Compared with adults, there are fewer clinical treatment medicine and methods for pediatric diseases, which are determined by the peculiarities of children’s bodies. Shufeng Jiedu Capsule has good clinical efficacy and extensive pharmacological effects.
Its application has gradually extended from adult applications to pediatric applications. In the past years 9 randomized controlled clinical trials (RTC) were conducted to evaluate the clinical effect and safety of SFJDC for the treatment of upper respiratory diseases in children between 2 and 12 years. The studies showed that the cure rate, improvement rate, the recovery time of antipyretic, cough relief, pharyngeal redness and swelling subside, nasal congestion and runny nose were better in the SFJDC group than in the control group. Furthermore, in 17 clinical trials the safety of the SFJDC treatment for children was analyzed. The results showed that the treatment of children with SFJDC causes only mild side effects with a very low adverse reaction rate of 4 % (54 adverse reaction/1352 children). Predominantly diarrhea, nausea, rash and gastrointestinal discomfort occurred. There were no serious side effects.
Pharmacological actionAnti-viral
Shufeng Jiedu Capsule can inhibit respiratory syncytial virus, Coxsackie virus type B3 and Herpes simplex virus type 1 [53], prevent H1N1 influenza virus infection in vivo [54, 55], also can inhibit human EV71H Hand-foot-and-mouth disease virus, CoxB3 and CoxB5 in vitro [56].
Anti-bacterial
Shufeng Jiedu Capsule can inhibit Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Shigella dysentery, Streptococcus pneumoniae, β Streptococcus, Bacillus mirabilis, Neisseria gonorrhoeae and Candida albicans [53, 57].
Antipyretic
Shufeng Jiedu Capsule can inhibit the production of inflammatory factor PGE2, control the production of pyrogenic cytokines TNF-α, IL-1α, IL-1β, IL-6 significantly, and reduce the amount of thermogenesis factor cAMP, Na+K+-ATPase, etc., decline cAMP/cGMP, decrease heat production, and increase the amount of endogenous antipyretic medium AVP and exert its antipyretic effect [58].
Anti-inflammatory, immune regulation and antitussive
The anti-inflammatory active monomer in Shufeng Jiedu Capsule acts on the signal pathways related to inflammation, immunity, collagen formation and muscle contraction by binding with the corresponding target proteins, it also induces IFN, increases the activity of natural killer cells, and exert anti-inflammatory, immune regulation and antitussive effects [59-61].
Sedation and analgesia
In the Shufeng Jiedu Capsule formula, Bupleurum chinense and Phragmites communis have sedation and analgesia function, Polygonum cuspidatum and Verbena officinalis have sedation function, and Patrinia scabiosifolia has analgesia function.
Clinical application
Upper respiratory tract infection
Mingyuan BI et al. used Shufeng Jiedu Capsule combined with Reduning injection to treat 42 cases of upper respiratory tract infections, the cure rate, apparent efficiency, total effective rate, and the disappearance time of cough, fever, nasal congestion, runny nose, and sore throat are all better than Reduning injection use alone [62]. Wen LI used Shufeng Jiedu Capsule combined with routine treatment to 125 cases of acute upper respiratory tract infection, the cure rate, effective rate, total effective rate, and abnormal body temperature, cough, redness and swelling of the pharynx, abnormal leukocytes or neutrophils, pulmonary rales and chest X-ray after 7 days of treatment are better than conventional treatment [63]. Xiaofeng ZHOU et al. used Shufeng Jiedu Capsule combined with Ribavirin injection to treat 70 cases of acute viral upper respiratory tract infection with Wind-heat syndrome, the cure rate, improvement rate, inefficiency, the recovery time of antipyretic, cough relief, pharyngeal redness and swelling subside, nasal congestion and runny nose are better than Ribavirin injection use alone [64]. Hong CHEN et al. combined with Shufeng Jiedu Capsule on the basis of conventional treatment to treat 78 cases of acute upper respiratory tract infections, the cure rate, effective rate and total effective rate, the recovery time of body temperature, cough, nasal congestion, runny nose, pharyngeal swelling and headache are better than conventional treatment [65]. Shuxia TIAN et al. used Shufeng Jiedu Capsule to treat 45 cases of acute upper respiratory tract infection, the apparent rate, effective rate, and total effective rate are better than Ribavirin injection [66]. Shufeng Jiedu Capsule can significantly improve the curative effect and shorten the duration of clinical symptoms and signs in the treatment of acute upper respiratory tract infection.
