The Efficacy and Immunomodulatory Effects of Ulinastatin and Thymosin α1 for Sepsis: A Systematic Review and Meta-Analysis

Table 1

Main characteristics of the studies included in the meta-analysis.

Reference	Design	Patients	Group	Population, ITT, (treatment group versus control group)
			Dose, treatment duration
Zhang et al. 2008 [14]	RCT (randomized and placebo controlled), patient blinded	Adult patients (18 years < age < 80 years) with confirmed sepsis	Ulinastatin, 200,000 U 3 times/day for 3 days; a subcutaneous dose of Tα1, 1.6 mg, 2 times/day for 3 days followed by 100,000 U ulinastatin 3 times/day plus 1.6 mg Tα1 once/day for 4 successive days. Placebo in the same way.	114 (59 versus 55)
Yumin et al. 2009 [15]	RCT (double-blinded placebo controlled clinical trial)	Adult patients with confirmed sepsis	For the first 3 days, 200K U ulinastatin and twice daily subcutaneous doses of 1.6 mg thymosin α1. For the next 4 days, intravenous doses of 100K U ulinastatin and twice daily subcutaneous doses of 1.6 mg thymosin α1. Placebo in the same way.	56 (23 versus 33)
Chen et al. 2009 [16]	Randomly assigned, placebo controlled, patient blinded	Adult patients (18 years < age < 80 years) with confirmed sepsis	200K U UTI 3 times per day plus a subcutaneous dose of 1.6 mg Tα1 twice a day for 3 days followed by a dose of 100K U UTI thrice a day plus 1.6 mg Tα1 once a day for four continuous days. Placebo in the same way.	114 (59 versus 55)
Huang et al. 2009 [17]	Randomized and placebo controlled, patient blinded	Adult patients (18 years < age < 80 years) with confirmed sepsis	200K U UTI 3 times per day plus a subcutaneous dose of 1.6 mg Tα1 twice a day for 3 days followed by a dose of 100K U UTI thrice a day plus 1.6 mg Tα1 once a day for four continuous days. Placebo in the same way.	70 (36 versus 34)
Lin 2007 [18]	Randomized and blank controlled, patient blinded	Adult patients (18 years < age < 80 years) with confirmed sepsis	600K U UTI intravenous injection once a day plus a subcutaneous dose of 3.2 mg Tα1 once a day for 7 days. Blank control.	322 (164 versus 158)
Su et al. 2009 [19]	Randomized and blank controlled, patient blinded	Adult patients (18 years < age < 80 years) with confirmed sepsis	200K U UTI 2 times per day plus a subcutaneous dose of 1.6 mg Tα1 twice a day for 4 days followed by a dose of 100K U UTI twice a day plus 1.6 mg Tα1 once a day for 6 continuous days. Blank control.	242 (128 versus 114)