[关键词]
[摘要]
观察桑杏止咳方治疗温燥犯肺型感染后咳嗽(postinfectious cough,PIC)的临床疗效及安全性。【方法】将2020年 1月至2022年6月广州中医药大学第一附属医院收治的66例温燥犯肺型感染后咳嗽患者随机分为治疗组和对照组,每组各 33例。治疗组给予桑杏止咳方联合复方甲氧那明胶囊治疗,对照组给予中药安慰剂联合复方甲氧那明胶囊治疗,疗程均为 7 d。观察2组患者治疗前后咳嗽严重程度视觉模拟量表(VAS)评分、咳嗽症状积分表评分及中医证候评分的变化情况,并评 价2组患者的临床疗效和安全性。【结果】(1)脱落情况方面,研究过程中,治疗组脱落1例,对照组脱落4例,最终实际完成 观察61例,其中治疗组32例,对照组29例。(2)疗效方面,治疗7 d后,治疗组的总有效率为84.38%(27/32),对照组为 58.62%(17/29),组间比较(χ2检验),治疗组的疗效明显优于对照组(P<0.05)。(3)咳嗽严重程度评估方面,治疗后,2组患 者的VAS评分及咳嗽症状积分表的日间咳嗽评分、夜间咳嗽评分和咳嗽总评分均较治疗前明显降低(P<0.05或P<0.01), 且治疗组对VAS评分及咳嗽总评分的降低幅度均明显优于对照组(P<0.05)。(4)中医证候评分方面,治疗后,治疗组的咳 嗽、咽痒、咽干、咽部异物感、咽痛、咽部体征等各项中医证候评分及总评分均较治疗前改善(P<0.01),而对照组仅咳 嗽、咽痒、咽干、咽痛评分及总评分较治疗前改善(P<0.05或P<0.01);治疗后组间比较,治疗组在改善咽痒、咽部异物 感、咽部体征评分及总评分方面均明显优于对照组(P<0.05或P<0.01)。(5)安全性方面,治疗过程中,2组患者均无明显不 良反应发生,且患者的血常规、肝肾功能等安全性指标均无异常变化。【结论】桑杏止咳方联合复方甲氧那明胶囊治疗温燥 犯肺型感染后咳嗽患者的临床疗效显著,其疗效明显优于单纯复方甲氧那明胶囊治疗,且具有较高的安全性。
[Key word]
[Abstract]
To observe the clinical efficacy and safety of Sangxing Zhike Prescription in treating postinfectious cough(PIC)of warm dryness invading the lung type. Methods A total of 66 PIC patients with warm dryness invading the lung type who were admitted to the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to June 2022 were randomly divided into a treatment group and a control group,with 33 patients in each group. The treatment group was given Sangxing Zhike Prescription combined with Compound Methoxyphenamine Capsules,and the control group was given Compound Methoxyphenamine Capsules combined with Chinese medicine placebo. The course of treatment covered 7 days. The changes in the Visual Analogue Scale(VAS)scores of the severity of cough,the scores of cough symptom,and the scores of traditional Chinese medicine(TCM)syndrome in the two groups were observed before and after the treatment. After treatment,the clinical efficacy and safety in the two groups were evaluated. Results(1)During the trial,one case fell off from the treatment group and 4 cases fell off from the control group, and eventually 61 cases completed the observation,of which 32 cases were in the treatment group and 29 cases were in the control group.(2)After 7 days of treatment,the total effective rate of the treatment group was 84.38%(27/32)and that of the control group was 58.62%(17/29),and the intergroup comparison(tested by chi-square test)showed that the therapeutic efficacy of the treatment group was significantly superior to that of the control group(P<0.05).(3)After treatment,the VAS scores of the severity of cough,and the scores of daytime cough,nighttime cough of the Cough Symptom Score Scale as well as the overall cough scores in the two groups were significantly lower than those before treatment(P< 0.05 or P<0.01), and the reduction of the VAS scores and the overall cough symptom scores in the treatment group was significantly superior to that in the control group(P<0.05).(4)After treatment,obvious improvement was presented in the scores of TCM symptoms of cough,throat itching,dry throat,foreign body sensation in the throat, sore throat and pharyngeal signs as well as total TCM syndrome scores in the treatment group when compared with the pre-treatment period(P<0.01), whereas in the control group, only the scores of cough, throat itching,dry throat,and sore throat and the total TCM syndrome scores were improved compared with the pre-treatment period(P<0.05 or P<0.01). The post-treatment intergroup comparison showed that the treatment group was significantly superior to the control group in improving the scores of throat itching, foreign body sensation in the throat,and pharyngeal signs as well as total TCM syndrome scores(P<0.05 or P<0.01).(5)During the treatment process, no significant adverse reactions occurred in both groups, or no abnormal changes were shown in the safety indexes such as blood routine test, liver and kidney functions of the patients. Conclusion Sangxing Zhike Prescription combined with Compound Methoxyphenamine Capsules exerts certain effect in treating patients with PIC of warm dryness invading the lung type, and its efficacy is significantly superior to that of Compound Methoxyphenamine Capsules treatment alone with relatively high safety profile
[中图分类号]
R256.11
[基金项目]
广州市科技计划项目(编号:202102010479)