| Background:Clinical practice has shown that Tripterygium Wilfordii treated rheumatoid arthritis, nephrotic syndrome, IgA nephropathy and so quite well. Yet, many adverse drug reactions (ADRs) have been reported by now, and thus State Food and Drug Administration made a warning about the application of Tripterygium Wilfordii and its preparations, strongly limiting their clinical use. However, there is still no comprehensive systematic review and Meta analysis directly about the ADR rates possibly caused by Tripterygium Willfordii and its preparations.Objective:To synthesize the ADRs possibly caused by Tripterygium Willfordii and its preparations and explore the possible relationship between the adverse events and some relevant elements.Methods:Systematically search all the relevant articles in Pubmed, CNKI, Wanfang Data, VIP Data and Sinomed from inception to Feb 25th,2014. Exclude animal experiments, cell experiments and reviews, and duplicated publications, research done with wrong random methods, plagiarism, articles with inconsistent data and Tripterygium Willfordii in both groups as basic treatment; include randomized controlled trials (RCT) that has at least one group which applied Tripterygium Wilfordii and its preparations and reported ADRs. Then, a data extraction table was drafted and two researchers respectively finished extracting the following items:author, publication date, subject, age, setting, preparation form, dosage, combination and ADRs. Next, carry out the quality evaluation of the included articles in Revman 5.3. Finally, summarize the collected data, analyze the data from the point of physiological systems, era, preparation form, setting and diseases and so on, and therefore make a conclusion of the relationship between the ADR rates possibly caused by Tripterygium Willfordii and its preparations and the relevant elements mentioned above.Outcome:Research results are as follows:290 articles in Pubmed,2608 in CNKI,1934 in Wanfang Data,1504 in Vip Data and 1805 in Sinomed. After exclusion of duplication and the reading of titles and abstracts,388 articles remained. And 260 articles were finally included after reading full-text articles, which recruited altogether 13301 patients. The included articles were classified into two groups, RCT1 and RCT2. In RCT1, Tripterygium Willfordii was mostly given to patients in the experiment group, but in some research, there are three or more groups, and Tripterygium Willfordii was given to patients both in the experiment group and the controlled group. In RCT2, Tripterygium Willfordii was only given to patients in the controlled group. Summary, analysis and conclusion were made in between the two groups. Outcome shows that ADR rates between RCT1 and RCT2 are quite different.In RCT1, the number of ADR in one article mostly ranged from 1 to 10 person-times, and the rate of the articles occupies 64.53%, compared to a range from 6 to 15 and article rate 50.88% in RCT2.In RCT1, ADR rate (per hundred people) of the digestive system is 14.73, reproductive system 8.25, liver system 6.50, renal system 6.79, blood system 6.73, cardiovascular system 2.35 and skin and mucous system 11.42, while the corresponding ADR rates in RCT2 are respectively 12.26,8.00,5.66,0.32,6.50, 0.67 and 4.78.90.64% articles in RCT1 and 98.24% in RCT2 were published after 2000, and ADR rate tends to downward in RCT1, but to fluctuate in RCT2.82.27% articles in RCT1 and 91.25% in RCT2 applied GTW, and the corresponding ADR rate is 27.18 and 29.14.In both RCT1 and RCT2, taking Tripterygium Willfordii and its preparations for three to six months means the lowest ADR rate, although the lowest ADR rates are different in the two groups,19.69 in RCT1 and 23.85 in RCT2.As for the relationship between Tripterygium Willfordii and diseases, ADR rates between different diseases vary a lot. In both groups, articles about rheumatoid arthritis amount to the most,22.17% in RCT1 and 63.16% in RCT2, and the corresponding ADR rates are 36.70 and 27.26. Besides, AE rates differ from cities to cities.The outcome of Meta analysis indicated that, odds ratio for the ADR rates of Triptergium Willfordii alone and combined with other drugs are very different both in physiological systems and various diseases.Conclusion:In general, ADR events for one patient taking Tripterygium Wilfordii and its preparations will not surpass 10 in all. Digestive system, reproductive system and liver system are with the top three ADR rate. Besides, children were likely to suffer higher ADR rates, while the elderly lower. As time went by, ADR rates related with Tripterygium Wilfordii tended to go down. GTW was associated with the lowest ADR rate and it seemed to be used the most widely in clinical practice. The duration of taking Tripterygium Wilfordii with the lowest ADR rate is three to 6 months. As for diseases, Tripterygium Wilfordii and its preparations were most common in treating RA and the corresponding ADR rates varied a lot for different diseases. Moreover, application of Tripterygium Wilfordii and its preparations alone may cause the highest ADR rate, combination of some common modern medicine the next and combination of some herbal medicine may lead to the lowest ADR rate.Adequate Tripterygium Wilfordii and its Preparations combined with some modern medicine or herbal medicine can be chosen for specific diseases and areas. During the procedure, take close care of the reaction of patients. Stop taking whenever necessary. In this way, AE rates can be minimized to the lowest. |
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