九味羌活软胶囊治疗上呼吸道感染（感冒风寒挟湿证）的临床观察

【作者】 左明晏；

【导师】 杨毅；

【作者基本信息】 湖北中医学院 ， 中医内科学， 2008， 硕士

【摘要】 目的:观察九味羌活软胶囊治疗上呼吸道感染(感冒风寒挟湿证)的临床疗效,并探讨九味羌活软胶囊的安全性,为临床用药提供科学依据。方法:选取符合西医上呼吸道感染诊断标准和中医感冒风寒挟湿证的患者48例,随机分为对照组和治疗组。对照组24例,其中男性15例,女性9例;年龄20～61岁,平均年龄为37.8岁;病程3天;病情属轻度者5例,中度者16例,重度者3例。治疗组24例,其中男性13例,女性11例;年龄18～60岁,平均年龄为36.4岁;病程3天;病情属轻度者6例,中度者16例,重度者2例。两组患者性别、年龄、病程、病情程度经统计学处理,无显著性差异,具有可比性。对照组患者给予九味羌活浓缩丸,4.5g/次(4.5g/袋),3次/日,加九味羌活软胶囊模拟剂6粒/次,3次/日,口服;治疗组给予九味羌活软胶囊6粒/次,(0.6g/袋),3次/日,加九味羌活浓缩丸模拟剂,4.5g/次(4.5g/袋),3次/日,口服。两组疗程均为3天。观察两组病例用药前后临床症状、体征、体温等的变化,并进行临床综合评价。所有病例在试验期间不得使用其他任何对上呼吸道感染有治疗作用的抗菌、抗病毒等药物。统计分析采用SPSS13.0统计软件,分类资料用x~2检验,计量资料用t检验,等级资料用Ridit检验。结果:1.两组总疗效比较治疗组总有效率91.67%,对照组总有效率87.50%,差异无显著性意义(P＞0.05),治疗组疗效等同于对照组。2.两组中医证候疗效比较治疗组总有效率91.66%,对照组总有效率91.66%,差异无显著性意义(P＞0.05),治疗组疗效等于对照组;中医单个证候疗效差异亦无显著性意义(P＞0.05),治疗组疗效等于对照组。3.两组患者体温起效及解热时间情况比较用药第3天,两组均有明显疗效,对照组起效率为99.11%,治疗组起效率为100.00%,两组间比较无显著性差异;对照组解热率为93.86%,治疗组解热率为91.96%,两组间比较无显著性差异。对比用药前后可以看出试验药在降低感冒风寒挟湿证患者的体温方面具有显著的作用,与对照组的疗效相当。4.安全性评价试验过程中,治疗组和对照组均无病例因不良事件退出。治疗前后两组病例的血、尿、粪常规、肝肾功能及心电图均无明显改变,提示治疗组、对照组药物的安全性均良好。结论:本试验采用随机、双盲双模拟、阳性药物对照试验方法。统计分析采用SPSS13.0统计软件,分类资料用x~2检验,计量资料用t检验,等级资料用Ridit检验。统计结果表明:(1)两组患者性别、年龄、病程、病情程度具有可比性;(2)两组病人用药前症状、体征的主症,次症,舌脉具有可比性;(3)两组患者总疗效,中医证候总疗效,症状体征总记分下降值,治疗后中医单个证候疗效比较无明显差异。(4)两组病人体温起效及解热时间比较无明显差异(5)提示治疗组、对照组药物的安全性均良好。经本次临床试验结果表明,九味羌活软胶囊治疗上呼吸道感染(感冒风寒挟湿证),具有解表散寒,化湿止痛的作用,对发热、恶风、头痛、肢体酸痛等症状具有较好的治疗效果。在总疗效率,中医证候改善方面有显著意义。与对照组比,统计学无明显差异。更多还原

