斯奇康注射液辅助治疗肺结核的临床研究

目的 观察斯奇康注射液辅助治疗肺结核的临床疗效、对细胞免疫功能的影响及不良反应的发生情况,为肺结核的辅助治疗提供一种安全、有效且价格低廉的药物.方法 将60例肺结核患者按随机数字表法分为治疗组和对照组,每组30例,两组均予标准抗结核化疗方案,治疗组加斯奇康注射液,观察患者的症状、病灶影像学改变、血常规、肝肾功能及T淋巴细胞亚群变化.结果 治疗后两组症状均较治疗前明显改善(P＜0.05),但治疗组明显优于对照组(P＜0.05);治疗组的有效率及控制率分别为36.7%(11/30)、96.7%(29/30),显著高于对照组的23.3%(7/30)、86.7%(26/30)(P＜0.05);治疗后,两组CD3、CD4和IL-2均升高,CD8下降,治疗组改善优于对照组(P＜0.05);治疗组白细胞减少率10.0%(3/30)]明显低于对照组33.3%(10/30)](P＜0.05).两组对肝肾功能损害程度差异无统计学意义.结论 斯奇康注射液治疗肺结核患者,能有效改善肺结核的症状,提高病灶吸收好转率,提高机体细胞免疫力,减轻结核化疗所致的白细胞下降的发生率,对肝肾功能无明显影响,临床用药较安全.

Abstract：

Objective To evaluate the effectiveness, the influence on cellular immune function and the side-effect of bacillus of Calmette-Guerin polysaccharide nucleic acid(BCG-PSN)combined with antituberculous chemotherapy in the treatment of pulmonary tuberculosis. Methods A total of 60 pulmonary tuberculosis patients were divided into treatment group(30 patients)and control group(30 patients)by random digits table. All patients accepted the same standard antituberculous chemotherapy, meanwhile patients in treatment group were injected with BCG-PSN. Observed and compared the clinical symptom,the size of the focas nidus,the change of toxic response and immunity. Results The symptoms were significantly relieved in both groups after treatment(P＜0.05), but it was significantly better in treatment group(P＜0.05), the effective rate and control rate in treatment group36.7%(11/30),96.7%(29/30)]were significantly higher than those in control group23.3%(7/30), 86.7%(26/30)](P ＜ 0.05). After treatment,the levels of CD3,CD4 and IL-2 were higher, and the level of CD8 was lower, but the treatment group improved significantly better than control group(P ＜ 0.05). The rate of leukopenia was lower in treatment group than that in control group10.0%(3/30)vs. 33.3%(10/30),P ＜0.05]. As to the safety,no other toxicities were observed in the treatment group. Conclusions BCG-PSN combined with antituberculous chemotherapy in the treatment of pulmonary tuberculosis contributes to relieve the symptom, reduce size of the nidus, decrease leukopenia incidence and enhance the cell immunity. It is safe.

Clinical studies of bacillus of Calmette-Guerin polysaccharide nucleic acid adjunctive therapy in pulmonary tuberculosis

Objective To evaluate the effectiveness, the influence on cellular immune function and the side-effect of bacillus of Calmette-Guerin polysaccharide nucleic acid(BCG-PSN)combined with antituberculous chemotherapy in the treatment of pulmonary tuberculosis. Methods A total of 60 pulmonary tuberculosis patients were divided into treatment group(30 patients)and control group(30 patients)by random digits table. All patients accepted the same standard antituberculous chemotherapy, meanwhile patients in treatment group were injected with BCG-PSN. Observed and compared the clinical symptom,the size of the focas nidus,the change of toxic response and immunity. Results The symptoms were significantly relieved in both groups after treatment(P＜0.05), but it was significantly better in treatment group(P＜0.05), the effective rate and control rate in treatment group36.7%(11/30),96.7%(29/30)]were significantly higher than those in control group23.3%(7/30), 86.7%(26/30)](P ＜ 0.05). After treatment,the levels of CD3,CD4 and IL-2 were higher, and the level of CD8 was lower, but the treatment group improved significantly better than control group(P ＜ 0.05). The rate of leukopenia was lower in treatment group than that in control group10.0%(3/30)vs. 33.3%(10/30),P ＜0.05]. As to the safety,no other toxicities were observed in the treatment group. Conclusions BCG-PSN combined with antituberculous chemotherapy in the treatment of pulmonary tuberculosis contributes to relieve the symptom, reduce size of the nidus, decrease leukopenia incidence and enhance the cell immunity. It is safe.