目的 观察免疫类中药协定处方——肺痨灵合剂治疗肺结核的临床疗效及安全性。方法 将120例肺结核患者,随机分为治疗组(n=60)和对照组(n=60)。治疗组用肺痨灵合剂加常规抗结核药治疗,并与单纯常规抗结核药治疗进行对照。观察两组临床疗效、病灶吸收和药物不良反应等情况。结果 在6个月疗程结束后治疗组临床症状改善情况优于对照组;两组2个月、6个月后痰菌转阴率及空洞闭合数无差异(P>0.05);但治疗组在治疗咯血、病灶吸收、白细胞降低、肝功能损害方面优于对照组,两组间比较差异显著(P<0.05);而在严重胃肠道反应方面,治疗组明显优于对照组,差异显著(P<0.01)。结论 肺痨灵合剂配合化学药常规抗痨治疗利于促进病灶吸收,明显减轻化学药不良反应,具有一定的临床价值。

Objective To observe the clinical effect and safety of Feilaoling preparation which is a traditional Chinese prescription that can improve immune function in 60 cases of untreated pulmonary tuberculosis patients. Methods Patients with pulmonary tuberculosis (120 cases) were randomly divided into treatment (n = 60) and control (n = 60) groups. The patients in the treatment group were treated with both Feilaoling preparation and conventional chemotherapy, and the patients in the control group were only treated with conventional chemotherapy. The clinical effects, lesions absorption, and side effects of drugs were observed in two groups. Results The clinical symptoms and signs in treatment group were better than those in control group. Sputum negative conversion rates of two months and six months and cavitates closure have no significant difference between two groups (P > 0.05). But the hemoptysis treatment, lesions absorption improved, incidence rates of liver damage, and white blood reduction in two groups were all effectively changed, the treatment group was better than the control group (P < 0.05). The treatment group has a significant change compared with the control group (P < 0.01) in the incidence rate of severe gastrointestinal discomfort. Conclusion Feilaoling preparation has a reliable effect on promotion lesions absorption and reducing the side effects of Western anti-tuberculosis, with certain clinical value.

浙江省医学会临床科研基金项目(2012ZYC-B4)