百合固金片辅助治疗初治肺结核的随机对照临床研究

A randomized clinical trial of Baihegujin Tablets for treatment of new pulmonary tuberculosis

目的 探讨百合固金片辅助治疗初治继发性肺结核（肺肾阴虚证）的有效性及安全性。方法 采用随机、双盲、安慰剂平行对照、多中心临床研究,将96例初治肺结核患者采用随机数字表法分为研究组72例和对照组24例,两组受试者均采用2H-R-E-Z/4H-R-E方案进行抗结核治疗,研究组加用百合固金片,对照组加用百合固金片模拟剂,分别于治疗前及治疗2周、4周及8周观察其安全性及各项中医证候。应用SAS 9.1统计软件进行统计学分析处理。计数资料的比较采用χ2检验,计量资料采用t检验,以P＜0.05为差异有统计学意义。结果 两组患者全分析集（full analysis set,FAS）结果显示,治疗2周末研究组和对照组的愈显率（临床痊愈＋显效）分别为40.28%（29/72）和25.00%（6/24）,差异无统计学意义（χ2=1.95,P=0.1624）;治疗4周及8周末,研究组的中医证候愈显率分别为70.83%（51/72）、86.11%（62/72）,对照组分别为45.83%（11/24）、66.67%（16/24）,两组愈显率之间差异均有统计学意义（4周末,χ2=5.54,P=0.0186;8周末,χ2=4.49,P=0.0341）,研究组优于对照组;治疗2周和4周末,研究组的有效率分别为93.06%（67/72）、98.61%（71/72）,对照组的有效率分别为66.67%（16/24）、83.33%（20/24）,两组之间差异均有统计学意义（2周末,χ2=10.66,P=0.0011;4周末,χ2=8.19,P=0.0042）,研究组优于对照组,治疗8周末研究组和对照组的有效率分别为97.22%（70/72）和91.67%（22/24）,两组之间差异无统计学意义（χ2=1.33,P=0.2482）。研究组和对照组的咳嗽消失时间分别为20.5 d和28 d,差异有统计学意义（χ2=6.25,P=0.0124）,研究组疗效优于对照组。研究组未出现中药相关的不良反应。结论 百合固金片辅助治疗初治继发性肺结核可有效改善结核中毒症状,并有效缩短咳嗽消失时间,安全性好。

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 （χ2=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,χ2=5.54,P=0.0186;after 8 weeks,χ2=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,χ2=10.66,P=0.0011;after 4 weeks,χ2=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 （χ2=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 （χ2=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.