| Objective:through the analysis of causes and characteristics of the adverse reactions caused by Qing Kai Ling Injection in the treatment of skin disease, and the changes of each indicator and skin lesion before and after the treatment, the thesis aims to display an objective evaluation on the safety, types of diseases, syndromes and clinical efficacy of the applications of Qingkailing Injection in dermatology so that a better guide for the rational use of the drug is expected.Methods:The study deals with evaluation of safety and healing effect of 'Qingkailing injection in clinical practice. First,565 cases of hospitalized patients are analyzed and those common features appeared, the performance of Qingkailing injection, laboratory results, adverse effect, changes in skin lesions and other information are collected and filled in Registration of Qing Kai Ling Injection in Dermatology Use "and " Registration of Adverse Reactions ". Then, by putting the data collected into EpiData database, and analyzed by SPSS 18.0 software, the final result comes up.Results:1. Adverse reaction rate of Qingkailing injection was 2.3%.2. The incidence of adverse reactions of different age groups was no significant difference.3. The incidence of adverse reactions of different sex groups was no significant difference.4. Adverse reaction rates of different diseases was significantly, Six cases are reported with the primary disease of eczema, account for 46.1%; and six cases appears among the total of 48 cases of eczema collected, taking up 12.5%.5. Patients with a history of allergic adverse reaction rate was 5.5%, higher than non-allergic patients with a history of adverse reaction rate of 1.2%.6. It often appears with the severity of mild to moderate, accounting for 92.3%, without no reports of complications and deaths.7. Clinical manifestations of adverse reactions include fever, chest tightness, skin itching, rash, arm pain, dry mouth, tachycardia, angioedema, and blood red.8. The reaction occurs more often than not after 3-30min of the infusion, and lasts between 1-3 hours.9. Those with no adverse reactions were 552 cases; the difference of RBC, HB, PRO, TP, A, G, AST, ALT, UA, R before and after use of Qingkailing was not statistically significant; the amount of WBC, NE%, URO, BLD, BUN, Cr, T, P after infusion is lower than that of before infusion, which was statistically significant; there's no increase of indicators in the test. 10. Qingkailing injection is mainly used in the treatment of psoriasis, herpes zoster, and other diseases; syndrome mainly appears in the form of blood heat syndrome, heat toxin syndrome. 11. The treatment usually lasts between 7-18 days.12. The four scores of Lesion size, color, infiltration and swelling, blisters decreased significantly after infusion compared with that of before infusion, which demonstrate a significant difference between the two.13. Efficacy Results are as follows:45 cases recovered, accounting for 8.2%, effective in 147 cases, accounting for 26.6%, effective in 207 cases, accounting for 37.5%, ineffective in 153 cases, accounting for 27.7%, and total effective rate was 34.8%.Conclusion:1. With its low incidence of adverse reactions, and its lesser degree of the reaction, Qingkailing injection will not cause damage to the function of blood system,liver and kidney in patients, but indications and allergic diseases should be strictly examined when it is in use especially among those patients with eczema or with a history of allergies.2. Qingkailing injection can be widely used in dermatology including the treatment of psoriasis, herpes zoster, and other diseases with red blood heat and heat toxin syndrome. The appropriate treatment time is between 1-2 weeks and the treatment is proved effective. |
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