Gankeshuangqing Capsule for Acute Upper Respiratory Infection: A Randomized Controlled Trial_Chinese Journal of Evidence-Based Medicine

Authors：

 TAN Yongmei , GAO Lan

Zhuhai City Traditional Chinese Medicine Hospital of Guangzhou University of Traditional Chinese Medicine, Zhuhai 519015, China;

Corresponding author：

TAN Yongmei, Email: tanyongmei@163.com

Keywords：

Acute upper respiratory infection; Wind-heat syndrome; Gankeshuangqing; Randomize controlled trial

DOI：

10.7507/1672-2531.20100425

Video：

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Objective 　To evaluate the clinical effect and safety of Gankeshuangqing capsule in the treatment of acute upper respiratory infection (AURI).
Methods 　A total of 144 patients with wind-heat syndrome (acute upper respiratory infection) were recruited and randomized into the Gankeshuangqing group (administered with Gankeshuangqing capsule and symptomatic treatment for 3 days) and the ribavirin group (administered with ribavirin tablets and symptomatic treatment for 3 days). And the severity scores of pathogenetic conditions, efficacy rates and adverse drug reaction were estimated at the end of the experiment.
Results 　A total of 144 patients (72 in the Gankeshuangqing group, 72 in the ribavirin group) were enrolled in this trial, of whom 9 were dropped out (3 from the Gankeshuangqing group, 6 from the ribavirin group) and 11 were excluded (4 from the Gankeshuangqing group, 7 from the ribavirin group). A significant difference was observed in the rates of cure and excellence: 85.51% (59/69) for the Gankeshuangqing group, and 66.67% (44/66) for the ribavirin group, respectively (P lt;0.05) (FAS data set). A significant difference was observed in the rates of cure in fervescence, pharyngodynia and pars nasalis catarrhus symptome: 70.00%, 78.26%, 56.90% in the Gankeshuangqing group, and 40.38%, 51.52%, 36.21% in the ribavirin group, respectively (P lt;0.05) (FAS data set). There was no significant difference in the rates of cure in tussis between the two groups: 32.08% for the Gankeshuangqing group, and 34.00% for the ribavirin group, respectively (P gt;0.05) (FAS data set). There were 2 adverse drug reactions observed in the ribavirin group, whose white blood cell count was decreased, but in the Gankeshuangqing group, no adverse drug reaction was found.
Conclusion 　The results indicate that Gankeshuangqing Capsule shows a definite effect on wind-heat syndrome (acute upper respiratory infection) with good safety.

Citation： TAN Yongmei,GAO Lan. Gankeshuangqing Capsule for Acute Upper Respiratory Infection: A Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2010, 10(4): 444-448. doi: 10.7507/1672-2531.20100425 Copy

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8.	Xia YF, Ye BQ, Li YD, et al. Andrographolide attenuates inflam mation by inhibition of NF-κB activation through covalent modification of reduced cysteine 62 of p50. J Immunol, 2004, 173(6): 4207-4217.
9.	李强, 郝晓锋, 郭礼新, 等. 感咳双清胶囊抗病毒作用的实验研究. 中国药房, 2005, 16(24): 1859-1860.
10.	包旭, 邱练芬, 胡开华. 黄心胶囊的体外抗病毒作用. 中药药理与临床, 2002, 18(4): 30-31.
11.	高雷, 陈鸿珊. 黄芩苷体外对流感病毒、单纯疱疹病毒和柯萨奇病毒的抑制作用. 中国新药杂志, 2008, 17(6): 474-478.
12.	Chen F, Chan KH, Jiang Y, et al. In vitro susceptibility of 10 clinical isolates of SARS coronavirus toselected antiviral compounds. Journal of Clinical Virology, 2004, 31(1): 69-75.
13.	赵晶, 张致平, 陈鸿珊, 等. 黄芩甙衍生物的合成及抗人免疫缺陷病毒活性研究. 药学学报, 1998, 33(1): 22-27.
14.	张丽亚, 董琳, 陈小芳, 等. 黄芩苷抗呼吸道合胞病毒感染作用的体外研究. 浙江临床医学, 2008, 10(12): 1528-1530.

1. 涂明华. ARI的病原学研究进展. 实用乡村医生杂志, 1998, 5(2): 9-10.
2. 王银玉, 王芳, 冯长生, 等. 感咳双清胶囊在耳鼻喉科治疗急性上呼吸道感染的临床研究. 中国伤残医学, 2008, 16(3): 63-65.
3. 王丛礼, 洪丽君, 邹华, 等. 感咳双清胶囊治疗急性上呼吸道感染53例的临床观察. 中华实用中西医杂志, 2007, 20(6): 471.
4. 侯晓燕, 王宏, 辛迪, 等. 感咳双清胶囊治疗小儿急性上呼吸道感染的疗效与观察. 中国医药导报, 2009, 6(9): 71.
5. 吕斌, 常克, 王志虹, 等. 感咳双清胶囊治疗外感风热证(急性上呼吸道感染、急性支气管炎)的Ⅱ期临床研究. 中医药通报, 2005, 4(2): 35-38.
6. Ono K, Nakane H, Fukushima M, et al. Inhibition of reverse transcriptase activity by a flanvonoid compound 5, 6, 7-trihydroxyflanvone. Biochemical and biophysical research communications, 1989, 160(3): 982-987.
7. YuKinoriT, CHI MY, Tomimori T, et al. Inhibition of Influenza virus sialidase and virus activity by plant flavonoids. Chem. Pharm Bull, 1990, 38(5): 1329-1332.
8. Xia YF, Ye BQ, Li YD, et al. Andrographolide attenuates inflam mation by inhibition of NF-κB activation through covalent modification of reduced cysteine 62 of p50. J Immunol, 2004, 173(6): 4207-4217.
9. 李强, 郝晓锋, 郭礼新, 等. 感咳双清胶囊抗病毒作用的实验研究. 中国药房, 2005, 16(24): 1859-1860.
10. 包旭, 邱练芬, 胡开华. 黄心胶囊的体外抗病毒作用. 中药药理与临床, 2002, 18(4): 30-31.
11. 高雷, 陈鸿珊. 黄芩苷体外对流感病毒、单纯疱疹病毒和柯萨奇病毒的抑制作用. 中国新药杂志, 2008, 17(6): 474-478.
12. Chen F, Chan KH, Jiang Y, et al. In vitro susceptibility of 10 clinical isolates of SARS coronavirus toselected antiviral compounds. Journal of Clinical Virology, 2004, 31(1): 69-75.
13. 赵晶, 张致平, 陈鸿珊, 等. 黄芩甙衍生物的合成及抗人免疫缺陷病毒活性研究. 药学学报, 1998, 33(1): 22-27.
14. 张丽亚, 董琳, 陈小芳, 等. 黄芩苷抗呼吸道合胞病毒感染作用的体外研究. 浙江临床医学, 2008, 10(12): 1528-1530.

Chinese Journal of Evidence-Based Medicine

Gankeshuangqing Capsule for Acute Upper Respiratory Infection: A Randomized Controlled Trial

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