| ObjectiveTo observe the effectã€safety and specificity of Suhuang Zhike Capsule on postinfectious cough of Wind Evil Invading Lungs Syndrome.Methods36cases were collected in outpatient Dept. of TCM respiratory, China-Japan Friendship Hospital from Sep.2011to Jul.2012which were diagnosed as postinfectious cough in west medicine and cough of wind evil invading lungs Syndrome. With sealed envelope method to hidden the random grouping information, patients would be treated with the specified drugs according to the visiting sequence. There were two groups. The treatment group had24patients and would take chinese patent drug-Suhuang Zhike Capsule,3times a day,3capsules each time,63capsules in all. While the control group12and would have west medicine-Codeine and Guaifenesin Syrup as the positive control drug,3times a day,10ml each time,210ml in all. Both were treated for7days. The varieties of index were observed for0days (baseline),3days,5days,7days of TCM syndromes (including the main symptoms, secondary symptoms and the total score) and cough visual analogue score. While the clinical efficacy, TCM syndrome efficacy, self efficacy evaluation and safety index would be counted and summarized.SPSS20.0statistical software would be used for data analysis:measurement data with independent t test, rank sum test; count data with chi square test, Fisher exact probability or non parametric test, etc. The results with two-sided tests would be adopted. P will be considered statistically significant when it is less than or equal to0.05.Results36cases were collected in total with15male(42%),21female(58%),11smokers(31%),25non-smokers(69%), and23cases of youth(64%),12cases of middle aged(33%) and1cases of elderly (3%) according to the United Nations world health organization (WHO) on the age criteria.In the comparison of clinical efficacy, the cured-effective rate and the total effective rate was54.2%and83.3%in the treatment group, which has no difference to that in the control group25.0%and75.0%, respectively (P=0.12>0.1). Analysis on TCM syndrome efficacy showed the superiority of the treatment group than the control group, with the cured-effective rate and the total effective rate was29.2%vs16.6%and95.8%vs58.4%, respectively (P=0.026<0.05).Mean while, the treatment group with the TCM syndromes scoresã€cough properties of mean symptoms and throat itching of secondary symptoms showed the superiority as well compared with the control group. The difference was statistically significant(respectively P=0.004ã€P=0.044P=0.002,and were all less than0.05). Analysis on the self efficacy evaluation and cough self testing scores also showed the superiority to the control group (respectively P=0.018<0.05, P=0.005<0.05).Assessment on safety:1patient once suffered from diarrhea and felt relieved after stopped to treat. It was supposed to have not much to do with the SuHuang ZhiKe Capsule. At the same time, the safety indexes of two groups had no exactly effective significance during this treatment. The analysis of safety index:The blood ALT difference of two groups was statistically significant after treatment, and P=0.037. While the comparison within the group respectively had no significant differences, namely P=0.748and P=0.125. Neither do others.Conclusion1. Using the evaluation method with percentages, traditional chinese medicine symptom integral makes a combination with the main and secondary symptoms and highlights the proportion of main symptoms which occupies in the total at the same time, which can be more delicate and concrete compared with the standard of clinical efficacy.2. SuHuang ZhiKe Capsule is effective in reducing the main symptom scores and has specificity in alleviating the secondary clinical symptoms (especially for throat itching). This is the uniqueness of SuHuang ZhiKe Capsule in treatment of postinfectious cough.3. With a group of medicine in pungent taste to have dispersing effect and dispelling wind, a group of medicine in sour and sweet taste to alleviate the urgency, a group of medicine has the function of searching the endogenous wind, SuHuang ZhiKe Capsule showed the uniqueness in prescription compatibility as well.4. Combined with the clinical features of drug-induced liver injury, I suppose that there is no much relationship between the variety of blood ALT and the treatment medicine. SuHuang ZhiKe Capsule is basically safe in treatment of postinfectious cough.In a word, SuHuang ZhiKe Capsule is effective, basically safe and has specificity in alleviating the secondary clinical symptoms and innovating the theory of prescription compatibility with treatment of postinfectious cough. |