Systematic Review And Clinical Observation Of Pipaqingfeiyin In The Treatment Of Acne Vulgaris Lung Channel Wind-heat Syndrome

Research objectives:Pi Pa Qingfeiyin as the prescription for “the Golden mirror of medicine” treatment of pulmonary wind syndrome acne, use since the Qing dynasty till today that the modern physicians according to its add prescription to treat acne. And a large number of clinical studies and literature reported that its clinical curative effect is satisfactory, but always lacked of evidence-based medicine(EBM) evidence to judge its effectiveness and safety. To provide more theoretical and practical evidences bases of pipaqingfeiyin in the treatment of acne vulgaris through the systematic review and clinical observation of pipaqingfeiyin in the treatment of acne vulgaris lung channel wind-heat syndrome.Research methods:This topic is divided into two parts,The first part was the systematic review of pipaqingfeiyin in the treatment of acne vulgaris; The second part was the clinical observation of pipaqingfeiyin in the treatment of acne vulgaris lung channel wind-heat syndrome.1.Systematic review: We retrieved in the pubmed, Medline, China National Academic magazine data-base(CNKI), Chinese Science and Technology periodical Database(VIP) and Wanfang database. The retrieval time was from January 1995 to November 2015. The acne vulgaris of patients in the experimental group were treated with pipaqingfeiyin as the basic prescription,western medicine and chinese patent medicine as the random control test(RCT).The data were independently extracted by two researchers in accordance with the Cochrane Handbook 5.0.2standard. The quality of the literature was evaluated and the crosscheck was performed. The Meta analysis was used to evaluate its efficacy,safety and recurrence using the Revman 5.3 software.2.Clinical research: 120 patients according with the inclusion and exclusion criteria were randomly divided into the treatment group and control group.60 cases in the treatment group orally took pipaqingfeiyin decoction; 60 cases in the control group took orally TanshinoneCapsule. The patients in the two groups externally used Adapalene gel. Treatment for 4 weeks,after the course evaluation of efficacy and safety, observe the relapse after followed up for 2weeks.Results First. System review:1. The basic characteristics of included criteria in the studyGenerally situation of the literature: A total of 28 randomized controlled clinical trials, all are single center study, the object of study is a total of 2751 cases; A clear diagnostic criteria of traditional Chinese and western medicine are 10, only eight clear diagnosis by western medicine, only six papers clear diagnostic criteria of traditional Chinese medicine; There is 15 papers with a clear criteria of the intake and exclusion and efficacy of decision criteria; Five articles mentioned safety indexes, 12 record each symptoms and the number of cases of adverse events. Study design: Interventions are included in the study of the treatment group with oral loquat clear lung drinks as the main intervention, control group with proprietary Chinese medicine, western medicine for the intervention measures. Syndrome type in 15 study with traditional Chinese medicine, 23 articles were made clear treatment time for the course; Outcome indicators, mainly efficient, adverse reactions, followed by the recurrence rate. Quality of literature evaluation: 23 for baseline comparability is described and the general equilibrium, according to the Jadad score, there are mainly 4 high quality researches,24 low quality researches.The Meta analysisMeta analysis of pipaqingfeiyin unusual type of acne treatment efficacy: Combining with the interventions measure, 28 study can be divided into three subgroups, respectively loquat clearing lung drinks with the western medicine group(oral), loquat clearing lung drinks and proprietary Chinese medicine group, loquat clear lung drinks with the western medicine group(external). Three groups of analysis found no significant heterogeneity, the choice of fixed effects model analysis, the first subgroup combination with OR=2.95,95%CI(2.10-4.16), the second subgroup OR = 4.35, 95% CI(2.60-7.25) the third subgroup merge OR = 3.21, 95%CI(1.63- 6.31), P values of third subgroup were less than 0.001, shows that treatmentcurative effect of loquat clear lung drinks in unusual type of acne is superior to western medicine(oral), proprietary Chinese medicine, western medicine group(external), with statistical significance.Each above Meta analysis through choosing different models for sensitivity analysis and conclusion there was no significant difference between each two analysis, explain each Meta analysis result is stable and reliable.Meta analysis of the adverse reactions: Eventually with the 8 studies, loquat clear lung drinks on the western medicine group(oral), there is heterogeneity among different research in heterogeneity inspection, choose the random effects model analysis, merger OR = 0.12,95% CI(0.05 0.29), P<0.001, Illustrate the loquat clear lung drinks treating unusual type of acne incidence of adverse reactions was lower than those of oral western medicine adverse reaction rate, and there are statistically significant, asymmetric funnel figure, there is a certain degree of publication bias.Meta analysis of the eventually included five studies, heterogeneity test, each see significant heterogeneity research, select random effects model is analyzed, merger OR = 0.29,95% CI(0.13- 0.64), that illustrate the recurrence rate of the loquat clear lung drinks treating unusual type of acne is lower than western medicine group, P<0.001, suggesting with the statistical significance.Second, the clinical research:1. The baseline data analysis, two groups before treatment of gender, age, course of the disease, the skin lesion score and TCM symptoms integral were no obvious difference,comparable.2. The total effective rate, according to the test group(89.1%) and the comparison group(71.4%), the difference was statistically significant(P<0.05).3. The lesion score comparison, before and after treatment comparison in the two groups before and after treatment group comparison between the two groups, the difference had statistical significance( P<0.05).4. After treatment of traditional Chinese medicine symptom integral comparison, test group(1.51±1.20) compared with the control group(2.48±2.14), the difference was statistically significant( P<0.05).5. To evaluate safety index test results before and after the test subjects have no obvious changes.6. The two groups’ statistical analysis and comparison in the incidence of adverse reaction and recurrence, cannot think the difference was statistically significant(P>0.05).Conclusion:1.Systematic review: This system evaluation included into 28 study.Meta analysis results show that pipaqingfeiyin treated acne vulgaris is effective and its curative effect is better than the traditional Chinese medicine and Western medicine. However for pipaqingfeiyin in the treatment of acne vulgaris adverse reactions and recurrence rate of correlation analysis, due to the heterogeneity and publication bias existed. There is no proof that pipaqingfeiyin Treatment of acne vulgaris of recurrence and the adverse reactions is lower than western medicine.Therefore it is necessary to carry out more methods of high quality, strict test design,large-scale randomized controlled trials.2.Clinical observation: In this study, we used randomized controlled study method to observe the curative effect of the disease and the improvement of clinical symptoms. Through of the test group and the control group total effectiveness, the score of lesions within the group and group and TCM symptom scores were statistically comparative analysis, fully illustrated the effectiveness of the treatment, the two groups, and prove that the patients of experiment group is better than control group. And can be evaluated by the test before and after the test results showed no significant abnormal changes in the test process, there were no systemic adverse drug reactions or serious adverse drug reactions. In summary, pipaqingfeiyin in the treatment of acne vulgaris in the lung by wind heat syndrome is effective, and no obvious toxic side effects and that is the effective prescription of acne vulgaris in the lung by wind heat syndrome treatment, and is worthy of clinical use.