Pharyngoconjunctival fever
Hongji XIE et al. used Shufeng Jiedu Capsule combined with Ganciclovir injection to treat 32 cases of pharyngeal conjunctival fever, the cure rate, apparent rate, effective rate, total effective rate, antipyretic, pharyngeal pain relief, and conjunctivitis resolution time are better than Ganciclovir injection use alone [67].
Herpangina
Chengxiang LIU used Shufeng Jiedu Capsule combined with Ribavirin injection to treat 37 cases of herpangina, the cure rate, apparent rate, total effective rate, antipyretic and herpes resolution time are better than Ribavirin injection use alone [68]. Meilian YANG used Shufeng Jiedu Capsule combined with Ribavirin injection to treat 123 cases of herpangina, the cure rate, improvement rate, total effective rate, antipyretic, start of eating, disappearance time of herpes or ulcer are better than Ribavirin injection use alone [69].
Acute tonsillitis
Zhiyuan ZHAO used Shufeng Jiedu Capsule combined with Cefuroxime injection to treat 58 cases of acute tonsillitis, the cure rate, apparent rate, effective rate, total effective rate, antipyretic, sore throat and cough disappearance, and tonsil swelling time are better than Cefuroxime injection use alone [70]. Peilian HUANG et al. used Shufeng Jiedu Capsule combined with Cefaclor for oral dry suspension to treat 60 cases of tonsillitis (Wind-heat syndrome), the cure rate, apparent rate, total effective rate, body temperature recovery, pharyngeal discomfort disappeared, tonsil redness and swelling subsided, and leukocyte count recovery time are better than Cefaclor for oral dry suspension use alone [71]. Chunxiang XU et al. used Shufeng Jiedu Capsule combined with Amoxicillin and Clavulanate potassium to treat 110 cases of acute tonsillitis, the cure rate, apparent rate, effective rate, total effective rate, antipyretic, sore throat, redness and swelling time are better than Amoxicillin and Clavulanate potassium use alone [72].
Influenza
Dongmei YUAN used Shufeng Jiedu Capsule combined with Ribavirin granules to treat 43 cases of influenza, the apparent efficiency, effective rate, and total effective rate are better than Ribavirin particles use alone [73].
Recurrent respiratory tract infection (RRTI)
On the basis of conventional treatment, Hong CHEN et al. used Shufeng Jiedu Capsule to treat 38 children of acute attacks of RRTI, compared with conventional treatment, the children’s serum IFN-1, IL-1p, IL-2 and IL-4 decrease more significantly, and the time for fever and cough relief is shorter than that of conventional treatment. Combined with Shufeng Jiedu Capsule to treat acute attacks of RRTI, its clinical symptoms subsided faster [74].
Acute bronchitis
Yuqin CHEN used Shufeng Jiedu Capsule combined with Amoxicillin and Clavulanate potassium suspensions to treat 40 cases of acute bacterial bronchitis, the cure rate, improvement rate, total effective rate, antipyretic, cough relieving, and cure time are better than Amoxicillin and Clavulanate potassium suspensions use alone [75].
Pneumonia
Meiying ZOU used Shufeng Jiedu Capsule combined with Amoxicillin and Clavulanate potassium to treat 60 cases of mild pneumonia, the cure rate, apparent rate, effective rate, total effective rate, antipyretic, cough disappearance, and disappearance time of rale are better than Amoxicillin and Clavulanate potassium use alone [76].
Epidemic parotitis
Hong CHEN et al. used Shufeng Jiedu Capsule combined with Cimetidine Injection to treat 48 cases of epidemic parotitis, the apparent rate, effective rate, and total effective rate, disappearance of parotid gland pain, disappearance of swelling, antipyretic, and the recovery time of urinary amylase are better than Cimetidine injection use alone [77].
