Abstract:

Objective To investigate efficacy and safety of Baihegujin Tablets in the adjunctive therapy for new pulmonary tuberculosis (yin deficiency syndrome of the lung and kidney).Methods By using the random number table,a randomized,double-blind,placebo-controlled,multi center clinical trial was conducted. 96 subjects with primary tuberculosis were divided into study group (72 cases) and control group (24 cases) respectively.The patients in the two groups were treated with conventional 2H-R-E-Z/4H-R-E,the study group was added with Baihegujin tablets, and the control group with Baihegujin simulation agent. The safety and the TCM syndromes were observed before treatment and after 2 weeks,4 weeks and 8 weeks treatment. The statistic analyses were performed using SAS 9.1,the Chi-square test and t test were used to anylyze the count and measurement data respectively,P value <0.05 was considered to be significantly different.Results The study group did not appear the adverse reaction of traditional Chinese medicine.Full analysis set (FAS) showed that the curative rates in study group and control group were 40.28% (29/72) and 25.00% (6/24) after 2 weeks respectively,there was no significant difference between the two groups (χ ²=1.95,P=0.1624); after 4 weeks and 8 weeks of treatment,the curative rates in study group were 70.83% (51/72) and 86.11% (62/72), which in control group were 45.83% (11/24) and 66.67% (16/24) respectively, there were significant differences between the two groups (after 4 weeks,χ ²=5.54,P=0.0186;after 8 weeks,χ ²=4.49,P=0.0341), the study group was better than the control group. After 2 weeks and 4 weeks treatment, the effective rates in study group were 93.06% (67/72) and 98.61% (71/72), which were 66.67% (16/24) and 83.33% (20/24) in control group respectively, there were significant differences between the two groups (after 2 weeks,χ ²=10.66,P=0.0011;after 4 weeks,χ ²=8.19,P=0.0042),the study group was better than the control group. The effective rates in study group and control group were 97.22% (70/72) and 91.67% (22/24) after 8 weeks respectively, there was no significant difference between the two groups (χ ²=1.33,P=0.2482). The cough disappearance time of study group and control group were 20.5 days and 28 days respectively,there were statistically significant (χ ²=6.25,P=0.0124). The curative effect of the group was better than that of the control group. There was no obvious adverse reaction related to traditional Chinese Medicine in study group. Conclusion Baihegujin Tablets can effectively improve the symptoms of tuberculosis,and effectively shorten the disappearance time of cough,and has good safety.

Key words: Tuberculosis, lung, Drug therapy, combination, Drugs, Chinese herbal, Treatment outcome, Baihegujin