210) and 1.0%(2/192)) (χ2=1.590, P=0.207; χ 2=0.732, P=0.392; Fisher’s exact probability method, P=0.234; Fisher’s exact probability method, P=0.487; χ 2=1.189,P=0.276;χ2=2.804,P=0.094; χ2=0.006, P=0.938). The incidence of total adverse events, liver injury and renal function injury in the observed group and the control group (43.3% (143/330) and 44.9% (141/314), 16.7% (55/330) and 18.5% (58/314), 23.6% (78/330) and 24.8% (78/314), respectively)were no statistically significant (χ 2=0.161, 0.362, 0.127, P=0.688, 0.547, 0.721). However, the incidence of reduced blood routine indicators in the control group (26.4% (83/314)) was higher than that in the observed group (17.9% (59/330)) (χ 2=6.850,P=0.009). Conclusion The anti-tuberculosis efficacy and safety of rifampicin capsule (Ⅱ) are not lower than rifampicin capsule, but with a lower dose. This drug provides a new direction for the selection of anti-tuberculosis drugs in China.

Key words: Tuberculosis, pulmonary, Rifampicin capsule (Ⅱ), Drug evaluation, Polypharmacy, Comparative effectiveness research, Data interpretation, statistical