Hand-foot-and-mouth disease (HFMD)
Bingze CHEN used Shufeng Jiedu Capsule combined with Ribavirin injection to treat 56 cases of HFMD, the cure rate, apparent rate, effective rate, and total effective rate are better than Ribavirin injection use alone [78]. Jingzhi HUANG et al. used Shufeng Jiedu Capsule to treat 60 cases of HFMD, the cure rate, improvement rate, total effective rate, antipyretic, the regression time of hand foot skin rash and oral ulcer are better than Lanqin liquid tonic or Ribavirin granules use alone [79]. Yuchang LI et al. used Shufeng Jiedu Capsule to treat 50 cases of EV71, the recovery rate, apparent rate, improvement rate, total effective rate, the time when the rash and herpes begin to subside, and the rash and herpes completely subside are better than Xiyanping injection or Ribavirin injection use alone [80]. Wenzhong ZHANG used Shufeng Jiedu Capsule combined with Ribavirin injection to treat 30 cases of HFMD, the subsidence time of fever, rash and herpes is better than Ribavirin injection use alone [81]. Weifeng ZHU used Shufeng Jiedu Capsule combined with IFN and Ribavirin injection in 48 cases of HFMD, the recovery rate, apparent rate, improvement rate, total effective rate, the improvement of fever, herpes and other symptoms after 5 days of treatment are better than IFN combined with Ribavirin injection [82].
Safety
In the 21 reference on the treatment of pediatric diseases with Shufeng Jiedu Capsule [62-82], 4 reference [73, 77, 79, 81] were not evaluated for safety, 17 reference were observed for adverse reactions, and 1 reference [66] was excluded from the observation of adverse reactions in the category of complications, 4 reference [68, 69, 70, 74] showed no adverse reactions, 12 reference had adverse reactions, among them, 8 cases of diarrhea, 7 cases of nausea, 2 cases of rash, and 1 case of gastrointestinal discomfort occurred in the Shufeng Jiedu Capsule group. The adverse reaction rate was 2.57% (18/701). In the control group, there were 10 cases of nausea, 8 cases of diarrhea, 5 cases of leukopenia, 4 cases of skin rash, 4 cases of gastrointestinal discomfort, 2 cases of injection site pain, 1 case of fever, 1 case of thrombocytopenia, 1 case of dizziness and headache. The incidence of adverse reactions 5.53% (36/651) were not given special treatment. Clinical observation results show that Shufeng Jiedu Capsule has few and mild adverse reactions, and the safety of pediatric clinical application is high.
Conclusion
Shufeng Jiedu Capsule has good anti-virus, anti-bacterial, antipyretic, anti-inflammatory, immune regulation, cough relief, sedation and analgesia functions, it can block the vicious cycle of multiple pathological links of the disease, and give full play to the advantages of multi-target, multi-link, and multi-channel treatment of traditional Chinese medicine [83]. Shufeng Jiedu Capsule is effective and safe in the treatment of acute upper respiratory tract infection, pharyngeal conjunctival fever, herpetic angina, acute tonsillitis, influenza, acute bronchitis, pneumonia, epidemic parotitis and HFMD.
Reference
53. 吕伟伟，朱童娜，邱欢，等.疏风解毒胶囊抗病毒及抗菌的体外药效学实验研究 [J].中药新药与临床药理，2013, 24 (3): 234-238.
54. 刘颖, 崔晓兰, 时瀚, 等.疏风解毒胶囊防治流感体内药效学实验研究 [J].世界中西医结合杂志, 2010, 5 (1): 35-39.
55. 刘颖, 时瀚, 金亚宏, 等.疏风解毒胶囊防治流感体内药效学研究 [J].世界中西医结合杂志, 2010, 5 (2): 107-110.
56. 郭姗姗, 金亚宏, 王意忠, 等.疏风解毒颗粒防治手足口病的体内外药效学研究 [J].中国实验方剂学杂志, 2012, 18 (2): 206-209.
57. 徐艳玲, 薛云丽, 张会红, 等.疏风解毒胶囊治疗急性上呼吸道感染风热证随机对照双盲试验 [J].中医杂志, 2015, 56 (8): 676-679.
58. 刘静, 马莉, 陆洁, 等.疏风解毒胶囊解热作用机制研究 [J].中草药, 2016, 47 (12): 2040-2043.
59. 张铁军, 朱月信, 刘岱琳, 等.疏风解毒胶囊药效物质基础及作用机制研究 [J].中草药, 2016, 47 (12): 2019-2026.
60. 何子龙, 方文娟, 张方博, 等．疏风解毒胶囊肠吸收液对LPS诱导巨噬细胞释放细胞因子的影响 [J].中国现代中药, 2015, 17 (4): 345-348．
61. 崔世兰, 李明瀚, 张颖.疏风解毒胶囊防治流感临床观察 [J].实用中医内科, 2015, 19 (11): 135-136.
