Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases.

OBJECTIVE: To investigate the safety profiles of Motherwort injection (MI). METHODS: A multi-center, prospective and drug- derived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications. This study was based on a very large population after the injection was approved and marketed in China. All patients using the injection in participating hospitals were monitored to determine the incidence, pattern, severity and outcome of associated adverse events. RESULTS: The post-marketing surveillance was performed in 10 094 female patients from April to December, 2015. The incidence of adverse drug reactions (ADRs) was 0.79¡ë(8/10 094). Among the 8 patients, the reported adverse events mainly included systemic abnormalities, such as fever, chills and eyelid edema; skin and appendages disorders, such as pruritus and rash; gastrointestinal disorders, such as nausea, abdominal distension and pain; heart rate and rhythm disorders, such as palpitation and increased heart rate. All of these ADRs were mild in severity. CONCLUSION: In this study the ADRs incidence rate of MI is very low, which supports that it is generally safe for use in obstetric and gynecological diseases. However, the total number of 8 ADRs recorded over a relatively short time span seems limited, and the low number of reports could not represent an absolute guarantee of safety.

Comparison of the effect and safety of Kuntai capsule and hormone replacement therapy in patients with perimenopausal syndrome: a systematic review and Meta-analysis.

OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome. METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews, PubMed, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving 1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limited to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3 months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol (E2) or blood follicle stimulating hormone (FSH) levels. Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding. RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio (OR): 1.05, 95% confidence intervals (CI): 0.71 to 1.55] and changes in FSH level [mean difference (MD): 2.14, 95% CI: -2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores (MD: -1.14, 95% CI: -2.03 to -0.25) and changes in E2 level (MD: -16.41, 95% CI: -18.83 to -13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group (OR: = 0.35, 95% CI: 0.25 to 0.48, P < 0.01). CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.

Association between genetic variants and characteristic symptoms of type 2 diabetes: A matched case-control study.

OBJECTIVE: To examine the association of genetic variants with characteristic symptoms of type 2 diabetes mellitus (T2DM). METHODS: A matched case-control study was performed to investigate the association between common variants in four genes (CDKAL1, GLIS3, GRK5, and TCF7L2) and symptoms of T2DM. Symptoms were examined with questionnaire for 710 subjects. Genomic DNA was extracted from peripheral blood mononuclear cell by salting-out procedure. Genotyping was carried out by direct sequencing of the unpurified polymerase chain reaction products. RESULT: Most of the T2DM patients pressented characteristic symptoms, such as feeling weak in limbs (P =0.0057), hand tremor (P =0.0208), bradymasesis (P =0.0234), and polyuria (P =0.0051). Some of the T2DM patients shared characteristic symptoms, such as desire for cold drinks (P =0.0304), polyphagia (P =0.0051), and furred tongue (P =0.028). The impaired glucose regulation (IGR) cases took only one characteristic symptom of frequent micturition (P =0.0422). GLIS3 rs7034200 and GRK5 rs10886471 were significantly associated with increased T2DM risk (GLIS3 rs7034200 under dominant model: P=0.0307; GRK5 rs10886471 under recessive model: P=0.0092). However, only the rs10886471 polymorphism in GRK5 showed a significant effect on both differentiated symptoms and T2DM risk. The C-allele was involved in both dampness-heat encumbering Pi (Spleen) syndrome (P =0.047) and qi-yin deficiency syndrome (P =0.002) via increased GRK5 expression. CONCLUSIONS: Both T2DM and IGR exhibited its corresponding characteristic symptoms. The variants of GRK5 were involved with both qi-yin deficiency syndrome and dampness-heat encumbering Pi syndrome.

Effects of Integrated Traditional Chinese and Western Medicine for the Treatment of Lupus Nephritis: A Meta-Analysis of Randomized Trials.

After a thorough search through the database as CNKI database, VIP database, Wanfang database, PubMed, and Cochrane Library, the clinical experimental articles have been selected out on the effects of Integrated Traditional Chinese and Western Medicine on the treatment of lupus nephritis. A meta-analysis was carried out in terms of clinical efficacy criteria and safety criteria by RevMan 5.3 software. Based on the results, we cautiously conclude that Integrated Traditional Chinese and Western Medicine used for lupus nephritis could improve the clinical efficacy while at same time lower the 24-hour urine protein, serum creatinine, and adverse drug reactions.

Development and Preliminary Validation of the Questionnaire (the First Edition) Based on TCM for Detecting Health Status in China.

Background. More and more people come to realize the importance of healthcare and early detecting of health status before becoming much more serious. Self-perceived health is an easy, economic, and effective indicator of health, which has been widely applied in measuring health. In this paper, the development and preliminary validation of the questionnaire (the First Edition) based on TCM theory were described and combined with Manual Mental Health Pattern for detecting health status in community of Tianjin, China. Methods. Questionnaire validity and reliability were evaluated in a small sample as a pilot study. Analyses included tests for reliability and internal consistency, exploratory factor analysis, and tests for discriminative ability and convergent validity. Results. Overall, 294 of 303 participants completed the questionnaire (97.3%). The questionnaire included 49 items. Cronbach's α was 0.83. Factor analysis established 10 distinct domains. The Pearson's rho correlation between the total scores and MHP (SCL) was statistically significant (r = 0.43, P < 0.001). t-test revealed significant differences (P < 0.05) in total scores between the healthy and unhealthy results distinguished by physical examination. Conclusions. Questionnaire reliability and validity were acceptable. Further work and larger sample would be warranted to refine items that measure the health status, to improve the reliability and discriminated validity of the questionnaire.