Clinical Efficacy Observation Of Zhenqifuzheng Particles Combine With 5-Aminolevulinic Acid Photodynamic On Condyloma Acuminatum Type Of Deficient Vital QI Leading To Lingering Of Pathogen

Objective:To observe the efficacy of Zhenqifuzheng particle combine with 5-aminolevulinic acid photodynamic therapy (ALA-PDT) treat condyloma acuminatum (CA) type of deficient vital QI leading to lingering of pathogen.Methods:a) From April 2014 to September 2015, patients with CA type of deficient vital QI leading to lingering of pathogen were selected from Department of Dermatology, Urology, Gynecology, Andrology department of Fuzhou General Hospital, Nanjing Military Command. The Patients were divided into two groups, ALA-PDT group (n=34) and Zhenqifuzheng+ALA-PDT particle groups (n=34).b) In line with the set of conditions, and obtain informed consent, two groups were treated with microwave and ALA-PDT treatment, the treatment group was given Zhenqifuzheng particle (5 g, po, bid) treatment to the end of the follow-up, the treatment group and the control group were observed for 3 months. Clinical efficacy and TCM symptom efficacy were observed and recorded the adverse reaction.c) Observation index:whether CA relapse or not and the size of CA, white vinegar test examination, and TCM symptoms score were observed and recorded by professional medical staff before and after treatment, and record the results.d) Safety evaluation:record whether patients with liver and kidney function, blood abnormalities, local skin lesions and whether abdominal pain, diarrhea, fever and other systemic anomalies after taking the drug.e) Evaluation standard:The evaluation to the curative.efficacy classify into 3 levels: invalid, effective and recover. The efficacy of TCM symptom may be classify into 4 levels: recover, effective, progressive and invalid. Cost-effectiveness analysis was been used in Pharmacoeconomics efficacy, the cost-effectiveness ratio (C/E)=cost/total effective treatment.Results:a) Clinical efficiency:the Zhenqifuzheng particle+ALA-PDT group(total effective rate at 93.8%) are more effective than the ALA-PDT group(total effective rate at 75.6%), with a significant difference(P<0.05).b) TCM symptoms efficiency:the Zhenqifuzheng particle+ALA-PDT(total effective rate at 90.6%)are more effective than the ALA-PDT(total effective rate at 63.6%), with a significant difference (P<0.05).c) Compared Zhenqifuzheng particle+ALA-PDT group with ALA-PDT group, positive rate of HPV-DNA with non-significant difference after treatment (P> 0.05).d) Pharmacoeconomics efficacy:the Zhenqifuzheng particle+ALA-PDT group(C/E=46.7) are less than the ALA-PDT group(C/E=49.4).e) Safety evaluation:The treatment group patients after treatment showed no abnormal in liver and kidney function, blood routine abnormalities, abdominal pain, diarrhea, fever and other adverse reactions.Conclusion:Zhenqifuzheng particle combine with 5-Aminolevulinic acid photodynamic improves TCM symptoms for CA type of deficient vital QI leading to lingering of pathogen is effective. The clinical curative effect for CA type of deficient vital QI leading to lingering of pathogen, it can reduce the recurrence rate, but it has no significant affect on HPV-DNA. It has good tolerance, high safety, and more economical in clinical use.