62. 毕明远, 冯伟伟.热毒宁注射液联合疏风解毒胶囊治疗小儿上呼吸道感染的临床疗效观察 [J].实用心脑肺血管病 杂志, 2015, 23 (7): 118-120.
63. 李文.疏风解毒胶囊治疗小儿急性上呼吸道感染的疗效观察 [J].现代药物与临床, 2015, 30 (9): 1140-1143.
64. 周小凤, 王小军.疏风解毒胶囊治疗小儿急性病毒性上呼吸道感染风热证临床观察 [J].北京中医药, 2016, 35 (1): 84-86.
65. 陈宏, 苏玉明, 栾俊琦.疏风解毒胶囊治疗小儿急性上呼吸道感染临床疗效观察 [J].世界中西医结合杂志, 2016, 11 (5): 716-718.
66. 田淑霞, 徐志英, 肖琼.疏风解毒胶囊治疗小儿急性上呼吸道感染的临床观察 [J].中外女性健康研究, 2016, 16: 166-168.
67. 谢宏基, 吴建辉.疏风解毒胶囊联合更昔洛韦注射液治疗小儿咽结膜热临床观察 [J].新中医, 2016, 48 (2): 159-160.
68. 刘呈祥.疏风解毒胶囊治疗小儿疱疹性咽峡炎37例 [J].河南中医, 2015, 35 (7): 1695-1696.
69. 杨梅莲.疏风解毒胶囊治疗小儿疱疹性咽峡炎123例疗效观察 [J].中国中医急症, 2016, 25 (12): 2364-2365.
70. 赵志远.疏风解毒胶囊治疗小儿急性扁桃体炎58例 [J].河南中医, 2015, 35 (7): 1690-1692.
71. 黄培练, 潘艳东.疏风解毒胶囊联合头孢克洛干混悬剂治疗小儿扁桃体炎 (风热证)临床观察 [J].中国中医急症, 2016, 25 (10): 1984-1986.
72. 徐春祥, 何四君.疏风解毒胶囊联合阿莫西林克拉维酸钾治疗急性扁桃体炎的临床观察 [J].中医药临床杂志, 2016, 28 (2): 224-226.
73. 袁冬梅.疏风解毒胶囊佐治儿童流感86例疗效观察 [J].北京医学, 2016, 38 (4): 351-352.
74. 陈宏, 陈群, 齐鑫, 等.疏风解毒胶囊对反复呼吸道感染急性发作患儿IFN-γ、IL-1β、IL-2和IL-4炎性因子的影响研究 [J].北京医学, 2016, 38 (10): 1130-1132.
75. 陈玉琴.疏风解毒胶囊联合阿莫西林克拉维酸钾混悬液治疗小儿急性细菌性支气管炎的临床疗效观察 [J].实用心脑肺血管病杂志, 2015, 23 (5): 118-120.
76. 邹美英.疏风解毒胶囊联合阿莫西林克拉维酸钾治疗轻度小儿肺炎的效果观察 [J].中国当代医药, 2015, 22 (26): 163-165.
77. 陈宏, 苏玉明, 祝金华.疏风解毒胶囊联合西咪替丁治疗小儿流行性腮腺炎的临床观察 [J].中国中医急症, 2016, 25 (5): 937-938.
78. 陈冰泽.疏风解毒胶囊治疗小儿手足口病56例疗效观察 [J].中国中西医结合儿科学, 2013, 5 (6): 539-540.
79. 黄敬之, 林楚.疏风解毒胶囊与蓝芩口服液治疗小儿手足口病疗效比较 [J].福建中医药, 2015, 46 (5): 70-71.
80. 李裕昌, 吕波, 吴赞开, 等.疏风解毒胶囊外泡内服治疗肠道病毒71型小儿手足口病疗效观察 [J].中国中医急症, 2016, 25 (7): 1430-1432.
81. 张文忠.疏风解毒胶囊联合利巴韦林治疗手口病的临床效果观察 [J].中国当代医药, 2016, 23 (31): 110-112.
82. 朱伟峰.疏风解毒胶囊联合干扰素及利巴韦林治疗小儿手足口病临床观察 [J].北京中医药, 2016, 35 (10): 979-981.
83. 邱欢, 李振兴, 朱童娜, 等.疏风解毒胶囊体内抗病毒作用的实验研究 [J].中药新药与临床药理, 2014, 25 (1): 14-17．