【Abstract】 Objective:To observe the 9 taste Rhizoma et Radix Notopterygii soft capsule on the treatment of respiratory tract infection (cold wet cold folder levy) the clinical efficacy and taste of nine Rhizoma et Radix Notopterygii the safety of soft gelatin capsules for clinical use to provide a scientific basis.Methods:Western medicine consultation with upper respiratory tract infection and the standard of Chinese medicine off a cold wet cold folder with the levy of 48 cases, a district group randomized, double-blind, double-simulation, the positive drug control parallel, multi-center experiment, divided into control and treatment Group. The control group of 24 cases, of which 15 cases of men, nine cases of women aged 20 to 61-year-old, the average age was 37.8 years;Course of three days; illness is mild, five cases, 16 patients with moderate to severe those three cases. The treatment group of 24 cases, of which 13 cases of men, 11 women aged 18 to 60-year-old, the average age was 36.4 years; course of three days; illness is mild, six cases, 16 patients with moderate to severe those two cases. Two groups of patients with gender, age, disease, the severity of Statistics Office Li, no significant difference, comparable. The control group nine flavor Rhizoma et Radix Notopterygii Nong Suwan, 4.5 g / times (4.5 g / bag), 3/9, and taste Rhizoma et Radix Notopterygii soft capsule simulation of 6 / time, 3 times / day, experimental group nine flavor Rhizoma et Radix Notopterygii soft capsule 6 / times, (0.6g / bag), three times / day, plus nine simulation of taste Rhizoma et Radix Notopterygii Nong Suwan, 4.5g / times (4.5 g /Three bags), three times / day, orally. Two courses are three days. Drug cases were observed before and after the clinical symptoms and signs, such as chest X-ray examination of the changes and a comprehensive clinical evaluation. All patients in the trial shall not use any other merger of the upper respiratory tract infection with the treatment of antibacterial, antiviral drugs. The statistical analysis uses the statistical analysis to use the SPSS10.0 statistics software, the grouped data with the chi-square test, the ranked data examines with Ridit, the measurement material uses the T-test.Results:(1) . Comparison of the two groups, treatment group, the total efficiency of 91.67 percent, the control group, the total efficiency of 87.50 percent, the difference was not significant (P> 0.05), equivalent to the effect of the treatment group the control group.(2) . Syndrome effect of the two groups of Chinese medicine, treatment group, the total efficiency of 91.66 percent, the control group, the total efficiency of 91.66 percent, the difference was not significant (P> 0.05), the treatment group effect equivalent to the control group, a single individual Syndrome efficacy of Chinese medicine No differences were significant (P> 0.05), the treatment group effect equivalent to the control group.(3) . Two groups of patients with body temperature of the onset time and antipyretic drugs compare to the first three days, two groups were significantly effect, the control group from the efficiency of 99.11 percent, to the efficiency of the treatment group from 100.00%, between the two groups showed no significant Differences in the treatment group antipyretic rate was 91.96 percent, the control group rate of 93.86 percent antipyretic, between the two groups showed no significant difference. Before and after contrast administration can be seen in the reduction of drug tests rely on a cold wet cold of the patients with body temperature has a prominent role, and the pilot group and the effect of a control group.(4). Safety evaluation test of the treatment and control groups did not withdraw from the case because of adverse events. Before and after treatment Two cases of blood, urine, fecal conventional, liver and kidney function and electrocardiogram did not change significantly, suggesting that the treatment group and control group of drug safety are good.Conclusion:This study uses a randomized, double-blind, double-dummy, the positive drug controls test methods. Statistical analysis using statistical analysis software used SPSS13.0 statistics, disaggregated data by x~2 testing,, measurement data used t-test., grading information with the Ridit test . Statistics show that: (1) in two groups by gender, age, disease, the severity comparable (2) two groups of patients before treatment symptoms, signs the main levy, the levy, tongue veins are comparable, (3) The effect of two groups of patients, the efficacy of Chinese medicine syndrome, the symptoms and signs of decline in value of points, after a single treatment effects of Chinese medicine syndrome there was no significant difference. (4) patients were temperature and antipyretic effect from the time showed no significant difference (5) suggested that the treatment group and control group of drug safety are good. After this clinical trial results showed that the nine soft capsule Rhizoma et Radix Notopterygii taste of upper respiratory tract infection (cold rely on wetlands permits), a table of cold-dispelling, Huashi the role of pain, fever, the evil wind, headaches, body pain and other symptoms of Better treatment. The total effect of Chinese medicine syndrome improve, security in both good results, compared with the control group, no statistically significant difference.更多还原