Clinical Research of the Efficacy ofShanggan Granulesin TreatingforAcuteUpper Respiratory Tract Infection with Fever

Amultiplecenter, Double simulation,double-dummy andrandomizedcontrolledtrial

Xi Zhaoqing¹, Liu Qingquan², Hao Li³, Zhang Xiaoyun⁴, Luo Yi⁵, Zhang Nianzhi⁶, Sun Baiqing⁷, Yu Yanliang¹, Bu Qingyan¹, Zou Jiandong¹, Rui Qingling¹, Zhang Li³, Yu Wanrong³, Geng Lianyi³, Xiong Ningning¹

1.Jiangsu Provincial Hospital of Traditional Chinese Medicine,Nanjing Jiangsu China 210029;

2.Dongzhimeng Hospital Affiliated to Beijing University of Chinese Medicine,Beijing China 100700;

3.Nanjing University of Chinese Medicine, Nanjing Jiangsu China 210023

4.Affiliated Hospital ofChengdu University of Chinese Medicine,Chengdu Sichuan China 610072

5.Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou Guangdong China 510120

ABSTRACT:To evaluate the clinical efficacy of Chinese Medicine Shanggan Granules in treatment of acute upper respiratory tract infection with fever. Patients were randomly divided into three groups: the experimental group, the control group and the placebo group.The instant fever clearance time, antipyretic efficacy, onset time, antipyretic time and clinical recovery rates were analyzed.The body temperature in the experimental and control groupsdeclinedwithin 1-4h after medication (P<0 .01). The body temperature in the placebo groupdroppedwithin 2-4h after medication (P<0 .01). Compared with the placebo group, the body temperature in the other two groups significantly decreased (P<0 .05 orP<0 .01).The antipyretic efficacy of the experimentaland control groupswere significantly better thanthat of theplacebo group (P<0 .01).The onset and antipyretic time of the control and experimental groups were less than that of the placebo group (P<0 .05).The recovery rate of theexperimental group was higher than the other two groups(P< 0.01 orP< 0.05), and thecontrol group was higher than the placebo group(P<0 .05).The study indicated that Shanggangranulescould reduce the body temperature, shorten the fever time, and improve the clinical symptoms of patients with acute upper respiratory tract infection with fever.

KEYWORDS:Shanggan granules;Bufferin Clod tablets;placebo;upper respiratory tract infection;exogenous fever

Upper respiratory tract infections are the most common infectious illnesses in the general population. More than 90% of the cases are caused by a viral infection and sometimes associated with a bacterial infection.The infection usually lasts between1 to 7 dayswith varying symptoms including: cough,runny nose,nasal congestionandgradualrecover mostlywithin 1 to 2 weeks. The current treatment can only relieve the symptoms of colds, but not shorten the duration. It has been confirmed thatShanggan granuleshave a good antipyretic effect in the treatment of acute upper respiratory tract infections with fever (exogenous fever syndrome in TCM)^[1-5].

In order to objectively evaluate the clinical efficacy of Shanggangranules in the treatment of respiratory tract infections with fever, a multicenter, randomized, double-blind, double-dummy, positive drug and placebo parallel-controlled trial was conducted and presented as follow.

1 Clinicaldata

1.1 Diagnosticcriteria

Chinesemedicinediagnosticcriteria: The differential diagnostic criteria of exogenous fever in TCM is made by referring toStandards of Diagnosis and Treatment for Exogenous High Fever^[6]: ① Nasal congestion, runny nose, sneezing, itchy throat, or pain, coughing and other clinical manifestations of lung function disorder; such as chills, fever,little or nosweat, headache, limb soreness and other malaise symptoms. ② Most often contagious, different agesand gendersmay sufferduringany season, but more frequentoccurrence isintheWinter or Spring.

Western medicinediagnosticcriteria:...